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Assessment of SPYGLASS Direct Visualization System for Cholangioscopy and Pancreatoscopy in 102 Consecutive Patients
Abstracts
Results: Out of total 84 procedures, CP failed in 7 (8.3%) cases. The reasons for failure were: equipment related 5 (71.4%), narrowed biliary duct 1, and sphincterotomy bleed 1. There was only one minor complication (1.19%; sphincterotomy-site bleed). The mean age was 64.78 years (range 18-97). Gender: F 46, and M 38 cases. Sedation type: monitored anesthesia care 78 (92.8%), 5 conscious sedation, and 1 general anesthesia. CP was used for diagnostic purpose in 62 (73.8%) and therapeutic in 22 (26.2%) cases. Therapeutic uses were: EHL (electrohydraulic lithotripsy) for stones in 20, and CP forceps for foreign body removal in 2 cases. Biliary findings/applications were (total 79 cases): 31 benign biliary stricture, 27 extrahepatic duct stone removal (size ranging from sludge to 2 cm), 10 malignant stricture, 3 removal of foreign body, 2 intrahepatic stone removal, 1 choledochol cyst, and unremarkable in 5 cases. Pancreatic findings were (total 5 cases): 3 IPMN (intraductal papillary mucinous neoplasia), 1 stone removal, and 1 stent removal. The diagnostic yield of CP forceps was obtained in 34 out of 39 cases (87.2%). Conclusion: We found peroral cholangiopancreatoscopy as a safe and effective technique with very low failure rate of 8.3% and various applications in clinical practice.
T1346 Assessment of SPYGLASS Direct Visualization System for Cholangioscopy and Pancreatoscopy in 102 Consecutive Patients Jayde Kurland, Nuri Ozden, Suck-Ho Lee, Rishi Pawa, Mandeep Sawhney, Ram Chuttani, Douglas K. Pleskow Background: Peroral cholangioscopy and pancreatoscopy allows direct visualization of bile ducts and pancreatic ducts while being able to take site directed biopsies and perform electrohydraulic lithotripsy. The aim of this study is to describe the performance, safety, and utility of the Spyglass in a single academic center. Methods: All patients who underwent cholangioscopy or pancreatoscopy between January 2006 and November 2008 using SPYGLASS system were identified. Patient demographics, procedural success, clinical outcomes, and procedural complications were recorded. Results: A total of 102 Spyglass examinations were performed after conventional ERCP in 102 patients (42 men and 60 women), mean age 63.1 17.4 years. Indications for the procedure included stone treatment in previously failed ERCP (44, 43%), indeterminate biliary stricture (37, 36%), screening in primary sclerosing cholangitis (5, 5%), suspicious lesion in the pancreatic duct (7, 7%), and other indications (9, 8.8%). Complete removal of stones using Spyglass directed lithotripsy was successful in 25 of 31 (80.6%) patients in whom previous attempts to remove stones using conventional ERCP techniques had failed. Lithotripsy was unsuccessful in 2 patients with cystic duct stones and 2 patients with left intrahepatic duct stones. Four biliary stictures of seventeen patients with previous benign cytology were found to be malignant as a result of Spyglass directed biopsies. Overall, spy directed biopsies had a sensitivity of 62.5%, specificity of 100%, accuracy of 82.4%, PPV of 100%, and NPV of 75% using positive cytology or surgical biopsy as the reference standard. A confirmed diagnosis of IPMN was made in three of three patients who underwent pancreatoscopy. Patient management was altered in 29 of 102 patients (28.4%) as a direct result of spyglass examination or biopsies. Four procedural complications occurred: pancreatitis-2 mild, cholangitis-1, and sedation related-overnight admission for poor clearance. Conclusion: Spyglass directed lithotripsy allows for safe and effective treatment of biliary stones when conventional techniques fail. Spyglass also increases diagnostic accuracy for biliary strictures and IPMN. Patient management was changed in more than one quarter of patients as a direct result of spyglass examination.
T1347 Application of CO2 Insufflations in Primary Screening Colonoscopy - A Single-Blinded Randomized Trial Han-Mo Chiu, Jaw-Town Lin, Yi-Chia Lee, Wei-Chih Liao, MingShiang Wu, Hsiu-Po Wang Background and Aim: It has been reported that carbon dioxide (CO2) insufflations can reduce abdominal discomfort during and after colonoscopy. We aim to elucidate its usefulness in primary colonoscopic screening in terms of patient satisfaction and detection rate of neoplasm. Material and Methods: 150 subjects who are scheduled to receive screening colonoscopy were randomized to either air or CO2 insufflations during screening colonoscopy. Examinees were blinded to the category of gas insufflated. Degree of abdominal bloating was assessed using visual analogue scale at 0, 2 and 8 hours after procedure. Tolerability and acceptance of the procedure was also accessed. All colonoscopy was performed by a single colonoscopist. T-test or chi-square test was applied for statistical analysis as indicated. Results: All subjects completed successful cecal intubation. Subjects in CO2 insufflations group has significantly lower degree of bloating and higher acceptance of examination at each time point. The number of detected neoplasm during colonoscopy was not different between two groups. Conclusion: CO2 insufflations during screening colonoscopy can markedly reduce abdominal bloating and improve acceptance of colonoscopy of the examinees with similar detection rate when compared with air insufflations.
