Evidence map›Paper›PMID 22350703›Full record

Trial reportJournal of gastroenterology2012

Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial.

Taiga Otsuka, Seiji Kawazoe, Shunya Nakashita, Saori Kamachi, Satoshi Oeda, Chinatsu Sumida, Takumi Akiyama, Keisuke Ario, Masaru Fujimoto, Masanobu Tabuchi and 1 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 51 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 11 pooled it
8.5field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02465138 phase4withdrawnnot on this mapstarted 2023, after this paper: background citation

A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis

TypeinterventionalSponsorUniversity of California, San FranciscoRan2023 to 2026Enrolled0ConditionsPancreatitisArmsKetorolac, Placebo
NCT03713879 phase3recruitingnot on this mapstarted 2019, after this paper: background citation

Comparative Effectiveness Between Rectally Administered Indomethacin and Pancreatic Stenting in the Prevention of Post Endoscopic Retrograde Cholangio-panceaticography (ERCP) Pancreatitis: a Randomized Trial

TypeinterventionalSponsorChinese University of Hong KongRan2019 to 2026Enrolled1,734ConditionsPost ERCP PancreatitisArmspancreatic stenting, Indomethacin
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 11 syntheses or guidelines pooled it, 132 citations in OpenAlex.

  1. Pooled it
  2. NSAIDs do not reduce severity among post-ERCP pancreatitis patients.Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] · 2024
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  3. Nonsteroidal Anti-inflammatory Drugs for Endoscopic Retrograde Cholangiopancreatography Postoperative Pancreatitis Prevention: a Systematic Review and Meta-analysis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2019
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 2 countries.

Taiga OtsukaDepartment of Hepato-Biliary-Pancreatology, Saga Prefectural Hospital Koseikan, 1-12-9 Mizugae, Saga, 840-8571, Japan. ootsuka-t@koseikan.jp
Seiji Kawazoe
Shunya Nakashita
Saori Kamachi
Satoshi Oeda
Chinatsu Sumida
Takumi Akiyama
Keisuke Ario
Masaru Fujimoto
Masanobu Tabuchi
Takahiro Noda
Red Cross Hospital · GRSaga-Ken Medical Centre Koseikan · JPTakamatsu Red Cross Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography (ERCP). Rectal nonsteroidal anti-inflammatory drugs (specifically, 100 mg of diclofenac or indomethacin) have shown promising prophylactic activity in post-ERCP pancreatitis (PEP). However, the 100-mg dose is higher than that ordinarily used in Japan.

methodsWe performed a prospective randomized controlled study to evaluate the efficacy of low-dose rectal diclofenac for the prevention of PEP. Patients who were scheduled to undergo ERCP were randomized to receive a saline infusion either with 50 mg of rectal diclofenac (diclofenac group) or without (control group) 30 min before ERCP. The dose of diclofenac was reduced to 25 mg in patients weighing <50 kg. The primary outcome measure was the occurrence of PEP.

resultsEnrollment was terminated early because the planned interim analysis found a statistically significant intergroup difference in the occurrence of PEP. A total of 104 patients were eligible for this study; 51 patients received rectal diclofenac. Twelve patients (11.5%) developed PEP: 3.9% (2/51) in the diclofenac group and 18.9% (10/53) in the control group (p = 0.017). After ERCP, the incidence of hyperamylasemia was not significantly different between the two groups. Post-ERCP pain was significantly more frequent in the control group than in the diclofenac group (37.7 vs. 7.8%, respectively; p < 0.001). There were no adverse events related to diclofenac.

conclusionsLow-dose rectal diclofenac can prevent PEP.

Indexed as

Cholangiopancreatography, Endoscopic RetrogradePostoperative ComplicationsAgedAnti-Inflammatory Agents, Non-SteroidalDiclofenacFemaleHumansIncidenceMalePancreatitisProspective StudiesTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalDiclofenac

Identifiers

PMID22350703
OpenAlexW2032706401

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.