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Efficacy and safety of double-balloon endoscopy-assisted endoscopic papillary large-balloon dilatation for common bile duct stone removal
Digestive and Liver Disease 47 (2015) 401–404
Contents lists available at ScienceDirect
Digestive and Liver Disease journal homepage: www.elsevier.com/locate/dld
Digestive Endoscopy
Efficacy and safety of double-balloon endoscopy-assisted endoscopic papillary large-balloon dilatation for common bile duct stone removal Shuhei Oana ∗ , Sho Shibata, Nozomi Matsuda, Takayuki Matsumoto Division of Gastroenterology, Department of Internal Medicine, Iwate Medical University, Japan
a r t i c l e
i n f o
Article history: Received 15 November 2014 Accepted 10 February 2015 Available online 20 February 2015 Keywords: Double-balloon endoscopy Endoscopic papillary large-balloon dilatation Endoscopic retrograde cholangiopancreatography Roux-en-Y reconstruction
a b s t r a c t Background: Endoscopic retrograde cholangiopancreatography is difficult to perform in patients with gastrointestinal tract reconstruction. Aims: To evaluate the efficacy and safety of double-balloon endoscopy-assisted endoscopic papillary large-balloon dilatation for common bile duct stones in patients with gastrointestinal tract reconstruction. Methods: We conducted a retrospective case series with a comparison to historical controls. During the period 2009–2013, 11 postoperative patients underwent endoscopic papillary large-balloon dilatation (Group A). Procedure efficacy and safety were compared with patients who underwent endoscopic sphincterotomy without endoscopic papillary large-balloon dilatation, who served as historical controls (Group B). Results: Group A consisted of 11 patients (63.6% males, mean age 78 ± 10 years), and Group B consisted of 32 patients (78.1% males, mean age 75 ± 7 years). The stone clearance rate was significantly higher in Group A than in Group B (100% vs. 65.6%, respectively; p < 0.05). Median procedure time was significantly shorter in Group A than in Group B (54 min vs. 102 min, respectively; p < 0.05), and the complication rate was not significantly different between groups (18% vs. 15.6%, respectively; p = 0.586). Conclusion: Endoscopic papillary large-balloon dilatation may be an effective and safe treatment procedure in patients with gastrointestinal tract reconstruction. © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
1. Introduction Endoscopic retrograde cholangiopancreatography (ERCP) is a difficult procedure to perform in patients with gastrointestinal (GI) tract reconstruction, because in those patients the endoscope cannot easily reach the duodenal papilla. The use of double-balloon endoscopy (DBE), which was developed and introduced for hepatobiliary disorders by Yamamoto et al. [1] in 2001, enabled the approach to the duodenal papilla through an anastomosis. Even with the use of DBE, however, therapeutic ERCP for the removal of common bile duct stones remains difficult, because devices for endoscopic mechanical lithotripsy and stone removal specific to forward-viewing endoscopes have not been developed. In 2003, Ersoz et al. [2] introduced the procedure of endoscopic papillary large-balloon dilatation (EPLBD), which has been
shown to be useful for the extraction of stones without crushing. Subsequently, Itoi et al. [3] successfully introduced the EPLBD procedure for the removal of common bile duct stones in patients with a prior Billroth-II gastro-jejunal anastomosis through balloon-assisted endoscopy (BAE). However, there have been few reports of DBE-assisted EPLBD (DBE-EPLBD) for common bile duct stone removal in patients with a Roux-en-Y reconstruction [4]. In the present study, we evaluated the efficacy and safety of DBE-EPLBD for the removal of common bile duct stones in patients with gastrointestinal reconstruction. Also, we compared the therapeutic efficacy of the procedure with that of DBE without EPLBD in a historical control population.
2. Materials and methods ∗ Corresponding author at: Division of Gastroenterology, Department of Internal Medicine, Iwate Medical University, Uchimaru 19-1, Morioka City, Iwate 020-8505, Japan. Tel.: +81 19 651 5111x2314; fax: +81 19 652 6664. E-mail address: [email protected] (S. Oana).
