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Multiple Endoscopic Biopsies in Research Subjects: Safety Results from An NIH Series
Abstracts
tertiary referral center. Results: 28 patients (acute pancreatitis (18), chronic pancreatitis (10)) received endoscopic ultrasound-guided drainage of 32 fluid collections (median largest diameter: 8 cm (range: 4-31) including 12 abscesses, 9 infected and 1 sterile necrosis, 5 acute fluid collections/pseudocysts, and 5 chronic pseudocysts. Drainage type: Transgastric (28), transduodenal (4). Median diameter of transmural stoma: 15 mm (6-20). Median number of endoscopic procedures: 6 (1-10). Complete resolution of collection: 26/28 patients (93%). Complications: Secondary infection (4), bleeding (3), pneumoperitoneum (4), stent migration (1). Treatment failures: 2. Median duration of hospitalization after drainage: 20 days (771) for acute pancreatitis, 11 days (4-105) for chronic pancreatitis. Conclusion: Endoscopic ultrasound-guided, transmural drainage of pancreatic fluid collections, including endoscopic necrosectomy, is a minimally invasive, effective, and safe treatment option in complicated pancreatitis.
W1428 Multiple Endoscopic Biopsies in Research Subjects: Safety Results from An NIH Series Michael D. Yao, Erik C. Von Rosenvinge, Catherine Groden, Peter Mannon Background: Routine endoscopic mucosal biopsies are generally considered safe. Major complications such as serious bleeding or perforation are uncommon. However, the risks of performing large numbers of biopsies often restricted to limited areas of the bowel have not been reported. These data can provide guidance to investigators and Ethics Committees when considering research study design and informed consent. Aim: To assess the safety of taking numerous (e.g. O20) mucosal biopsies during endoscopic procedures in research subjects. Patients & Methods: A retrospective chart review of patients who underwent research endoscopies with large numbers of biopsies at the National Institutes of Health (NIH) from 2001-2007 was performed. Eligible subjects included patients with Crohn’s disease, ulcerative colitis, HIV, Hermansky-Pudlak syndrome, and healthy volunteers. Charts were reviewed for demographics, underlying disease, number and location of biopsies, incidence of polypectomy, use of non-steroidal anti-inflammatory drugs (NSAIDS), and presence of procedure-related major/minor complications. Major complications were defined as: perforation; bleeding requiring repeat endoscopy, hospitalization or transfusion; sepsis; myocardial infarction; and death. Bleeding not meeting major criteria and pain were classified as minor complications. Statistical analysis was performed using t-test and chisquare test. Results: A total of 240 research endosopies were performed on 123 patients (80 male, 43 female; mean age 39, range 14-66): 160 colonoscopies, 60 sigmoidoscopies, and 20 upper endoscopies. The majority of patients (85.8% of procedures) had documented protocol-related hospitalization, telephone follow-up, and/or an outpatient visit within 30 days of the procedure. A total of 8992 biopsies were taken for research and histopathology (mean 37.5/procedure, range 13-85). The average number of research biopsies per segment were 24.1 duodenal, 28.7 terminal ileal, and 25.8 random colonic, or 24.7 recto-sigmoid. No major complications were identified. Minor complications occurred with 12 lower endoscopic procedures (5.0%) and included bleeding (4), pain (4), or both (4), resolving quickly. There was no statistically significant correlation between the number of biopsies, type of procedure, location of research biopsies, incidence of polypectomy, or the use of NSAIDS and the risk of complications. Conclusion: This is the first report on the safety of performing numerous endoscopic biopsies in research subjects. This practice is safe, well-tolerated, and does not add appreciably to the risk of research endoscopies.
