***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    Input: BACKGROUND & AIMS Rectal indomethacin , a nonsteroidal anti-inflammatory drug , is given to prevent pancreatitis in high-risk patients undergoing endoscopic retro grade cholangiopancreatography ( ERCP ) , based on findings from clinical trials . The European Society for Gastrointestinal Endoscopy guidelines recently recommended prophylactic rectal indomethacin for all patients undergoing ERCP , including those at average risk for pancreatitis . We performed a r and omized controlled trail to investigate the efficacy of this approach . METHODS We performed a prospect i ve , double-blind , placebo-controlled trial of 449 consecutive patients undergoing ERCP at Dartmouth Hitchcock Medical Center , from March 2013 through December 2014 . Approximately 70 % of the cohort were at average risk for PEP . Subjects were assigned r and omly to groups given either a single 100-mg dose of rectal indomethacin ( n = 223 ) or a placebo suppository ( n = 226 ) during the procedure . The primary outcome was the development of post-ERCP pancreatitis ( PEP ) , defined by new upper-abdominal pain , a lipase level more than 3-fold the upper limit of normal , and hospitalization after ERCP for 2 consecutive nights . RESULTS There were no differences between the groups in baseline clinical or procedural characteristics . Sixteen patients in the indomethacin group ( 7.2 % ) and 11 in the placebo group ( 4.9 % ) developed PEP ( P = .33 ) . Complications and the severity of PEP were similar between groups . Per a priori protocol guidelines , the study was stopped owing to futility . CONCLUSIONS In a r and omized controlled study of consecutive patients undergoing ERCP , rectal indomethacin did not prevent post-ERCP pancreatitis . ClincialTrials.gov no : NCT01774604 BACKGROUND AND AIMS Acute pancreatitis following endoscopic retro grade cholangiography  presents a unique opportunity for prophylaxis and early modification of the disease process because the initial triggering event is temporally well defined and takes place in the hospital . We report a prospect i ve , single-center , r and omized , double-blind controlled trial to determine if rectal diclofenac reduces the incidence of pancreatitis following cholangiopancreatography . METHODS Entry to the trial was restricted to patients who underwent endoscopic retro grade pancreatography .  Immediately after endoscopy , patients were given a suppository containing either 100 mg diclofenac or placebo . Estimation of serum amylase level and clinical evaluation were performed in all patients . RESULTS One hundred patients entered the trial , and 50 received  rectal diclofenac . Fifteen patients developed pancreatitis ( 15 % ) , of whom two received rectal diclofenac and 13 received placebo ( P < 0.01 ) . CONCLUSIONS This trial shows that rectal diclofenac given immediately after endoscopic retro grade cholangiopancreatography can reduce the incidence of acute pancreatitis BACKGROUND Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retro grade cholangiopancreatography ( ERCP ) . METHODS In this multicenter , r and omized , placebo-controlled , double-blind clinical trial , we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP . Patients were determined to be at high risk on the basis of vali date d patient- and procedure-related risk factors . The primary outcome was post-ERCP pancreatitis , which was defined as new upper abdominal pain , an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure , and hospitalization for at least 2 nights . RESULTS A total of 602 patients were enrolled and completed follow-up . The majority of patients ( 82 % ) had a clinical suspicion of sphincter of Oddi dysfunction . Post-ERCP pancreatitis developed in 27 of 295 patients ( 9.2 % ) in the indomethacin group and in 52 of 307 patients ( 16.9 % ) in the placebo group ( P=0.005 ) . Moderate-to-severe pancreatitis developed in 13 patients ( 4.4 % ) in the indomethacin group and in 27 patients ( 8.8 % ) in the placebo group ( P=0.03 ) . CONCLUSIONS Among patients at high risk for post-ERCP pancreatitis , rectal indomethacin significantly reduced the incidence of the condition . ( Funded by the National Institutes of Health ; Clinical Trials.gov number , NCT00820612 . ) Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background Acute pancreatitis is the most common major complication after endoscopic retro grade cholangiopancreatography ( ERCP ) . Many drugs have been evaluated for prophylaxis , including nonsteroidal anti-inflammatory drugs ( NSAIDs ) , which are potent inhibitors of phospholipase A2 and play a role in the pathogenesis of acute pancreatitis . Rectal NSAIDs have been shown in prospect i ve studies to decrease the incidence of this complication , but the indication is not generalized in clinical practice . The aim of this study was to evaluate the efficacy of rectal administration of indomethacin in reducing the incidence of  post-ERCP pancreatitis in high-risk patients . Methods This was a controlled clinical trial where patients with an elevated risk of developing post-ERCP pancreatitis were assigned to receive 100 mg of rectal indomethacin or a 2.6 g suppository of glycerin immediately after ERCP , without placement of a pancreatic stent . The patients were determined to be at high risk based on vali date d patient- and procedure-related risk factors . Post-ERCP pancreatitis was defined as the presence of new upper abdominal pain , hyperamylasemia/hyperlipasemia ( at least three times the upper limit ) 2 hours after the procedure and hospitalization at least 48 hours because of the complication . Pancreatitis severity was defined according to Cotton ’s criteria . Results One hundred sixty-six patients were included ; 82 in the study group and 84 in the placebo group . Patients had at least one major and /or two minor risk factors for developing post-ERCP pancreatitis .  The incidence of the complication was 4.87 % ( 4/82 ) in the study group and 20.23 % ( 17/84 ) in the placebo group ; this difference was significant ( P = 0.01 ) . According to Cotton ’s criteria , 17 patients ( 80.9 % ) developed mild pancreatitis and 4 ( 19.1 % ) had moderate pancreatitis ; 3 of these 4 patients belonged to the placebo group ( P = 0.60 ) . Based on these results , an absolute risk reduction of 0.15 ( 15 % ) , a relative risk reduction of 0.75 ( 75 % ) and a number needed to treat of 6.5 patients were calculated to prevent an episode of post-ERCP pancreatitis . There was no mortality . Conclusions Rectal indomethacin reduced the incidence of post-ERCP pancreatitis among patients at high risk of developing this complication . Trial registration National Clinical Trials NCT02110810 . Date April 7 , 2014 Background and study aims : Several meta-analyses and r and omized control trials have demonstrated the efficacy of rectal nonsteroidal anti-inflammatory drugs for preventing post-endoscopic retro grade cholangiopancreatography ( ERCP ) pancreatitis ( PEP ) . Diclofenac or indomethacin was administered at a dose of 100 mg in those studies , which may be too high for Asian population . In addition , rectal administration can be considered complicated . Patients and methods : This study was a prospect i ve , r and omized , placebo-controlled trial . Patients with a PEP risk score ≥ 1 were r and omly assigned to receive intravenous injection of 50 mg flurbiprofen axetil ( flurbiprofen group ) or saline only ( placebo group ) . The primary outcome was reduced PEP . The secondary outcome was amylase level after 2 hours of ERCP as a predictor of PEP . ( Clinical Trials.gov , ID UMIN000011322 ) Results : In total , 144 patients were enrolled from August 2013 to March 2015 . We performed an interim analysis of the first 100 patients : 47 received flurbiprofen axetil and 53 received placebo  . PEP occurred in 11 patients ( 11 % ): 2 of 47 ( 4.3 % ) in the flurbiprofen group and 9 of 53 ( 17 % ) in the placebo group ( P = 0.042 ) . Relative risk reduction was 62.4 % . Hyperamylasemia did not differ significantly ( 17.0 % vs. 26.4 % , P = 0.109 ) . This analysis result ed in early termination of the study for ethical reasons . Conclusions : Intravenous injection of low-dose flurbiprofen axetil after ERCP can reduce the incidence of PEP in high-risk BACKGROUND Post-ERCP pancreatitis is poorly understood . The goal of this study was to comprehensively evaluate potential procedure- and patient-related risk factors for post-ERCP pancreatitis over a wide spectrum of centers . METHODS Consecutive ERCP procedures were prospect ively studied at 11 centers ( 6 private , 5 university ) . Complications were assessed at 30 days by using established consensus criteria . RESULTS Pancreatitis occurred after 131 ( 6.7 % ) of 1963 consecutive ERCP procedures ( mild 70 , moderate 55 , severe 6 ) . By univariate analysis , 23 of 32 investigated variables were significant . Multivariate risk factors with adjusted odds ratios ( OR ) were prior ERCP-induced pancreatitis ( OR 5.4 ) , suspected sphincter of Oddi dysfunction ( OR 2.6 ) , female gender ( OR 2.5 ) , normal serum bilirubin ( OR 1.9 ) , absence of chronic pancreatitis ( OR 1.9 ) , biliary sphincter balloon dilation ( OR 4.5 ) , difficult cannulation ( OR 3.4 ) , pancreatic sphincterotomy ( OR 3.1 ) , and 1 or more injections of contrast into the pancreatic duct ( OR 2.7 ) . Small bile duct diameter , sphincter of Oddi manometry , biliary sphincterotomy , and lower ERCP case volume were not multivariate risk factors for pancreatitis , although endoscopists performing on average more than 2 ERCPs per week had significantly greater success at bile duct cannulation ( 96.5 % versus 91.5 % , p = 0.0001 ) . Combinations of patient characteristics including female gender , normal serum bilirubin , recurrent abdominal pain , and previous post-ERCP pancreatitis placed patients at increasingly higher risk of pancreatitis , regardless of whether ERCP was diagnostic , manometric , or therapeutic . CONCLUSIONS Patient-related factors are as important as procedure-related factors in determining risk for post-ERCP pancreatitis . These data emphasize the importance of careful patient selection as well as choice of technique in the avoidance of post-ERCP pancreatitis AIM To determine the efficacy of rectally administered naproxen for the prevention of  post-endoscopic retro grade cholangiopancreatography ( ERCP ) pancreatitis ( PEP ) . METHODS This double-blind r and omized control trial conducted from January 2013 to April 2014 at the Gastrointestinal and Liver Diseases Research Center in Rasht , Iran . A total of 324 patients were selected from c and i date s for diagnostic or therapeutic ERCP by using the simple sampling method . Patients received a single dose of Naproxen ( 500 mg ; n = 162 ) or a placebo ( n = 162 ) per rectum immediately before ERCP . The overall incidence of PEP , incidence of mild to severe PEP , serum amylase levels and adverse effects were measured . The primary outcome measure was the development of pancreatitis onset of pain in the upper abdomen and elevation of the serum amylase level to > 3 × the upper normal limit ( 60 - 100 IU/L ) within 24 h after ERCP . The severity of PEP was classified according to the duration of therapeutic intervention for PEP : mild , 2 - 3 d ; moderate 4 - 10 d ; and severe , > 10 d and /or necessitated surgical or intensive treatment , or contributed to death . RESULTS PEP occurred in 12 % ( 40/324 ) of participants , and was significantly more frequent in the placebo group compared to the naproxen group ( P < 0.01 ) . Of the participants , 25.9 % ( 84/324 ) developed hyperamylasemia within 2 h of procedure completion , among whom only 35 cases belonged to the naproxen group ( P < 0. 
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Subgroup analyses showed difference in clinical efficacy of NSAID prophylaxis regardless of route , timing , or specific type of NSAID .
Conclusion NSAIDs were associated with a significant reduction in risk of PEP and moderate to severe PEP compared to the control group