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275 Optimizing Bile Duct Cannulation: Randomized Trial of Short vs. Long-Wire Systems and Small vs. Standard Sphincterotomes
Abstracts
274 Does Submucosal Injection Papillectomy Improve Procedure Outcomes Than Simple Snare Papillectomy? Tae Hoon Lee*1, Jong Jin Hyun2, Joung-Ho Han3, Seok Jeong4, Seon Mee Park3, Sang-Heum Park1 1 Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea (the Republic of); 2Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea (the Republic of); 3 Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Korea (the Republic of); 4Internal Medicine, Inha University School of Medicine, Incheon, Korea (the Republic of) Background and Aims: Injecting saline or diluted epinephrine solution into the submucosal layer of the gastrointestinal tract to lift the tumorous lesions is a common practice during endoscopic mucosal or submucosal resection. However, whether these solutions should also be used to lift the ampullary tumors during endoscopic snare papillectomy is not established, especially in view of achieving complete resection or preventing post-papillectomy bleeding. This study aimed to investigate the clinical efficacy of simple snaring papillectomy (SSP) versus submucosal injection papillectomy (SIP) in patients with ampulla of Vater adenoma. Methods: Prospective multicenter study was performed at four tertiary referral centers. Patients with papillary lesions were randomized to undergo either SSP or SIP. SIP group underwent papillectomy following submucosal injection of 1:10,000 diluted epinephrine. Prophylactic pancreatic duct stent was permitted. The main outcome measures were complete resection rate and post-papillectomy complications. Results: A total of 50 patients with biopsy proven papillary adenoma were enrolled (26 SSP and 24 SIP). Baseline characteristics were not different between the two groups. Complete resection (negative lateral and deep resection margin on pathology) rate was 80.8% (21/26) in SSP group and 50.0% (12/24) in SIP group, respectively (pZ0.022). Lateral and deep resection margin was more frequently positive in SIP group (5 vs. 12 patients). Mean tumor size was 12.0 mm in SSP group and 9.9 mm in SIP group (pZ0.133). Mean procedure time was 21.2 min and 18.1 min, respectively (pZ0.128). The average amount of injected diluted epinephrine solution in SIP group was 3.7 ml. Tumor recurrence at 3 months (after the procedure) was not different (15.4% vs. 8.3%, pZ0.373) despite initial difference in the prevalence of positive resection margin. Post-papillectomy bleeding developed in 42.3% (11/26) in SSP group and 45.8% (11/24) in SIP group, respectively (pZ0.802). Delayed bleeding after 12 hours occurred in 27.3% (3/11) and 36.4% (4/11), respectively (pZ0.500). Post-procedure pancreatitis occurred in 15.4% (4/26) and 25.0% (6/24), respectively (pZ0.490). Severity of pancreatitis was also not different and there was no procedure related mortality. Conclusions: Initial complete resection rate was higher in SSP group compared with SIP, however short term recurrence at three months was not different between the two groups. Post-papillectomy complications including bleeding or pancreatitis were not different between the two groups.
275 Optimizing Bile Duct Cannulation: Randomized Trial of Short vs. Long-Wire Systems and Small vs. Standard Sphincterotomes James L. Buxbaum*1, Paul Leonor1, Jonathan Tung1, Daniel Cho1, Ara Sahakian1, Loren Laine2 1 Division of Gastrointestinal & Liver Diseases, Univ. of Southern California, Los Angeles, CA; 2Division of Gastroenterology, Yale University, New Haven, CT Introduction: Biliary cannulation is the most crucial and challenging component of most ERCPs. Recent techniques employed to improve safety and efficacy include wire passage to decrease post-ERCP pancreatitis and use of sphincterotomes to improve access. However, a variety of options are available in applying these techniques and the optimum strategies are not defined. Short wire systems are available, which enable the endoscopist, as opposed to the assistant, to maintain tactile control of the guidewire. Small diameter sphincterotomes are also frequently used in the belief that they more readily achieve bile duct access. Our aim was to assess whether use of short vs. long-wire systems and small vs. standard-diameter sphincterotomes improve safety and/or efficacy of bile duct cannulation. Methods: Patients were randomized using a 2 x 2 factorial design to initial cannulation attempt with short vs. long-wire systems (1:1 ratio) and small (3.9Fr) vs. standard (4.3Fr) diameter (tip) sphincterotomes (1:1 ratio). Those who had undergone prior ERCP were excluded. If cannulation was not achieved with the assigned strategy within 8 attempts, the endoscopist could use precut or other methods to achieve biliary access. The primary efficacy outcome was successful deep bile duct cannulation within 8 attempts. An attempt was defined as any advancement of the sphincterotome into the biliary orifice. Additional outcomes were number of cannulation attempts, time to cannulation and fluoroscopy time. Safety outcomes included post-ERCP pancreatitis and other complications of cholangitis, bleeding, and perforation. Sample size of 498 was planned to demonstrate a significant increase in cannulation of 10%. Interim analysis was planned after 200 patients–with a stopping rule pre-defined for a significant difference in the composite safety endpoint (pancreatitis, cholangitis, bleeding, perforation). Results: Characteristics of the patient groups were similar (Table 1). The study was stopped after the interim analysis with a total of 216 patients randomized due to a significant difference in the safety endpoint with short vs.
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long-wire system (Table 2). Two complications were fatal (both in the long-wire group). Complications occurred in 9/54 (16.7%) with long-wire plus standard sphincterotome and 1/55 (1.8%) with short-wire plus small sphincterotome. The difference in complications for small-diameter versus standard sphincterotomes did not reach significance (pZ0.106). The efficacy results regarding cannulation were very similar for short vs. long-wire and small-diameter vs. standard sphincterotome with <1% difference in the primary endpoint of successful cannulation (Table 2). Conclusion: Use of the short-wire system rather than long-wire system does not improve bile duct cannulation but reduces complications of ERCP such as pancreatitis. Table 1. Selected Characteristics of the Study Groups Wire System Comparison Sphincterotome Comparison
Age, yrs (mean) Female Indication Stones Leak Obstruction Other Sedation strategy Anesthesia care Moderate sedation Rectal indomethacin Pancreas stent
Short (N[109)
Long (N[107)
Small (N[108)
Standard (N[108)
46 67 (61%)
46 71 (66%)
45 61 (56%)
46 77 (71%)
84 5 16 5
(75%) (5%) (15%) (5%)
85 5 13 4
(79%) (5%) (12%) (4%)
85 3 16 4
(79%) (3%) (15%) (4%)
82 7 13 5
(76%) (6%) (12%) (5%)
78 31 80 20
(72%) (28%) (73%) (18%)
68 39 71 19
(64%) (36%) (66%) (18%)
66 42 75 23
(61%) (39%) (69%) (21%)
80 28 76 16
(74%) (26%) (70%) (15%)
Table 2. Outcomes in the Study Groups Wire System Comparison
Safety Endpoints Complications Post-ERCP Pancreatitis Efficacy Endpoints Cannulation in 8 attempts Cannulation attempts (median) Minutes to cannulation (median) Minutes of fluoroscopy (median) Precut required
Sphincterotome Comparison
Short (N[109)
Long (N[107)
Small (N[108)
Standard (N[108)
3 (2.8%) 3 (2.8%)
12 (11.2%)* 10 (9.3%)*
4 (3.7%) 4 (3.7%)
11 (10.2%) 9 (8.9%)
81 (74.3%)
80 (74.8%)
80 (74.1%)
81 (75.0%)
4
4
4
4
11
9
10
10
2.8
2.5
2.9
2.2
19 (17%)
12 (11%)
15 (14%)
16 (15%)
*p<0.05.
276 Feasibility and Accuracy of a Point-of-Care Test for Carbapenem-Resistant Enterobacteriaceae (CRE) Detection Rahul Pannala*1, Bruce Baldwin1, Vijay Aluru1, Thomas Grys2, Jordan D. Holmes1, Laurence J. Miller1, M. E.wyn Harrison1, Cuong C. Nguyen1, Fred Tenover3, David H. Persing3, Douglas O. Faigel1 1 Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, AZ; 2 Laboratory Medicine and Pathology, Mayo Clinic, Scottsdale, AZ; 3 Cepheid, Sunnyvale, CA Background/Aims: CRE transmission through exposure to duodenoscopes is an important public health concern. Current polymerase chain reaction (PCR)-based tests and culture for CRE are laboratory-based and require 48-72 hours for results. In an investigator-initiated study, we evaluated the performance characteristics of a point-of-care (POC) PCR test (Xpert CARBA-R Assay), as compared to the reference PCR, in patients undergoing ERCPs and in a hospital outbreak investigation. Methods: After informed consent, patients undergoing ERCP at Mayo Clinic Hospital from September 17th- November 20th, 2015 were included in the study (nZ76). Two rectal swabs, one each for institutional standard-of-care PCR test and POC testing were obtained. At our institution, duodenoscopes are double reprocessed and sequestered until PCR results are available (48-72 hrs); a positive CRE test prompts ethylene oxide (EtO) sterilization. The Xpert CARBA-R Assay (Cepheid Inc.) performed in the GeneXpert Dx Systems is a qualitative assay for the rapid detection of
Volume 83, No. 5S : 2016 GASTROINTESTINAL ENDOSCOPY AB137
274 Does Submucosal Injection Papillectomy Improve Procedure Outcomes Than Simple Snare Papillectomy? Tae Hoon Lee*1, Jong Jin Hyun2, Joung-Ho Han3, Seok Jeong4, Seon Mee Park3, Sang-Heum Park1 1 Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea (the Republic of); 2Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea (the Republic of); 3 Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Korea (the Republic of); 4Internal Medicine, Inha University School of Medicine, Incheon, Korea (the Republic of) Background and Aims: Injecting saline or diluted epinephrine solution into the submucosal layer of the gastrointestinal tract to lift the tumorous lesions is a common practice during endoscopic mucosal or submucosal resection. However, whether these solutions should also be used to lift the ampullary tumors during endoscopic snare papillectomy is not established, especially in view of achieving complete resection or preventing post-papillectomy bleeding. This study aimed to investigate the clinical efficacy of simple snaring papillectomy (SSP) versus submucosal injection papillectomy (SIP) in patients with ampulla of Vater adenoma. Methods: Prospective multicenter study was performed at four tertiary referral centers. Patients with papillary lesions were randomized to undergo either SSP or SIP. SIP group underwent papillectomy following submucosal injection of 1:10,000 diluted epinephrine. Prophylactic pancreatic duct stent was permitted. The main outcome measures were complete resection rate and post-papillectomy complications. Results: A total of 50 patients with biopsy proven papillary adenoma were enrolled (26 SSP and 24 SIP). Baseline characteristics were not different between the two groups. Complete resection (negative lateral and deep resection margin on pathology) rate was 80.8% (21/26) in SSP group and 50.0% (12/24) in SIP group, respectively (pZ0.022). Lateral and deep resection margin was more frequently positive in SIP group (5 vs. 12 patients). Mean tumor size was 12.0 mm in SSP group and 9.9 mm in SIP group (pZ0.133). Mean procedure time was 21.2 min and 18.1 min, respectively (pZ0.128). The average amount of injected diluted epinephrine solution in SIP group was 3.7 ml. Tumor recurrence at 3 months (after the procedure) was not different (15.4% vs. 8.3%, pZ0.373) despite initial difference in the prevalence of positive resection margin. Post-papillectomy bleeding developed in 42.3% (11/26) in SSP group and 45.8% (11/24) in SIP group, respectively (pZ0.802). Delayed bleeding after 12 hours occurred in 27.3% (3/11) and 36.4% (4/11), respectively (pZ0.500). Post-procedure pancreatitis occurred in 15.4% (4/26) and 25.0% (6/24), respectively (pZ0.490). Severity of pancreatitis was also not different and there was no procedure related mortality. Conclusions: Initial complete resection rate was higher in SSP group compared with SIP, however short term recurrence at three months was not different between the two groups. Post-papillectomy complications including bleeding or pancreatitis were not different between the two groups.
275 Optimizing Bile Duct Cannulation: Randomized Trial of Short vs. Long-Wire Systems and Small vs. Standard Sphincterotomes James L. Buxbaum*1, Paul Leonor1, Jonathan Tung1, Daniel Cho1, Ara Sahakian1, Loren Laine2 1 Division of Gastrointestinal & Liver Diseases, Univ. of Southern California, Los Angeles, CA; 2Division of Gastroenterology, Yale University, New Haven, CT Introduction: Biliary cannulation is the most crucial and challenging component of most ERCPs. Recent techniques employed to improve safety and efficacy include wire passage to decrease post-ERCP pancreatitis and use of sphincterotomes to improve access. However, a variety of options are available in applying these techniques and the optimum strategies are not defined. Short wire systems are available, which enable the endoscopist, as opposed to the assistant, to maintain tactile control of the guidewire. Small diameter sphincterotomes are also frequently used in the belief that they more readily achieve bile duct access. Our aim was to assess whether use of short vs. long-wire systems and small vs. standard-diameter sphincterotomes improve safety and/or efficacy of bile duct cannulation. Methods: Patients were randomized using a 2 x 2 factorial design to initial cannulation attempt with short vs. long-wire systems (1:1 ratio) and small (3.9Fr) vs. standard (4.3Fr) diameter (tip) sphincterotomes (1:1 ratio). Those who had undergone prior ERCP were excluded. If cannulation was not achieved with the assigned strategy within 8 attempts, the endoscopist could use precut or other methods to achieve biliary access. The primary efficacy outcome was successful deep bile duct cannulation within 8 attempts. An attempt was defined as any advancement of the sphincterotome into the biliary orifice. Additional outcomes were number of cannulation attempts, time to cannulation and fluoroscopy time. Safety outcomes included post-ERCP pancreatitis and other complications of cholangitis, bleeding, and perforation. Sample size of 498 was planned to demonstrate a significant increase in cannulation of 10%. Interim analysis was planned after 200 patients–with a stopping rule pre-defined for a significant difference in the composite safety endpoint (pancreatitis, cholangitis, bleeding, perforation). Results: Characteristics of the patient groups were similar (Table 1). The study was stopped after the interim analysis with a total of 216 patients randomized due to a significant difference in the safety endpoint with short vs.
