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720 A Randomized Controlled Trial of Rectal Indomethacin for the Prevention of Post-ERCP Pancreatitis
Abstracts
treatment of intraoperative bleeding (0.96⫾1.4 vs. 2.4⫾2.5,p⫽0.045). The number of hemostatic clips was the same (HybridKnife:6.2⫾1.2, conv. 6.8⫾1.6). There were no perforations in both groups. No procedure needed surgical intervention. Cutaneous emphysema occurred in 1 case in the HybridKnife group and in 4 cases in the conv. group. (Figure 1 and 2). Conclusions: Water-jet assisted POEM with the HybridKnife lead to significantly shorter operation time, lower bleeding rate and a lower frequency of usage of coagulation forceps. The water-jet assisted procedure simplifies the POEM procedure and makes it safer. This clinical trial of 43 patients demonstrate that water-jet assisted POEM using the HybridKnife® is a serious alternative in terms of speed, complications and handling compared to the conv. POEM technique.
esophageal mucosal incision.
720 A Randomized Controlled Trial of Rectal Indomethacin for the Prevention of Post-ERCP Pancreatitis B. J. Elmunzer*1, James M. Scheiman1, Glen A. Lehman2, Amitabh Chak3, Patrick Mosler4, Peter D. Higgins1, Rodney A. Hayward1, Joseph Romagnuolo5, Grace H. Elta1, Stuart Sherman2, Evan L. Fogel2 1 Univ Michigan, Ann Arbor, MI; 2Indiana University, Indianapolis, IN; 3 Case Western Reserve University, Cleveland, OH; 4University of Kentucky, Lexington, KY; 5Medical University of South Carolina, Charleston, SC Background: Pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP), accounting for substantial morbidity, occasional mortality, and considerable health care expenditures. Preliminary research suggests that rectally administered non-steroidal antiinflammatory drugs (NSAIDs) may substantially reduce the incidence of postERCP pancreatitis (PEP). Our aim was to more rigorously evaluate the efficacy of rectal indomethacin for the prevention of PEP in high-risk cases. Methods: A multi-center, randomized, placebo-controlled, double-blinded clinical trial enrolling subjects at elevated risk for PEP was conducted. High-risk subjects were included on the basis of validated patient and procedure-related risk factors, including clinical suspicion of sphincter of Oddi dysfunction (SOD), history of PEP, difficult cannulation, pre-cut (access) sphincterotomy, and pancreatic sphincterotomy. Enrolled subjects were randomized by concealed allocation to receive two 50 mg indomethacin suppositories or two identicalappearing placebo suppositories immediately after ERCP. The primary and secondary endpoints were the development of post-ERCP pancreatitis and the severity of PEP respectively, and were defined according to consensus criteria. Subjects were followed for 30 days after the ERCP to assess for delayed adverse events potentially attributable to the study intervention. Results: Six hundred and two subjects of an intended 948 were enrolled prior to early termination of the study by the Data and Safety Monitoring Board based on the overwhelming benefit of indomethacin compared to placebo. Fifty-two of 307 (16.9%) patients in the placebo group developed PEP compared to 27 of 295 (9.2%) patients in the indomethacin group, corresponding to a relative risk reduction of 46% (95% confidence interval ⫽ 17%-65%, p⫽0.005) and an absolute risk reduction of 7.7% (number needed to treat to prevent one episode of PEP ⫽ 13). Twenty-seven patients (8.8%) in the placebo group developed moderate to severe PEP whereas 13 patients (4.4%) in the indomethacin group developed this composite endpoint (p⫽0.034). The majority of enrolled subjects (82%) had a clinical suspicion of SOD, although indomethacin appeared equally protective in patients without this condition. There was no difference in adverse events potentially attributable to the study intervention between the indomethacin and placebo groups. Conclusions: Rectal indomethacin significantly reduces the incidence and severity of PEP in patients at elevated risk for this complication, particularly in those with a clinical suspicion of SOD. Given its apparent benefit in non-SOD patients as well as its favorable safety and cost profiles, prophylactic indomethacin is reasonable to consider for all high-risk patients undergoing ERCP.
