The safety and efficacy of Ringer's solution loading with rectal diclofenac for prevention of post‐endoscopic retrograde cholangiopancreatography pancreatitis: The RESOLUTION‐PEP study

Author:

Hattori Aiji12ORCID,Yamada Reiko1,Murabayashi Toji3ORCID,Sugimoto Shinya3,Imai Hajime4,Nojiri Keiichiro5,Kuroda Naoki6,Tano Shunsuke7,Tanaka Hiroki8,Matsusaki Shimpei8,Nishikawa Kenichiro2,Naota Hiroaki9ORCID,Moritani Isao10,Kurata Kazunari11,Fukui Toshitaka12,Tanaka Kyosuke13,Nakagawa Hayato1

Affiliation:

1. Department of Gastroenterology and Hepatology Mie University Hospital Mie Japan

2. Department of Gastroenterology Matsusaka Municipal Hospital Mie Japan

3. Department of Gastroenterology Ise Red Cross Hospital Mie Japan

4. Department of Gastroenterology Okanami General Hospital Mie Japan

5. Department of Gastroenterology Kuwana City Medical Center Mie Japan

6. Department of Gastroenterology Saiseikai Matsusaka General Hospital Mie Japan

7. Department of Gastroenterology Suzuka Kaisei Hospital Mie Japan

8. Department of Gastroenterology Suzuka General Hospital Mie Japan

9. Department of Gastroenterology Matsusaka Chuo General Hospital Mie Japan

10. Department of Gastroenterology Mie Prefectural General Medical Center Mie Japan

11. Department of Gastroenterology Mie Chuo Medical Center Mie Japan

12. Department of Gastroenterology Yokkaichi Hazu Medical Center Mie Japan

13. Department of Endoscopic Medicine Mie University Hospital Mie Japan

Abstract

AbstractObjectivesWe 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).MethodsThis 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.ResultsThe 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.ConclusionsAggressive hydration combined with rectal diclofenac may be a promising strategy for the prevention of PEP. Furthermore, it is safe even for older individuals.

Publisher

Wiley

Subject

Organic Chemistry,Biochemistry

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