2.1. Study design This is a retrospective case series with a comparison to historical controls.
http://dx.doi.org/10.1016/j.dld.2015.02.006 1590-8658/© 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
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2.2. Subjects From June 2009 to October 2013, at our institution we treated 11 postoperative patients with common bile duct stones with DBEEPLBD (Group A). From November 2004 to October 2011, we treated 32 postoperative patients with common bile duct stones with DBE and without EPLBD (Group B); these patients served as controls for comparison of the therapeutic efficacy and safety of EPLBD. Common bile duct stones were confirmed by computed tomography or magnetic resonance cholangiopancreatography. All patients in both groups had an intact papilla. 2.3. Measurements The results were evaluated based on the following parameters: utilization rate of mechanical lithotripsy, procedure time, singleprocedure stone clearance rate, complication rate, and recurrence. 2.4. Devices and procedures We used short-type DBE (EC-450BI5; Fuji, Tokyo, Japan) under carbon dioxide insufflation to approach the ampulla. For a tip hood, Elastictouch (Top Co., Tokyo, Japan) was used for all cases when performing the enteroscopy part of the procedure. For EPLBD, one of two types of through-the-scope balloon was applied, either a CRE balloon (Boston Scientific, CA, USA) or a Giga balloon (Kaneka Co., Tokyo, Japan). The former balloon ranged from 12 to 15 mm in its largest diameter with a length of 5.5 cm, and the latter ranged from 12 to 14 mm in diameter with a length of 4 cm. For sphincterotomy, Clevercut (Olympus Tokyo) or a double-lumen guided B-II sphincterotome (Cook Medical, CA) was used. The stones were removed from the bile duct with a basket or a balloon catheter (Extracter XL, Boston Scientific, CA). When an impaction of the stone in the duodenal ampulla was suspected, a mechanical lithotriptor (Xemex Crusher Catheter, Zeon Medical, Tokyo) was added for removal. The procedure for EPLBD was the following (Figs. 1 and 2): (a) to confirm the presence of a common bile duct stone, we first cannulated the duodenal papilla and performed ERCP in a standard manner; (b) after the existence of a stone was confirmed, the condition was rated from minor to moderate, and endoscopic sphincterotomy was carried out before EPLBD in all patients; (c) a large balloon catheter was positioned across the main duodenal papilla; (d) the balloon was dilated with a pressure great enough to obtain the largest inflation for 1 min. The size of the balloon was chosen on the basis of the diameter of the stone and the transverse diameter of the dilated bile duct to avoid bile duct perforation. 2.5. Assessment All the following parameters were then reviewed: the size and the number of extracted stones, the advisability of the balloonexpanded diameter up to the bile duct transverse diameter, the utilization of mechanical lithotripsy, the success of stone clearance in a single procedure, as well as the procedure time, complications, and subsequent clinical course. Adverse events were classified as pancreatitis, bleeding, perforation, and others. Post-ERCP pancreatitis (PEP) was defined according to the Cotton classification. 2.6. Statistical analyses Statistical analyses were carried out with SPSS version 11.0J software (SPSS Inc., Chicago, IL, USA). The significance of differences in categorical variables was determined either with a chi-square test or Fisher’s exact test. Quantitative data were analyzed either by the unpaired Student’s t test or Mann–Whitney test, and are presented
as mean ± SD. A p value below 0.05 was regarded as statistically significant. 3. Results Group A consisted of 11 patients (63.6% males, mean age 78 ± 10 years), and Group B consisted of 32 patients (78.1% males, mean age 75 ± 7 years). In Group A, 10 patients had a Rouxen-Y reconstruction and one had a Billroth-II reconstruction; in Group B, 27 patients had a Roux-en-Y reconstruction and 5 had a Billroth-II reconstruction. All patients had an intact papilla; subjects with hepaticojejunostomy were not enrolled. Eight patients had not undergone cholecystectomy, and one had gallbladder stones. Table 1 shows the demographical data and the results of the procedures for patients who underwent DBE-EPLBD (Group A) and those who underwent DBE without EPLBD (Group B). Patients’ age and gender, as well as type of intestinal reconstruction did not differ between the two Groups. In Group A, we could reach the papilla to apply the balloon dilatation in all patients. The size of the balloon was 15 mm for 5 patients, 13 mm for 3 patients, and 12 mm, 13.5 mm, and 14 mm for 1 patient each. While we were able to dilate the balloon to the diameter of the bile duct in 10 patients, such a dilatation could not be achieved in the remaining patient, who had a tightly bent bile duct. The mean number of stones extracted was not significantly different between groups (Group A: n = 2, range, 1–3 vs. Group B: n = 1.6, range 1–6). Both groups had similar mean stone diameters (Group A: 12 ± 4.9 mm vs. Group B: 11.3 ± 4.5 mm, p = 0.061). The utilization rate of mechanical lithotripsy was