721 Elevated Pancreatic Sphincter Basal Pressure Predicts Outcome in Patients With Idiopathic Recurrent Acute Pancreatitis, but Pancreatobiliary Sphincterotomy Is Not Superior to Biliary Sphincterotomy in Reducing Future Episodes of Pancreatitis Gregory A. Cote*, Suzette E. Schmidt, Evan L. Fogel, Glen A. Lehman, Lee Mchenry, James L. Watkins, Stuart Sherman Gastroenterology, Indiana University, Indianapolis, IN
submucosal “tunnelling” by endoscopic submucosal dissection (ESD) technique and endoscopic myotomy of the circular muscle
Background: The therapeutic impact of ERCP with sphincterotomy in the management of patients with idiopathic recurrent acute pancreatitis (RAP) needs further study. We conducted a single center, feasibility, randomized trial to determine 1) the role of pancreatic manometry in predicting future episodes of RAP and 2) differences in the efficacy of no, biliary (BES) or pancreatobiliary (dual) endoscopic sphincterotomy (DES). Methods: Patients with idiopathic RAP, defined as ⱖ2 unexplained (per the treating physician) episodes of acute pancreatitis (based on standard criteria) requiring hospitalization, were prospectively enrolled. All patients underwent ERCP with manometry, with stratified randomization based on the assessment of pancreatic basal sphincter pressure. If ⬍40mmHg, the patient was randomized to sham or BES. If ⱖ40mmHg, the patient was randomized to BES or DES. Patients and physicians were not blinded to the assignment group. Patients were followed for up to 10 years to determine 1) incidence of RAP requiring hospitalization (using standard definitions) or 2) interval development of chronic pancreatitis (CP). Data are presented as simple proportions or medians with interquartile ranges. Differences between patients who did and did not develop RAP during followup were compared, including a multivariable regression for all factors having p ⬍ 0.10 on univariate analysis. Results: We identified 86 eligible RAP patients (median episodes 3 (2, 4). Of these, 66 (76.7%) had elevated pancreatic pressure and were randomized to BES (n⫽31) or DES (n⫽35); the remaining 20 were
AB161 GASTROINTESTINAL ENDOSCOPY Volume 75, No. 4S : 2012
www.giejournal.org
treatment of intraoperative bleeding (0.96⫾1.4 vs. 2.4⫾2.5,p⫽0.045). The number of hemostatic clips was the same (HybridKnife:6.2⫾1.2, conv. 6.8⫾1.6). There were no perforations in both groups. No procedure needed surgical intervention. Cutaneous emphysema occurred in 1 case in the HybridKnife group and in 4 cases in the conv. group. (Figure 1 and 2). Conclusions: Water-jet assisted POEM with the HybridKnife lead to significantly shorter operation time, lower bleeding rate and a lower frequency of usage of coagulation forceps. The water-jet assisted procedure simplifies the POEM procedure and makes it safer. This clinical trial of 43 patients demonstrate that water-jet assisted POEM using the HybridKnife® is a serious alternative in terms of speed, complications and handling compared to the conv. POEM technique.
esophageal mucosal incision.