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Study Results CO2(nZ75)
Air(nZ75)
p Value
Sex (male/female) 45/30 46/29 1.000 Age [mean (SD)] 51.67 (13.01) 50.32 (12.19) 0.511 History of abdominal surgery 0 2 (2.7%) 0.497 Previous CF experience 34 (45.3%) 35 (46.7%) 1.000 No. with biopsy or polypectomy or EMR 23 (30.7%) 16 (21.3%) 0.264 No. of neoplasm detected 21 (28%) 15 (20%) 0.339 Conscious sedation 66 (88%) 69 (92%) 0.588 Bloating Immediately after procedure 0 (0-1) 1 (0-3) !0.001 2 hrs after procedure 0 (0-1) 0 (0-2) 0.085 8 hrs after procedure 0 (0-1) 0 (0-1) 0.047 Tolerability & Acceptance Comfortable 50 (66.7 %) 38 (50.7 %) 0.028 Tolerable 25 (33.3%) 33 (44%) Uncomfortable 0 4 (5.3%) Intolerable 0 0 Comparison with previous experience More comfortable 22 (58.5%) 14 (24.6 %) 0.001 Same 31 (41.5%) 33 (57.9 %) More discomfort 10 (17.5 %)
T1348 Colonic Stenting Versus Emergency Surgery for Management of Acute Left-Sided Malignant Colonic Obstruction: A Multicenter Randomized Trial (Stent-In 2 Study) Jeanin E. Van Hooft, Willem A. Bemelman, Bas Oldenburg, Mirjam A. Sprangers, Patrick M. Bossuyt, Paul Fockens Patients with acute left-sided malignant colonic obstruction are usually treated with emergency surgery. These operations have a high morbidity and mortality. Stent placement as bridge to elective surgery has been suggested to decrease morbidity, mortality and the number of colostomies. No adequately powered randomized controlled trials have been reported in the literature. The objective of this study is to compare the effectiveness and costs of these two treatment algorithms. Methods: This is a prospective multicenter (25 centers) randomized controlled trial. Patients with acute left-sided malignant colonic obstruction are randomly allocated to emergency surgery or colonic stenting as bridge to surgery. Inclusion criteria are ileus less than 1 week with malignant obstruction on imaging, exclusion criteria are serious complications demanding urgent surgery; ASA IV or V; distal tumor margin less than 10 cm from the anal verge. Effectiveness is evaluated in terms of quality of life, morbidity and mortality. Quality of life is measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQVAS). The total costs of treatment are evaluated by counting volumes and calculating unit prices. Patients are followed for a period of 6 months. Including 120 patients on a 1: 1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. After inclusion of 60 patients an interim analysis will be performed. Results: From 04/2007 until 10/2008 47 patients (24 men, mean age 69 years) have been enrolled in 17 participating centers. 24 Patients have been assigned to emergency surgery and 23 to stenting. All patients randomized for emergency surgery were treated accordingly. Of the patients randomized to stenting 7 did not receive an enteral stent: 4 appeared to have a diverticular stenosis, 1 patient had a tumor fistula to the small bowel and in 2 patients there was a technical failure. Pathology confirmed malignancy in 22 of the 24 patients assigned to emergency surgery and in 18 of the 23 patients allocated to enteral stenting. With the current inclusion rate, the interim analysis is expected in spring 2009 and the inclusion should be completed in 2011. Conclusion: Endoscopic colonic stent placement as bridge to elective surgery seems to be an attractive alternative to emergency surgery in patients with acute left-sided malignant colonic obstruction. Evidence for its wide-spread application is not yet available. Its effectiveness and costs are currently investigated in a multicenter randomized trial in the Netherlands.
T1349 Yield of Follow Up Colonoscopy Is Not Associated with Initial Bowel Preparation Cara S. Weiner, Gregory S. Cooper Background: Current guidelines for screening and surveillance colonoscopy intervals are based on the assumption that patients have a satisfactory bowel preparation. It is unknown whether the yield on follow up examinations in patients with suboptimal bowel preparation differs from those with adequate preparation. Methods: We reviewed all adult colonoscopies that were complete to the cecum performed in 2001 at an urban university hospital. We included those patients in
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB273
Results: Out of total 84 procedures, CP failed in 7 (8.3%) cases. The reasons for failure were: equipment related 5 (71.4%), narrowed biliary duct 1, and sphincterotomy bleed 1. There was only one minor complication (1.19%; sphincterotomy-site bleed). The mean age was 64.78 years (range 18-97). Gender: F 46, and M 38 cases. Sedation type: monitored anesthesia care 78 (92.8%), 5 conscious sedation, and 1 general anesthesia. CP was used for diagnostic purpose in 62 (73.8%) and therapeutic in 22 (26.2%) cases. Therapeutic uses were: EHL (electrohydraulic lithotripsy) for stones in 20, and CP forceps for foreign body removal in 2 cases. Biliary findings/applications were (total 79 cases): 31 benign biliary stricture, 27 extrahepatic duct stone removal (size ranging from sludge to 2 cm), 10 malignant stricture, 3 removal of foreign body, 2 intrahepatic stone removal, 1 choledochol cyst, and unremarkable in 5 cases. Pancreatic findings were (total 5 cases): 3 IPMN (intraductal papillary mucinous neoplasia), 1 stone removal, and 1 stent removal. The diagnostic yield of CP forceps was obtained in 34 out of 39 cases (87.2%). Conclusion: We found peroral cholangiopancreatoscopy as a safe and effective technique with very low failure rate of 8.3% and various applications in clinical practice.
T1346 Assessment of SPYGLASS Direct Visualization System for Cholangioscopy and Pancreatoscopy in 102 Consecutive Patients Jayde Kurland, Nuri Ozden, Suck-Ho Lee, Rishi Pawa, Mandeep Sawhney, Ram Chuttani, Douglas K. Pleskow Background: Peroral cholangioscopy and pancreatoscopy allows direct visualization of bile ducts and pancreatic ducts while being able to take site directed biopsies and perform electrohydraulic lithotripsy. The aim of this study is to describe the performance, safety, and utility of the Spyglass in a single academic center. Methods: All patients who underwent cholangioscopy or pancreatoscopy between January 2006 and November 2008 using SPYGLASS system were identified. Patient demographics, procedural success, clinical outcomes, and procedural complications were recorded. Results: A total of 102 Spyglass examinations were performed after conventional ERCP in 102 patients (42 men and 60 women), mean age 63.1 17.4 years. Indications for the procedure included stone treatment in previously failed ERCP (44, 43%), indeterminate biliary stricture (37, 36%), screening in primary sclerosing cholangitis (5, 5%), suspicious lesion in the pancreatic duct (7, 7%), and other indications (9, 8.8%). Complete removal of stones using Spyglass directed lithotripsy was successful in 25 of 31 (80.6%) patients in whom previous attempts to remove stones using conventional ERCP techniques had failed. Lithotripsy was unsuccessful in 2 patients with cystic duct stones and 2 patients with left intrahepatic duct stones. Four biliary stictures of seventeen patients with previous benign cytology were found to be malignant as a result of Spyglass directed biopsies. Overall, spy directed biopsies had a sensitivity of 62.5%, specificity of 100%, accuracy of 82.4%, PPV of 100%, and NPV of 75% using positive cytology or surgical biopsy as the reference standard. A confirmed diagnosis of IPMN was made in three of three patients who underwent pancreatoscopy. Patient management was altered in 29 of 102 patients (28.4%) as a direct result of spyglass examination or biopsies. Four procedural complications occurred: pancreatitis-2 mild, cholangitis-1, and sedation related-overnight admission for poor clearance. Conclusion: Spyglass directed lithotripsy allows for safe and effective treatment of biliary stones when conventional techniques fail. Spyglass also increases diagnostic accuracy for biliary strictures and IPMN. Patient management was changed in more than one quarter of patients as a direct result of spyglass examination.
T1347 Application of CO2 Insufflations in Primary Screening Colonoscopy - A Single-Blinded Randomized Trial Han-Mo Chiu, Jaw-Town Lin, Yi-Chia Lee, Wei-Chih Liao, MingShiang Wu, Hsiu-Po Wang Background and Aim: It has been reported that carbon dioxide (CO2) insufflations can reduce abdominal discomfort during and after colonoscopy. We aim to elucidate its usefulness in primary colonoscopic screening in terms of patient satisfaction and detection rate of neoplasm. Material and Methods: 150 subjects who are scheduled to receive screening colonoscopy were randomized to either air or CO2 insufflations during screening colonoscopy. Examinees were blinded to the category of gas insufflated. Degree of abdominal bloating was assessed using visual analogue scale at 0, 2 and 8 hours after procedure. Tolerability and acceptance of the procedure was also accessed. All colonoscopy was performed by a single colonoscopist. T-test or chi-square test was applied for statistical analysis as indicated. Results: All subjects completed successful cecal intubation. Subjects in CO2 insufflations group has significantly lower degree of bloating and higher acceptance of examination at each time point. The number of detected neoplasm during colonoscopy was not different between two groups. Conclusion: CO2 insufflations during screening colonoscopy can markedly reduce abdominal bloating and improve acceptance of colonoscopy of the examinees with similar detection rate when compared with air insufflations.
www.giejournal.org
Study Results CO2(nZ75)
Air(nZ75)
p Value
Sex (male/female) 45/30 46/29 1.000 Age [mean (SD)] 51.67 (13.01) 50.32 (12.19) 0.511 History of abdominal surgery 0 2 (2.7%) 0.497 Previous CF experience 34 (45.3%) 35 (46.7%) 1.000 No. with biopsy or polypectomy or EMR 23 (30.7%) 16 (21.3%) 0.264 No. of neoplasm detected 21 (28%) 15 (20%) 0.339 Conscious sedation 66 (88%) 69 (92%) 0.588 Bloating Immediately after procedure 0 (0-1) 1 (0-3) !0.001 2 hrs after procedure 0 (0-1) 0 (0-2) 0.085 8 hrs after procedure 0 (0-1) 0 (0-1) 0.047 Tolerability & Acceptance Comfortable 50 (66.7 %) 38 (50.7 %) 0.028 Tolerable 25 (33.3%) 33 (44%) Uncomfortable 0 4 (5.3%) Intolerable 0 0 Comparison with previous experience More comfortable 22 (58.5%) 14 (24.6 %) 0.001 Same 31 (41.5%) 33 (57.9 %) More discomfort 10 (17.5 %)
T1348 Colonic Stenting Versus Emergency Surgery for Management of Acute Left-Sided Malignant Colonic Obstruction: A Multicenter Randomized Trial (Stent-In 2 Study) Jeanin E. Van Hooft, Willem A. Bemelman, Bas Oldenburg, Mirjam A. Sprangers, Patrick M. Bossuyt, Paul Fockens Patients with acute left-sided malignant colonic obstruction are usually treated with emergency surgery. These operations have a high morbidity and mortality. Stent placement as bridge to elective surgery has been suggested to decrease morbidity, mortality and the number of colostomies. No adequately powered randomized controlled trials have been reported in the literature. The objective of this study is to compare the effectiveness and costs of these two treatment algorithms. Methods: This is a prospective multicenter (25 centers) randomized controlled trial. Patients with acute left-sided malignant colonic obstruction are randomly allocated to emergency surgery or colonic stenting as bridge to surgery. Inclusion criteria are ileus less than 1 week with malignant obstruction on imaging, exclusion criteria are serious complications demanding urgent surgery; ASA IV or V; distal tumor margin less than 10 cm from the anal verge. Effectiveness is evaluated in terms of quality of life, morbidity and mortality. Quality of life is measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQVAS). The total costs of treatment are evaluated by counting volumes and calculating unit prices. Patients are followed for a period of 6 months. Including 120 patients on a 1: 1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. After inclusion of 60 patients an interim analysis will be performed. Results: From 04/2007 until 10/2008 47 patients (24 men, mean age 69 years) have been enrolled in 17 participating centers. 24 Patients have been assigned to emergency surgery and 23 to stenting. All patients randomized for emergency surgery were treated accordingly. Of the patients randomized to stenting 7 did not receive an enteral stent: 4 appeared to have a diverticular stenosis, 1 patient had a tumor fistula to the small bowel and in 2 patients there was a technical failure. Pathology confirmed malignancy in 22 of the 24 patients assigned to emergency surgery and in 18 of the 23 patients allocated to enteral stenting. With the current inclusion rate, the interim analysis is expected in spring 2009 and the inclusion should be completed in 2011. Conclusion: Endoscopic colonic stent placement as bridge to elective surgery seems to be an attractive alternative to emergency surgery in patients with acute left-sided malignant colonic obstruction. Evidence for its wide-spread application is not yet available. Its effectiveness and costs are currently investigated in a multicenter randomized trial in the Netherlands.
T1349 Yield of Follow Up Colonoscopy Is Not Associated with Initial Bowel Preparation Cara S. Weiner, Gregory S. Cooper Background: Current guidelines for screening and surveillance colonoscopy intervals are based on the assumption that patients have a satisfactory bowel preparation. It is unknown whether the yield on follow up examinations in patients with suboptimal bowel preparation differs from those with adequate preparation. Methods: We reviewed all adult colonoscopies that were complete to the cecum performed in 2001 at an urban university hospital. We included those patients in
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB273