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ERCP service in China: results from a national survey
ORIGINAL ARTICLE: Clinical Endoscopy
ERCP service in China: results from a national survey Zhuan Liao, MD,* Liang-Hao Hu, MD,* Lei Xin, MD,* Zhao-Shen Li, MD Audit of ERCP of the Chinese Society of Digestive Endoscopy, Shanghai, China
Background: ERCP had been performed throughout China for decades. Objective: To determine the status of ERCP service in China. Design: A national survey. Setting: All of the hospitals performing ERCP in mainland China in 2006. Patients: All of the patients undergoing ERCP in mainland China in 2006. Main Outcome Measurements: The questionnaire included the (1) type of hospitals involved; (2) ownership of the endoscopy unit; (3) ERCP infrastructure; (4) volume, indication, setting, and anesthesia methods; and (5) training and research. The correlation between economic development and ERCP status in different regions was investigated, and the ERCP rates in China and developed countries were compared. Results: Completed questionnaires were returned by 449 (95.5%) of the 470 hospitals providing ERCP service. Among the 449 hospitals, 186 (41.4%) did not have separate ERCP suites, 379 (84.4%) shared fluoroscopy with their radiology departments, and the average number of duodenoscopes was 1.58. A total of 63,787 ERCP procedures were performed in mainland China in 2006, with an estimated annual ERCP rate of 4.87 per 100,000 inhabitants, much lower than that of developed countries. Ninety-six percent of patients were admitted to undergo ERCP, and 94.4% of hospitals used pharyngeal local anesthesia and conscious sedation, whereas 5.6% used general anesthesia. There was a significant correlation between the ERCP rate and gross domestic product per capita (r ⫽ 0.871, P ⬍ .001). Limitations: The survey was retrospective and descriptive. Conclusions: There is an enormous gap in ERCP service between China and developed countries. The imbalance of ERCP status between different regions is significant, which correlates with economic development. Great effort is needed to develop the technique nationwide. (Gastrointest Endosc 2013;77:39-46.)
Since ERCP was introduced in 1968,1 this procedure has been established as an effective tool for the diagnosis and treatment of biliary, pancreatic, and liver diseases. After the first successful endoscopic sphincterotomy was performed in 1974,2,3 this technique gained further acceptance worldwide. Currently, ERCP plays a major role in the treatment of biliary and pancreatic diseases.4,5 China has the largest population in the world, with a large number of patients with GI and liver diseases. Biliary diseases, especially bile duct stones, are common in the
Chinese population.6 Moreover, the incidence of pancreatic diseases, such as chronic pancreatitis and pancreatic cancer, is increasing rapidly.7,8 Thus, ERCP service should be established to provide a promising technique for patients with biliary and pancreatic diseases in China. The first ERCP was performed in China in 1973.9 However, after the evolution for more than 3 decades, the status of ERCP service in China remains unknown. Therefore, the Chinese Society of Digestive Endoscopy (CSDE) conducted a national survey to determine the number and
Abbreviation: CSDE, Chinese Society of Digestive Endoscopy.
Received March 21, 2012. Accepted August 30, 2012.
DISCLOSURE: The authors disclosed no financial relationships relevant to this publication. *Drs Liao, Hu, and Xin contributed equally to this article.
Current affiliations: Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Second Military Medical University, Shanghai, China.
Copyright © 2013 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2012.08.035
Reprint requests: Zhao-Shen Li, MD, Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Second Military Medical University, 168 Changhai Road, Shanghai 200433, China.
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ERCP service in China
distribution of hospitals that performed ERCP and the infrastructure and the volume of ERCPs performed nationwide. The ERCP status among different regions of China and the differences in ERCP service between China and developed countries were also analyzed.
METHODS
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Take-home Message ●
●
The imbalance of ERCP status between different regions is significant, which correlates with economic development. Great effort is required to develop the technique nationwide.
Organizer, industry partners, and participants This study was initiated and organized by the CSDE. All 31 provincial branches of CSDE in mainland China participated in the survey. Considering that no academic society, administrative authority, or commercial company had a comprehensive database containing information on the performance of ERCP nationwide, collection of the initial information from industry partners was a suboptimal but was the most feasible approach to determine the current status of ERCP availability in China as accurately as possible. In response to a request from the CSDE, the manufacturers or suppliers of endoscopes (Olympus, Stamford, CT, Pentax, Tokyo, Japan, Fujinon, Tokyo, Japan, and the domestic companies) and endoscopic accessories (Boston Scientific, Natick, MA, Cook, Bloomington, IN, and the domestic companies) provided information on account sales to the CSDE to confirm which hospitals provide ERCP in China (except Taiwan, Hong Kong, and Macao).
Conduct of the survey The survey was conducted from March 2007 to September 2007. Each branch of the CSDE sent a predesigned standard structured questionnaire to all hospitals performing ERCP in the corresponding regions. The questionnaire was completed by a designated senior endoscopist at each hospital and then returned to the CSDE branches; the questionnaires were collected at the CSDE headquarters in Shanghai for analysis. The questionnaire included data on (1) hospital type and grading; (2) the ownership of the endoscopy unit; (3) the number of ERCP suites, X-ray fluoroscopes, and duodenoscopes; (4) the volume, indications, setting, and anesthesia methods for ERCP procedures; and (5) the status of training and scientific research. All data entered in the questionnaire were to be consistent with the status of the hospital and the endoscopy unit in 2006. After the questionnaires were returned to the organizer, one tenth of the hospitals involved were selected through simple random sampling. From November 2007 to February 2008, the involved individual branches of the CSDE covering these selected hospitals collected the official annual reports from the hospitals and checked the data on the questionnaires as much as possible. The results of the data check were then returned to the organizer. If there were significant discrepancies in the data between the 2 data checks and the questionnaire, then the questionnaire and was considered invalid and not included in the analysis. 40 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 1 : 2013
Hospital type was defined as the ownership of the hospital. In China, the hospitals are categorized as public or private according to ownership. The public hospitals are further categorized into those affiliated with a university or those administered by the government or military institutions. In addition, large-scale hospitals were further graded, from the lower to higher levels, as I, II, or III according to the scale and technique capability by the Chinese Ministry of Health (Supplemental tables 1 and 2, available online at www.giejournal.org).
Data collection and synthesis A returned questionnaire was considered valid if all of the required information was provided and consistent with the results of the data check. The data were extracted and summarized in a database for further analysis. To determine the correlation between the ERCP status and the economic development and the differences in ERCP availability between mainland China and developed countries (eg, European countries, United States, and Canada), the 1-year ERCP rate was used as a main index to represent the status of ERCP availability. To calculate the ERCP rate in mainland China, if a hospital provided ERCP in 2006 but failed to return the relevant data, its ERCP volume in 2006 would be estimated according to other hospitals with similar grading, scale, and geographic location. The economic status (ie, gross domestic product per capita) of 31 provincial regions of mainland China was retrieved from the China Statistical Yearbook 2007.10 The ERCP rates of the United States, United Kingdom, Canada (Alberta province as representative), Austria, Norway, Sweden, and Denmark around 2006 were retrieved or calculated through published data resources.11-17
Statistical analysis Categorical data are shown as percentages. The nonparametric correlation statistical test (Spearman’s test) was used to analyze the correlations between regional gross domestic product per capita and the ERCP rate. Statistical analyses were performed by using SPSS version 13.0 for Windows (SPSS Inc, Chicago, Ill). A P value of ⬍.05 was considered statistically significant.
RESULTS In 2006, there were 19,852 hospitals in China. Apart from 9918 small-scale hospitals, which were not included www.giejournal.org
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in the national grading system, 9934 were graded, including 704 IIIA hospitals at the top grade (Appendices 1 and 2, available online at www.giejournal.org). According to the account sales of the manufacturers and suppliers in China, 470 hospitals provided ERCP service in 2006, all of which were graded hospitals.
ERCP service in China
TABLE 1. Infrastructure of the ERCP service in the 449 hospitals participating in the national survey in mainland China Infrastructure
No. (%) of hospitals
No. of ERCP suites
Responses to the survey
0 (shared with other operations)
186 (41.4)
Of the 470 hospitals that provided ERCP service, 449 returned completed questionnaires, representing a 95.5% effective return rate. A data check was performed in 45 of the 449 hospitals that returned completed questionnaires, and all the data were virtually consistent with the official reports. There were 211 university-affiliated hospitals (47.0%), 214 government-administered hospitals (47.7%), 18 military hospitals (4.0%), and 6 private hospitals (1.3%). Of these 449 hospitals, 287 (63.9%), 52 (11.6%), and 89 (19.8%) were grades IIIA, IIIB, and IIA, respectively. Overall, 40.8% (287/704) of grade IIIA hospitals and 16.0% (52/326) of grade IIIB hospitals in the mainland China provided ERCP service.
1
219 (48. 8)
2
34 (7.6)
ⱖ3
10 (2.2)
Organization and infrastructure for ERCP service Of the 449 hospitals, 341 (76.0%) had an established endoscopy unit, and 108 (24.0%) did not. ERCP service was provided by the Department of Gastroenterology in 308 hospitals (68.6%), Department of General Surgery in 30 hospitals (6.7%) or other departments (eg, interventional radiology, oncology) in 38 hospitals (8.5%), or independently operated by an endoscopy division in 73 hospitals (16.3%). Among the 449 hospitals supplying ERCP service, 186 (41.4%) had no separate ERCP suite, 219 (48.8%) had only 1, 34 (7.6%) had 2, and 10 (2.2%) had 3 or more ERCP suites. In 379 hospitals (84.4%), X-ray fluoroscopes used during ERCP procedures were shared with the Department of Radiology. In only 70 hospitals (15.6%) were X-ray fluoroscopes owned by the endoscopy unit; 61 had 1 and 9 had 2 or more (Table 1). Of the 449 hospitals, 258 (57.5%) had only 1, 124 (27.6%) had 2, 45 (10.0%) had 3, and 22 (4.9%) had 4 or more duodenoscopes, with an average of 1.58 duodenoscopes in each hospital. Three hundred sixteen (70.4%), 71 (15.8%), and 54 (12.0%) hospitals used ERCP equipment mainly manufactured by Olympus (Japan), Pentax (Japan), and Fujinon (Japan), respectively. Only 8 (1.8%) hospitals used the ERCP equipment from domestic manufacturers.
Total
449 (100.0)
No. of X-ray fluoroscopes 0 (shared with other department)
379 (84.4)
1
61 (13.6)
ⱖ2 Total
9 (2.0) 449 (100.0)
No. of duodenoscopes 1
258 (57.5)
2
124 (27.6)
3
45 (10.0)
ⱖ4
22 (4.9)
Total
755 (100.0)
Of the 449 hospitals, 200 (44.5%) provided ERCP service for less than 5 years, 134 (29.8%) for 6 to 10 years, 87 (19.4%) for 11 to 20 years, and 28 (6.2%) for more than 20 years. In the 28 hospitals providing ERCP service for more
than 20 years, most (89.3%) were categorized grade IIIA hospitals (Table 2). A total of 61,044 ERCP procedures were performed in the 449 hospitals in 2006. Combining the estimated ERCP procedures of the other 21 hospitals that provided ERCP service but did not participate in the survey, the estimated total ERCP volume in mainland China would be 63,787 with an estimated ERCP rate of 4.87 per 100,000 inhabitants (1.31 billion as the total population), which was much lower than the rates in developed countries. The comparison between China and developed countries is shown in Figure 1. In 2006, 35,947 (58.9%) of 61,044 ERCP procedures were indicated for cholelithiasis, 4634 procedures (7.6%) for malignant bile duct stricture, 3744 (6.1%) for chronic pancreatitis, 2297 (3.8%) for pancreatic cancer, and 14,422 (23.6%) for others (Fig. 2). In 431 (96.0%) of the 449 hospitals, patients were admitted to hospital for at least 1 night to monitor for postERCP adverse events, whereas in 18 hospitals (4.0%), ERCP was performed on an outpatient basis. The anesthesia methods varied among the hospitals; pharyngeal local anesthesia and conscious sedation were mainly used in 424 hospitals (94.4%), whereas general anesthesia was mainly used in 25 hospitals (5.6%).
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ERCP procedures
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TABLE 2. Duration of ERCP service in the 449 hospitals participating in the national survey Duration of ERCP service, y
Grade IIIA
Grade IIIB
Grade IIA
Lower than grade IIA
No. (%) of hospitals
ⱕ5
48
46
85
21
200 (44.5)
6-10
130
1
3
0
134 (29.8)
11-20
84
3
0
0
87 (19.4)
⬎20
25
2
1
0
28 (6.2)
Total
287
52
89
21
449
Figure 1. Comparison of the annual ERCP rates in China and developed countries. *The original data were estimated from the figures involved.
between the volume of ERCP rate and gross domestic product per capita in China (r ⫽ 0.871, P ⬍ .001). Generally, the more economically developed a region was, the higher ERCP rate it had.
Training and research relating to ERCP
The economic and demographic data of 31 administrative regions of mainland China were retrieved from the China Statistical Yearbook 2007. The ERCP rates of individual provincial regions in 2006 are shown in Figure 3. Figure 4 shows that there was a significant correlation
Of the 449 hospitals, 126 (28.1%) provided ERCP training, and 38 (8.5%) conducted training courses annually. Live demonstration and hands-on training were the major educational methods of ERCP in China, and simulator and animal models were rarely used. There were only 3 hospitals that trained more than 50 trainees per year; most hospitals (94.7%) providing ERCP training were grade IIIA (Table 3). Overall, 135 of the 449 hospitals (30.1%) had scientific research plans for ERCP, and an average of 1.4 research projects per hospital were under investigation every year. In addition, only 22 hospitals (4.9%) published scientific articles involving ERCP in international journals in 2006.
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Figure 2. The indications for 61,044 ERCP procedures performed in China in 2006.
Correlation of the ERCP volume and economic development
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ERCP service in China
Figure 3. The ERCP rate in the 31 provinces/autonomous regions/municipalities of mainland China in 2006.
Figure 4. Scatterplot depicting the relationship between ERCP volume and gross domestic product (GDP) per capita in different regions in China. RMB, renminbi.
DISCUSSION This national survey on the ERCP service was the first comprehensive survey ever undertaken in China, and the
findings would be representative of the status of ERCP service in mainland China. There were 470 hospitals providing ERCP service in mainland China in 2006, 449 (95.5%) of which returned the completed questionnaire.
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The data clearly showed that the ERCP infrastructure such as ERCP suite, X-ray fluoroscopes, and duodenoscopes was significantly lacking in most of these hospitals. In 2006, approximately 63,787 ERCP procedures were performed in mainland China, with an estimated annual ERCP rate of 4.87 per 100,000 inhabitants, which was much lower than the rates of developed countries. The indications were biliary diseases (75.9%), pancreatic diseases (13.9%), duodenal papillary diseases (6.7%), and others (3.4%). There was a significant correlation between the volume of ERCP procedures and gross domestic product per capita. The development of ERCP in China can be traced back to the first introduction of the procedure by Dr. Min-Zhang Chen in 1973, 5 years after McCune et al1 reported the first performance of ERCP in the world.9 During the past 3 decades, Chinese endoscopists have tried their best to follow the development and advances of ERCP. In 1985, the CSDE was established in Shanghai, which had made remarkable achievements in establishing and improving the widespread application of GI endoscopy in China.9 As a result, ERCP service had been provided throughout mainland China, and the application of new techniques and equipment, clinical research, technology innovation, and continuous medical education has developed significantly and has been accepted worldwide.18-22 However, it must be acknowledged that the overall ERCP service in mainland China still needs substantial improvement. Although the estimated total ERCP volume reached 63,787 in 2006, considering the largest population base in the world, this figure was much less than that in the developed countries. In the United States, 652 hospitals provide ERCP service, and approximately 52,000 inpatient and 12,000 outpatient ERCPs are performed annually.11 In the United Kingdom, approximately 48,000 ERCPs were performed by 236 acute hospitals in 2004.12 As shown in Figure 2, there was an enormous gap in ERCP service between China and developed countries when the annual ERCP rate was used as a main index. Even in Shanghai, the most developed city in China, the ERCP rate (the estimated ERCP rate of Shanghai in 2006 was 44.7 per 100,000 in-
habitants) was far from adequate. If 1/1000 was used as the proportion of the average adult population undergoing ERCP each year, according to Cotton,23 the annual ERCP volume of China would be as much as 1 million. Moreover, in Chinese population, there is very high prevalence of cholangiopancreatic disease, especially the common bile duct stones and chronic pancreatitis,6,21,24 both of which are indications for ERCP, suggesting that there would be even more potential patients with indications for ERCP in mainland China. Therefore, it is believed that a considerable proportion of patients had received no effective but less-invasive therapy or unnecessary surgery considering the extremely low annual ERCP rate and the large number of patients with indications for ERCP. The main reason to restrict ERCP service in China is the lack of infrastructure. As shown in this survey, there were only 470 of 19,852 hospitals capable of independently performing ERCP, and more than half of Chinese topgrade hospitals (grade IIIA) were not able to provide this service. Among the 449 hospitals providing ERCP and participating our survey, 41.43% did not own separate ERCP suites, 84.4% shared X-ray equipment with the Department of Radiology, and the average number of duodenoscopes was 1.58 per hospital. In the United Kingdom, 72% of ERCP units have a recovery area, 87% with an appropriately stocked resuscitation trolley and 84% with EUS or magnetic resonance cholangiography available on-site.10,11 These facilities or systems were virtually absent in China at least up to 2006. The benefits of endoscopy, including ERCP, are maximized when procedures are performed at an optimal level of quality, which depends largely on the quality of training.25 However, our survey showed that the ERCP training was inadequate in China, which also contributed to the restriction of ERCP service. Although 126 of 449 hospitals (28.1%) could provide ERCP training, only 38 hospitals (8.5%) conducted training courses annually. According to Cotton,23 860 more endoscopists who perform ERCP are required when the annual ERCP rate is increased by every 10/100,000. The huge demand for endoscopists proficient in performing ERCP means that the current scale of ERCP training is far from sufficient. Additionally, there was no national standard for ERCP training in China. Live demonstration and hands-on training were the major methods, and simulator and animal models were rarely used. Besides the low annual ERCP rate and obvious shortage of ERCP infrastructure in China, the other critical problem shown in this survey was that there were evident imbalances in ERCP service across the whole country. First, there was a significant gap in ERCP status among different regions (Fig. 3). On one hand, more than 8000 ERCPs were performed in hospitals in Shanghai, and more than 5000 ERCPs were performed in hospitals in Beijing, Jiangsu, and Zhejiang; the procedures performed in the hospitals in these 4 regions accounted for nearly 40% of all the procedures performed in China in 2006. On the other hand,
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TABLE 3. Number of trainees per annum in different endoscopy centers No. of trainees
Grade IIIA
Grade IIIB
Grade IIA and lower
No. (%) of hospitals
⬍10
14
1
0
15 (3.3)
10-20
9
1
0
10 (2.2)
21-50
10
0
0
10 (2.2)
⬎50
3
0
0
3 (0.8)
Total
36
2
0
38 (8.5)
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fewer than 500 ERCPs were performed in hospitals in each of another 4 regions, namely, Qinghai, Tibet, Hainan, and Guangxi. The imbalanced economic and social development among different regions continues to exist and is believed to be the leading cause, as shown in this study. The overall development in the central and west hinterland regions has lagged far behind that in the east coast region. Consequently, some hospitals in the central and west regions even had to abandon ERCP service because these hospitals could not afford to maintain ERCP equipment without adequate funds, and/or it was difficult to maintain the necessary skills when the volume of ERCPs was low.26 A study from the Mayo Clinic tracked the development of ERCP skills by a single advanced trainee through fellowship and beyond and showed that 350 to 400 procedures were required to consistently achieve a success rate higher than 80% for deep biliary cannulation through native papillae. This success rate improved to more than 95% after a further 300 procedures.27 Thus, continuous service is essential to maintain a sustainable ERCP service. Therefore, the Chinese government at different levels should provide even stronger support for the central and west regions to speed up the development of social programs including health care and education systems and help these regions gradually narrow the widening gap between the central/west region and the east coast region. The second imbalance, according to this survey, was that ERCP service in China was mostly provided by public hospitals (ie, university affiliated, government administered, and military hospitals; 98.7%) or by high-grade hospitals (IIA or higher, 95.3%). In the health care system of China, these hospitals play a major role as tertiary referral centers in a large city or town, which in turn indicates that the ERCP service is uncommon in the vast rural areas and community settings, even in large cities or towns. In contrast, in developed countries, ERCP service provided by community health providers covers a substantial proportion of the population, with the success rate and adverse event rate of routine ERCPs being comparable or slightly inferior to those at academic medical centers.28-31 In fact, there is little difference for a technically competent gastroenterologist to perform the procedure whether it is at a community or academic medical center.30 If great efforts are made in the ERCP infrastructure and training in communities in the future, the status of ERCP service in China will improve significantly. There are limitations in our study. First, the electronic endoscopy databases are not available at most hospitals in China, not to mention a nationwide ERCP database. The communication with industry partners and each of the involved hospitals and the data check and analysis took several years. However, ERCP is a relatively advanced technique, and over the past years, it has not been the priority for government funding. In our experience, the status of the ERCP service in China has not developed
dramatically during the past 5 years, and we believe that the data in this study demonstrate the current status to a large extent, if not completely. Second, the questionnaire of this survey was retrospective and descriptive, and the reliability and validity were not strictly assessed. Thus, this study was not able to provide deep insight into and detailed data on the ERCP service in China. Moreover, the retrospective design of this survey could not avoid recall bias. Third, this survey did not include the incidence of adverse events, which is an important issue of ERCP. The difficulty in data check about adverse events and the differences in the definitions of adverse events among hospitals were the main reasons. Recently, Coté et al32 reported an anonymous electronic survey based on endoscopists that characterized the ERCP practice of U.S. gastroenterologists stratified by their annual case volume. A survey with a design similar to this may be the most feasible approach to reveal adverse events of ERCP in China in the future. In conclusion, there is an enormous gap in ERCP service between mainland China and developed countries. There are significant imbalances in ERCP status among different regions, which correlates with economic development. Great efforts are required to improve the infrastructure, volume of procedures, training, and scientific research of ERCP service.
