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Early Pre-Cut for Biliary Access Is Safe and Effective
Abstracts
bile exfoliate cytology has been suggested but is rarely performed. The aim of this prospective study was to assess the diagnostic performance bile aspiration associated with biliary brushing during an ERCP. Patients and Methods: From Jan 2007 to Sept 2008, 82 patients (51 M, 31 F), mean age 70 (32 - 93), among whom ERCP was performed for the treatment of a biliary stricture with suspicion of malignancy, were included. A final diagnosis of cancer was established in 57/82 patients by histology. A surgical resection was contra indicated for highly suspicious of malignant strictures because of the patient terrain or tumoral involvement. After sphincterotomy and crossing of the stricture with a guide wire, a single use brush protected by an 8 Fr catheter (ref. FS-CB-1.5 Cook Ò) slipped on the wire was positioned above the stricture. Three to 10 ml of bile were aspirated and collected in a dry sterile tube before and after brushing. Brushing was performed with 10 passages in to-and-fro fashion across the stricture for classical cytological analysis (MGG, Papanicolaou) and in thin layer (Preservcyt Ò). After centrifugation of the 2 samples of bile, an analysis was performed on a slide (MGG, Papanicolaou). Results: The biliary strictures were related to 34 pancreatic cancers, 16 cholangiocarcinoma and 7 other cancers including 4 metastatic tumors. Twenty-five were benign. One cholecystitis occurred (1.2%): . For the diagnosis of malignancy, the performance of procedures were as follows: brushing; Se Z 65.5%, Sp Z 100%, PPV Z 100%, NPV Z 54.5%, bile samples before brushing: Se Z 75.9%, Sp Z 100%, PPV Z 100%, NPVZ 63.2%. Bile samples after brushing did not provide additional diagnostic performance. The cellularity of samples was associated with better sensitivity for the cytological analysis of bile before brushing (p !0001) and brushing (p Z 0.02). The best diagnostic performance was obtained by combining cytological analysis of bile before brushing and brushing: Se Z 81%, Sp Z 100%, PPV Z 100%, NPV Z 68.6%. The diagnostic sensitivity of combining cytological analysis was significantly higher for cholangiocarcinoma (100%) than for pancreatic cancer (82%) and metastases (66%) (p !0.01). Conclusion: In case of biliary stricture, the aspiration of bile before brushing during an ERCP is a simple and safe procedure. Analysis of bile before brushing in combination with brushing increase significantly the performance of cytological diagnosis of malignant strictures especially for cholangiocarcinoma.
S1353 Early Pre-Cut for Biliary Access Is Safe and Effective Tiing Leong Ang, Andrew Kwek, Kieron B. Lim, Kwong Ming Fock, Teo Eng Kiong Background: Successful selective cannulation of the common bile duct (CBD) or pancreatic duct is a prerequisite for therapeutic endoscopic retrograde cholangiopancreatography (ERCP). Cannulation failure rates of 5 - 20% have been reported. Pre-cut sphincterotomy will allow access in such difficult cases, but its use remains controversial. Pre-cut sphincterotomy has been implicated in the occurrence of local complications such as post-ERCP pancreatitis, bleeding and perforation at an overall rate of 2 - 20%. Conversely by performing early pre-cut, one could potentially avoid papilla edema from prolonged cannulation and hence reduce the risk of postERCP pancreatitis. It may be easier and potentially safer to perform early pre-cut, before the papilla becomes edematous and distorted. Aim: This study examined the safety and efficacy of early pre-cut sphincterotomy for biliary access using a needle knife. Methods: Consecutive patients undergoing ERCP over a 22-month period were enrolled. All patients underwent wire-guided cannulation during ERCP. Early pre-cut was performed using a needle knife prior to occurrence of papilla trauma in the following situations: 1) inadvertent guidewire cannulation of pancreatic duct on 3 occasions; 2) presence of impacted CBD stone at papilla; 3) inability to achieve deep cannulation within 10 minutes. Exclusion criteria were as follow: 1) inability to visualize the papilla due to anatomical distortions; 2) inability to perform therapeutic ERCP due to a complete occlusion of the distal CBD. Results: A total of 567 patients underwent ERCP during this period. Five patients were excluded; in 2 cases the papilla could not be visualised and in 3 cases there was complete occlusion of the distal CBD by peri-ampulla cancer. Biliary ERCP accounted for 97.7% of the cases. The most common indication was choledocholithiasis (84%) followed by pancreaticobiliary malignancies (7.5%). Other indications included chronic pancreatitis, recurrent pyogenic cholangitis, benign CBD stricture, pancreatic tuberculosis and severe pancreatitis with pancreatic duct disruption. ERCP was successfully performed in all 562 patients, of which early pre-cut was performed in 33/562 cases (5.9%). No local complications occurred in the group who received early pre-cut. The overall complication rate was 10/562 (1.8%). Post-ERCP pancreatitis occurred in 5/562 (0.9%), post-sphincterotomy bleeding in 3/562 (0.5%) and biliary perforation in 2/562 (0.4%). There were no deaths. Conclusion: Early pre-cut for biliary access is safe and effective. It does not further increase the rates of local complications over the baseline risk.
S1354 Endoscopic Papillary Balloon Dilation for Bile Duct Stones in Patients Aged 60 Years Old or Younger Takeshi Tsujino, Hirofumi Kogure, Yukiko Ito, Yousuke Nakai, Naoki Sasahira, Kenji Hirano, Hiroyuki Isayama, Minoru Tada, Takao Kawabe, Masao Omata Background: Endoscopic papillary balloon dilation (EPBD) is theoretically suited for young patients because this procedure is expected to preserve the sphincter function. While concern has been raised that EPBD may carry a substantial risk of
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severe pancreatitis in young patients, little is not known about immediate and longterm outcomes of EPBD in this group of patients. Methods: Between 1994 and 2008, a total of 1,336 patients with bile duct stones underwent EPBD in our institutions. Among these patients, 311 patients were 60 yr or younger at the time of EPBD (mean age, 48.9 9.9 yr; range, 21-60; men/women, 183/128). Immediate and long-term outcomes were evaluated. Results: Complete stone removal was successful with EPBD alone in 304 patients (97.7%) in a mean of 1.3 endoscopic sessions; bile duct clearance was achieved in one endoscopic session in 239 patients (76.8%). Forty-eight patients (15.4%) required mechanical lithotripsy before stone extraction. After EPBD and stone removal, pancreatitis occurred in 24 patients (7.7%); mild in 18, moderate in 5, and severe in 1. Long-term outcomes were evaluated in 217 patients, who were followed for at least one year after complete stone removal by EPBD. During a mean follow-up period of 5.5 years (range, 1.0-13.1 years), stone recurrence was observed in 13 patients (6.0%). The cumulative stone recurrence rates at 5 and 10 years after EPBD were 5.9% and 7.2%, respectively. Recurrent stones were managed endoscopically. Conclusion: In young patients, EPBD is effective to remove bile duct stones without an increasing risk of severe pancreatitis. Long-term outcomes after EPBD seem favorable for young patients.
Cumulatieve stone recurrence rate after EPBD
S1355 Is Repeat ERCP Required At the Time of Biliary Stent Removal After Clinical Resolution of An Endoscopically Managed PostCholecystectomy Bile Leak? Nayantara Coelho-Prabhu, Todd H. Baron Background: Bile duct leak following cholecystectomy is a serious complication and the incidence has increased since the advent of laparoscopic cholecystectomy. Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a biliary stent either with or without sphincterotomy is now the initial therapy of choice for its management. A repeat ERCP at the time of biliary stent removal is commonly performed to confirm closure of the leak and to exclude other pathology. Aims: 1. To determine whether follow-up ECRP is necessary at the time of stent removal, 2. To evaluate risk factors predicting failure of closure of bile leak, 3. To perform a cost comparison between ERCP and EGD for stent removal. Methods: All patients who were referred for or diagnosed with a bile leak between August 1, 1996 and September 30, 2008 were identified from the Mayo Clinic endoscopy database. Of the 202 patients identified, 128 were excluded who had liver resection. 74 patients with post-cholecystectomy bile leaks that were managed with placement of a biliary stent were identified. 53 of the 74 had follow up ERCPs and were included in the analysis. Risk factors that were considered as potential contributors to delayed closure included: patients’ age, type of cholecystectomy performed (open versus lap), year of surgery, and diameter of stent placed. These were analyzed using fit proportional hazards models. Cost comparison was performed between ERCP with stent removal which costs $418 per medicare estimates and an EGD with stent removal which costs $176. Results: All the patients had clinically resolved the leak by symptoms, drainage output and/or removal of external drains by the time of the repeat ERCP where successful closure of the bile leak was confirmed. The median time to closure of the leak was 42.7 (IQR 30-55) days. By 80 days after stent placement, 48 of 53 (90%) of all leaks were closed at follow-up ERCP. The median time to closure for leaks from the cystic duct stump and ducts of Luschka (nZ35) was 38.6 (IQR 27-52) days and for leaks from other sites (nZ18) was 48.4 (IQR 34-59) days. All the above risk factors were found to be not significant. Conclusion: 1. In patients with post-cholecystectomy bile leaks managed by ERCP and biliary stent placement, a follow-up ERCP at the time of biliary stent removal is not necessary if the leak has clinically resolved. 2. Biliary stent removal via EGD is much less expensive than ERCP with stent removal, results in cost-savings and may carry a lower complication rate. 3. EGD with stent removal saves approximately $242 per patient and can decrease costs to the patient and the health care system.
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB151
bile exfoliate cytology has been suggested but is rarely performed. The aim of this prospective study was to assess the diagnostic performance bile aspiration associated with biliary brushing during an ERCP. Patients and Methods: From Jan 2007 to Sept 2008, 82 patients (51 M, 31 F), mean age 70 (32 - 93), among whom ERCP was performed for the treatment of a biliary stricture with suspicion of malignancy, were included. A final diagnosis of cancer was established in 57/82 patients by histology. A surgical resection was contra indicated for highly suspicious of malignant strictures because of the patient terrain or tumoral involvement. After sphincterotomy and crossing of the stricture with a guide wire, a single use brush protected by an 8 Fr catheter (ref. FS-CB-1.5 Cook Ò) slipped on the wire was positioned above the stricture. Three to 10 ml of bile were aspirated and collected in a dry sterile tube before and after brushing. Brushing was performed with 10 passages in to-and-fro fashion across the stricture for classical cytological analysis (MGG, Papanicolaou) and in thin layer (Preservcyt Ò). After centrifugation of the 2 samples of bile, an analysis was performed on a slide (MGG, Papanicolaou). Results: The biliary strictures were related to 34 pancreatic cancers, 16 cholangiocarcinoma and 7 other cancers including 4 metastatic tumors. Twenty-five were benign. One cholecystitis occurred (1.2%): . For the diagnosis of malignancy, the performance of procedures were as follows: brushing; Se Z 65.5%, Sp Z 100%, PPV Z 100%, NPV Z 54.5%, bile samples before brushing: Se Z 75.9%, Sp Z 100%, PPV Z 100%, NPVZ 63.2%. Bile samples after brushing did not provide additional diagnostic performance. The cellularity of samples was associated with better sensitivity for the cytological analysis of bile before brushing (p !0001) and brushing (p Z 0.02). The best diagnostic performance was obtained by combining cytological analysis of bile before brushing and brushing: Se Z 81%, Sp Z 100%, PPV Z 100%, NPV Z 68.6%. The diagnostic sensitivity of combining cytological analysis was significantly higher for cholangiocarcinoma (100%) than for pancreatic cancer (82%) and metastases (66%) (p !0.01). Conclusion: In case of biliary stricture, the aspiration of bile before brushing during an ERCP is a simple and safe procedure. Analysis of bile before brushing in combination with brushing increase significantly the performance of cytological diagnosis of malignant strictures especially for cholangiocarcinoma.
S1353 Early Pre-Cut for Biliary Access Is Safe and Effective Tiing Leong Ang, Andrew Kwek, Kieron B. Lim, Kwong Ming Fock, Teo Eng Kiong Background: Successful selective cannulation of the common bile duct (CBD) or pancreatic duct is a prerequisite for therapeutic endoscopic retrograde cholangiopancreatography (ERCP). Cannulation failure rates of 5 - 20% have been reported. Pre-cut sphincterotomy will allow access in such difficult cases, but its use remains controversial. Pre-cut sphincterotomy has been implicated in the occurrence of local complications such as post-ERCP pancreatitis, bleeding and perforation at an overall rate of 2 - 20%. Conversely by performing early pre-cut, one could potentially avoid papilla edema from prolonged cannulation and hence reduce the risk of postERCP pancreatitis. It may be easier and potentially safer to perform early pre-cut, before the papilla becomes edematous and distorted. Aim: This study examined the safety and efficacy of early pre-cut sphincterotomy for biliary access using a needle knife. Methods: Consecutive patients undergoing ERCP over a 22-month period were enrolled. All patients underwent wire-guided cannulation during ERCP. Early pre-cut was performed using a needle knife prior to occurrence of papilla trauma in the following situations: 1) inadvertent guidewire cannulation of pancreatic duct on 3 occasions; 2) presence of impacted CBD stone at papilla; 3) inability to achieve deep cannulation within 10 minutes. Exclusion criteria were as follow: 1) inability to visualize the papilla due to anatomical distortions; 2) inability to perform therapeutic ERCP due to a complete occlusion of the distal CBD. Results: A total of 567 patients underwent ERCP during this period. Five patients were excluded; in 2 cases the papilla could not be visualised and in 3 cases there was complete occlusion of the distal CBD by peri-ampulla cancer. Biliary ERCP accounted for 97.7% of the cases. The most common indication was choledocholithiasis (84%) followed by pancreaticobiliary malignancies (7.5%). Other indications included chronic pancreatitis, recurrent pyogenic cholangitis, benign CBD stricture, pancreatic tuberculosis and severe pancreatitis with pancreatic duct disruption. ERCP was successfully performed in all 562 patients, of which early pre-cut was performed in 33/562 cases (5.9%). No local complications occurred in the group who received early pre-cut. The overall complication rate was 10/562 (1.8%). Post-ERCP pancreatitis occurred in 5/562 (0.9%), post-sphincterotomy bleeding in 3/562 (0.5%) and biliary perforation in 2/562 (0.4%). There were no deaths. Conclusion: Early pre-cut for biliary access is safe and effective. It does not further increase the rates of local complications over the baseline risk.