720 A Randomized Controlled Trial of Rectal Indomethacin for the Prevention of Post-ERCP Pancreatitis B. J. Elmunzer*1, James M. Scheiman1, Glen A. Lehman2, Amitabh Chak3, Patrick Mosler4, Peter D. Higgins1, Rodney A. Hayward1, Joseph Romagnuolo5, Grace H. Elta1, Stuart Sherman2, Evan L. Fogel2 1 Univ Michigan, Ann Arbor, MI; 2Indiana University, Indianapolis, IN; 3 Case Western Reserve University, Cleveland, OH; 4University of Kentucky, Lexington, KY; 5Medical University of South Carolina, Charleston, SC Background: Pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP), accounting for substantial morbidity, occasional mortality, and considerable health care expenditures. Preliminary research suggests that rectally administered non-steroidal antiinflammatory drugs (NSAIDs) may substantially reduce the incidence of postERCP pancreatitis (PEP). Our aim was to more rigorously evaluate the efficacy of rectal indomethacin for the prevention of PEP in high-risk cases. Methods: A multi-center, randomized, placebo-controlled, double-blinded clinical trial enrolling subjects at elevated risk for PEP was conducted. High-risk subjects were included on the basis of validated patient and procedure-related risk factors, including clinical suspicion of sphincter of Oddi dysfunction (SOD), history of PEP, difficult cannulation, pre-cut (access) sphincterotomy, and pancreatic sphincterotomy. Enrolled subjects were randomized by concealed allocation to receive two 50 mg indomethacin suppositories or two identicalappearing placebo suppositories immediately after ERCP. The primary and secondary endpoints were the development of post-ERCP pancreatitis and the severity of PEP respectively, and were defined according to consensus criteria. Subjects were followed for 30 days after the ERCP to assess for delayed adverse events potentially attributable to the study intervention. Results: Six hundred and two subjects of an intended 948 were enrolled prior to early termination of the study by the Data and Safety Monitoring Board based on the overwhelming benefit of indomethacin compared to placebo. Fifty-two of 307 (16.9%) patients in the placebo group developed PEP compared to 27 of 295 (9.2%) patients in the indomethacin group, corresponding to a relative risk reduction of 46% (95% confidence interval ⫽ 17%-65%, p⫽0.005) and an absolute risk reduction of 7.7% (number needed to treat to prevent one episode of PEP ⫽ 13). Twenty-seven patients (8.8%) in the placebo group developed moderate to severe PEP whereas 13 patients (4.4%) in the indomethacin group developed this composite endpoint (p⫽0.034). The majority of enrolled subjects (82%) had a clinical suspicion of SOD, although indomethacin appeared equally protective in patients without this condition. There was no difference in adverse events potentially attributable to the study intervention between the indomethacin and placebo groups. Conclusions: Rectal indomethacin significantly reduces the incidence and severity of PEP in patients at elevated risk for this complication, particularly in those with a clinical suspicion of SOD. Given its apparent benefit in non-SOD patients as well as its favorable safety and cost profiles, prophylactic indomethacin is reasonable to consider for all high-risk patients undergoing ERCP.
721 Elevated Pancreatic Sphincter Basal Pressure Predicts Outcome in Patients With Idiopathic Recurrent Acute Pancreatitis, but Pancreatobiliary Sphincterotomy Is Not Superior to Biliary Sphincterotomy in Reducing Future Episodes of Pancreatitis Gregory A. Cote*, Suzette E. Schmidt, Evan L. Fogel, Glen A. Lehman, Lee Mchenry, James L. Watkins, Stuart Sherman Gastroenterology, Indiana University, Indianapolis, IN
submucosal “tunnelling” by endoscopic submucosal dissection (ESD) technique and endoscopic myotomy of the circular muscle
Background: The therapeutic impact of ERCP with sphincterotomy in the management of patients with idiopathic recurrent acute pancreatitis (RAP) needs further study. We conducted a single center, feasibility, randomized trial to determine 1) the role of pancreatic manometry in predicting future episodes of RAP and 2) differences in the efficacy of no, biliary (BES) or pancreatobiliary (dual) endoscopic sphincterotomy (DES). Methods: Patients with idiopathic RAP, defined as ⱖ2 unexplained (per the treating physician) episodes of acute pancreatitis (based on standard criteria) requiring hospitalization, were prospectively enrolled. All patients underwent ERCP with manometry, with stratified randomization based on the assessment of pancreatic basal sphincter pressure. If ⬍40mmHg, the patient was randomized to sham or BES. If ⱖ40mmHg, the patient was randomized to BES or DES. Patients and physicians were not blinded to the assignment group. Patients were followed for up to 10 years to determine 1) incidence of RAP requiring hospitalization (using standard definitions) or 2) interval development of chronic pancreatitis (CP). Data are presented as simple proportions or medians with interquartile ranges. Differences between patients who did and did not develop RAP during followup were compared, including a multivariable regression for all factors having p ⬍ 0.10 on univariate analysis. Results: We identified 86 eligible RAP patients (median episodes 3 (2, 4). Of these, 66 (76.7%) had elevated pancreatic pressure and were randomized to BES (n⫽31) or DES (n⫽35); the remaining 20 were
AB161 GASTROINTESTINAL ENDOSCOPY Volume 75, No. 4S : 2012
www.giejournal.org