Reevaluating the Design of Multicenter Surgical Trials for Esophagogastric Cancer.

ABSTRACT:

Background

Multicenter 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.

Methods

We 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 im

SUBMITTER: Das B 

PROVIDER: S-EPMC12765741 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature