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Su1345 Endoscopic Papillectomy: Risk Factors Associated With Incomplete Resection and Recurrence During Long Term Follow-up
Abstracts
Su1343 Outcome of Repeat ERCP After Biliary Cannulation Failure Following Needle Knife Sphincterotomy Hiroyuki Hisai*, Yutaka Okagawa, Hironori Wada, Yutaka Koshiba, Etsu Miyazaki Department of Gastroenterology, Japan Red Cross Date General Hospital, Date, Japan Background: Needle knife sphincterotomy (NKS) is often used to gain biliary access in failed standard cannulation techniques. If selective biliary cannulation is unsuccessful, the next step may include either percutaneous or EUS-guided biliary drainage. ERCP is sometimes repeatedly performed in clinically stable patients. However, there are few reports about the outcome. The aim of this study was to assess the outcome of repeat ERCP after failure with NKS for selective biliary access. Materials & Methods: Between September 2000 and November 2012, we performed NKS in failed standard biliary cannulation in 147 pts (65 men, 82 women; mean age 78 years, range 41-97 years). Surgically altered anatomy was noticed in 3 pts. The indications for ERCP were choledocolithiasis including biliary pancreatitis in 85 pts (57.8%), malignant biliary strictures in 42 (28.6%), cholecystitis in 6 (4.1%), and miscellaneous in 14. Sixty-nine pts (46.9%) underwent prior placement of a pancreatic stent (a straight, double-barbed, 5 Fr in diameter and 3 cm in length). Success was defined as deep placement of a catheter into the common bile duct. A diagnosis and severity of complication was made according to Cotton’s classification. Success of repeat ERCP in gaining biliary access, repeat ERCP time interval, and complications were retrospectively evaluated. Results: Selective biliary cannulation was successful after the initial NKS in 99 pts (67.3%), during a second ERCP in 38 (25.9%), in a third ERCP in 3 (1.4%), and in a fourth ERCP in 1 (0.7%), achieving a total cannulation rate of 95.9% (141 of 147) with additional NKS in 4 pts. Among the 6 patients (4.1%) with biliary cannulation failure, ERCP was not attempted again in 4 pts. The median time to repeat ERCP was 1 days (range 1-13 days). Of 48 pts, common causes of failed initial NKS were biliary deep cannulation failure in 41 patients (85.4%) and blocking of the endoscopic view due to bleeding in 7 (14.6%). The success rate of the second ERCP after one day was lower than that of more than 2 days later (76% vs. 100%, P⫽0.064). Fifteen complications (10.2%) occurred in 14 (9.5%) pts (pancreatitis in 11, bleeding in 4) after initial NKS, however, moderate perforation developed in 1 (2.3%) after second ERCP. The use of a pancreatic stent was not related to complication rate. There was no procedure-related mortality, and all complications were resolved by conservative management. Conclusions: Repeat ERCP after failed initial NKS for biliary access is safe and effective in the majority of cases. It is more worthwhile repeating ERCP more than 2 days later such failure than one day later, if the patient’s clinical condition permits.
Su1344 Early Precut Fistulotomy - an Effective Time Saving Strategy for a Successful Biliary Cannulation Luis Lopes*1,2, Jose Ramada1, Anabela Parente1, Mario Dinis-Ribeiro3, Carla Rolanda2,4 1 Department of Gastroenterology, Hospital de Santa Luzia, Viana do Castelo, Portugal; 2Life and Health Sciences Research Institute (ICVS)/ ICVS/3B’s, PT Government Associate Laboratory/School of Health Sciences, University of Minho, Braga, Portugal; 3Departamento de Ciências de Informação e Decisão em Saúde (CIDES), Faculty of Medicine, University of Porto, Porto, Portugal; 4Department of Gastroenterology, Hospital of Braga, Braga, Portugal Introduction and Aim: Deep cannulation into the common bile duct is the most important step for successful biliary therapeutic endoscopy. Precut may improve the cannulation success rate usually referred to be around 80-90% after a single ERCP. However, several prospective studies have concluded that this procedure is an independent risk factor for post-ERCP complications. Moreover, the timing of the precut in the cannulation strategy is a matter of debate. We aimed at assessing success, safety, and procedure duration of an early precut fistulotomy vs a ‘classic strategy’ of precut after a difficult biliary cannulation. Material and Methods: Between January 2011 and Februray 2012, a prospective study on 348 consecutive patients with naive papillas referred for ERCP was conducted. Patients were assigned to undergo either an early precut fistulotomy (performed within 5 minutes or ⬍ 5 attempts, Group A, n⫽178) or a precut fistulotomy only after a failed difficult biliary cannulation (defined as ⬎15 minutes or ⬎ 10 attempts, Group B, n⫽172). No differences were noticeable for age (mean age 69 vs 67), gender (44% vs 46% male), ASA grade III-IV (25% vs 28%), indications and findings in both groups (45% of choledocolithiasis and 18% of malignant strictures). Before January 2011, the two endoscopists involved in the study (⬎200 ERCP/year) used the precut fistulotomy as a rescue technique only after a difficult biliary cannulation and had comparable results in terms of success and complications. During the study, one endoscopist kept this cannulation strategy (Group B) while the other was asked to decide for fistulotomy at an early phase. Measures of success and safety were assessed by a research nurse not involved in the allocation and procedures. Limitations: single center, non-randomized
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study. Results (see Table): Similar successful cannulation and pancreatitis rates were observed between groups A and B. Neverthless, the mean duration for the complete ERCP procedure in Group A was significantly shorter than in group B, both when the biliary cannulation was achieved without precut (14 vs 25 min, p ⬍0,001) or if precut was performed (18 vs 31min, p⬍0,0001). Also, a trend to higher proportion of pancreatitis was observed in Group B (9% vs 4%, ns). Conclusions: This study suggests that an early use of a precut fistulotomy is as safe and effective as the classic approach of performing the precut only after a difficult biliary cannulation. Also, it suggests that the risk for pancreatitis may be due to the difficult cannulation and not to the fistulotomy. Moreover, this strategy decreases substantially the ERCP procedure duration which, should be addressed in further studies, from other perpectives such as costs, scheduling and anesthesia.
BEFORE PRECUT Cannulation rate (%) Total time of procedure (mean (std. error)) Pancreatitis (%) PRECUT ATTEMPT n(%) Precut success (%) Total time of procedure (mean (std. error)) Pancreatitis (%) GLOBAL RESULTS Cannulation rate in first ERCP (%) Complications (%)
Group A (nⴝ178)
Group B (nⴝ172)
P
73 14 (1,152) 4 48 (27) 85 18 (1,892) 4
80 25 (1,134) 4 35 (20) 69 31 (2,639) 9
0,092 ⬍0.001 0.536 0,092 0,059 ⬍0,001 0,352
96 6
94 6
0,221 0.565
Su1345 Endoscopic Papillectomy: Risk Factors Associated With Incomplete Resection and Recurrence During Long Term Follow-up Gregory A. Cote*, Damien Tan, Wiriyaporn Ridtitid, James L. Watkins, Evan L. Fogel, Glen A. Lehman, Lee Mchenry, Stuart Sherman Gastroenterology, Indiana University, Indianapolis, IN Background: The safety and efficacy of endoscopic papillectomy are well established. However, patient and lesion characteristics associated with incomplete resection or recurrence during long term follow-up requires clarification. Methods: Cohort study of patients who underwent endoscopic papillectomy between 1995 and 2010 for ampullary adenoma. Patients considered unresectable at the time of endoscopic retrograde cholangiopancreatography (ERCP) were excluded. Patients were dichotomized into those having complete endoscopic resection (after one or more ERCPs), defined as no visible adenomatous tissue following papillectomy and negative surveillance endoscopy with biopsy when available. The decision to perform follow-up endoscopy was determined by the treating physician, with last followup date being the most recent surveillance endoscopy. Patient (age, presenting symptoms, presence of familial adenomatous polyposis (FAP), lesion (size, intraductal extension) and technical (cauterization of margin, en bloc v. piecemeal papillectomy) variables were measured in an effort to define risk factors associated with inability to achieve complete resection (logistic regression). Kaplan Meier survival analysis was used to measure the risk of adenoma/carcinoma recurrence during follow-up, limited to those with complete resection. Results: We identified 164 patients (mean age 60.6⫾16.4, 51.2% female) who underwent endoscopic papillectomy for an ampullary adenoma identified after an episode of pancreatitis (34.8%), surveillance endoscopy in the setting of FAP (27.4%), incidental endoscopic finding (25.0%), after abnormal laboratory testing (8.5%) or other (4.3%). Short term complications occurred in 36 (22.0%), including bleeding (n⫽18), pancreatitis (n⫽8), perforation (n⫽3), other (n⫽7). Complete resection was achieved in 120 (73.2%), 98 (59.8%) after the initial ERCP. Patient, lesion, and technical variables are compared (table). Utilization of the en bloc resection technique was associated with a higher rate of complete resection (Odds ratio (OR) 2.89, p⫽0.012) whereas intraductal involvement at ERCP (OR 0.24, p⫽0.001) and abnormal liver tests at the time of presentation (OR 0.26, p⫽0.035) with a lower rate. Patients with complete resection (n⫽120) were followed for a median of 4.2 months (range, 0.0, 143.0). Among patients achieving complete resection, recurrence occurred in 16 after a median of 17.5 months (range 3, 65) (figure). Conclusion: Clinical presentation (abnormal liver tests) and suspected intraductal involvement at ERCP are associated with a lower rate of complete endoscopic resection, whereas the ability to perform en bloc papillectomy increases the odds of complete resection. Long term follow-up demonstrates a small but clinically significant risk of recurrence, up to 5 years after papillectomy.
Volume 77, No. 5S : 2013
GASTROINTESTINAL ENDOSCOPY
AB291
Abstracts
Patient, Lesion, and Endoscopic Factors associated with complete resection
Variable Patient characteristics Mean age (SD) % female sex % jaundice Clinical presentation Incidental finding FAP surveillance Abnormal liver function tests Pancreatitis/ pancreatobiliary-type pain Lesion characteristics & Endoscopic Technique Intraductal involvement at ERCP Mean lesion size† (mm, SD) En bloc resection technique Adjuvant cautery Endoscopist impression of complete resection‡
Complete resection (nⴝ120)
Multivariate No complete resection Univariate odds ratio Multivariate (95% CI) p value (nⴝ44) p value
59.4 (16.4) 64.0 (16.2) 49.2 (40.2, 58.1) 56.8 (42.2, 71.5) 7.5 (2.8, 12.2) 15.9 (5.1, 26.7)
0.12 0.39 0.11
82.9 (71.2, 94.7) 17.1 (5.3, 28.8) 75.6 (62.8, 88.3) 24.4 (11.7, 37.2) 42.9 (15.8, 70.0) 57.1 (30., 84.2)
0.023
1.00 (0.97, 1.02)
0.88
0.56 (0.17, 1.86)
0.35
0.26 (0.07, 0.91)
0.035
0.24 (0.10, 0.56)
0.001
2.89 (1.27, 6.60)
0.012
68.4 (56.2, 80.7) 31.6 (19.3, 43.8)
12.5 (6.6, 18.4) 40.9 (26.4, 55.4) 16.8 (11.8)
19.5 (11.2)
⬍0.001 0.24
52.1 (43.1, 61.1) 25.0 (12.2, 37.8)
0.002
29.4 (21.2, 37.6) 29.5 (16.1, 43.0) 86.6 (80.4, 92.3) 54.5 (39.8, 69.3)
0.99 ⬍0.001
†Based on histopathological review of endoscopic specimen. ‡Endoscopist reported impression of whether or not visible adenomatous tissue remained. Inclusion of this variable into the regression model did not impact the results (data not shown). All numbers are proportions (95% confidence intervals) unless otherwise specified.
Kaplan Meier analysis survivor function illustrates the rate of recurrence of ampullary adenoma among patients who underwent endoscopic papillectomy with complete resection after one or more ERCPs. This figure highlights the importance of long term (⬎ 24 month) endoscopic surveillance.
