|
|
|
| Safety of rectal indomethacin (100 mg) for the prevention of post-ERCP pancreatitis in the Japanese population: A single-center prospective pilot study |
| Kotaro Takeshita a , ∗, Satoshi Asai a , Naoki Fujimoto a , Takumi Ichinona a , Eisuke Akamine a , Mamoru Takenaka b |
a Department of Gastroenterology, Tane General Hospital, Osaka 550-0025, Japan
b Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama 589-8511, Japan
∗ Corresponding author.
E-mail address: k.takeshita@tane.or.jp (K. Takeshita). |
|
|
|
|
Abstract Endoscopic retrograde cholangiopancreatography (ERCP) causes adverse events; post-ERCP pancreatitis (PEP) is one of the frequent adverse events. Recently, the efficacy of rectal administration of non-steroidal anti-inflammatory drugs (NSAIDs) before or after ERCP for PEP prevention has been reported [1]. The European Society of Gastrointestinal Endoscopy and American Society for Gastrointestinal Endoscopy recommend routine rectal administration of 100 mg NSAIDs immediately before or after ERCP for patients without any contraindication [2,3]. However, the use of rectal administration of 100 mg NSAIDs is uncommon in Japan and not covered by health insurance policies. The feasibility and safety of NSAID use at low doses (25–50 mg) for PEP prevention have been certainly obtained only from single-center randomized and retrospective studies [4,5]. The clinical trial in China indicated that the rectal administration of 100 mg indomethacin does not cause drugrelated severe adverse events and its PEP-reducing effect is obvious [6] . It demonstrates the safety and efficacy of rectal administration of 100 mg indomethacin for PEP prophylaxis in an Asian population. Moreover, recently the ineffectiveness of low-dose indomethacin in terms of PEP prevention was reported [7]. As there is no report on the safety of rectal administration of 100 mg indomethacin in Japanese individuals, we conducted this single-arm, prospective, pilot study. The protocol of this trial was approved by the Institutional Review Board of Tane General Hospital and registered in the University Hospital Medical Information Network Clinical Trials Registry (Registration number: UMIN0000289000). This study was performed in compliance with the Ethical Principles for Medical Research Involving Human Subjects outlined in the Declaration of Helsinki in 1975 (revised in 2013).
|
|
|
|
|
|
|
|
|
2022, Vol. 21 