significantly lower in Group A than in Group B (18% vs. 53%, respectively; p = 0.046). The stone clearance rate was significantly higher in Group A than in Group B (100% vs. 65.6%, respectively; p < 0.05). Furthermore, the median procedure time was significantly shorter in Group A than in Group B (52 ± 27 min vs. 101.6 ± 45.6 min, respectively; p < 0.05). The complication rate was not significantly different between Group A and Group B (18% vs. 15.6%, respectively; p = 0.586). No serious complications occurred in Group A, despite two patients experienced post-ERCP pancreatitis of moderate severity. Complications occurred in five patients in Group B: three patients developed post-ERCP pancreatitis of mild to moderate severity, one of the remaining patients had perforation, and the other had retroperitoneal emphysema. The incidence of stone recurrence was not significantly different between Group A and Group B (1 vs. 0, respectively; p = 0.256). After a mean follow-up period of 528 days, only in 1 patient the dilation of the balloon to the diameter of the common bile duct could not be achieved during the initial DBE-EPLBD. 4. Discussion Management of CBD stones remains a challenging issue for patients with intestinal reconstruction. Since the introduction of DBE, ERCP-related intervention therapy has become possible for patients with GI tract reconstruction who have an intact papilla, such as patients who have undergone B-II and RY anastomosis [5–9]. Nevertheless, extraction of CBD stones remains problematic because of the technical difficulties in cannulation and sphincterotomy for an intact papilla with a forward-viewing endoscope [10]. In addition, the small diameter of the working channel of DBE (2.8 mm or 3.2 mm) does not easily allow for the application of commercially available devices, such as wire-guided mechanical lithotripsy and the basket catheter. At present, the Crusher Catheter is the only mechanical lithotripter applicable to DBE. However, the catheter should be
S. Oana et al. / Digestive and Liver Disease 47 (2015) 401–404
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Fig. 1. Double-balloon endoscopy assisted endoscopic retrograde cholangiopancreatography with endoscopic papillary large-balloon dilatation in a patient with a Roux-en-Y anastomosis. Panel A: Cholangiography depicts a small bile duct stone. Panel B: The ampulla is dilated by endoscopic papillary large-balloon dilatation with a 15-mm balloon. The balloon is notched at the site of the ampulla.
inserted repeatedly with a guide wire for the extraction of multiple CBD stones, and presents difficulties in insertion through the axis of the CBD. While Shimatani et al. [10,11] collected a large number of cases of patients with intestinal reconstruction examined by DBEERCP and found success rates of 97% for deep cannulation and 98% for cholangiography, the success rate of CBD stone extraction with DBE has been unsatisfactory, as found in our historical controls. In 2003, Ersoz et al. [2] introduced EPLBD for the treatment of CBD stones in 58 patients without intestinal reconstruction. They reported a success rate of 83% in the extraction of stones, with a
need for mechanical lithotripsy in only 7%. Subsequently, EPLBD has been used in various clinical trials for the treatment of CBD stones in patients without intestinal reconstruction. These clinical observations have indicated that the success rate of stone extraction in a single attempt ranged from 83% to 100%, with a need for mechanical lithotripsy in 0–39% of the cases [2,12–16]. Furthermore, the complication rate of the procedure is not very high (range 4–16%). In a prospective, randomized study for patients with CBD stones without prior intestinal reconstruction, Stefanidis et al. [14] have shown that EPLBD resulted in extraction of fewer crushed stones,
Fig. 2. Procedures for endoscopic papillary large-balloon dilatation in the patient shown in Fig. 1. Panel A: The papilla is identified. Panel B: A minimal endoscopic sphincterotomy is added. Panel C: A 15-mm balloon catheter is inserted through the papilla. The balloon is under insufflation. Panel D: After endoscopic papillary large-balloon dilatation, the papilla is dilated.
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Table 1 Comparison of demographics, efficacy, and safety in patients who underwent double-balloon endoscopy with (Group A) and without (Group B) endoscopic papillary largeballoon dilatation. Group A (n = 11) Age, years Male, gender (%) Type of surgery (%) R-Y B-II Number of stones (range) Diameter of stone, mm Utilization rate of mechanical lithotripsy (%) Procedure time, min Technical success rate in a single procedure (%) Complications (%) Stone recurrence (%)
78 ± 10 7 (63.6)
Group B (n = 32) 75 ± 7 25 (78.1)
10 (90.9) 1 2 (1–3) 12 ± 4.9 2 (18.2) 52 ± 27 11 (100) 2 (18.2) 1 (9.1)
27 (78.1) 5 1.6 (1–6) 11.3 ± 4.5 17 (53.1) 101.6 ± 45.6 21 (65.6) 5 (15.6) 0 (0)
p value 0.201 0.284 0.512
0.4 0.061 0.046 0.0001 0.022 0.586 0.256
Continuous variables are reported as mean ± standard deviation. DBE: double-balloon endoscopy; EPLBD: endoscopic papillary large-balloon dilatation; R-Y: Roux-en-Y reconstruction; B-II: Billroth-II reconstruction.
with less intervention time and less use of mechanical lithotripsy. To date, however, there have been few attempts to investigate the application of EPLBD for patients with intestinal reconstruction [3,4,17]. The results of our retrospective analysis indicate that even in patients with intestinal reconstruction EPLBD resulted in a higher success rate for the extraction of stones and a shorter examination time than mechanical lithotripsy without EPLBD. Since all the procedures, for both DBE-EPLBD and DBE without EPLBD, were performed by the same endoscopist, the possible effect of a difference in experience seems to be small. The better performance of EPLBD in patients with intestinal reconstruction may be explained by the avoidance of impaction of the stones at the papilla. In fact, in our case series, simply pulling back the balloon catheter into the duodenal lumen without the use of mechanical lithotripsy occasionally resulted in the extraction of the stones. Itoi et al. [4] recently applied EPLBD together with mechanical lithotripsy in 15 patients with a Roux-en-Y anastomosis with single-balloon endoscopy (SBE), and reported a success rate of 100% without any crushed stones and a complication rate of 0%. While it remains obscure whether DBE or SBE is more appropriate for EPLBD in patients with intestinal reconstruction, it seems likely that EPLBD should be seriously considered for post-operative patients with CBD stones. Thus, the development of easily applicable devices for EPLBD with BAE is highly warranted. There are several limitations in the interpretation of this retrospective analysis. First, we could not take into account the learning curves, especially for cases of EPLBD. Since the endoscopist was familiar with non-EPLBD procedures, we may have underestimated the applicability of EPLBD in our analysis. Second, the retrospective nature of this investigation seems to be a source of differences in demographics of the study population. Therefore, a prospective multi-centre clinical trial is mandatory to show the efficacy of EPLBD in patients with intestinal reconstruction. In conclusion, our retrospective analysis of patients with intestinal reconstruction and CBD stones suggests that EPLBD coupled with a DBE-assisted approach and ERCP may be an effective alternative for the extraction of stones with respect to success rate and examination time. Because of the small sample size, clinical trials with larger numbers of patients should be carried out to confirm the efficacy of the procedure. Conflict of interest None declared.
References [1] Yamamoto H, Sekine Y, Sato Y, et al. Total enteroscopy with a nonsurgical steerable double-balloon methodsteerable double-balloon method. Gastrointest Endoscopy 2001;53:216–20. [2] Ersoz G, Tekesin O, Ozutemiz AO. Biliary sphincterotomy plus dilation with a large balloon for bile duct stones that are difficult to extract. Gastrointest Endoscopy 2003;57:156–9. [3] Itoi T, Ishii K, Itokawa F, et al. Large balloon papillary dilation for removal of bile duct stones in patients who have undergone a billroth II gastrectomy. Digestive Endoscopy 2010;22:98–102. [4] Itoi T, Ishii K, Sofuni A, et al. Large balloon dilatation following endoscopic sphincterotomy using a balloon enteroscope for the bile duct stone extractions in patients with Roux-en-Y anastomosis. Digestive and Liver Disease 2011;43:237–41. [5] Aabakken L, Bretthauer M, Line PD, et al. Double-balloon enteroscopy for endoscopic retrograde cholangiography in patients with a Roux-en-Y anastomosis. Endoscopy 2007;39:1068–71. [6] Masser C, Lenze F, Bokemeyer M, et al. Double balloon enteroscopy: a useful tool for diagnostic and therapeutic procedures in the pancreaticobiliary system. American Journal of Gastroenterology 2008;103:894–900. [7] Mönkemüller K, Bellutti M, Neumann H, et al. Thrapeutic ERCP with the doubleballoon enteroscope in patients with Roux-en-Y anastomosis. Gastrointest Endoscopy 2008;67:992–6. [8] Maaser C, Lenze F, Bokemeyer M, et al. Double balloon enterscopy. A useful tool for diagnostic and therapeutic procedures in the pancreaticobiliary system. American Journal of Gastroenterology 2008;103:894–900. [9] Cho S, Kamalaporn P, Kandel G, et al. ‘Short’ double-balloon enteroscope for endoscopic retrograde cholangiopancreatography in patients with a surgically altered upper gastrointestinal tract. Canadian Journal of Gastroenterology 2011;25:615–9. [10] Shimatani M, Matsushita M, Takaoka M, et al. Effective “short” double-balloon enteroscope for diagnositic and therapeutic ERCP in patients with altered gastrointestinal anatomy: a large cases serise. Endoscopy 2009;41:849–54. [11] Shimatani M, Takaoka M, Okazaki K, et al. Tips for double balloon enteroscopy in patients with Roux-en-Y reconstruction and modified child surgery. Journal of Hepato-Biliary-Pancreatic Sciences 2014;21:22–8. [12] Lee DK, Lee BJ, Hwhang SJ, et al. Endoscopic papillary large balloon dilatation after endoscopic sphincterotomy for treatment of large common bile duct stone. Digestive Endoscopy 2007;19:52–6. [13] Itoi T, Itokawa F, Sofuni A, et al. Endoscopic sphincterotomy combined with large balloon dilatation can reduce the procedure time and fluoroscopy time for removal of large bile duct stiones. American Journal of Gastroenterology 2009;104:560–5. [14] Stefanidis G, Viazis N, Pleskow D, et al. Large balloon dilatation vs. mechanical lithotripsy for the management of large bile duct stones: a prospective randomized study. American Journal of Gastroenterology 2011;106:278–85. [15] Yang XM, Hu B, Pan YM, et al. Endoscopic papillary large-balloon dilatation following limited sphincterotomy for the removal of refractory bile duct stones: experience of 169 cases in a single Chinese center. Journal of Digestive Diseases 2013;14:125–31. [16] Kim JH, Yang MJ, Hwang JC, et al. Endoscopic papillary large balloon dilatation for the removal of bile duct stones. World Journal of Gastroenterology 2013;19:8580–94. [17] Jang HW, Lee KJ, Jung MJ, et al. Endoscopic large balloon dilatation alone is safe and effective for the treatment of difficult chloedocholithiasis Billroth II gastrectomy: a single center experience. Digestive Diseases and Sciences 2013;58:1737–43.
Contents lists available at ScienceDirect
Digestive and Liver Disease journal homepage: www.elsevier.com/locate/dld
Digestive Endoscopy
Efficacy and safety of double-balloon endoscopy-assisted endoscopic papillary large-balloon dilatation for common bile duct stone removal Shuhei Oana ∗ , Sho Shibata, Nozomi Matsuda, Takayuki Matsumoto Division of Gastroenterology, Department of Internal Medicine, Iwate Medical University, Japan
a r t i c l e
i n f o
Article history: Received 15 November 2014 Accepted 10 February 2015 Available online 20 February 2015 Keywords: Double-balloon endoscopy Endoscopic papillary large-balloon dilatation Endoscopic retrograde cholangiopancreatography Roux-en-Y reconstruction
a b s t r a c t Background: Endoscopic retrograde cholangiopancreatography is difficult to perform in patients with gastrointestinal tract reconstruction. Aims: To evaluate the efficacy and safety of double-balloon endoscopy-assisted endoscopic papillary large-balloon dilatation for common bile duct stones in patients with gastrointestinal tract reconstruction. Methods: We conducted a retrospective case series with a comparison to historical controls. During the period 2009–2013, 11 postoperative patients underwent endoscopic papillary large-balloon dilatation (Group A). Procedure efficacy and safety were compared with patients who underwent endoscopic sphincterotomy without endoscopic papillary large-balloon dilatation, who served as historical controls (Group B). Results: Group A consisted of 11 patients (63.6% males, mean age 78 ± 10 years), and Group B consisted of 32 patients (78.1% males, mean age 75 ± 7 years). The stone clearance rate was significantly higher in Group A than in Group B (100% vs. 65.6%, respectively; p < 0.05). Median procedure time was significantly shorter in Group A than in Group B (54 min vs. 102 min, respectively; p < 0.05), and the complication rate was not significantly different between groups (18% vs. 15.6%, respectively; p = 0.586). Conclusion: Endoscopic papillary large-balloon dilatation may be an effective and safe treatment procedure in patients with gastrointestinal tract reconstruction. © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
1. Introduction Endoscopic retrograde cholangiopancreatography (ERCP) is a difficult procedure to perform in patients with gastrointestinal (GI) tract reconstruction, because in those patients the endoscope cannot easily reach the duodenal papilla. The use of double-balloon endoscopy (DBE), which was developed and introduced for hepatobiliary disorders by Yamamoto et al. [1] in 2001, enabled the approach to the duodenal papilla through an anastomosis. Even with the use of DBE, however, therapeutic ERCP for the removal of common bile duct stones remains difficult, because devices for endoscopic mechanical lithotripsy and stone removal specific to forward-viewing endoscopes have not been developed. In 2003, Ersoz et al. [2] introduced the procedure of endoscopic papillary large-balloon dilatation (EPLBD), which has been
shown to be useful for the extraction of stones without crushing. Subsequently, Itoi et al. [3] successfully introduced the EPLBD procedure for the removal of common bile duct stones in patients with a prior Billroth-II gastro-jejunal anastomosis through balloon-assisted endoscopy (BAE). However, there have been few reports of DBE-assisted EPLBD (DBE-EPLBD) for common bile duct stone removal in patients with a Roux-en-Y reconstruction [4]. In the present study, we evaluated the efficacy and safety of DBE-EPLBD for the removal of common bile duct stones in patients with gastrointestinal reconstruction. Also, we compared the therapeutic efficacy of the procedure with that of DBE without EPLBD in a historical control population.
2. Materials and methods ∗ Corresponding author at: Division of Gastroenterology, Department of Internal Medicine, Iwate Medical University, Uchimaru 19-1, Morioka City, Iwate 020-8505, Japan. Tel.: +81 19 651 5111x2314; fax: +81 19 652 6664. E-mail address: [email protected] (S. Oana).
2.1. Study design This is a retrospective case series with a comparison to historical controls.
http://dx.doi.org/10.1016/j.dld.2015.02.006 1590-8658/© 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
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2.2. Subjects From June 2009 to October 2013, at our institution we treated 11 postoperative patients with common bile duct stones with DBEEPLBD (Group A). From November 2004 to October 2011, we treated 32 postoperative patients with common bile duct stones with DBE and without EPLBD (Group B); these patients served as controls for comparison of the therapeutic efficacy and safety of EPLBD. Common bile duct stones were confirmed by computed tomography or magnetic resonance cholangiopancreatography. All patients in both groups had an intact papilla. 2.3. Measurements The results were evaluated based on the following parameters: utilization rate of mechanical lithotripsy, procedure time, singleprocedure stone clearance rate, complication rate, and recurrence. 2.4. Devices and procedures We used short-type DBE (EC-450BI5; Fuji, Tokyo, Japan) under carbon dioxide insufflation to approach the ampulla. For a tip hood, Elastictouch (Top Co., Tokyo, Japan) was used for all cases when performing the enteroscopy part of the procedure. For EPLBD, one of two types of through-the-scope balloon was applied, either a CRE balloon (Boston Scientific, CA, USA) or a Giga balloon (Kaneka Co., Tokyo, Japan). The former balloon ranged from 12 to 15 mm in its largest diameter with a length of 5.5 cm, and the latter ranged from 12 to 14 mm in diameter with a length of 4 cm. For sphincterotomy, Clevercut (Olympus Tokyo) or a double-lumen guided B-II sphincterotome (Cook Medical, CA) was used. The stones were removed from the bile duct with a basket or a balloon catheter (Extracter XL, Boston Scientific, CA). When an impaction of the stone in the duodenal ampulla was suspected, a mechanical lithotriptor (Xemex Crusher Catheter, Zeon Medical, Tokyo) was added for removal. The procedure for EPLBD was the following (Figs. 1 and 2): (a) to confirm the presence of a common bile duct stone, we first cannulated the duodenal papilla and performed ERCP in a standard manner; (b) after the existence of a stone was confirmed, the condition was rated from minor to moderate, and endoscopic sphincterotomy was carried out before EPLBD in all patients; (c) a large balloon catheter was positioned across the main duodenal papilla; (d) the balloon was dilated with a pressure great enough to obtain the largest inflation for 1 min. The size of the balloon was chosen on the basis of the diameter of the stone and the transverse diameter of the dilated bile duct to avoid bile duct perforation. 2.5. Assessment All the following parameters were then reviewed: the size and the number of extracted stones, the advisability of the balloonexpanded diameter up to the bile duct transverse diameter, the utilization of mechanical lithotripsy, the success of stone clearance in a single procedure, as well as the procedure time, complications, and subsequent clinical course. Adverse events were classified as pancreatitis, bleeding, perforation, and others. Post-ERCP pancreatitis (PEP) was defined according to the Cotton classification. 2.6. Statistical analyses Statistical analyses were carried out with SPSS version 11.0J software (SPSS Inc., Chicago, IL, USA). The significance of differences in categorical variables was determined either with a chi-square test or Fisher’s exact test. Quantitative data were analyzed either by the unpaired Student’s t test or Mann–Whitney test, and are presented
