Evidence map›Paper›PMID 41131389›Full record

SynthesisAnnals of surgical oncology2026

Reevaluating the Design of Multicenter Surgical Trials for Esophagogastric Cancer.

Bibek Das, Anuja T Mitra, Patrick Bossuyt, George B Hanna

Abstract readSystematic Review
In one paragraph

Synthesis in Annals of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. Review
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

4 authors.

Bibek DasDivision of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK. bibek.das07@imperial.ac.uk.
Anuja T MitraDivision of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
Patrick BossuytDepartment of Epidemiology and Data Science, Amsterdam Public Health, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
George B HannaDivision of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMulticenter randomized controlled trials (RCTs) in esophagogastric cancer surgery have repeatedly failed to demonstrate overall survival (OS) benefits for technical interventions. This raises concerns about trial design frameworks, particularly surgical quality assurance (SQA) and their impact on statistical power and sample size requirements.

methodsWe conducted a systematic review of MEDLINE, Embase, and Cochrane CENTRAL (January 1990 to June 2024) to identify multicenter RCTs evaluating curative surgical interventions for esophageal or gastric cancer that reported OS outcomes with ≥ 12 months of follow-up. Trials were assessed for SQA strategies, protocol adherence, and sample size assumptions. Post hoc power analyses and statistical simulations modeled the impact of surgical variability on trial outcomes.

resultsWe identified 27 eligible RCTs; 10 were powered for OS superiority, but none showed significant OS benefit. Suboptimal SQA was common, including limited surgeon credentialing, poor adherence monitoring, and inadequate technical standardization. Three trials were underpowered at design, and three failed to meet recruitment targets. Simulations showed that a technical nonadherence rate of 10% per arm could halve statistical power. Sample size requirements to preserve 80% power increased markedly, sometimes by thousands of participants. Most trials lacked internal piloting to assess protocol feasibility and baseline adherence.

conclusionsInadequate SQA and failure to account for surgical variability may partly explain the lack of OS benefit in multicenter surgical RCTs. Embedding SQA and internal pilot studies into trial design may improve feasibility, ensure protocol fidelity, and strengthen the validity of future trials in complex oncologic surgery.

Indexed as

Esophageal NeoplasmsMulticenter Studies as TopicRandomized Controlled Trials as TopicResearch DesignStomach NeoplasmsHumansSurvival RateRandomized controlled trialsSurgical oncologySurgical qualityTrial methodology

Identifiers

PMID41131389
PMCPMC12765741

What OpenQuestion holds

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Registered trials

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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.