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ACKNOWLEDGMENTS We sincerely thank all those members of CSDE who assisted in data collection and local coordination of the project. We also thank the endoscopy companies (Olympus, Pentax, Fujinon, Boston Scientific, and Cook) who provided information on the ERCP use to the CSDE. REFERENCES 1. McCune WS, Shorb PE, Moscovitz H. Endoscopic cannulation of the ampulla of Vater: a preliminary report. Ann Surg 1968;167:752-6. 2. Kawai K, Akasaka Y, Murakami K, et al. Endoscopic sphincterotomy of the ampulla of Vater. Gastrointest Endosc 1974;20:148-51. 3. Classen M, Demling L. Endoskopische Sphinkterotomie der Papilla Vateri und Steinextraktion aus dem Ductus choledochus [German]. Dtsch Med Wochenschr 1974;99:496-7. 4. Adler DG, Baron TH, Davila RE, et al. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc 2005; 62:1-8. 5. Dumonceau JM, Andriulli A, Deviere J, et al. European Society of Gastrointestinal Endoscopy. European Society of Gastrointestinal Endoscopy (ESGE) Guideline: prophylaxis of post-ERCP pancreatitis. Endoscopy 2010;42:503-15. 6. Zhu X, Zhang S, Huang Z. The trend in gallstone disease in China over the past decade [Chinese]. Zhonghua Wai Ke Za Zhi 1995;33:652-8. 7. Wang LW, Li ZS, Li SD, et al. Prevalence and clinical features of chronic pancreatitis in China. Pancreas 2009;38:248-54. 8. Raimondi S, Maisonneuve P, Lowenfels AB. Epidemiology of pancreatic cancer: an overview. Nat Rev Gastroenterol Hepatol 2009;6:699-708. 9. Zhu XG, Zhang SD, Huang ZQ. Evolution of gastrointestinal endoscopy in the mainland of China. Chin Med J [English] 2009;122:2220-3.
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Liao et al
10. China Statistical Yearbook 2007. http://www.stats.gov.cn/tjsj/ndsj/ 2007/indexeh.htm. Accessed February 12, 2012. 11. Jamal MM, Yoon EJ, Saadi A, et al. Trends in the utilization of endoscopic retrograde cholangiopancreatography (ERCP) in the United States. Am J Gastroenterol 2007;102:966-75. 12. Williams EJ, Taylor S, Fairclough P, et al. Are we meeting the standards set for endoscopy? Results of a large-scale prospective study of endoscopic practice. Gut 2007;56:796-801. 13. Hilsden RJ, Romagnuolo J, May GR. Patterns of use of endoscopic retrograde cholangiopancreatography in a Canadian province. Can J Gastroenterol 2004;18:619-24. 14. Kapral C, Duller C, Wewalka F, et al. Case volume and outcome of endoscopic retrograde cholangiopancreatography: results of a nationwide Austrian benchmarking project. Endoscopy 2008;40:625-30. 15. Glomsaker T, Søreide K, Aabakken L, et al. A national audit of temporal trends in endoscopic retrograde cholangiopancreatography in Norway. Scand J Gastroenterol 2011;46:116-21. 16. Enochsson L, Swahn F, Arnelo U, et al. Nationwide, population-based data from 11,074 ERCP procedures from the Swedish Registry for Gallstone Surgery and ERCP. Gastrointest Endosc 2010;72:1175-84. 17. Allison MC, Ramanaden DN, Fouweather MG, et al. Provision of ERCP services and training in the United Kingdom. Endoscopy 2000;32:693-9. 18. Liao Z, Li ZS, Leung JW, et al. How safe and successful are live demonstrations of therapeutic ERCP? A large multicenter study. Am J Gastroenterol 2009;104:47-52. 19. Liao Z, Li ZS, Leung JW, et al. Success rate and complications of ERCP performed during hands-on training courses: a multicenter study in China. Gastrointest Endosc 2009;69:230-7. 20. Zhou W, Li Y, Zhang Q, et al. Risk factors for postendoscopic retrograde cholangiopancreatography pancreatitis: a retrospective analysis of 7,168 cases. Pancreatology 2011;11:399-405.
21. Wang P, Li ZS, Liu F, et al. Risk factors for ERCP-related complications: a prospective multicenter study. Am J Gastroenterol 2009;104:31-40. 22. Liao Z, Hu LH, Li ZS, et al. Multidisciplinary team meeting before therapeutic ERCP: a prospective study with 1,909 cases. J Interv Gastroenterol 2011;1:64-9. 23. Cotton PB. Are low-volume ERCPists a problem in the United States? A plea to examine and improve ERCP practice-NOW. Gastrointest Endosc 2011;74:161-6. 24. Su CH, Lui WY, Peng FK. Relative prevalence of gallstone diseases in Taiwan: A nationwide cooperative study. Dig Dis Sci 1992;37:764-8. 25. Cotton PB. Quality endoscopists and quality endoscopy units. J Interv Gastroenterol 2011;1:83-7. 26. Baillie J. Is ERCP headed for extinction? Am J Gastroenterol 2008;103: 1888-90. 27. Verma D, Gostout CJ, Petersen BT, et al. Establishing a true assessment of endoscopic competence in ERCP during training and beyond: a single-operator learning curve for deep biliary cannulation in patients with native papillary anatomy. Gastrointest Endosc 2007;65:394-400. 28. Dumonceau JM, Rigaux J, Kahaleh M, et al. Prophylaxis of post-ERCP pancreatitis: a practice survey. Gastrointest Endosc 2010;71:934-9. 29. Colton JB, Curran CC. Quality indicators, including complications, of ERCP in a community setting: a prospective study. Gastrointest Endosc 2009;70:457-67. 30. Nagar AB. ERCP in the community: the benchmarks have been set. Gastrointest Endosc 2009;70:468-70. 31. Rábago L, Guerra I, Moran M, et al. Is outpatient ERCP suitable, feasible, and safe? The experience of a Spanish community hospital. Surg Endosc 2010;24:1701-6. 32. Coté GA, Keswani RN, Jackson T, et al. Individual and practice differences among physicians who perform ERCP at varying frequency: a national survey. Gastrointest Endosc 2011;74:65-73.
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Appendix 1. The hospital grading system in the mainland China Hospital grading* III
II
I
Definition The number of beds is more than 500, to provide quality specialist in several areas of sexual health services and the implementation of higher education and research tasks The number of beds is between 101 to 500, to provide comprehensive medical and health services to the various communities, commitment to a certain teaching and research mission The number of beds is less than 100, to provide prevention, medical care, health care, rehabilitation to a certain population of the community
*In 2006, 9918 small-scale hospitals did not meet the standard above and thus were not graded, the graded hospitals were further classified into A, B, or C in each grade, based on the hospital’s technical force, management level, equipment condition, research capacity, with the IIIA being the highest grade and IC the lowest. The details are stated in China Statistical Yearbook-2007 (http:// www.stats.gov.cn/tjsj/ndsj/2007/indexeh.htm).
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Appendix 2. The distribution of hospitals in the mainland China in 2006 according to the grading Hospital grading
Number
Proportions (%)
IIIA
704
7.09
IIIB
326
3.28
IIIC
15
0.15
IIA
3521
35.44
IIB
2187
22.02
IIC
95
0.96
IA
2563
25.80
IB
430
4.33
IC
93
0.94
Total
9934
100.00
The details are stated in China Statistical Yearbook-2007 (http:// www.stats.gov.cn/tjsj/ndsj/2007/indexeh.htm).
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GASTROINTESTINAL ENDOSCOPY
46.e1
ERCP service in China: results from a national survey Zhuan Liao, MD,* Liang-Hao Hu, MD,* Lei Xin, MD,* Zhao-Shen Li, MD Audit of ERCP of the Chinese Society of Digestive Endoscopy, Shanghai, China
Background: ERCP had been performed throughout China for decades. Objective: To determine the status of ERCP service in China. Design: A national survey. Setting: All of the hospitals performing ERCP in mainland China in 2006. Patients: All of the patients undergoing ERCP in mainland China in 2006. Main Outcome Measurements: The questionnaire included the (1) type of hospitals involved; (2) ownership of the endoscopy unit; (3) ERCP infrastructure; (4) volume, indication, setting, and anesthesia methods; and (5) training and research. The correlation between economic development and ERCP status in different regions was investigated, and the ERCP rates in China and developed countries were compared. Results: Completed questionnaires were returned by 449 (95.5%) of the 470 hospitals providing ERCP service. Among the 449 hospitals, 186 (41.4%) did not have separate ERCP suites, 379 (84.4%) shared fluoroscopy with their radiology departments, and the average number of duodenoscopes was 1.58. A total of 63,787 ERCP procedures were performed in mainland China in 2006, with an estimated annual ERCP rate of 4.87 per 100,000 inhabitants, much lower than that of developed countries. Ninety-six percent of patients were admitted to undergo ERCP, and 94.4% of hospitals used pharyngeal local anesthesia and conscious sedation, whereas 5.6% used general anesthesia. There was a significant correlation between the ERCP rate and gross domestic product per capita (r ⫽ 0.871, P ⬍ .001). Limitations: The survey was retrospective and descriptive. Conclusions: There is an enormous gap in ERCP service between China and developed countries. The imbalance of ERCP status between different regions is significant, which correlates with economic development. Great effort is needed to develop the technique nationwide. (Gastrointest Endosc 2013;77:39-46.)
Since ERCP was introduced in 1968,1 this procedure has been established as an effective tool for the diagnosis and treatment of biliary, pancreatic, and liver diseases. After the first successful endoscopic sphincterotomy was performed in 1974,2,3 this technique gained further acceptance worldwide. Currently, ERCP plays a major role in the treatment of biliary and pancreatic diseases.4,5 China has the largest population in the world, with a large number of patients with GI and liver diseases. Biliary diseases, especially bile duct stones, are common in the
Chinese population.6 Moreover, the incidence of pancreatic diseases, such as chronic pancreatitis and pancreatic cancer, is increasing rapidly.7,8 Thus, ERCP service should be established to provide a promising technique for patients with biliary and pancreatic diseases in China. The first ERCP was performed in China in 1973.9 However, after the evolution for more than 3 decades, the status of ERCP service in China remains unknown. Therefore, the Chinese Society of Digestive Endoscopy (CSDE) conducted a national survey to determine the number and
Abbreviation: CSDE, Chinese Society of Digestive Endoscopy.
Received March 21, 2012. Accepted August 30, 2012.
DISCLOSURE: The authors disclosed no financial relationships relevant to this publication. *Drs Liao, Hu, and Xin contributed equally to this article.
Current affiliations: Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Second Military Medical University, Shanghai, China.
Copyright © 2013 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2012.08.035
Reprint requests: Zhao-Shen Li, MD, Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Second Military Medical University, 168 Changhai Road, Shanghai 200433, China.
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Volume 77, No. 1 : 2013 GASTROINTESTINAL ENDOSCOPY 39
ERCP service in China
distribution of hospitals that performed ERCP and the infrastructure and the volume of ERCPs performed nationwide. The ERCP status among different regions of China and the differences in ERCP service between China and developed countries were also analyzed.
METHODS
Liao et al
Take-home Message ●
●
The imbalance of ERCP status between different regions is significant, which correlates with economic development. Great effort is required to develop the technique nationwide.
Organizer, industry partners, and participants This study was initiated and organized by the CSDE. All 31 provincial branches of CSDE in mainland China participated in the survey. Considering that no academic society, administrative authority, or commercial company had a comprehensive database containing information on the performance of ERCP nationwide, collection of the initial information from industry partners was a suboptimal but was the most feasible approach to determine the current status of ERCP availability in China as accurately as possible. In response to a request from the CSDE, the manufacturers or suppliers of endoscopes (Olympus, Stamford, CT, Pentax, Tokyo, Japan, Fujinon, Tokyo, Japan, and the domestic companies) and endoscopic accessories (Boston Scientific, Natick, MA, Cook, Bloomington, IN, and the domestic companies) provided information on account sales to the CSDE to confirm which hospitals provide ERCP in China (except Taiwan, Hong Kong, and Macao).
Conduct of the survey The survey was conducted from March 2007 to September 2007. Each branch of the CSDE sent a predesigned standard structured questionnaire to all hospitals performing ERCP in the corresponding regions. The questionnaire was completed by a designated senior endoscopist at each hospital and then returned to the CSDE branches; the questionnaires were collected at the CSDE headquarters in Shanghai for analysis. The questionnaire included data on (1) hospital type and grading; (2) the ownership of the endoscopy unit; (3) the number of ERCP suites, X-ray fluoroscopes, and duodenoscopes; (4) the volume, indications, setting, and anesthesia methods for ERCP procedures; and (5) the status of training and scientific research. All data entered in the questionnaire were to be consistent with the status of the hospital and the endoscopy unit in 2006. After the questionnaires were returned to the organizer, one tenth of the hospitals involved were selected through simple random sampling. From November 2007 to February 2008, the involved individual branches of the CSDE covering these selected hospitals collected the official annual reports from the hospitals and checked the data on the questionnaires as much as possible. The results of the data check were then returned to the organizer. If there were significant discrepancies in the data between the 2 data checks and the questionnaire, then the questionnaire and was considered invalid and not included in the analysis. 40 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 1 : 2013
Hospital type was defined as the ownership of the hospital. In China, the hospitals are categorized as public or private according to ownership. The public hospitals are further categorized into those affiliated with a university or those administered by the government or military institutions. In addition, large-scale hospitals were further graded, from the lower to higher levels, as I, II, or III according to the scale and technique capability by the Chinese Ministry of Health (Supplemental tables 1 and 2, available online at www.giejournal.org).
Data collection and synthesis A returned questionnaire was considered valid if all of the required information was provided and consistent with the results of the data check. The data were extracted and summarized in a database for further analysis. To determine the correlation between the ERCP status and the economic development and the differences in ERCP availability between mainland China and developed countries (eg, European countries, United States, and Canada), the 1-year ERCP rate was used as a main index to represent the status of ERCP availability. To calculate the ERCP rate in mainland China, if a hospital provided ERCP in 2006 but failed to return the relevant data, its ERCP volume in 2006 would be estimated according to other hospitals with similar grading, scale, and geographic location. The economic status (ie, gross domestic product per capita) of 31 provincial regions of mainland China was retrieved from the China Statistical Yearbook 2007.10 The ERCP rates of the United States, United Kingdom, Canada (Alberta province as representative), Austria, Norway, Sweden, and Denmark around 2006 were retrieved or calculated through published data resources.11-17
Statistical analysis Categorical data are shown as percentages. The nonparametric correlation statistical test (Spearman’s test) was used to analyze the correlations between regional gross domestic product per capita and the ERCP rate. Statistical analyses were performed by using SPSS version 13.0 for Windows (SPSS Inc, Chicago, Ill). A P value of ⬍.05 was considered statistically significant.
RESULTS In 2006, there were 19,852 hospitals in China. Apart from 9918 small-scale hospitals, which were not included www.giejournal.org
Liao et al
in the national grading system, 9934 were graded, including 704 IIIA hospitals at the top grade (Appendices 1 and 2, available online at www.giejournal.org). According to the account sales of the manufacturers and suppliers in China, 470 hospitals provided ERCP service in 2006, all of which were graded hospitals.
