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Related Experiment Video

Updated: Jan 14, 2026

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Reevaluating the Design of Multicenter Surgical Trials for Esophagogastric Cancer.

Bibek Das1, Anuja T Mitra2, Patrick Bossuyt3

  • 1Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK. bibek.das07@imperial.ac.uk.

Annals of Surgical Oncology
|October 23, 2025
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Summary

Multicenter surgical trials for esophagogastric cancer often lack overall survival benefits due to poor surgical quality assurance. Improving trial design with robust quality control is crucial for future complex oncologic surgery research.

Keywords:
Randomized controlled trialsSurgical oncologySurgical qualityTrial methodology

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Area of Science:

  • Oncology
  • Surgical Research
  • Clinical Trials

Background:

  • Multicenter randomized controlled trials (RCTs) in esophagogastric cancer surgery frequently fail to show survival benefits for technical interventions.
  • This highlights potential issues in trial design, specifically surgical quality assurance (SQA) and its influence on statistical power and sample size.

Purpose of the Study:

  • To systematically review multicenter RCTs in esophagogastric cancer surgery.
  • To assess the impact of SQA strategies and surgical variability on trial outcomes and statistical power.

Main Methods:

  • Systematic review of MEDLINE, Embase, and Cochrane CENTRAL (1990-2024) for RCTs on curative surgical interventions for esophageal or gastric cancer with OS outcomes.
  • Assessment of SQA, protocol adherence, and sample size assumptions; post hoc power analyses and simulations to model surgical variability's impact.

Main Results:

  • 27 RCTs were identified; 10 were powered for OS superiority, but none demonstrated significant OS benefit.
  • Suboptimal SQA was prevalent, characterized by limited credentialing, poor monitoring, and inadequate standardization.
  • Simulations indicated that a 10% nonadherence rate could halve statistical power, significantly increasing required sample sizes.

Conclusions:

  • Inadequate SQA and failure to account for surgical variability likely contribute to the lack of OS benefits in these trials.
  • Integrating robust SQA and internal pilot studies into trial design is recommended to enhance feasibility, fidelity, and validity in complex oncologic surgery research.