Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial

[1]  A. Chak,et al.  The risk of post-ERCP pancreatitis and the protective effect of rectal indomethacin in cases of attempted but unsuccessful prophylactic pancreatic stent placement. , 2015, Gastrointestinal endoscopy.

[2]  C. Hassan,et al.  Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Updated June 2014 , 2014, Endoscopy.

[3]  B. Han,et al.  Rectal NSAIDs for the prevention of post-ERCP pancreatitis: a meta-analysis of randomized controlled trials. , 2014, The surgeon : journal of the Royal Colleges of Surgeons of Edinburgh and Ireland.

[4]  S. Saini,et al.  Do Larger Periprocedural Fluid Volumes Reduce the Severity of Post–Endoscopic Retrograde Cholangiopancreatography Pancreatitis? , 2014, Pancreas.

[5]  V. Wadhwa,et al.  A Meta-Analysis on the Role of Rectal Diclofenac and Indomethacin in the Prevention of Post–Endoscopic Retrograde Cholangiopancreatography Pancreatitis , 2014, Pancreas.

[6]  L. Laine,et al.  Aggressive hydration with lactated Ringer's solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. , 2014, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association.

[7]  Zhen Wang,et al.  Rectal nonsteroidal anti-inflammatory drugs are superior to pancreatic duct stents in preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a network meta-analysis. , 2013, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association.

[8]  A. Chak,et al.  Does Rectal Indomethacin Eliminate the Need for Prophylactic Pancreatic Stent Placement in Patients Undergoing High-Risk ERCP? Post hoc Efficacy and Cost-Benefit Analyses Using Prospective Clinical Trial Data , 2013, The American Journal of Gastroenterology.

[9]  H. Williams,et al.  When inferiority meets non-inferiority: Implications for interim analyses , 2012, Clinical trials.

[10]  Richard S. Kwon,et al.  A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. , 2012, The New England journal of medicine.

[11]  Guosheng Yin,et al.  Fundamentals of Clinical Trials , 2012 .

[12]  Shunsuke Ono,et al.  Choice of control group in efficacy-showing clinical trials in Japan: does the ICH-E10 guideline change conventions? , 2002, International Journal of Pharmaceutical Medicine.

[13]  Richard S. Kwon,et al.  Prophylactic 5-Fr pancreatic duct stents are superior to 3-Fr stents: a randomized controlled trial. , 2011, Endoscopy.

[14]  T. Takayama,et al.  Prophylactic pancreatic stent placement and post-ERCP pancreatitis: a systematic review and meta-analysis , 2010, Endoscopy.

[15]  M. Sivak,et al.  Pancreatic-stent placement for prevention of post-ERCP pancreatitis: a cost-effectiveness analysis. , 2007, Gastrointestinal endoscopy.

[16]  COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE ( CHMP ) GUIDELINE ON CONDUCT OF PHARMACOVIGILANCE FOR MEDICINES USED BY THE PAEDIATRIC POPULATION , 2007 .

[17]  P. Schoenfeld,et al.  A survey of physician practices on prophylactic pancreatic stents. , 2006, Gastrointestinal endoscopy.

[18]  Hiroshi Nishiyama,et al.  Introduction of "Points to Consider on Switching between Superiority and Non-inferiority" and "Guideline on the Choice of the Non-inferiority Margin" , 2006 .

[19]  Harald Enzmann,et al.  Committee for medicinal products for human use (CHMP) guideline on the choice of the non‐inferiority margin , 2022 .

[20]  M. Freeman,et al.  Prevention of post-ERCP pancreatitis: a comprehensive review. , 2004, Gastrointestinal endoscopy.

[21]  M. Catalano,et al.  Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study. , 2003, Gastrointestinal endoscopy.

[22]  G. Haber.  Prevention of post-ERCP pancreatitis. , 2000, Gastrointestinal endoscopy.

[23]  P. Cotton,et al.  Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction. , 1998, Gastroenterology.

[24]  C Liguory,et al.  Endoscopic sphincterotomy complications and their management: an attempt at consensus. , 1991, Gastrointestinal endoscopy.