ERCP service in China
TABLE 1. Infrastructure of the ERCP service in the 449 hospitals participating in the national survey in mainland China Infrastructure
No. (%) of hospitals
No. of ERCP suites
Responses to the survey
0 (shared with other operations)
186 (41.4)
Of the 470 hospitals that provided ERCP service, 449 returned completed questionnaires, representing a 95.5% effective return rate. A data check was performed in 45 of the 449 hospitals that returned completed questionnaires, and all the data were virtually consistent with the official reports. There were 211 university-affiliated hospitals (47.0%), 214 government-administered hospitals (47.7%), 18 military hospitals (4.0%), and 6 private hospitals (1.3%). Of these 449 hospitals, 287 (63.9%), 52 (11.6%), and 89 (19.8%) were grades IIIA, IIIB, and IIA, respectively. Overall, 40.8% (287/704) of grade IIIA hospitals and 16.0% (52/326) of grade IIIB hospitals in the mainland China provided ERCP service.
1
219 (48. 8)
2
34 (7.6)
ⱖ3
10 (2.2)
Organization and infrastructure for ERCP service Of the 449 hospitals, 341 (76.0%) had an established endoscopy unit, and 108 (24.0%) did not. ERCP service was provided by the Department of Gastroenterology in 308 hospitals (68.6%), Department of General Surgery in 30 hospitals (6.7%) or other departments (eg, interventional radiology, oncology) in 38 hospitals (8.5%), or independently operated by an endoscopy division in 73 hospitals (16.3%). Among the 449 hospitals supplying ERCP service, 186 (41.4%) had no separate ERCP suite, 219 (48.8%) had only 1, 34 (7.6%) had 2, and 10 (2.2%) had 3 or more ERCP suites. In 379 hospitals (84.4%), X-ray fluoroscopes used during ERCP procedures were shared with the Department of Radiology. In only 70 hospitals (15.6%) were X-ray fluoroscopes owned by the endoscopy unit; 61 had 1 and 9 had 2 or more (Table 1). Of the 449 hospitals, 258 (57.5%) had only 1, 124 (27.6%) had 2, 45 (10.0%) had 3, and 22 (4.9%) had 4 or more duodenoscopes, with an average of 1.58 duodenoscopes in each hospital. Three hundred sixteen (70.4%), 71 (15.8%), and 54 (12.0%) hospitals used ERCP equipment mainly manufactured by Olympus (Japan), Pentax (Japan), and Fujinon (Japan), respectively. Only 8 (1.8%) hospitals used the ERCP equipment from domestic manufacturers.
Total
449 (100.0)
No. of X-ray fluoroscopes 0 (shared with other department)
379 (84.4)
1
61 (13.6)
ⱖ2 Total
9 (2.0) 449 (100.0)
No. of duodenoscopes 1
258 (57.5)
2
124 (27.6)
3
45 (10.0)
ⱖ4
22 (4.9)
Total
755 (100.0)
Of the 449 hospitals, 200 (44.5%) provided ERCP service for less than 5 years, 134 (29.8%) for 6 to 10 years, 87 (19.4%) for 11 to 20 years, and 28 (6.2%) for more than 20 years. In the 28 hospitals providing ERCP service for more
than 20 years, most (89.3%) were categorized grade IIIA hospitals (Table 2). A total of 61,044 ERCP procedures were performed in the 449 hospitals in 2006. Combining the estimated ERCP procedures of the other 21 hospitals that provided ERCP service but did not participate in the survey, the estimated total ERCP volume in mainland China would be 63,787 with an estimated ERCP rate of 4.87 per 100,000 inhabitants (1.31 billion as the total population), which was much lower than the rates in developed countries. The comparison between China and developed countries is shown in Figure 1. In 2006, 35,947 (58.9%) of 61,044 ERCP procedures were indicated for cholelithiasis, 4634 procedures (7.6%) for malignant bile duct stricture, 3744 (6.1%) for chronic pancreatitis, 2297 (3.8%) for pancreatic cancer, and 14,422 (23.6%) for others (Fig. 2). In 431 (96.0%) of the 449 hospitals, patients were admitted to hospital for at least 1 night to monitor for postERCP adverse events, whereas in 18 hospitals (4.0%), ERCP was performed on an outpatient basis. The anesthesia methods varied among the hospitals; pharyngeal local anesthesia and conscious sedation were mainly used in 424 hospitals (94.4%), whereas general anesthesia was mainly used in 25 hospitals (5.6%).
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ERCP procedures
ERCP service in China
Liao et al
TABLE 2. Duration of ERCP service in the 449 hospitals participating in the national survey Duration of ERCP service, y
Grade IIIA
Grade IIIB
Grade IIA
Lower than grade IIA
No. (%) of hospitals
ⱕ5
48
46
85
21
200 (44.5)
6-10
130
1
3
0
134 (29.8)
11-20
84
3
0
0
87 (19.4)
⬎20
25
2
1
0
28 (6.2)
Total
287
52
89
21
449
Figure 1. Comparison of the annual ERCP rates in China and developed countries. *The original data were estimated from the figures involved.
between the volume of ERCP rate and gross domestic product per capita in China (r ⫽ 0.871, P ⬍ .001). Generally, the more economically developed a region was, the higher ERCP rate it had.
Training and research relating to ERCP
The economic and demographic data of 31 administrative regions of mainland China were retrieved from the China Statistical Yearbook 2007. The ERCP rates of individual provincial regions in 2006 are shown in Figure 3. Figure 4 shows that there was a significant correlation
Of the 449 hospitals, 126 (28.1%) provided ERCP training, and 38 (8.5%) conducted training courses annually. Live demonstration and hands-on training were the major educational methods of ERCP in China, and simulator and animal models were rarely used. There were only 3 hospitals that trained more than 50 trainees per year; most hospitals (94.7%) providing ERCP training were grade IIIA (Table 3). Overall, 135 of the 449 hospitals (30.1%) had scientific research plans for ERCP, and an average of 1.4 research projects per hospital were under investigation every year. In addition, only 22 hospitals (4.9%) published scientific articles involving ERCP in international journals in 2006.
42 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 1 : 2013
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Figure 2. The indications for 61,044 ERCP procedures performed in China in 2006.
Correlation of the ERCP volume and economic development
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ERCP service in China
Figure 3. The ERCP rate in the 31 provinces/autonomous regions/municipalities of mainland China in 2006.
Figure 4. Scatterplot depicting the relationship between ERCP volume and gross domestic product (GDP) per capita in different regions in China. RMB, renminbi.
DISCUSSION This national survey on the ERCP service was the first comprehensive survey ever undertaken in China, and the
findings would be representative of the status of ERCP service in mainland China. There were 470 hospitals providing ERCP service in mainland China in 2006, 449 (95.5%) of which returned the completed questionnaire.
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ERCP service in China
Liao et al
The data clearly showed that the ERCP infrastructure such as ERCP suite, X-ray fluoroscopes, and duodenoscopes was significantly lacking in most of these hospitals. In 2006, approximately 63,787 ERCP procedures were performed in mainland China, with an estimated annual ERCP rate of 4.87 per 100,000 inhabitants, which was much lower than the rates of developed countries. The indications were biliary diseases (75.9%), pancreatic diseases (13.9%), duodenal papillary diseases (6.7%), and others (3.4%). There was a significant correlation between the volume of ERCP procedures and gross domestic product per capita. The development of ERCP in China can be traced back to the first introduction of the procedure by Dr. Min-Zhang Chen in 1973, 5 years after McCune et al1 reported the first performance of ERCP in the world.9 During the past 3 decades, Chinese endoscopists have tried their best to follow the development and advances of ERCP. In 1985, the CSDE was established in Shanghai, which had made remarkable achievements in establishing and improving the widespread application of GI endoscopy in China.9 As a result, ERCP service had been provided throughout mainland China, and the application of new techniques and equipment, clinical research, technology innovation, and continuous medical education has developed significantly and has been accepted worldwide.18-22 However, it must be acknowledged that the overall ERCP service in mainland China still needs substantial improvement. Although the estimated total ERCP volume reached 63,787 in 2006, considering the largest population base in the world, this figure was much less than that in the developed countries. In the United States, 652 hospitals provide ERCP service, and approximately 52,000 inpatient and 12,000 outpatient ERCPs are performed annually.11 In the United Kingdom, approximately 48,000 ERCPs were performed by 236 acute hospitals in 2004.12 As shown in Figure 2, there was an enormous gap in ERCP service between China and developed countries when the annual ERCP rate was used as a main index. Even in Shanghai, the most developed city in China, the ERCP rate (the estimated ERCP rate of Shanghai in 2006 was 44.7 per 100,000 in-
habitants) was far from adequate. If 1/1000 was used as the proportion of the average adult population undergoing ERCP each year, according to Cotton,23 the annual ERCP volume of China would be as much as 1 million. Moreover, in Chinese population, there is very high prevalence of cholangiopancreatic disease, especially the common bile duct stones and chronic pancreatitis,6,21,24 both of which are indications for ERCP, suggesting that there would be even more potential patients with indications for ERCP in mainland China. Therefore, it is believed that a considerable proportion of patients had received no effective but less-invasive therapy or unnecessary surgery considering the extremely low annual ERCP rate and the large number of patients with indications for ERCP. The main reason to restrict ERCP service in China is the lack of infrastructure. As shown in this survey, there were only 470 of 19,852 hospitals capable of independently performing ERCP, and more than half of Chinese topgrade hospitals (grade IIIA) were not able to provide this service. Among the 449 hospitals providing ERCP and participating our survey, 41.43% did not own separate ERCP suites, 84.4% shared X-ray equipment with the Department of Radiology, and the average number of duodenoscopes was 1.58 per hospital. In the United Kingdom, 72% of ERCP units have a recovery area, 87% with an appropriately stocked resuscitation trolley and 84% with EUS or magnetic resonance cholangiography available on-site.10,11 These facilities or systems were virtually absent in China at least up to 2006. The benefits of endoscopy, including ERCP, are maximized when procedures are performed at an optimal level of quality, which depends largely on the quality of training.25 However, our survey showed that the ERCP training was inadequate in China, which also contributed to the restriction of ERCP service. Although 126 of 449 hospitals (28.1%) could provide ERCP training, only 38 hospitals (8.5%) conducted training courses annually. According to Cotton,23 860 more endoscopists who perform ERCP are required when the annual ERCP rate is increased by every 10/100,000. The huge demand for endoscopists proficient in performing ERCP means that the current scale of ERCP training is far from sufficient. Additionally, there was no national standard for ERCP training in China. Live demonstration and hands-on training were the major methods, and simulator and animal models were rarely used. Besides the low annual ERCP rate and obvious shortage of ERCP infrastructure in China, the other critical problem shown in this survey was that there were evident imbalances in ERCP service across the whole country. First, there was a significant gap in ERCP status among different regions (Fig. 3). On one hand, more than 8000 ERCPs were performed in hospitals in Shanghai, and more than 5000 ERCPs were performed in hospitals in Beijing, Jiangsu, and Zhejiang; the procedures performed in the hospitals in these 4 regions accounted for nearly 40% of all the procedures performed in China in 2006. On the other hand,
44 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 1 : 2013
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TABLE 3. Number of trainees per annum in different endoscopy centers No. of trainees
Grade IIIA
Grade IIIB
Grade IIA and lower
No. (%) of hospitals
⬍10
14
1
0
15 (3.3)
10-20
9
1
0
10 (2.2)
21-50
10
0
0
10 (2.2)
⬎50
3
0
0
3 (0.8)
Total
36
2
0
38 (8.5)
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ERCP service in China
fewer than 500 ERCPs were performed in hospitals in each of another 4 regions, namely, Qinghai, Tibet, Hainan, and Guangxi. The imbalanced economic and social development among different regions continues to exist and is believed to be the leading cause, as shown in this study. The overall development in the central and west hinterland regions has lagged far behind that in the east coast region. Consequently, some hospitals in the central and west regions even had to abandon ERCP service because these hospitals could not afford to maintain ERCP equipment without adequate funds, and/or it was difficult to maintain the necessary skills when the volume of ERCPs was low.26 A study from the Mayo Clinic tracked the development of ERCP skills by a single advanced trainee through fellowship and beyond and showed that 350 to 400 procedures were required to consistently achieve a success rate higher than 80% for deep biliary cannulation through native papillae. This success rate improved to more than 95% after a further 300 procedures.27 Thus, continuous service is essential to maintain a sustainable ERCP service. Therefore, the Chinese government at different levels should provide even stronger support for the central and west regions to speed up the development of social programs including health care and education systems and help these regions gradually narrow the widening gap between the central/west region and the east coast region. The second imbalance, according to this survey, was that ERCP service in China was mostly provided by public hospitals (ie, university affiliated, government administered, and military hospitals; 98.7%) or by high-grade hospitals (IIA or higher, 95.3%). In the health care system of China, these hospitals play a major role as tertiary referral centers in a large city or town, which in turn indicates that the ERCP service is uncommon in the vast rural areas and community settings, even in large cities or towns. In contrast, in developed countries, ERCP service provided by community health providers covers a substantial proportion of the population, with the success rate and adverse event rate of routine ERCPs being comparable or slightly inferior to those at academic medical centers.28-31 In fact, there is little difference for a technically competent gastroenterologist to perform the procedure whether it is at a community or academic medical center.30 If great efforts are made in the ERCP infrastructure and training in communities in the future, the status of ERCP service in China will improve significantly. There are limitations in our study. First, the electronic endoscopy databases are not available at most hospitals in China, not to mention a nationwide ERCP database. The communication with industry partners and each of the involved hospitals and the data check and analysis took several years. However, ERCP is a relatively advanced technique, and over the past years, it has not been the priority for government funding. In our experience, the status of the ERCP service in China has not developed
dramatically during the past 5 years, and we believe that the data in this study demonstrate the current status to a large extent, if not completely. Second, the questionnaire of this survey was retrospective and descriptive, and the reliability and validity were not strictly assessed. Thus, this study was not able to provide deep insight into and detailed data on the ERCP service in China. Moreover, the retrospective design of this survey could not avoid recall bias. Third, this survey did not include the incidence of adverse events, which is an important issue of ERCP. The difficulty in data check about adverse events and the differences in the definitions of adverse events among hospitals were the main reasons. Recently, Coté et al32 reported an anonymous electronic survey based on endoscopists that characterized the ERCP practice of U.S. gastroenterologists stratified by their annual case volume. A survey with a design similar to this may be the most feasible approach to reveal adverse events of ERCP in China in the future. In conclusion, there is an enormous gap in ERCP service between mainland China and developed countries. There are significant imbalances in ERCP status among different regions, which correlates with economic development. Great efforts are required to improve the infrastructure, volume of procedures, training, and scientific research of ERCP service.
