Evidence map›Paper›PMID 30200135›Full record

SynthesisMedicine2018

Early precut sphincterotomy does not increase the risk of adverse events for patients with difficult biliary access: A systematic review of randomized clinical trials with meta-analysis and trial sequential analysis.

Zengwei Tang, Yuan Yang, Zhangfu Yang, Wenbo Meng, Xun Li

Abstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

25 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

5 authors.

Zengwei TangThe First Clinical Medical School of Lanzhou University Department of Special Minimally Invasive Surgery, The first Hospital of Lanzhou University, Lanzhou Department of Liver Surgery, Liver Cancer Institute, Zhongshan Hospital,Fudan University, and Key Laboratory of Carcinogenesis and Cancer Invasion, Ministry of Education, Shanghai The second department of General Surgery, The first Hospital of Lanzhou University, Lanzhou, China.
Yuan Yang
Zhangfu Yang
Wenbo Meng
Xun Li

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe present study was conducted to investigate whether early precut sphincterotomy (EPS) itself increases the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), bleeding, and perforation, or improves the overall success rates of biliary cannulation.

methodsFour electronical databases were searched systematically for randomized controlled trials (RCTs) reporting the incidence of adverse events for difficult biliary access (DBA) between EPS groups and persistent cannulation attempts (PCA). The primary endpoint was the incidence of PEP. Secondary outcomes were the incidence of bleeding and perforation, and the overall success rates of biliary cannulation. The Mantel-Haenszel method was used to pool data on the outcomes into random-effect models. Heterogeneity, sensitivity, and stratified analyses were performed with Review Manager 5.3. Furthermore, we performed trial sequential analysis (TSA) to evaluate the reliability of the primary endpoint and secondary outcomes.

resultsSeven RCTs (999 patients with DBA of 10450, 9.5%) were included. The incidence of PEP was significantly lower in EPS groups than PCA (risk ratio [RR] = 0.57, 95% confidence interval [CI] 0.36, 0.92, P = .02). Furthermore, TSA (TSA-adjusted 95% CI 0.30-0.82, P = .0061) and subgroup analysis stratified by the fellow involvement in initial cannulation before randomization, technique of precut, and the definition of DBA confirmed this finding. Success rates of overall cannulation (RR = 1.00, P = .94), bleeding (RR = 1.22, P = .58), and perforation (RR = 1.59, P = .32) were similar in both groups; however, the results of TSA could not confirm these findings.

conclusionBoth the quality and the quantity of evidence supporting, compared with PCA, EPS itself do not increase the risk of PEP for DBA patients. Moreover, subgroup analysis demonstrated that EPS can significantly decrease the risk of PEP when it is performed by qualified staff endoscopists with using needle-knife fistulutomy earlier for patients with DBA.

Indexed as

Biliary Tract Surgical ProceduresCholangiopancreatography, Endoscopic RetrogradeHumansPancreatitisPostoperative ComplicationsRandomized Controlled Trials as TopicRiskSphincterotomy

Identifiers

PMID30200135
PMCPMC6133433

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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.