S1354 Endoscopic Papillary Balloon Dilation for Bile Duct Stones in Patients Aged 60 Years Old or Younger Takeshi Tsujino, Hirofumi Kogure, Yukiko Ito, Yousuke Nakai, Naoki Sasahira, Kenji Hirano, Hiroyuki Isayama, Minoru Tada, Takao Kawabe, Masao Omata Background: Endoscopic papillary balloon dilation (EPBD) is theoretically suited for young patients because this procedure is expected to preserve the sphincter function. While concern has been raised that EPBD may carry a substantial risk of
www.giejournal.org
severe pancreatitis in young patients, little is not known about immediate and longterm outcomes of EPBD in this group of patients. Methods: Between 1994 and 2008, a total of 1,336 patients with bile duct stones underwent EPBD in our institutions. Among these patients, 311 patients were 60 yr or younger at the time of EPBD (mean age, 48.9 9.9 yr; range, 21-60; men/women, 183/128). Immediate and long-term outcomes were evaluated. Results: Complete stone removal was successful with EPBD alone in 304 patients (97.7%) in a mean of 1.3 endoscopic sessions; bile duct clearance was achieved in one endoscopic session in 239 patients (76.8%). Forty-eight patients (15.4%) required mechanical lithotripsy before stone extraction. After EPBD and stone removal, pancreatitis occurred in 24 patients (7.7%); mild in 18, moderate in 5, and severe in 1. Long-term outcomes were evaluated in 217 patients, who were followed for at least one year after complete stone removal by EPBD. During a mean follow-up period of 5.5 years (range, 1.0-13.1 years), stone recurrence was observed in 13 patients (6.0%). The cumulative stone recurrence rates at 5 and 10 years after EPBD were 5.9% and 7.2%, respectively. Recurrent stones were managed endoscopically. Conclusion: In young patients, EPBD is effective to remove bile duct stones without an increasing risk of severe pancreatitis. Long-term outcomes after EPBD seem favorable for young patients.
Cumulatieve stone recurrence rate after EPBD
S1355 Is Repeat ERCP Required At the Time of Biliary Stent Removal After Clinical Resolution of An Endoscopically Managed PostCholecystectomy Bile Leak? Nayantara Coelho-Prabhu, Todd H. Baron Background: Bile duct leak following cholecystectomy is a serious complication and the incidence has increased since the advent of laparoscopic cholecystectomy. Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a biliary stent either with or without sphincterotomy is now the initial therapy of choice for its management. A repeat ERCP at the time of biliary stent removal is commonly performed to confirm closure of the leak and to exclude other pathology. Aims: 1. To determine whether follow-up ECRP is necessary at the time of stent removal, 2. To evaluate risk factors predicting failure of closure of bile leak, 3. To perform a cost comparison between ERCP and EGD for stent removal. Methods: All patients who were referred for or diagnosed with a bile leak between August 1, 1996 and September 30, 2008 were identified from the Mayo Clinic endoscopy database. Of the 202 patients identified, 128 were excluded who had liver resection. 74 patients with post-cholecystectomy bile leaks that were managed with placement of a biliary stent were identified. 53 of the 74 had follow up ERCPs and were included in the analysis. Risk factors that were considered as potential contributors to delayed closure included: patients’ age, type of cholecystectomy performed (open versus lap), year of surgery, and diameter of stent placed. These were analyzed using fit proportional hazards models. Cost comparison was performed between ERCP with stent removal which costs $418 per medicare estimates and an EGD with stent removal which costs $176. Results: All the patients had clinically resolved the leak by symptoms, drainage output and/or removal of external drains by the time of the repeat ERCP where successful closure of the bile leak was confirmed. The median time to closure of the leak was 42.7 (IQR 30-55) days. By 80 days after stent placement, 48 of 53 (90%) of all leaks were closed at follow-up ERCP. The median time to closure for leaks from the cystic duct stump and ducts of Luschka (nZ35) was 38.6 (IQR 27-52) days and for leaks from other sites (nZ18) was 48.4 (IQR 34-59) days. All the above risk factors were found to be not significant. Conclusion: 1. In patients with post-cholecystectomy bile leaks managed by ERCP and biliary stent placement, a follow-up ERCP at the time of biliary stent removal is not necessary if the leak has clinically resolved. 2. Biliary stent removal via EGD is much less expensive than ERCP with stent removal, results in cost-savings and may carry a lower complication rate. 3. EGD with stent removal saves approximately $242 per patient and can decrease costs to the patient and the health care system.
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB151