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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

A meta-analysis for the effect of prophylactic GTN on the incidence of post-ERCP pancreatitis and on the successful rate of cannulation of bile ducts

B Chen, T Fan, and CH Wang.

Review published: 2010.

CRD summary

The review concluded that prophylactic administration of glyceryl trinitrate may significantly reduce the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) but may not be helpful for bile duct cannulation in adult patients scheduled to undergo endoscopic retrograde cholangiopancreatography pancreatitis (ERCP). The review was generally well conducted. The authors’ conclusions were based on the evidence and appear appropriate.

Authors' objectives

To evaluate whether prophylactic use of glyceryl trinitrate can reduce the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) and/or increase the success rate of bile duct cannulation.

Searching

EMBASE, PubMed and Cochrane Central Register of Controlled Trials (CENTRAL) were searched to September 2009 for articles published in any language. Search terms were reported. Reference lists of relevant articles were also searched.

Study selection

Randomised controlled trials (RCTs) that examined the effects of glyceryl trinitrate versus placebo on the incidence of PEP and/or bile duct cannulation in adult patients scheduled to undergo endoscopic retrograde cholangiopancreatography pancreatitis (ERCP) were eligible for inclusion. Trials had to be placebo controlled. Cointerventions were allowed if they were administered equally to both study groups. Trials that did not report complete raw data were excluded.

The included trials studied glyceryl trinitrate administered sublingually (0.4mg to 5mg dose), topically (5mg to 10mg dose), transdermally (5mg to 15mg dose) and intravenously (dose not reported) compared with placebo. Most studies were single centre. Most studies were conducted in Europe; studies in China and Australia were also included.

Two reviewers independently performed study selection.

Assessment of study quality

Quality assessment was undertaken using the Jadad scale of randomisation blinding, and withdrawals/dropouts to give trials a score out of 5.

The authors did not state how many authors undertook validity assessment.

Data extraction

Data were extracted on PEP and bile duct cannulation and used to calculate odds ratios (ORs) and 95% confidence intervals (CIs). Data on adverse events were extracted.

Two reviewers independently extracted data.

Methods of synthesis

A fixed-effects meta-analysis was undertaken to calculate pooled odds ratios and 95% CIs. Statistical heterogeneity was assessed using X2 (p=0.05) and I2. Where statistical heterogeneity was present, a random-effects meta-analysis was used. Clinical heterogeneity precluded pooling. Subgroup analysis was undertaken based on the route of administration. Sensitivity analysis was undertaken based on the definition of PEP and incidence of PEP in the placebo groups.

Results of the review

Nine RCTs were included in the review (n=2,174 patients). There were three trials of transdermal glyceryl trinitrate, three trials of sublingual, two trials of topical and one trial of intravenous. Trial sample sizes ranged from 74 to 806 patients. Trial quality was good (4 out of 5) to excellent (5 out of 5).

Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) (seven trials, n=1,841 patients): Compared with placebo, there was a statistically significantly lower incidence of PEP with glyceryl trinitrate (OR 0.56, 95% CI 0.40 to 0.79, I2=1.4%; seven RCTs). Subgroup analysis indicated that results were more significant with sublingual administration (OR 0.34, 95% CI 0.16 to 0.75, I2=0%; two RCTs). Results were not significant with transdermal glyceryl trinitrate (OR 0.64, 95% CI 0.40 to 1.01, I2=47%; three RCTs). Sensitivity analysis revealed that the definition of PEP used in the RCTs and the incidence of PEP in the placebo arm affected the significance of results.

Bile duct cannulation (seven trials, n=1,294 patients): Compared with placebo, there was no statistically significant difference in the primary rate of bile duct cannulation (OR 0.99, 95% CI 0.93 to 1.06, I2=0%; five RCTs). The type of administration did not alter the results.

Adverse events: Hypotension and headache were more common in the glyceryl trinitrate group.

Authors' conclusions

Prophylactic administration of glyceryl trinitrate may significantly reduce the incidence of PEP, but may not be helpful for bile duct cannulation.

CRD commentary

Inclusion criteria for the review were clearly defined. Three relevant data sources were searched. There were no language restrictions. Publication bias was not assessed and could not be ruled out. Attempts were made to reduce reviewer error and bias during study selection and data extraction; it was not clear whether such methods were used for quality assessment. Quality assessment was based on a standard checklist, which indicated the generally high quality of the included trials. A fixed-effects meta-analysis was conducted. Statistical heterogeneity was assessed.

The review was generally well conducted. The authors’ conclusions were based on the evidence and appear appropriate.

Implications of the review for practice and research

Practice: The authors did not state any implications for practice.

Research: The authors stated that there is a need for more multicentre RCTs with large sample sizes to confirm the effects of glyceryl trinitrate on PEP before widespread adoption of this strategy. There was also a need for further trials to explore the effectiveness of sublingual administration of PEP.

Funding

Not stated.

Bibliographic details

Chen B, Fan T, Wang CH. A meta-analysis for the effect of prophylactic GTN on the incidence of post-ERCP pancreatitis and on the successful rate of cannulation of bile ducts. BMC Gastroenterology 2010; 10:85. [PMC free article: PMC2921391] [PubMed: 20673365]

Indexing Status

Subject indexing assigned by NLM

MeSH

Bile Ducts; Catheterization /methods; Cholangiopancreatography, Endoscopic Retrograde /adverse effects; Humans; Incidence; Nitroglycerin /adverse effects /therapeutic use; Pancreatitis /epidemiology /etiology /prevention & control; Treatment Outcome; Vasodilator Agents /adverse effects /therapeutic use

AccessionNumber

12010007534

Database entry date

28/09/2011

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 20673365

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