Evidence map›Paper›PMID 27317032›Full record

Trial reportSurgical endoscopy2017

Diclofenac sodium versus ceftazidime for preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a prospective, randomized, controlled trial.

Goran Hauser, Ivana Blažević, Nermin Salkić, Goran Poropat, Vanja Giljača, Zlatko Bulić, Davor Štimac

Erratum issuedAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 21% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 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
    Pooled it
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 2 countries.

Goran HauserDepartment of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia. goran.hauser@medri.uniri.hr.ORCID 0000-0002-4758-1717
Ivana BlaževićDepartment of Emergency Medicine, Clinical Hospital Centre Rijeka, Rijeka, Croatia.
Nermin SalkićDepartment of Gastroenterology and Hepatology, University Clinical Centre Tuzla, Tuzla, Bosnia and Herzegovina.
Goran PoropatDepartment of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia.
Vanja GiljačaDepartment of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia.
Zlatko BulićDepartment of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia.
Davor ŠtimacDepartment of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia.
University Hospital Centre Zagreb · HRUniversity Clinical Center Tuzla · BA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsWe aimed to compare the efficacy of prophylactic, parenterally administered ceftazidime and rectally applied diclofenac sodium for the prophylaxis of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP).

methodsWe prospectively enrolled patients who underwent ERCP. In a double-blind, randomized, controlled trial, patients received a suppository containing diclofenac sodium rectally (100 mg) and placebo intravenously (group A) or ceftazidime intravenously (1 g) and placebo rectally (group B) immediately before the procedure. The serum and urine amylase levels were recorded and the patients were clinically evaluated after ERCP.

resultsOf the 272 patients enrolled (group A: 129; group B: 143), 32 developed pancreatitis (group A: 11 [8.5 %]; group B: 21 [14.7 %]; P = 0.17; relative risk = 1.72; 95 % confidence interval [CI] = 0.86-3.43). The severity of the pancreatitis or complications did not significantly differ between the groups. A serum amylase level of ≥560 U/L and urine amylase level of ≥1150 U/L indicated a positive likelihood ratio for post-ERCP pancreatitis of ≥10. Moreover, the threshold visual analog scale score of ≤5 for abdominal pain after ERCP had excellent diagnostic potential for predicting the presence or absence of post-ERCP pancreatitis.

conclusionsThe PEP incidence did not differ between the ceftazidime and diclofenac sodium groups. In patients with nonsteroidal anti-inflammatory drug contraindications, antibiotics can be considered a safe alternative to diclofenac sodium for PEP prevention. Moreover, the visual analog scale for abdominal pain has excellent diagnostic value for predicting PEP. CLINICAL TRIALS. GOV NUMBER: NCT 01784445.

Indexed as

Abdominal PainAdministration, IntravenousAdministration, RectalAdultAgedAged, 80 and overAnti-Bacterial AgentsAnti-Inflammatory Agents, Non-SteroidalCeftazidimeCholangiopancreatography, Endoscopic RetrogradeDiclofenacDouble-Blind MethodFemaleHumansIncidenceMaleAnti-Bacterial AgentsAnti-Inflammatory Agents, Non-SteroidalCeftazidimeDiclofenacAnti-inflammatory agentsERCPNonsteroidalPancreatitis

Identifiers

PMID27317032
OpenAlexW2443924808

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.