The safety and efficacy of Ringer's solution loading with rectal diclofenac for prevention of post‐endoscopic retrograde cholangiopancreatography pancreatitis: The RESOLUTION‐PEP study
Aiji Hattori,
Reiko Yamada,
Toji Murabayashi,
Shinya Sugimoto,
Hajime Imai,
Keiichiro Nojiri,
Naoki Kuroda,
Shunsuke Tano,
Hiroki Tanaka,
Shimpei Matsusaki,
Kenichiro Nishikawa,
Hiroaki Naota,
Isao Moritani,
Kazunari Kurata,
Toshitaka Fukui,
Kyosuke Tanaka,
Hayato Nakagawa
Affiliations
Aiji Hattori
Department of Gastroenterology and Hepatology Mie University Hospital Mie Japan
Reiko Yamada
Department of Gastroenterology and Hepatology Mie University Hospital Mie Japan
Toji Murabayashi
Department of Gastroenterology Ise Red Cross Hospital Mie Japan
Shinya Sugimoto
Department of Gastroenterology Ise Red Cross Hospital Mie Japan
Hajime Imai
Department of Gastroenterology Okanami General Hospital Mie Japan
Keiichiro Nojiri
Department of Gastroenterology Kuwana City Medical Center Mie Japan
Naoki Kuroda
Department of Gastroenterology Saiseikai Matsusaka General Hospital Mie Japan
Shunsuke Tano
Department of Gastroenterology Suzuka Kaisei Hospital Mie Japan
Hiroki Tanaka
Department of Gastroenterology Suzuka General Hospital Mie Japan
Shimpei Matsusaki
Department of Gastroenterology Suzuka General Hospital Mie Japan
Kenichiro Nishikawa
Department of Gastroenterology Matsusaka Municipal Hospital Mie Japan
Hiroaki Naota
Department of Gastroenterology Matsusaka Chuo General Hospital Mie Japan
Isao Moritani
Department of Gastroenterology Mie Prefectural General Medical Center Mie Japan
Kazunari Kurata
Department of Gastroenterology Mie Chuo Medical Center Mie Japan
Toshitaka Fukui
Department of Gastroenterology Yokkaichi Hazu Medical Center Mie Japan
Kyosuke Tanaka
Department of Endoscopic Medicine Mie University Hospital Mie Japan
Hayato Nakagawa
Department of Gastroenterology and Hepatology Mie University Hospital Mie Japan
Abstract Objectives We evaluated the safety and efficacy of aggressive hydration with rectal non‐steroidal anti‐inflammatory drugs for the prevention of post‐endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Methods This prospective, single‐arm, multicenter trial was conducted at 12 institutions between October 2020 and August 2021. We enrolled 231 patients who had intact papillae and were scheduled to undergo ERCP. All patients were administered rectal diclofenac before ERCP. They received aggressive hydration with intravenous lactated Ringer's solution in an initial bolus of 5 ml/kg at the start of ERCP, followed by 3 ml/kg/h for 8 h after the procedure. The primary outcome was the occurrence of PEP. Secondary outcomes included PEP severity, hyperamylasemia, and adverse events. Results The mean age of the patients was 68.8 ± 13.7 years, and 81 patients (35.1%) were 75 years or older. Thirteen patients developed PEP (5.6%, 95% confidence interval 3.0%–9.4%). There were 11 cases (4.8%) of mild pancreatitis and two cases (0.9%) of severe pancreatitis. Forty‐five patients (19.5%) developed hyperamylasemia and one patient developed non‐severe peripheral edema. Conclusions Aggressive hydration combined with rectal diclofenac may be a promising strategy for the prevention of PEP. Furthermore, it is safe even for older individuals.
