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Underestimation of adverse events following ERCP: A prospective 30 day follow-up study
ERCP--BILIAR Y "~449
t451
RESULTS AND LONG-TERM FOLLOW-UP OF COMBINED ENDOSCOPIC SPHINCTEROTOMY (ES) AND PERCUTANEOUS ENDOSCOPIC CHOLECYSTOLITHOTOMY (PECL) IN THE MANAGEMENT OF COMPLICATED BILIARY TRACT STONE DISEASE IN THE ELDERLY R. Neidich, C. Courtois, H. Chokshi, S. Edmundowicz, L. Marshall, D. Picus, and G. AlJperti, Divisions of Gastroenterology & Mallinckrodt Institute of Radiology. Washington University School of Medicine, St. Louis, MO Surgery for symptomatic gallstone disease in elderly patients, especially those with underlying cardiac or pulmonary disease, is associated with significant morbidity and mortality. Laparoscopic cholecystectomy may not substantially reduce complications in this setting, as general anesthesia is still required and clearance of the CBD can be difficult. Here we report our experience using PECL and ERCP with ES to clear the biliary tree of gallstones in elderly patients at very high surgical risk. METHODS: Between 5/89 and 10/92, seven male and seven female patients with cholelithiasis (14), choledocholithiasis (14), and cystic duct stones (4) were treated with the combined use of PECL and ES. Mean age was 76.4 years. Patients presented with acute cholecystitis (7), gallstone pancreatitis (3), jaundice (4), and recurrent symptomatic stone disease (4). Contraindications to surgery included severe cardiac (8), pulmonary (6), and/or neurologic problems (2). PECL involved cholecystostorny tube placement followed by pereutaneous stone removal. ERCP, ES, and endoscopic stone extraction were performed using standard techniques. RESULTS: Complete stone extraction was accomplished in 13 of 14 patients after a mean of 1.2 ERCP/ES sessions and 1.6 percutaneous stone removal sessions. Mean time from the first procedure until biliary clearance was 14 days. Four patients had complications which included C. difticile colitis, sepsis, a small retroperitoneal perforation, and minor bleeding. All recovered uneventfully. No procedurally-related deaths occurred. After a mean follow-up of 3.3 years, four patients remain alive and are free of biliary symptoms. Ten patients died of causes unrelated to the biliary tract. Of these, one died prior to complete stone clearance due to fungemia and severe cardiopulmonary disease. The remaining nine patients were free of biliary symptoms until death, which occurred after a mean of 1.5 years following cholecystostorny tube removal. CONCLUSIONS: (1) Combination of percutaneous and endoscopic management of complicated biliary tract stone disease provides safe, effective treatment tbr patients at very high surgical risk. (2) Biliary stone clearance using PECL and ERCP with ES results in sustained relief of symptoms in this patient population.
UNDERESTIMATION OF ADVERSE EVENTS FOLLOWING ERCP: A PROSPECTIVE 30 DAY FOLLOW-UP STUDY IvlK Newcomer, PS/dwell, PB Cotton, J Affroati, MS Branch, S Guarisco, I Leung, J Baillie, Division of Gastroenterology, Duke University Medical Center, Durham, NC Published estimates of endoscopic complications vary greatly and are prone to measurement biases which may cause the true complication rate to be underestimated. Objectives: 1) Identify all related adverse events resulting in unplanned hospitalization within 30 days of ERCP, 2) compare the results of this method to our standard mechanism (weekly QA review) using definitions developed at our institution (Gastrointest Endosc. 1991;37:383). Methods: Related adverse events were defined as either ~lir_ect: panereatitis, cholangitis, bleeding or perforation occurring in the 30 days post procedure, or indirect: cardiac, pulmonary, metabolic, neurologic or medication reaction occurring in the 3 days post procedure. 30 day follow-up was achieved by a standardized phone questionnaire and/or chart review. Results: Over, a 10 month period, 85% of 814 patients had successful 30 day phor~e follow-up; chart review was performed for specific indications. The charts of patients not reached by phone were also reviewed. The reported ERCP complication rate for this 10 month period was 6.2%9 Using 30 day telephone follow-up, an additional 25 unplanned hospitalizations (3.1%) were identified. These were all direct events: pancreatitis (17), cholangitis/stent occlusion or migration (6), infected pseudocyst (1) and delayed sphincterotomy bleed (1). No additional indirect events were identified. When the survey data are included, the 30 day adverse event rate increases to 9.3%. Conclusions: Adverse events following ERCP are underestimated by weekly QA review. A prospective, 30 day telephone follow-up identified up to 50% more adverse events. These data suggest that supplementing standard QA review with a 30 day phone survey substantially increases the yield of adverse events.
~'450
452
ENDOSCOPIC SPHINCTEROTOMY (ES) FOR GALLSTONE PANCREATITIS (GSP) WITH INTACT GALLBLADDER (GB): A PROSPECTIVE MULTICENTER STUDY. ~ , M Freeman, R Erickson, M Ryan, K Man, J Cunningharn, S Sherman, J DiSario, G Logan, L Labs. VA Medical Center and Hennepin County Medical Center, Minneapolis, MN and the "MESH" Study Group. Purpose: There are few prospective data on the effectiveness of ES for preventing recurrent GSP in pts with intact GBs. In pts having ES for OSP, we prospectively compared outcomes in those having early (within 30 day) cholecystectorny (CCx) vs. those in whom CCx was not planned (intact GB). Methods: Consecutive pts undergoing ES for acute GSP without prior CCx at 9 centers since 1992 were prospectively contacted, and the cumulative incidence of pancreatic and biliary outcomes was determined. The frequency of recurrent pancreatitis, choledocholithiasis, and death was compared between pts with an intact GB and those having early CCx. Results: 86 pts had ES for GSP; 8 pts were lost to follow-up and 2 died within 30 days post-ES. 36 pts underwent early CCx (within 30 days). 40 pts with intact GB were followed for a mean of 16.4 months (range 1.929.t mos.); of these, 9 pts subsequently underwent elective CCx at a mean of 6.4 mos, post-ES (4 asyrnptornatic, 5 biliary colic). Compared to pts undergoing early CCx, pts in whom the GB was left intact were significantly oider (mean age 66.t vs. 55.0;p=.006) and had a higher cumulative mortality (20.0% vs. 0%;p=.02); no deaths were related to biliary tract disease. There was no difference in the rate of recurrent GSP (2.5% vs, 2.7%, NS) or recurrent choledocholithiasis (0% vs. 0%, NS). Conclusions: Patients undergoing ES for acute gallstone pancreatitis in whom GB is left intact, despite being older and sicker, had no greater risk of recurrent pancreatitis than pts undergoing early cholecystectorny. ES appears to be as effective as cholecystectomy in preventing recurrent gallstone pancreatitis.
A COMPARATIVE STUDY OF P R E C U R V E D PAPILLOTOMES VS. STANDARD TYPE PAPILLOTOMES IN CLINICAL PRACTICE. ~ , Department of Gastroenterology, St. Joseph Medical Center and Franklin Square Hospital, Baltimore, MD. One frequent problem during papillotomy is incorrect papillotome wire direction. A previous trial demonstrated that 49-65% of all standard papillotomes (SP) are defective for this reason. A precurved papillotome was developed which was found to exhibit correct wire direction 99% of the time. The precurved papillotome was created by a process of high temperature preeuawing of the teflon prior to wire insertion. This technique was successful in maintaining 12 o'clock wire direction in the face of uncontrolled variables introduced including gas..sterilization, packaging stress, wire insertion site and mechantcally transmitted endoscope force. A study was then undertaken to confirm these results a n d t o evaluate s t a n ~ d y~ l?rer162 ~api,ll~l~0gl~:w~h~reg~l t~ f.~s[ rA~duet~on anti perfisrm~ce: P~pi'llbtoffjes e~va~uated ihi:luded'P,recurred (Wiltelk),~ai~r~aittbme'(~lt~b~51~) ' ~ a Y~r~ifbi~'e:(Microvasive). PapilldtO~ds~wi~req'afatr/o~ly~eleCtedft~O~opeastock. If the ,~ife~dir~ttol~ .-~t~,in~t~c~:a ,different~pltp.iilotom~~ a ~ . / selected. This process was repeated until a papdlotome was found with the wire in the 12 o-clock direction. During a one),ear period of time 68 papillotomies were performed in five hospitals. Failure rates due to improper wire direction were: Precurved - 0%; Cannulotome - 52%; Fluorotome - 58%. For papillotomes with the correct wire direction, there was no difference m performance or complication rates. A total of 103 papillotomes were used, 68 with correct direction and 35 defective. Based on these findings: 1) precurved papillotomes are significantly better than standard papillotomes with regard to wire direction, 2) cost savings of $100-200 per procedure are possible due to initial papillotome suitability and 3) additional studies should be performed to determine if precurved papillotome use may impact by lowering potential complication rates associated with sphincterotomy.
408
GASTROINTESTINAL
ENDOSCOPY
V O L U M E 41, NO. 4, 1995
t451
RESULTS AND LONG-TERM FOLLOW-UP OF COMBINED ENDOSCOPIC SPHINCTEROTOMY (ES) AND PERCUTANEOUS ENDOSCOPIC CHOLECYSTOLITHOTOMY (PECL) IN THE MANAGEMENT OF COMPLICATED BILIARY TRACT STONE DISEASE IN THE ELDERLY R. Neidich, C. Courtois, H. Chokshi, S. Edmundowicz, L. Marshall, D. Picus, and G. AlJperti, Divisions of Gastroenterology & Mallinckrodt Institute of Radiology. Washington University School of Medicine, St. Louis, MO Surgery for symptomatic gallstone disease in elderly patients, especially those with underlying cardiac or pulmonary disease, is associated with significant morbidity and mortality. Laparoscopic cholecystectomy may not substantially reduce complications in this setting, as general anesthesia is still required and clearance of the CBD can be difficult. Here we report our experience using PECL and ERCP with ES to clear the biliary tree of gallstones in elderly patients at very high surgical risk. METHODS: Between 5/89 and 10/92, seven male and seven female patients with cholelithiasis (14), choledocholithiasis (14), and cystic duct stones (4) were treated with the combined use of PECL and ES. Mean age was 76.4 years. Patients presented with acute cholecystitis (7), gallstone pancreatitis (3), jaundice (4), and recurrent symptomatic stone disease (4). Contraindications to surgery included severe cardiac (8), pulmonary (6), and/or neurologic problems (2). PECL involved cholecystostorny tube placement followed by pereutaneous stone removal. ERCP, ES, and endoscopic stone extraction were performed using standard techniques. RESULTS: Complete stone extraction was accomplished in 13 of 14 patients after a mean of 1.2 ERCP/ES sessions and 1.6 percutaneous stone removal sessions. Mean time from the first procedure until biliary clearance was 14 days. Four patients had complications which included C. difticile colitis, sepsis, a small retroperitoneal perforation, and minor bleeding. All recovered uneventfully. No procedurally-related deaths occurred. After a mean follow-up of 3.3 years, four patients remain alive and are free of biliary symptoms. Ten patients died of causes unrelated to the biliary tract. Of these, one died prior to complete stone clearance due to fungemia and severe cardiopulmonary disease. The remaining nine patients were free of biliary symptoms until death, which occurred after a mean of 1.5 years following cholecystostorny tube removal. CONCLUSIONS: (1) Combination of percutaneous and endoscopic management of complicated biliary tract stone disease provides safe, effective treatment tbr patients at very high surgical risk. (2) Biliary stone clearance using PECL and ERCP with ES results in sustained relief of symptoms in this patient population.
UNDERESTIMATION OF ADVERSE EVENTS FOLLOWING ERCP: A PROSPECTIVE 30 DAY FOLLOW-UP STUDY IvlK Newcomer, PS/dwell, PB Cotton, J Affroati, MS Branch, S Guarisco, I Leung, J Baillie, Division of Gastroenterology, Duke University Medical Center, Durham, NC Published estimates of endoscopic complications vary greatly and are prone to measurement biases which may cause the true complication rate to be underestimated. Objectives: 1) Identify all related adverse events resulting in unplanned hospitalization within 30 days of ERCP, 2) compare the results of this method to our standard mechanism (weekly QA review) using definitions developed at our institution (Gastrointest Endosc. 1991;37:383). Methods: Related adverse events were defined as either ~lir_ect: panereatitis, cholangitis, bleeding or perforation occurring in the 30 days post procedure, or indirect: cardiac, pulmonary, metabolic, neurologic or medication reaction occurring in the 3 days post procedure. 30 day follow-up was achieved by a standardized phone questionnaire and/or chart review. Results: Over, a 10 month period, 85% of 814 patients had successful 30 day phor~e follow-up; chart review was performed for specific indications. The charts of patients not reached by phone were also reviewed. The reported ERCP complication rate for this 10 month period was 6.2%9 Using 30 day telephone follow-up, an additional 25 unplanned hospitalizations (3.1%) were identified. These were all direct events: pancreatitis (17), cholangitis/stent occlusion or migration (6), infected pseudocyst (1) and delayed sphincterotomy bleed (1). No additional indirect events were identified. When the survey data are included, the 30 day adverse event rate increases to 9.3%. Conclusions: Adverse events following ERCP are underestimated by weekly QA review. A prospective, 30 day telephone follow-up identified up to 50% more adverse events. These data suggest that supplementing standard QA review with a 30 day phone survey substantially increases the yield of adverse events.
~'450
452
ENDOSCOPIC SPHINCTEROTOMY (ES) FOR GALLSTONE PANCREATITIS (GSP) WITH INTACT GALLBLADDER (GB): A PROSPECTIVE MULTICENTER STUDY. ~ , M Freeman, R Erickson, M Ryan, K Man, J Cunningharn, S Sherman, J DiSario, G Logan, L Labs. VA Medical Center and Hennepin County Medical Center, Minneapolis, MN and the "MESH" Study Group. Purpose: There are few prospective data on the effectiveness of ES for preventing recurrent GSP in pts with intact GBs. In pts having ES for OSP, we prospectively compared outcomes in those having early (within 30 day) cholecystectorny (CCx) vs. those in whom CCx was not planned (intact GB). Methods: Consecutive pts undergoing ES for acute GSP without prior CCx at 9 centers since 1992 were prospectively contacted, and the cumulative incidence of pancreatic and biliary outcomes was determined. The frequency of recurrent pancreatitis, choledocholithiasis, and death was compared between pts with an intact GB and those having early CCx. Results: 86 pts had ES for GSP; 8 pts were lost to follow-up and 2 died within 30 days post-ES. 36 pts underwent early CCx (within 30 days). 40 pts with intact GB were followed for a mean of 16.4 months (range 1.929.t mos.); of these, 9 pts subsequently underwent elective CCx at a mean of 6.4 mos, post-ES (4 asyrnptornatic, 5 biliary colic). Compared to pts undergoing early CCx, pts in whom the GB was left intact were significantly oider (mean age 66.t vs. 55.0;p=.006) and had a higher cumulative mortality (20.0% vs. 0%;p=.02); no deaths were related to biliary tract disease. There was no difference in the rate of recurrent GSP (2.5% vs, 2.7%, NS) or recurrent choledocholithiasis (0% vs. 0%, NS). Conclusions: Patients undergoing ES for acute gallstone pancreatitis in whom GB is left intact, despite being older and sicker, had no greater risk of recurrent pancreatitis than pts undergoing early cholecystectorny. ES appears to be as effective as cholecystectomy in preventing recurrent gallstone pancreatitis.
A COMPARATIVE STUDY OF P R E C U R V E D PAPILLOTOMES VS. STANDARD TYPE PAPILLOTOMES IN CLINICAL PRACTICE. ~ , Department of Gastroenterology, St. Joseph Medical Center and Franklin Square Hospital, Baltimore, MD. One frequent problem during papillotomy is incorrect papillotome wire direction. A previous trial demonstrated that 49-65% of all standard papillotomes (SP) are defective for this reason. A precurved papillotome was developed which was found to exhibit correct wire direction 99% of the time. The precurved papillotome was created by a process of high temperature preeuawing of the teflon prior to wire insertion. This technique was successful in maintaining 12 o'clock wire direction in the face of uncontrolled variables introduced including gas..sterilization, packaging stress, wire insertion site and mechantcally transmitted endoscope force. A study was then undertaken to confirm these results a n d t o evaluate s t a n ~ d y~ l?rer162 ~api,ll~l~0gl~:w~h~reg~l t~ f.~s[ rA~duet~on anti perfisrm~ce: P~pi'llbtoffjes e~va~uated ihi:luded'P,recurred (Wiltelk),~ai~r~aittbme'(~lt~b~51~) ' ~ a Y~r~ifbi~'e:(Microvasive). PapilldtO~ds~wi~req'afatr/o~ly~eleCtedft~O~opeastock. If the ,~ife~dir~ttol~ .-~t~,in~t~c~:a ,different~pltp.iilotom~~ a ~ . / selected. This process was repeated until a papdlotome was found with the wire in the 12 o-clock direction. During a one),ear period of time 68 papillotomies were performed in five hospitals. Failure rates due to improper wire direction were: Precurved - 0%; Cannulotome - 52%; Fluorotome - 58%. For papillotomes with the correct wire direction, there was no difference m performance or complication rates. A total of 103 papillotomes were used, 68 with correct direction and 35 defective. Based on these findings: 1) precurved papillotomes are significantly better than standard papillotomes with regard to wire direction, 2) cost savings of $100-200 per procedure are possible due to initial papillotome suitability and 3) additional studies should be performed to determine if precurved papillotome use may impact by lowering potential complication rates associated with sphincterotomy.
408
GASTROINTESTINAL
ENDOSCOPY
V O L U M E 41, NO. 4, 1995