Su1346 Prophalactic Hemoclip Application At ERCP to Prevent Post-ES Bleeding in Patients Receiving Anticoagulation or Antiplatelet Therapy David Klibansky, Emily A. Rolfsmeyer, Sam Yoselevitz, Bryce C. Mays, David Y. Lo, Douglas A. Howell* Pancreaticobiliary Center, Maine Medical Center, Portland, ME Background: The risk of immediate or delayed post-endoscopic sphincterotomy bleeding (PESB) is reported to range from 2.0-5.3%, but can be as high as 10% to 25% in the setting of high risk patients (pts) receiving anti-platelet agents or anticoagulation therapy. These pts present a particular challenge when definitive ERCP sphincterotomy (ES) is indicated. Mechanical clipping of PESB has been reported but infrequently used due to the difficulty in placing the current generation of clips using ERCP endoscopes as well as the potential risk of inadvertent application of clips on the pancreatic orifice. However, hemoclip
placement has been shown to be highly effective in mechanical closure of a wide variety of bleeding and potential bleeding lesions of the GI tract. We present our single center experience with prophylactic hemoclip placement to prevent PESB in the setting of antiplatelet/anticoagulation Rx. Patients: 35 consecutive pts identified as increased risk for PESB underwent ES followed by prophylactic clip placement. Indications for ES included: choledocholithiasis n⫽15, cholangitis n⫽12, ampullary stenosis n⫽7, and management of pancreatic fistula n⫽1. 25 patients required chronic coumadin therapy: 3 were therapeutic at time of intervention, 14 discontinued Coumadin with sub-therapeutic INR at time of ES but resumed immediately post-procedure, 8 were with sub-therapeutic INR and immediately bridged. 4 pts were actively anticoagulated with therapeutic Heparin and 6 pts were actively receiving Clopidogrel. Methods: Following standard pull-type biliary ES with mono-filament papilotomes and blended current, two or more detachable short hemostatic clips (Quickclip, Olympus) were used after trimming back the outer sheath 1.5cm to facilitate their function over the ERCP elevator. The endoscope was then positioned above the sphincterotomy, and the clips placed on opposing sides of the cut, taking care not to obstruct the pancreatic orifice. Results: Placement of hemostatic clips was technically possible in 100% of pts. 2/35 (5.7%) pts experienced delayed postsphincterotomy bleeding. In one case, ES was performed in context of INR ⬎ 2, the other with Lovenox plus Plavix therapy. Both pts experienced delayed bleeding at 48 hours of moderate severity. Repeat endoscopy procedure. Repeat endoscopy revealed premature clip dislodgement in both cases and bleeding was treated with repeat clip placement. 1/35 treated pts experienced post-ERCP pancreatitis (3%), which was mild. Conclusions: Although technically difficult, hemoclip application to prevent post-sphincterotomy bleeding in the setting of anticoagulation is feasible, safe, and may be effective. However, premature clip dislodgement may limit longer-term prophylaxis in the setting of full dose anticoagulation or multiple agents.
Su1347 Drugs for Moderate Sedation in Endoscopic Retrograde Cholangiopancreatography - Are Dosages a Limiting Factor? Fatema S. Uddin*, Pragathi Kandunoori, Jayaprakash Sreenarasimhaiah, Deepak Agrawal Division of Digestive and Liver Diseases, UT Southwestern, Dallas, TX Background: Benzodiazepines and narcotics are used for moderate sedation. Even though these medications have been used extensively for many years, there is scant data on how much dose can be given safely. In fact, there are reports of procedures being aborted after a set dose limit of these medications have been given due to concern for safety and side effects. Aim: To determine if there is a maximum limit of benzodiazepines and narcotics that can be given safely for endoscopic procedures. Methods: We retrospectively identified all patients who underwent ERCP with moderate sedation at a large academic institution from 2008-2012. Medical records were then reviewed to gather information on patient demographics, indications of procedures and maximum dosages given and any complications (defined as procedure aborted due to cardio pulmonary status, use of reversal agents, need for intubation and transfer to higher level of care). High doses of medications were considered to be midazolam ⱖ10mg, fentanyl ⱖ200mcg, meperidine ⱖ150 mg. Results: 1615 charts were reviewed. 1219 patients (75%) of these patients underwent ERCP with moderate sedation. Median doses of midazolam and fentanyl were 7mg and 150mcg, respectively. 258 received (21%) received ⱖ10mg of midazolam and 340 received (28%) received ⱖ200 mcg of fentanyl. The maximum dose of midazolam, fentanyl and meperidine that were given were 22mg, 475 mcg, 225 mg respectively. All the cases involved therapeutic interventions. 64 (4%) of patients failed moderate sedation and subsequently required general anesthesia. There were no other adverse outcomes related to procedure or sedation. Conclusions: This study supports the idea that most patients can safely undergo ERCP with moderate sedation. High doses of midazolam and fentanyl are safe in selected patients and careful monitoring. Endoscopic procedures should not be delayed or aborted simply out of concern for use of high doses of medications.
Su1348 Newer Generation Fluoroscopy Units Reduce Fluoroscopy Exposure During ERCP Robert A. Lockwood*1, Charles W. Shrode1, James T. Patrie2, Dawn G. COX1, Vanessa M. Shami1, Bryan G. Sauer1, James A. Mann1, Andrew Y. Wang1 1 Division of Gastroenterology and Hepatology, University of Virginia, Charlottesville, VA; 2Division of Biostatistics and Epidemiology, University of Virginia, Charlottesville, VA Background: Radiation exposure is associated with short- and long-term deleterious health effects. Fluoroscopic time (FT) has been used as a surrogate marker of radiation exposure during ERCP. Due to renovations in 2011-2012, ERCPs were performed in 3 settings: (group A) older generation (non-digital,
AB292 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 5S : 2013
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Su1343 Outcome of Repeat ERCP After Biliary Cannulation Failure Following Needle Knife Sphincterotomy Hiroyuki Hisai*, Yutaka Okagawa, Hironori Wada, Yutaka Koshiba, Etsu Miyazaki Department of Gastroenterology, Japan Red Cross Date General Hospital, Date, Japan Background: Needle knife sphincterotomy (NKS) is often used to gain biliary access in failed standard cannulation techniques. If selective biliary cannulation is unsuccessful, the next step may include either percutaneous or EUS-guided biliary drainage. ERCP is sometimes repeatedly performed in clinically stable patients. However, there are few reports about the outcome. The aim of this study was to assess the outcome of repeat ERCP after failure with NKS for selective biliary access. Materials & Methods: Between September 2000 and November 2012, we performed NKS in failed standard biliary cannulation in 147 pts (65 men, 82 women; mean age 78 years, range 41-97 years). Surgically altered anatomy was noticed in 3 pts. The indications for ERCP were choledocolithiasis including biliary pancreatitis in 85 pts (57.8%), malignant biliary strictures in 42 (28.6%), cholecystitis in 6 (4.1%), and miscellaneous in 14. Sixty-nine pts (46.9%) underwent prior placement of a pancreatic stent (a straight, double-barbed, 5 Fr in diameter and 3 cm in length). Success was defined as deep placement of a catheter into the common bile duct. A diagnosis and severity of complication was made according to Cotton’s classification. Success of repeat ERCP in gaining biliary access, repeat ERCP time interval, and complications were retrospectively evaluated. Results: Selective biliary cannulation was successful after the initial NKS in 99 pts (67.3%), during a second ERCP in 38 (25.9%), in a third ERCP in 3 (1.4%), and in a fourth ERCP in 1 (0.7%), achieving a total cannulation rate of 95.9% (141 of 147) with additional NKS in 4 pts. Among the 6 patients (4.1%) with biliary cannulation failure, ERCP was not attempted again in 4 pts. The median time to repeat ERCP was 1 days (range 1-13 days). Of 48 pts, common causes of failed initial NKS were biliary deep cannulation failure in 41 patients (85.4%) and blocking of the endoscopic view due to bleeding in 7 (14.6%). The success rate of the second ERCP after one day was lower than that of more than 2 days later (76% vs. 100%, P⫽0.064). Fifteen complications (10.2%) occurred in 14 (9.5%) pts (pancreatitis in 11, bleeding in 4) after initial NKS, however, moderate perforation developed in 1 (2.3%) after second ERCP. The use of a pancreatic stent was not related to complication rate. There was no procedure-related mortality, and all complications were resolved by conservative management. Conclusions: Repeat ERCP after failed initial NKS for biliary access is safe and effective in the majority of cases. It is more worthwhile repeating ERCP more than 2 days later such failure than one day later, if the patient’s clinical condition permits.
Su1344 Early Precut Fistulotomy - an Effective Time Saving Strategy for a Successful Biliary Cannulation Luis Lopes*1,2, Jose Ramada1, Anabela Parente1, Mario Dinis-Ribeiro3, Carla Rolanda2,4 1 Department of Gastroenterology, Hospital de Santa Luzia, Viana do Castelo, Portugal; 2Life and Health Sciences Research Institute (ICVS)/ ICVS/3B’s, PT Government Associate Laboratory/School of Health Sciences, University of Minho, Braga, Portugal; 3Departamento de Ciências de Informação e Decisão em Saúde (CIDES), Faculty of Medicine, University of Porto, Porto, Portugal; 4Department of Gastroenterology, Hospital of Braga, Braga, Portugal Introduction and Aim: Deep cannulation into the common bile duct is the most important step for successful biliary therapeutic endoscopy. Precut may improve the cannulation success rate usually referred to be around 80-90% after a single ERCP. However, several prospective studies have concluded that this procedure is an independent risk factor for post-ERCP complications. Moreover, the timing of the precut in the cannulation strategy is a matter of debate. We aimed at assessing success, safety, and procedure duration of an early precut fistulotomy vs a ‘classic strategy’ of precut after a difficult biliary cannulation. Material and Methods: Between January 2011 and Februray 2012, a prospective study on 348 consecutive patients with naive papillas referred for ERCP was conducted. Patients were assigned to undergo either an early precut fistulotomy (performed within 5 minutes or ⬍ 5 attempts, Group A, n⫽178) or a precut fistulotomy only after a failed difficult biliary cannulation (defined as ⬎15 minutes or ⬎ 10 attempts, Group B, n⫽172). No differences were noticeable for age (mean age 69 vs 67), gender (44% vs 46% male), ASA grade III-IV (25% vs 28%), indications and findings in both groups (45% of choledocolithiasis and 18% of malignant strictures). Before January 2011, the two endoscopists involved in the study (⬎200 ERCP/year) used the precut fistulotomy as a rescue technique only after a difficult biliary cannulation and had comparable results in terms of success and complications. During the study, one endoscopist kept this cannulation strategy (Group B) while the other was asked to decide for fistulotomy at an early phase. Measures of success and safety were assessed by a research nurse not involved in the allocation and procedures. Limitations: single center, non-randomized
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study. Results (see Table): Similar successful cannulation and pancreatitis rates were observed between groups A and B. Neverthless, the mean duration for the complete ERCP procedure in Group A was significantly shorter than in group B, both when the biliary cannulation was achieved without precut (14 vs 25 min, p ⬍0,001) or if precut was performed (18 vs 31min, p⬍0,0001). Also, a trend to higher proportion of pancreatitis was observed in Group B (9% vs 4%, ns). Conclusions: This study suggests that an early use of a precut fistulotomy is as safe and effective as the classic approach of performing the precut only after a difficult biliary cannulation. Also, it suggests that the risk for pancreatitis may be due to the difficult cannulation and not to the fistulotomy. Moreover, this strategy decreases substantially the ERCP procedure duration which, should be addressed in further studies, from other perpectives such as costs, scheduling and anesthesia.
BEFORE PRECUT Cannulation rate (%) Total time of procedure (mean (std. error)) Pancreatitis (%) PRECUT ATTEMPT n(%) Precut success (%) Total time of procedure (mean (std. error)) Pancreatitis (%) GLOBAL RESULTS Cannulation rate in first ERCP (%) Complications (%)
Group A (nⴝ178)
Group B (nⴝ172)
P
73 14 (1,152) 4 48 (27) 85 18 (1,892) 4
80 25 (1,134) 4 35 (20) 69 31 (2,639) 9
0,092 ⬍0.001 0.536 0,092 0,059 ⬍0,001 0,352
96 6
94 6
0,221 0.565
Su1345 Endoscopic Papillectomy: Risk Factors Associated With Incomplete Resection and Recurrence During Long Term Follow-up Gregory A. Cote*, Damien Tan, Wiriyaporn Ridtitid, James L. Watkins, Evan L. Fogel, Glen A. Lehman, Lee Mchenry, Stuart Sherman Gastroenterology, Indiana University, Indianapolis, IN Background: The safety and efficacy of endoscopic papillectomy are well established. However, patient and lesion characteristics associated with incomplete resection or recurrence during long term follow-up requires clarification. Methods: Cohort study of patients who underwent endoscopic papillectomy between 1995 and 2010 for ampullary adenoma. Patients considered unresectable at the time of endoscopic retrograde cholangiopancreatography (ERCP) were excluded. Patients were dichotomized into those having complete endoscopic resection (after one or more ERCPs), defined as no visible adenomatous tissue following papillectomy and negative surveillance endoscopy with biopsy when available. The decision to perform follow-up endoscopy was determined by the treating physician, with last followup date being the most recent surveillance endoscopy. Patient (age, presenting symptoms, presence of familial adenomatous polyposis (FAP), lesion (size, intraductal extension) and technical (cauterization of margin, en bloc v. piecemeal papillectomy) variables were measured in an effort to define risk factors associated with inability to achieve complete resection (logistic regression). Kaplan Meier survival analysis was used to measure the risk of adenoma/carcinoma recurrence during follow-up, limited to those with complete resection. Results: We identified 164 patients (mean age 60.6⫾16.4, 51.2% female) who underwent endoscopic papillectomy for an ampullary adenoma identified after an episode of pancreatitis (34.8%), surveillance endoscopy in the setting of FAP (27.4%), incidental endoscopic finding (25.0%), after abnormal laboratory testing (8.5%) or other (4.3%). Short term complications occurred in 36 (22.0%), including bleeding (n⫽18), pancreatitis (n⫽8), perforation (n⫽3), other (n⫽7). Complete resection was achieved in 120 (73.2%), 98 (59.8%) after the initial ERCP. Patient, lesion, and technical variables are compared (table). Utilization of the en bloc resection technique was associated with a higher rate of complete resection (Odds ratio (OR) 2.89, p⫽0.012) whereas intraductal involvement at ERCP (OR 0.24, p⫽0.001) and abnormal liver tests at the time of presentation (OR 0.26, p⫽0.035) with a lower rate. Patients with complete resection (n⫽120) were followed for a median of 4.2 months (range, 0.0, 143.0). Among patients achieving complete resection, recurrence occurred in 16 after a median of 17.5 months (range 3, 65) (figure). Conclusion: Clinical presentation (abnormal liver tests) and suspected intraductal involvement at ERCP are associated with a lower rate of complete endoscopic resection, whereas the ability to perform en bloc papillectomy increases the odds of complete resection. Long term follow-up demonstrates a small but clinically significant risk of recurrence, up to 5 years after papillectomy.
Volume 77, No. 5S : 2013
GASTROINTESTINAL ENDOSCOPY
AB291
Abstracts
Patient, Lesion, and Endoscopic Factors associated with complete resection
Variable Patient characteristics Mean age (SD) % female sex % jaundice Clinical presentation Incidental finding FAP surveillance Abnormal liver function tests Pancreatitis/ pancreatobiliary-type pain Lesion characteristics & Endoscopic Technique Intraductal involvement at ERCP Mean lesion size† (mm, SD) En bloc resection technique Adjuvant cautery Endoscopist impression of complete resection‡
Complete resection (nⴝ120)
Multivariate No complete resection Univariate odds ratio Multivariate (95% CI) p value (nⴝ44) p value
59.4 (16.4) 64.0 (16.2) 49.2 (40.2, 58.1) 56.8 (42.2, 71.5) 7.5 (2.8, 12.2) 15.9 (5.1, 26.7)
0.12 0.39 0.11
82.9 (71.2, 94.7) 17.1 (5.3, 28.8) 75.6 (62.8, 88.3) 24.4 (11.7, 37.2) 42.9 (15.8, 70.0) 57.1 (30., 84.2)
0.023
1.00 (0.97, 1.02)
0.88
0.56 (0.17, 1.86)
0.35
0.26 (0.07, 0.91)
0.035
0.24 (0.10, 0.56)
0.001
2.89 (1.27, 6.60)
0.012
68.4 (56.2, 80.7) 31.6 (19.3, 43.8)
12.5 (6.6, 18.4) 40.9 (26.4, 55.4) 16.8 (11.8)
19.5 (11.2)
⬍0.001 0.24
52.1 (43.1, 61.1) 25.0 (12.2, 37.8)
0.002
29.4 (21.2, 37.6) 29.5 (16.1, 43.0) 86.6 (80.4, 92.3) 54.5 (39.8, 69.3)
0.99 ⬍0.001
†Based on histopathological review of endoscopic specimen. ‡Endoscopist reported impression of whether or not visible adenomatous tissue remained. Inclusion of this variable into the regression model did not impact the results (data not shown). All numbers are proportions (95% confidence intervals) unless otherwise specified.
Kaplan Meier analysis survivor function illustrates the rate of recurrence of ampullary adenoma among patients who underwent endoscopic papillectomy with complete resection after one or more ERCPs. This figure highlights the importance of long term (⬎ 24 month) endoscopic surveillance.