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ACKNOWLEDGMENTS We sincerely thank all those members of CSDE who assisted in data collection and local coordination of the project. We also thank the endoscopy companies (Olympus, Pentax, Fujinon, Boston Scientific, and Cook) who provided information on the ERCP use to the CSDE. REFERENCES 1. McCune WS, Shorb PE, Moscovitz H. Endoscopic cannulation of the ampulla of Vater: a preliminary report. Ann Surg 1968;167:752-6. 2. Kawai K, Akasaka Y, Murakami K, et al. Endoscopic sphincterotomy of the ampulla of Vater. Gastrointest Endosc 1974;20:148-51. 3. Classen M, Demling L. Endoskopische Sphinkterotomie der Papilla Vateri und Steinextraktion aus dem Ductus choledochus [German]. Dtsch Med Wochenschr 1974;99:496-7. 4. Adler DG, Baron TH, Davila RE, et al. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc 2005; 62:1-8. 5. Dumonceau JM, Andriulli A, Deviere J, et al. European Society of Gastrointestinal Endoscopy. European Society of Gastrointestinal Endoscopy (ESGE) Guideline: prophylaxis of post-ERCP pancreatitis. Endoscopy 2010;42:503-15. 6. Zhu X, Zhang S, Huang Z. The trend in gallstone disease in China over the past decade [Chinese]. Zhonghua Wai Ke Za Zhi 1995;33:652-8. 7. Wang LW, Li ZS, Li SD, et al. Prevalence and clinical features of chronic pancreatitis in China. Pancreas 2009;38:248-54. 8. Raimondi S, Maisonneuve P, Lowenfels AB. Epidemiology of pancreatic cancer: an overview. Nat Rev Gastroenterol Hepatol 2009;6:699-708. 9. Zhu XG, Zhang SD, Huang ZQ. Evolution of gastrointestinal endoscopy in the mainland of China. Chin Med J [English] 2009;122:2220-3.
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Liao et al
10. China Statistical Yearbook 2007. http://www.stats.gov.cn/tjsj/ndsj/ 2007/indexeh.htm. Accessed February 12, 2012. 11. Jamal MM, Yoon EJ, Saadi A, et al. Trends in the utilization of endoscopic retrograde cholangiopancreatography (ERCP) in the United States. Am J Gastroenterol 2007;102:966-75. 12. Williams EJ, Taylor S, Fairclough P, et al. Are we meeting the standards set for endoscopy? Results of a large-scale prospective study of endoscopic practice. Gut 2007;56:796-801. 13. Hilsden RJ, Romagnuolo J, May GR. Patterns of use of endoscopic retrograde cholangiopancreatography in a Canadian province. Can J Gastroenterol 2004;18:619-24. 14. Kapral C, Duller C, Wewalka F, et al. Case volume and outcome of endoscopic retrograde cholangiopancreatography: results of a nationwide Austrian benchmarking project. Endoscopy 2008;40:625-30. 15. Glomsaker T, Søreide K, Aabakken L, et al. A national audit of temporal trends in endoscopic retrograde cholangiopancreatography in Norway. Scand J Gastroenterol 2011;46:116-21. 16. Enochsson L, Swahn F, Arnelo U, et al. Nationwide, population-based data from 11,074 ERCP procedures from the Swedish Registry for Gallstone Surgery and ERCP. Gastrointest Endosc 2010;72:1175-84. 17. Allison MC, Ramanaden DN, Fouweather MG, et al. Provision of ERCP services and training in the United Kingdom. Endoscopy 2000;32:693-9. 18. Liao Z, Li ZS, Leung JW, et al. How safe and successful are live demonstrations of therapeutic ERCP? A large multicenter study. Am J Gastroenterol 2009;104:47-52. 19. Liao Z, Li ZS, Leung JW, et al. Success rate and complications of ERCP performed during hands-on training courses: a multicenter study in China. Gastrointest Endosc 2009;69:230-7. 20. Zhou W, Li Y, Zhang Q, et al. Risk factors for postendoscopic retrograde cholangiopancreatography pancreatitis: a retrospective analysis of 7,168 cases. Pancreatology 2011;11:399-405.
21. Wang P, Li ZS, Liu F, et al. Risk factors for ERCP-related complications: a prospective multicenter study. Am J Gastroenterol 2009;104:31-40. 22. Liao Z, Hu LH, Li ZS, et al. Multidisciplinary team meeting before therapeutic ERCP: a prospective study with 1,909 cases. J Interv Gastroenterol 2011;1:64-9. 23. Cotton PB. Are low-volume ERCPists a problem in the United States? A plea to examine and improve ERCP practice-NOW. Gastrointest Endosc 2011;74:161-6. 24. Su CH, Lui WY, Peng FK. Relative prevalence of gallstone diseases in Taiwan: A nationwide cooperative study. Dig Dis Sci 1992;37:764-8. 25. Cotton PB. Quality endoscopists and quality endoscopy units. J Interv Gastroenterol 2011;1:83-7. 26. Baillie J. Is ERCP headed for extinction? Am J Gastroenterol 2008;103: 1888-90. 27. Verma D, Gostout CJ, Petersen BT, et al. Establishing a true assessment of endoscopic competence in ERCP during training and beyond: a single-operator learning curve for deep biliary cannulation in patients with native papillary anatomy. Gastrointest Endosc 2007;65:394-400. 28. Dumonceau JM, Rigaux J, Kahaleh M, et al. Prophylaxis of post-ERCP pancreatitis: a practice survey. Gastrointest Endosc 2010;71:934-9. 29. Colton JB, Curran CC. Quality indicators, including complications, of ERCP in a community setting: a prospective study. Gastrointest Endosc 2009;70:457-67. 30. Nagar AB. ERCP in the community: the benchmarks have been set. Gastrointest Endosc 2009;70:468-70. 31. Rábago L, Guerra I, Moran M, et al. Is outpatient ERCP suitable, feasible, and safe? The experience of a Spanish community hospital. Surg Endosc 2010;24:1701-6. 32. Coté GA, Keswani RN, Jackson T, et al. Individual and practice differences among physicians who perform ERCP at varying frequency: a national survey. Gastrointest Endosc 2011;74:65-73.
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Appendix 1. The hospital grading system in the mainland China Hospital grading* III
II
I
Definition The number of beds is more than 500, to provide quality specialist in several areas of sexual health services and the implementation of higher education and research tasks The number of beds is between 101 to 500, to provide comprehensive medical and health services to the various communities, commitment to a certain teaching and research mission The number of beds is less than 100, to provide prevention, medical care, health care, rehabilitation to a certain population of the community
*In 2006, 9918 small-scale hospitals did not meet the standard above and thus were not graded, the graded hospitals were further classified into A, B, or C in each grade, based on the hospital’s technical force, management level, equipment condition, research capacity, with the IIIA being the highest grade and IC the lowest. The details are stated in China Statistical Yearbook-2007 (http:// www.stats.gov.cn/tjsj/ndsj/2007/indexeh.htm).
www.giejournal.org
Appendix 2. The distribution of hospitals in the mainland China in 2006 according to the grading Hospital grading
Number
Proportions (%)
IIIA
704
7.09
IIIB
326
3.28
IIIC
15
0.15
IIA
3521
35.44
IIB
2187
22.02
IIC
95
0.96
IA
2563
25.80
IB
430
4.33
IC
93
0.94
Total
9934
100.00
The details are stated in China Statistical Yearbook-2007 (http:// www.stats.gov.cn/tjsj/ndsj/2007/indexeh.htm).
Volume 77, No. 1 : 2013
GASTROINTESTINAL ENDOSCOPY
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