Evidence map›Paper›PMID 27447477›Full record

Trial reportDigestive diseases and sciences2016

No Benefit of Oral Diclofenac on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.

Hirotoshi Ishiwatari, Takahiro Urata, Ichiro Yasuda, Shimpei Matsusaki, Hiroyuki Hisai, Hiroshi Kawakami, Michihiro Ono, Takuji Iwashita, Shinpei Doi, Kazumichi Kawakubo and 4 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. 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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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

14 authors at 6 institutions in 1 country.

Hirotoshi IshiwatariDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan. ishihiro481019@gmail.com.
Takahiro UrataDepartment of Gastroenterology, Japanese Red Cross Kumamoto Hospital, 1-1-2, Nagamineminami, Higashiku, Kumamoto, 861-8520, Japan.
Ichiro YasudaDepartment of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3, Mizonokuchi, Takatsuku, Kawasaki, Kanagawa, 213-8507, Japan.
Shimpei MatsusakiDepartment of Gastroenterology, Suzuka General Hospital, 53-1275, Uyamanohana, Yasuzukacho, Suzuka, Mie, 513-8630, Japan.
Hiroyuki HisaiDepartment of Gastroenterology, Japanese Red Cross Date Hospital, 81, Suenagacho, Date, Hokkaido, 052-8511, Japan.
Hiroshi KawakamiDepartment of Gastroenterology and Hepatology, Center for Digestive Disease, University of Miyazaki, 5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki, 889-1692, Japan.
Michihiro OnoDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.
Takuji IwashitaFirst Department of Internal Medicine, Gifu University Hospital, 1-1, Yanagito, Gifu, Gifu, 501-1194, Japan.
Shinpei DoiDepartment of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3, Mizonokuchi, Takatsuku, Kawasaki, Kanagawa, 213-8507, Japan.
Kazumichi KawakuboDepartment of Gastroenterology and Hepatology, Hokkaido University Hospital, West 5, North 14, Kitaku, Sapporo, Hokkaido, 060-8648, Japan.
Tsuyoshi HayashiDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.
Tomoko SonodaDepartment of Public Health, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.
Naoya SakamotoDepartment of Gastroenterology and Hepatology, Hokkaido University Hospital, West 5, North 14, Kitaku, Sapporo, Hokkaido, 060-8648, Japan.
Junji KatoDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.
Sapporo Medical University · JPHokkaido University Hospital · JPTeikyo University · JPGifu University Hospital · JPJapanese Red Cross Kumamoto Hospital · JPUniversity of Miyazaki · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a serious complication. Rectal diclofenac (100 mg) has been shown to reduce the incidence of pancreatitis; however, this dosage form is unavailable in several countries.

aimsWe aimed to investigate the preventive effect of oral diclofenac on pancreatitis after ERCP in a multicenter, randomized, prospective, placebo-controlled, double-blind trial.

methodsPatients undergoing a first ERCP in seven high-volume centers between July 2012 and August 2014 were considered eligible. Participants were administered oral diclofenac (50 mg) or placebo before and after ERCP. The primary endpoint was the incidence of pancreatitis. A subgroup analysis was performed for patients at high or low risk of pancreatitis. Secondary endpoints were pancreatic enzyme levels (amylase and lipase).

resultsWe initially enrolled 430 patients (216 in the diclofenac and 214 in the placebo group), and 23 were excluded after randomization. The overall incidence of pancreatitis was 9.8 % (20/205) and 9.4 % (19/202) in the diclofenac and placebo groups, respectively (p = 0.90). The incidence of pancreatitis was 20.3 % (13/64) and 21.3 % (13/61) in patients at high risk of pancreatitis (p = 0.78) and 5.0 % (7/141) and 4.3 % (6/141) in patients at low risk of pancreatitis in the diclofenac and placebo groups (p = 0.94), respectively. There were no significant differences in serum amylase and lipase levels between the two groups before and 24 h after ERCP.

conclusionsOral administration of diclofenac before and after ERCP showed no benefit in the prevention of pancreatitis. CLINICAL TRIALS REGISTRY NO: UMIN000008109.

Indexed as

Administration, OralAgedAged, 80 and overAmylasesAnti-Inflammatory Agents, Non-SteroidalAutoimmune DiseasesBile Duct NeoplasmsCholangiopancreatography, Endoscopic RetrogradeCholangitisCholelithiasisDiclofenacDouble-Blind MethodFemaleHospitals, UniversityHumansImmunoglobulin GAmylasesAnti-Inflammatory Agents, Non-SteroidalDiclofenacImmunoglobulin GLipaseDiclofenacEndoscopic retrograde cholangiopancreatographyPancreaticobiliary diseasePancreatitis

Identifiers

PMID27447477
OpenAlexW2504640945

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.