Su1346 Prophalactic Hemoclip Application At ERCP to Prevent Post-ES Bleeding in Patients Receiving Anticoagulation or Antiplatelet Therapy David Klibansky, Emily A. Rolfsmeyer, Sam Yoselevitz, Bryce C. Mays, David Y. Lo, Douglas A. Howell* Pancreaticobiliary Center, Maine Medical Center, Portland, ME Background: The risk of immediate or delayed post-endoscopic sphincterotomy bleeding (PESB) is reported to range from 2.0-5.3%, but can be as high as 10% to 25% in the setting of high risk patients (pts) receiving anti-platelet agents or anticoagulation therapy. These pts present a particular challenge when definitive ERCP sphincterotomy (ES) is indicated. Mechanical clipping of PESB has been reported but infrequently used due to the difficulty in placing the current generation of clips using ERCP endoscopes as well as the potential risk of inadvertent application of clips on the pancreatic orifice. However, hemoclip
placement has been shown to be highly effective in mechanical closure of a wide variety of bleeding and potential bleeding lesions of the GI tract. We present our single center experience with prophylactic hemoclip placement to prevent PESB in the setting of antiplatelet/anticoagulation Rx. Patients: 35 consecutive pts identified as increased risk for PESB underwent ES followed by prophylactic clip placement. Indications for ES included: choledocholithiasis n⫽15, cholangitis n⫽12, ampullary stenosis n⫽7, and management of pancreatic fistula n⫽1. 25 patients required chronic coumadin therapy: 3 were therapeutic at time of intervention, 14 discontinued Coumadin with sub-therapeutic INR at time of ES but resumed immediately post-procedure, 8 were with sub-therapeutic INR and immediately bridged. 4 pts were actively anticoagulated with therapeutic Heparin and 6 pts were actively receiving Clopidogrel. Methods: Following standard pull-type biliary ES with mono-filament papilotomes and blended current, two or more detachable short hemostatic clips (Quickclip, Olympus) were used after trimming back the outer sheath 1.5cm to facilitate their function over the ERCP elevator. The endoscope was then positioned above the sphincterotomy, and the clips placed on opposing sides of the cut, taking care not to obstruct the pancreatic orifice. Results: Placement of hemostatic clips was technically possible in 100% of pts. 2/35 (5.7%) pts experienced delayed postsphincterotomy bleeding. In one case, ES was performed in context of INR ⬎ 2, the other with Lovenox plus Plavix therapy. Both pts experienced delayed bleeding at 48 hours of moderate severity. Repeat endoscopy procedure. Repeat endoscopy revealed premature clip dislodgement in both cases and bleeding was treated with repeat clip placement. 1/35 treated pts experienced post-ERCP pancreatitis (3%), which was mild. Conclusions: Although technically difficult, hemoclip application to prevent post-sphincterotomy bleeding in the setting of anticoagulation is feasible, safe, and may be effective. However, premature clip dislodgement may limit longer-term prophylaxis in the setting of full dose anticoagulation or multiple agents.
Su1347 Drugs for Moderate Sedation in Endoscopic Retrograde Cholangiopancreatography - Are Dosages a Limiting Factor? Fatema S. Uddin*, Pragathi Kandunoori, Jayaprakash Sreenarasimhaiah, Deepak Agrawal Division of Digestive and Liver Diseases, UT Southwestern, Dallas, TX Background: Benzodiazepines and narcotics are used for moderate sedation. Even though these medications have been used extensively for many years, there is scant data on how much dose can be given safely. In fact, there are reports of procedures being aborted after a set dose limit of these medications have been given due to concern for safety and side effects. Aim: To determine if there is a maximum limit of benzodiazepines and narcotics that can be given safely for endoscopic procedures. Methods: We retrospectively identified all patients who underwent ERCP with moderate sedation at a large academic institution from 2008-2012. Medical records were then reviewed to gather information on patient demographics, indications of procedures and maximum dosages given and any complications (defined as procedure aborted due to cardio pulmonary status, use of reversal agents, need for intubation and transfer to higher level of care). High doses of medications were considered to be midazolam ⱖ10mg, fentanyl ⱖ200mcg, meperidine ⱖ150 mg. Results: 1615 charts were reviewed. 1219 patients (75%) of these patients underwent ERCP with moderate sedation. Median doses of midazolam and fentanyl were 7mg and 150mcg, respectively. 258 received (21%) received ⱖ10mg of midazolam and 340 received (28%) received ⱖ200 mcg of fentanyl. The maximum dose of midazolam, fentanyl and meperidine that were given were 22mg, 475 mcg, 225 mg respectively. All the cases involved therapeutic interventions. 64 (4%) of patients failed moderate sedation and subsequently required general anesthesia. There were no other adverse outcomes related to procedure or sedation. Conclusions: This study supports the idea that most patients can safely undergo ERCP with moderate sedation. High doses of midazolam and fentanyl are safe in selected patients and careful monitoring. Endoscopic procedures should not be delayed or aborted simply out of concern for use of high doses of medications.
Su1348 Newer Generation Fluoroscopy Units Reduce Fluoroscopy Exposure During ERCP Robert A. Lockwood*1, Charles W. Shrode1, James T. Patrie2, Dawn G. COX1, Vanessa M. Shami1, Bryan G. Sauer1, James A. Mann1, Andrew Y. Wang1 1 Division of Gastroenterology and Hepatology, University of Virginia, Charlottesville, VA; 2Division of Biostatistics and Epidemiology, University of Virginia, Charlottesville, VA Background: Radiation exposure is associated with short- and long-term deleterious health effects. Fluoroscopic time (FT) has been used as a surrogate marker of radiation exposure during ERCP. Due to renovations in 2011-2012, ERCPs were performed in 3 settings: (group A) older generation (non-digital,
AB292 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 5S : 2013
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