www.giejournal.org
long-wire system (Table 2). Two complications were fatal (both in the long-wire group). Complications occurred in 9/54 (16.7%) with long-wire plus standard sphincterotome and 1/55 (1.8%) with short-wire plus small sphincterotome. The difference in complications for small-diameter versus standard sphincterotomes did not reach significance (pZ0.106). The efficacy results regarding cannulation were very similar for short vs. long-wire and small-diameter vs. standard sphincterotome with <1% difference in the primary endpoint of successful cannulation (Table 2). Conclusion: Use of the short-wire system rather than long-wire system does not improve bile duct cannulation but reduces complications of ERCP such as pancreatitis. Table 1. Selected Characteristics of the Study Groups Wire System Comparison Sphincterotome Comparison
Age, yrs (mean) Female Indication Stones Leak Obstruction Other Sedation strategy Anesthesia care Moderate sedation Rectal indomethacin Pancreas stent
Short (N[109)
Long (N[107)
Small (N[108)
Standard (N[108)
46 67 (61%)
46 71 (66%)
45 61 (56%)
46 77 (71%)
84 5 16 5
(75%) (5%) (15%) (5%)
85 5 13 4
(79%) (5%) (12%) (4%)
85 3 16 4
(79%) (3%) (15%) (4%)
82 7 13 5
(76%) (6%) (12%) (5%)
78 31 80 20
(72%) (28%) (73%) (18%)
68 39 71 19
(64%) (36%) (66%) (18%)
66 42 75 23
(61%) (39%) (69%) (21%)
80 28 76 16
(74%) (26%) (70%) (15%)
Table 2. Outcomes in the Study Groups Wire System Comparison
Safety Endpoints Complications Post-ERCP Pancreatitis Efficacy Endpoints Cannulation in 8 attempts Cannulation attempts (median) Minutes to cannulation (median) Minutes of fluoroscopy (median) Precut required
Sphincterotome Comparison
Short (N[109)
Long (N[107)
Small (N[108)
Standard (N[108)
3 (2.8%) 3 (2.8%)
12 (11.2%)* 10 (9.3%)*
4 (3.7%) 4 (3.7%)
11 (10.2%) 9 (8.9%)
81 (74.3%)
80 (74.8%)
80 (74.1%)
81 (75.0%)
4
4
4
4
11
9
10
10
2.8
2.5
2.9
2.2
19 (17%)
12 (11%)
15 (14%)
16 (15%)
*p<0.05.
276 Feasibility and Accuracy of a Point-of-Care Test for Carbapenem-Resistant Enterobacteriaceae (CRE) Detection Rahul Pannala*1, Bruce Baldwin1, Vijay Aluru1, Thomas Grys2, Jordan D. Holmes1, Laurence J. Miller1, M. E.wyn Harrison1, Cuong C. Nguyen1, Fred Tenover3, David H. Persing3, Douglas O. Faigel1 1 Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, AZ; 2 Laboratory Medicine and Pathology, Mayo Clinic, Scottsdale, AZ; 3 Cepheid, Sunnyvale, CA Background/Aims: CRE transmission through exposure to duodenoscopes is an important public health concern. Current polymerase chain reaction (PCR)-based tests and culture for CRE are laboratory-based and require 48-72 hours for results. In an investigator-initiated study, we evaluated the performance characteristics of a point-of-care (POC) PCR test (Xpert CARBA-R Assay), as compared to the reference PCR, in patients undergoing ERCPs and in a hospital outbreak investigation. Methods: After informed consent, patients undergoing ERCP at Mayo Clinic Hospital from September 17th- November 20th, 2015 were included in the study (nZ76). Two rectal swabs, one each for institutional standard-of-care PCR test and POC testing were obtained. At our institution, duodenoscopes are double reprocessed and sequestered until PCR results are available (48-72 hrs); a positive CRE test prompts ethylene oxide (EtO) sterilization. The Xpert CARBA-R Assay (Cepheid Inc.) performed in the GeneXpert Dx Systems is a qualitative assay for the rapid detection of
Volume 83, No. 5S : 2016 GASTROINTESTINAL ENDOSCOPY AB137