as mean ± SD. A p value below 0.05 was regarded as statistically significant. 3. Results Group A consisted of 11 patients (63.6% males, mean age 78 ± 10 years), and Group B consisted of 32 patients (78.1% males, mean age 75 ± 7 years). In Group A, 10 patients had a Rouxen-Y reconstruction and one had a Billroth-II reconstruction; in Group B, 27 patients had a Roux-en-Y reconstruction and 5 had a Billroth-II reconstruction. All patients had an intact papilla; subjects with hepaticojejunostomy were not enrolled. Eight patients had not undergone cholecystectomy, and one had gallbladder stones. Table 1 shows the demographical data and the results of the procedures for patients who underwent DBE-EPLBD (Group A) and those who underwent DBE without EPLBD (Group B). Patients’ age and gender, as well as type of intestinal reconstruction did not differ between the two Groups. In Group A, we could reach the papilla to apply the balloon dilatation in all patients. The size of the balloon was 15 mm for 5 patients, 13 mm for 3 patients, and 12 mm, 13.5 mm, and 14 mm for 1 patient each. While we were able to dilate the balloon to the diameter of the bile duct in 10 patients, such a dilatation could not be achieved in the remaining patient, who had a tightly bent bile duct. The mean number of stones extracted was not significantly different between groups (Group A: n = 2, range, 1–3 vs. Group B: n = 1.6, range 1–6). Both groups had similar mean stone diameters (Group A: 12 ± 4.9 mm vs. Group B: 11.3 ± 4.5 mm, p = 0.061). The utilization rate of mechanical lithotripsy was significantly lower in Group A than in Group B (18% vs. 53%, respectively; p = 0.046). The stone clearance rate was significantly higher in Group A than in Group B (100% vs. 65.6%, respectively; p < 0.05). Furthermore, the median procedure time was significantly shorter in Group A than in Group B (52 ± 27 min vs. 101.6 ± 45.6 min, respectively; p < 0.05). The complication rate was not significantly different between Group A and Group B (18% vs. 15.6%, respectively; p = 0.586). No serious complications occurred in Group A, despite two patients experienced post-ERCP pancreatitis of moderate severity. Complications occurred in five patients in Group B: three patients developed post-ERCP pancreatitis of mild to moderate severity, one of the remaining patients had perforation, and the other had retroperitoneal emphysema. The incidence of stone recurrence was not significantly different between Group A and Group B (1 vs. 0, respectively; p = 0.256). After a mean follow-up period of 528 days, only in 1 patient the dilation of the balloon to the diameter of the common bile duct could not be achieved during the initial DBE-EPLBD. 4. Discussion Management of CBD stones remains a challenging issue for patients with intestinal reconstruction. Since the introduction of DBE, ERCP-related intervention therapy has become possible for patients with GI tract reconstruction who have an intact papilla, such as patients who have undergone B-II and RY anastomosis [5–9]. Nevertheless, extraction of CBD stones remains problematic because of the technical difficulties in cannulation and sphincterotomy for an intact papilla with a forward-viewing endoscope [10]. In addition, the small diameter of the working channel of DBE (2.8 mm or 3.2 mm) does not easily allow for the application of commercially available devices, such as wire-guided mechanical lithotripsy and the basket catheter. At present, the Crusher Catheter is the only mechanical lithotripter applicable to DBE. However, the catheter should be
S. Oana et al. / Digestive and Liver Disease 47 (2015) 401–404
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Fig. 1. Double-balloon endoscopy assisted endoscopic retrograde cholangiopancreatography with endoscopic papillary large-balloon dilatation in a patient with a Roux-en-Y anastomosis. Panel A: Cholangiography depicts a small bile duct stone. Panel B: The ampulla is dilated by endoscopic papillary large-balloon dilatation with a 15-mm balloon. The balloon is notched at the site of the ampulla.
inserted repeatedly with a guide wire for the extraction of multiple CBD stones, and presents difficulties in insertion through the axis of the CBD. While Shimatani et al. [10,11] collected a large number of cases of patients with intestinal reconstruction examined by DBEERCP and found success rates of 97% for deep cannulation and 98% for cholangiography, the success rate of CBD stone extraction with DBE has been unsatisfactory, as found in our historical controls. In 2003, Ersoz et al. [2] introduced EPLBD for the treatment of CBD stones in 58 patients without intestinal reconstruction. They reported a success rate of 83% in the extraction of stones, with a
need for mechanical lithotripsy in only 7%. Subsequently, EPLBD has been used in various clinical trials for the treatment of CBD stones in patients without intestinal reconstruction. These clinical observations have indicated that the success rate of stone extraction in a single attempt ranged from 83% to 100%, with a need for mechanical lithotripsy in 0–39% of the cases [2,12–16]. Furthermore, the complication rate of the procedure is not very high (range 4–16%). In a prospective, randomized study for patients with CBD stones without prior intestinal reconstruction, Stefanidis et al. [14] have shown that EPLBD resulted in extraction of fewer crushed stones,
Fig. 2. Procedures for endoscopic papillary large-balloon dilatation in the patient shown in Fig. 1. Panel A: The papilla is identified. Panel B: A minimal endoscopic sphincterotomy is added. Panel C: A 15-mm balloon catheter is inserted through the papilla. The balloon is under insufflation. Panel D: After endoscopic papillary large-balloon dilatation, the papilla is dilated.
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Table 1 Comparison of demographics, efficacy, and safety in patients who underwent double-balloon endoscopy with (Group A) and without (Group B) endoscopic papillary largeballoon dilatation. Group A (n = 11) Age, years Male, gender (%) Type of surgery (%) R-Y B-II Number of stones (range) Diameter of stone, mm Utilization rate of mechanical lithotripsy (%) Procedure time, min Technical success rate in a single procedure (%) Complications (%) Stone recurrence (%)
78 ± 10 7 (63.6)
Group B (n = 32) 75 ± 7 25 (78.1)
10 (90.9) 1 2 (1–3) 12 ± 4.9 2 (18.2) 52 ± 27 11 (100) 2 (18.2) 1 (9.1)
27 (78.1) 5 1.6 (1–6) 11.3 ± 4.5 17 (53.1) 101.6 ± 45.6 21 (65.6) 5 (15.6) 0 (0)
p value 0.201 0.284 0.512
0.4 0.061 0.046 0.0001 0.022 0.586 0.256
Continuous variables are reported as mean ± standard deviation. DBE: double-balloon endoscopy; EPLBD: endoscopic papillary large-balloon dilatation; R-Y: Roux-en-Y reconstruction; B-II: Billroth-II reconstruction.
with less intervention time and less use of mechanical lithotripsy. To date, however, there have been few attempts to investigate the application of EPLBD for patients with intestinal reconstruction [3,4,17]. The results of our retrospective analysis indicate that even in patients with intestinal reconstruction EPLBD resulted in a higher success rate for the extraction of stones and a shorter examination time than mechanical lithotripsy without EPLBD. Since all the procedures, for both DBE-EPLBD and DBE without EPLBD, were performed by the same endoscopist, the possible effect of a difference in experience seems to be small. The better performance of EPLBD in patients with intestinal reconstruction may be explained by the avoidance of impaction of the stones at the papilla. In fact, in our case series, simply pulling back the balloon catheter into the duodenal lumen without the use of mechanical lithotripsy occasionally resulted in the extraction of the stones. Itoi et al. [4] recently applied EPLBD together with mechanical lithotripsy in 15 patients with a Roux-en-Y anastomosis with single-balloon endoscopy (SBE), and reported a success rate of 100% without any crushed stones and a complication rate of 0%. While it remains obscure whether DBE or SBE is more appropriate for EPLBD in patients with intestinal reconstruction, it seems likely that EPLBD should be seriously considered for post-operative patients with CBD stones. Thus, the development of easily applicable devices for EPLBD with BAE is highly warranted. There are several limitations in the interpretation of this retrospective analysis. First, we could not take into account the learning curves, especially for cases of EPLBD. Since the endoscopist was familiar with non-EPLBD procedures, we may have underestimated the applicability of EPLBD in our analysis. Second, the retrospective nature of this investigation seems to be a source of differences in demographics of the study population. Therefore, a prospective multi-centre clinical trial is mandatory to show the efficacy of EPLBD in patients with intestinal reconstruction. In conclusion, our retrospective analysis of patients with intestinal reconstruction and CBD stones suggests that EPLBD coupled with a DBE-assisted approach and ERCP may be an effective alternative for the extraction of stones with respect to success rate and examination time. Because of the small sample size, clinical trials with larger numbers of patients should be carried out to confirm the efficacy of the procedure. Conflict of interest None declared.
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