W1429 Clinical Efficacy of Endoscopic Submucosal Dissection in Patients with Comorbid Diseases Beom Jin Kim, Jae J. Kim, Byung-Hoon Min, Won Kyoung Yun, Hoi Jin Kim, Jun Haeng Lee, Dong Kyung Chang, Young-Ho Kim, Hee Jung Son, Poong-Lyul Rhee, Jong Chul Rhee, Kyung Mi Kim, Cheol Keun Park Background/Aim: Endoscopic submucosal dissection(ESD) is a new method for the curative treatment of gastrointestinal neoplasm. Increased operation time and complication risks with ESD compared with EMR remain problematic. The aim of the present study is to evaluate the efficacy and safety of ESD in patients with comorbid diseases. Methods: From April 2003 through December 2006, 306 patients treated by ESD for early gastric cancer at Samsung Medical Center were retrospectively analyzed. They were categorized as low risk group (score 0) and high risk group (score 1-4) according to Charlson comorbidity scale which has been used to estimate the risk of death from comorbid diseases in oncologic condition. Location, size, depth of invasion, procedure time, complete en bloc resection rate, complication, recurrence of high risk group were compared with those of low risk group. Results: Seventy seven patients had high risk diseases listed in Charlson’s comorbidity scale and 229 patients had none or low risk diseases. The mean age of high risk group was 65.8 yr whereas that of low risk group was 60.9 yr (p ! 0.001). There were no significant differences in the location, size, depth of invasion, procedure time between the two groups (p O 0.05). There were no significant difference in the complete en bloc resection rate, complication and recurrence rate between the two groups (p O 0.05). Conclusion: ESD could be a safe and effective treatment for early gastric cancer in patients with comorbid diseases.
www.giejournal.org
W1430 Prolonged Intestinal Transit: An Important Factor in NonObstructive Capsule Retention Nam Q. Nguyen, Margaret Allen, Kenneth F. Binmoeller Introduction: Approximately 15-20% of small intestine (SI) examinations by capsule enteroscopy (CE) are incomplete and a significant proportion of these are not related to stricture or short battery life [Rondonotti et al. GIE 2005]. Whilst repeated capsule examination in these patients poses significant cost to the health care system, little is known about the underlying causes of non-obstructive capsule retention. Aim: To evaluate factors that may be responsible for incomplete SI examination that is not related to structural obstruction or short battery life. Methods: Data of all patients who referred to our Unit for SI examination by CE over 12 months were reviewed. Patients who had (i) an incomplete SI examination (defined by failure of the capsule to reach the colon), (ii) spontaneous capsule excretion within 2 weeks (confirmed with abdominal X-ray), and (iii) a normal battery life (w8h) were identified. Demographics, co-morbidities, medications, gastric and SI transit time were compared to patients who had a successfully completed CE examination. Results: Of the 24 (26%) patients who had incompleted SI examination, 19 (20%) were not related to stricture or short battery life. Completed SI examination was achieved in 69 (74%) patients. Compared to patients who completed capsule study, SI transit time (486 16 vs. 220 11 min, P ! 0.0001) but not gastric transit time (74 16 vs. 61 6 min, P Z 0.40) was significantly prolonged in patients with non-obstructive capsule retention. While there was no difference in gender (11M:8F vs. 30M:39F, P Z 0.30) between the groups, patients with non-obstructive capsule retention were more likely to have (i) chronic renal failure (RR Z 3.6, P Z 0.001), (ii) diabetes mellitus (DM) (RR Z 2.5, P Z 0.03), (iii) cardio-vascular disease (RR Z 2.3, P Z 0.04), (iv) greater than 3 co-morbidities (RR Z 3.3, P Z 0.05), (iv) on beta-blocker medication (RR Z 3.8, P Z 0.0004) and (v) older age (68.4 3.6 vs. 59.7 2.4 yr, P Z 0.05). In DM, both gastric (95 24 vs. 53 5 min, P Z 0.02) and SI (300 36 vs. 224 13 min, P Z 0.01) transit time were significantly longer than non-DM. Overall, SI transit time was correlated positively with age (r Z 0.25, P Z 0.02) and the number of co-morbidities (r Z 0.32, P Z 0.002). Conclusion: Small intestinal but not gastric transit time is significantly prolonged in patients with non-obstructive capsule, which is associated with older age, DM, chronic renal insufficiency, cardiovascular disease, multiple co-morbidities and on beta-blocker medication. Pre-emptive use of prokinetic agents to reduce SI transit time in ‘‘at-risk’’ patients may minimize the need for repeated capsule study and reduce health care cost.
W1431 Nasal Vs Oro-Nasal Oxygenation and Capnography During Endoscopy Sanjay Ramrakha, Thomas J. Borody, Kylie J. Herdman, Jordana Campbell, Loraine Holley Background: Oxygenation during upper endoscopy reduces cardio-respiratory complications. Capnography detects hypoventilation and apnoea. This study compared efficiency of oxygen delivery and reliability of CO2 detection using either a nasal cannula (NC) or the new, dual oro-nasal (ON) oxygenating device (TwinguardTM) during upper GI endoscopic examination. Design: Ethics approved, prospective, parallel, open labelled, randomised trial in 150 patients undergoing routine upper endoscopy. Oxygen was administered to deeply sedated, spontaneously breathing patients at 4 L/min either via NC or ON when oxygen saturation (SatO2) fell below 90%. Levels of sedation were plotted with SatO2 and capnography against time. Statistics: Paired and unpaired t-tests, chi tests and Wilcoxon’s sum rank test. Results: After a predictable sedation-induced fall in SatO2, the two equally matched groups, showed equivalent oxygenation. Higher baseline CO2 was seen in the NC group 31.3 vs. 28.8. Some 30 sec after commencement of O2, at intubation, and on completion of the procedure CO2 was 28.8 vs. 31.3 (p ! 0.001), 32 vs. 30.3 (p ! 004) and 35.5 vs. 29.9 (p ! 0.004) respectively. In the ON group however, the trend baseline was more predictive of concomitant decreased oxygen saturation (p ! 001). In the NC group 15/75 failed to detect CO2. No failures were seen in the ON group (P ! 0005). Conclusions: Oxygen delivery is equivalent by nasal vs. oro-nasal TwinguardTM device. The oronasal device is markedly more reliable and predictive for CO2 detection in this adult group. Reliable capnography via the TwinguardTM is important in monitoring ventilation in sedated patients undergoing upper GI endoscopy.
W1432 Comparison of Two Methods of Stent Placement in Esophageal Malignant Strictures: With Fluoroscopy and Without Fluoroscopy Take in Consideration the Safe and Efficacy ´Rgio A. Barrichello, Eduardo G. De Moura, Decio S. Couto, Se Paulo Sakai Background: Expandable metal stents are used increasingly as a non-surgical alternative for the palliation of luminal gastrointestinal neoplasms, particularly esophageal cancer. Fluoroscopy is normaly used to guide the placement of selfexpanding metallic stents for the palliative treatment of patients with esophageal malignant strictures. This is a description of a comparison of two methods of stent placement: With fluoroscopy and without fluoroscopy by direct endoscopic view, take inconsideration the safe and efficacy. Methods: The technique without fluoroscopy relies on a clear endoscopic view of the proximal radiopaque marker on
Volume 67, No. 5 : 2008 GASTROINTESTINAL ENDOSCOPY AB283
tertiary referral center. Results: 28 patients (acute pancreatitis (18), chronic pancreatitis (10)) received endoscopic ultrasound-guided drainage of 32 fluid collections (median largest diameter: 8 cm (range: 4-31) including 12 abscesses, 9 infected and 1 sterile necrosis, 5 acute fluid collections/pseudocysts, and 5 chronic pseudocysts. Drainage type: Transgastric (28), transduodenal (4). Median diameter of transmural stoma: 15 mm (6-20). Median number of endoscopic procedures: 6 (1-10). Complete resolution of collection: 26/28 patients (93%). Complications: Secondary infection (4), bleeding (3), pneumoperitoneum (4), stent migration (1). Treatment failures: 2. Median duration of hospitalization after drainage: 20 days (771) for acute pancreatitis, 11 days (4-105) for chronic pancreatitis. Conclusion: Endoscopic ultrasound-guided, transmural drainage of pancreatic fluid collections, including endoscopic necrosectomy, is a minimally invasive, effective, and safe treatment option in complicated pancreatitis.
W1428 Multiple Endoscopic Biopsies in Research Subjects: Safety Results from An NIH Series Michael D. Yao, Erik C. Von Rosenvinge, Catherine Groden, Peter Mannon Background: Routine endoscopic mucosal biopsies are generally considered safe. Major complications such as serious bleeding or perforation are uncommon. However, the risks of performing large numbers of biopsies often restricted to limited areas of the bowel have not been reported. These data can provide guidance to investigators and Ethics Committees when considering research study design and informed consent. Aim: To assess the safety of taking numerous (e.g. O20) mucosal biopsies during endoscopic procedures in research subjects. Patients & Methods: A retrospective chart review of patients who underwent research endoscopies with large numbers of biopsies at the National Institutes of Health (NIH) from 2001-2007 was performed. Eligible subjects included patients with Crohn’s disease, ulcerative colitis, HIV, Hermansky-Pudlak syndrome, and healthy volunteers. Charts were reviewed for demographics, underlying disease, number and location of biopsies, incidence of polypectomy, use of non-steroidal anti-inflammatory drugs (NSAIDS), and presence of procedure-related major/minor complications. Major complications were defined as: perforation; bleeding requiring repeat endoscopy, hospitalization or transfusion; sepsis; myocardial infarction; and death. Bleeding not meeting major criteria and pain were classified as minor complications. Statistical analysis was performed using t-test and chisquare test. Results: A total of 240 research endosopies were performed on 123 patients (80 male, 43 female; mean age 39, range 14-66): 160 colonoscopies, 60 sigmoidoscopies, and 20 upper endoscopies. The majority of patients (85.8% of procedures) had documented protocol-related hospitalization, telephone follow-up, and/or an outpatient visit within 30 days of the procedure. A total of 8992 biopsies were taken for research and histopathology (mean 37.5/procedure, range 13-85). The average number of research biopsies per segment were 24.1 duodenal, 28.7 terminal ileal, and 25.8 random colonic, or 24.7 recto-sigmoid. No major complications were identified. Minor complications occurred with 12 lower endoscopic procedures (5.0%) and included bleeding (4), pain (4), or both (4), resolving quickly. There was no statistically significant correlation between the number of biopsies, type of procedure, location of research biopsies, incidence of polypectomy, or the use of NSAIDS and the risk of complications. Conclusion: This is the first report on the safety of performing numerous endoscopic biopsies in research subjects. This practice is safe, well-tolerated, and does not add appreciably to the risk of research endoscopies.
W1429 Clinical Efficacy of Endoscopic Submucosal Dissection in Patients with Comorbid Diseases Beom Jin Kim, Jae J. Kim, Byung-Hoon Min, Won Kyoung Yun, Hoi Jin Kim, Jun Haeng Lee, Dong Kyung Chang, Young-Ho Kim, Hee Jung Son, Poong-Lyul Rhee, Jong Chul Rhee, Kyung Mi Kim, Cheol Keun Park Background/Aim: Endoscopic submucosal dissection(ESD) is a new method for the curative treatment of gastrointestinal neoplasm. Increased operation time and complication risks with ESD compared with EMR remain problematic. The aim of the present study is to evaluate the efficacy and safety of ESD in patients with comorbid diseases. Methods: From April 2003 through December 2006, 306 patients treated by ESD for early gastric cancer at Samsung Medical Center were retrospectively analyzed. They were categorized as low risk group (score 0) and high risk group (score 1-4) according to Charlson comorbidity scale which has been used to estimate the risk of death from comorbid diseases in oncologic condition. Location, size, depth of invasion, procedure time, complete en bloc resection rate, complication, recurrence of high risk group were compared with those of low risk group. Results: Seventy seven patients had high risk diseases listed in Charlson’s comorbidity scale and 229 patients had none or low risk diseases. The mean age of high risk group was 65.8 yr whereas that of low risk group was 60.9 yr (p ! 0.001). There were no significant differences in the location, size, depth of invasion, procedure time between the two groups (p O 0.05). There were no significant difference in the complete en bloc resection rate, complication and recurrence rate between the two groups (p O 0.05). Conclusion: ESD could be a safe and effective treatment for early gastric cancer in patients with comorbid diseases.
www.giejournal.org
W1430 Prolonged Intestinal Transit: An Important Factor in NonObstructive Capsule Retention Nam Q. Nguyen, Margaret Allen, Kenneth F. Binmoeller Introduction: Approximately 15-20% of small intestine (SI) examinations by capsule enteroscopy (CE) are incomplete and a significant proportion of these are not related to stricture or short battery life [Rondonotti et al. GIE 2005]. Whilst repeated capsule examination in these patients poses significant cost to the health care system, little is known about the underlying causes of non-obstructive capsule retention. Aim: To evaluate factors that may be responsible for incomplete SI examination that is not related to structural obstruction or short battery life. Methods: Data of all patients who referred to our Unit for SI examination by CE over 12 months were reviewed. Patients who had (i) an incomplete SI examination (defined by failure of the capsule to reach the colon), (ii) spontaneous capsule excretion within 2 weeks (confirmed with abdominal X-ray), and (iii) a normal battery life (w8h) were identified. Demographics, co-morbidities, medications, gastric and SI transit time were compared to patients who had a successfully completed CE examination. Results: Of the 24 (26%) patients who had incompleted SI examination, 19 (20%) were not related to stricture or short battery life. Completed SI examination was achieved in 69 (74%) patients. Compared to patients who completed capsule study, SI transit time (486 16 vs. 220 11 min, P ! 0.0001) but not gastric transit time (74 16 vs. 61 6 min, P Z 0.40) was significantly prolonged in patients with non-obstructive capsule retention. While there was no difference in gender (11M:8F vs. 30M:39F, P Z 0.30) between the groups, patients with non-obstructive capsule retention were more likely to have (i) chronic renal failure (RR Z 3.6, P Z 0.001), (ii) diabetes mellitus (DM) (RR Z 2.5, P Z 0.03), (iii) cardio-vascular disease (RR Z 2.3, P Z 0.04), (iv) greater than 3 co-morbidities (RR Z 3.3, P Z 0.05), (iv) on beta-blocker medication (RR Z 3.8, P Z 0.0004) and (v) older age (68.4 3.6 vs. 59.7 2.4 yr, P Z 0.05). In DM, both gastric (95 24 vs. 53 5 min, P Z 0.02) and SI (300 36 vs. 224 13 min, P Z 0.01) transit time were significantly longer than non-DM. Overall, SI transit time was correlated positively with age (r Z 0.25, P Z 0.02) and the number of co-morbidities (r Z 0.32, P Z 0.002). Conclusion: Small intestinal but not gastric transit time is significantly prolonged in patients with non-obstructive capsule, which is associated with older age, DM, chronic renal insufficiency, cardiovascular disease, multiple co-morbidities and on beta-blocker medication. Pre-emptive use of prokinetic agents to reduce SI transit time in ‘‘at-risk’’ patients may minimize the need for repeated capsule study and reduce health care cost.
W1431 Nasal Vs Oro-Nasal Oxygenation and Capnography During Endoscopy Sanjay Ramrakha, Thomas J. Borody, Kylie J. Herdman, Jordana Campbell, Loraine Holley Background: Oxygenation during upper endoscopy reduces cardio-respiratory complications. Capnography detects hypoventilation and apnoea. This study compared efficiency of oxygen delivery and reliability of CO2 detection using either a nasal cannula (NC) or the new, dual oro-nasal (ON) oxygenating device (TwinguardTM) during upper GI endoscopic examination. Design: Ethics approved, prospective, parallel, open labelled, randomised trial in 150 patients undergoing routine upper endoscopy. Oxygen was administered to deeply sedated, spontaneously breathing patients at 4 L/min either via NC or ON when oxygen saturation (SatO2) fell below 90%. Levels of sedation were plotted with SatO2 and capnography against time. Statistics: Paired and unpaired t-tests, chi tests and Wilcoxon’s sum rank test. Results: After a predictable sedation-induced fall in SatO2, the two equally matched groups, showed equivalent oxygenation. Higher baseline CO2 was seen in the NC group 31.3 vs. 28.8. Some 30 sec after commencement of O2, at intubation, and on completion of the procedure CO2 was 28.8 vs. 31.3 (p ! 0.001), 32 vs. 30.3 (p ! 004) and 35.5 vs. 29.9 (p ! 0.004) respectively. In the ON group however, the trend baseline was more predictive of concomitant decreased oxygen saturation (p ! 001). In the NC group 15/75 failed to detect CO2. No failures were seen in the ON group (P ! 0005). Conclusions: Oxygen delivery is equivalent by nasal vs. oro-nasal TwinguardTM device. The oronasal device is markedly more reliable and predictive for CO2 detection in this adult group. Reliable capnography via the TwinguardTM is important in monitoring ventilation in sedated patients undergoing upper GI endoscopy.
W1432 Comparison of Two Methods of Stent Placement in Esophageal Malignant Strictures: With Fluoroscopy and Without Fluoroscopy Take in Consideration the Safe and Efficacy ´Rgio A. Barrichello, Eduardo G. De Moura, Decio S. Couto, Se Paulo Sakai Background: Expandable metal stents are used increasingly as a non-surgical alternative for the palliation of luminal gastrointestinal neoplasms, particularly esophageal cancer. Fluoroscopy is normaly used to guide the placement of selfexpanding metallic stents for the palliative treatment of patients with esophageal malignant strictures. This is a description of a comparison of two methods of stent placement: With fluoroscopy and without fluoroscopy by direct endoscopic view, take inconsideration the safe and efficacy. Methods: The technique without fluoroscopy relies on a clear endoscopic view of the proximal radiopaque marker on
Volume 67, No. 5 : 2008 GASTROINTESTINAL ENDOSCOPY AB283