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[Quality control of surgery in multicenter study--interinstitutional and individual differences]

A Nashimoto1, T Nakajima, T Kito

  • 1Division of Surgery, Niigata Cancer Center Hospital, Japan.

Gan to Kagaku Ryoho. Cancer & Chemotherapy
|January 1, 1996
PubMed
Summary

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This prospective randomized controlled trial found no significant differences in postoperative survival rates or surgical factors between institutions for gastric cancer patients. Confirming consistency across centers is crucial before initiating survival-focused trials.

Area of Science:

  • Oncology
  • Clinical Trials
  • Surgical Outcomes

Background:

  • Adjuvant chemotherapy is a critical treatment for gastric cancer.
  • Prospective randomized controlled trials (PRCTs) are essential for evaluating treatment efficacy.
  • Understanding inter-institutional and inter-individual variability is key for trial design.

Purpose of the Study:

  • To analyze inter-institutional and inter-individual differences in surgical factors and remote survival rates in a PRCT of adjuvant chemotherapy for gastric cancer.
  • To assess the impact of institutional policies and patient background on trial outcomes.
  • To provide recommendations for designing future multi-center oncology trials.

Main Methods:

  • A prospective randomized controlled trial involving 1,049 gastric cancer patients across 6 cancer centers.

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  • Patients were stratified into 6 groups based on serosal invasion grade and curability.
  • Statistical analysis was performed to evaluate inter-institutional and inter-individual variations.

    • Main Results:

    • No significant inter-institutional differences were observed in postoperative survival rates.
    • Surgical factors like operative time, bleeding volume, and administration periods showed no inter-institutional variability.
    • Minor inter-individual differences were noted in operative time and hemorrhage volume, but not in administration periods.

    Conclusions:

    • Inter-institutional consistency in surgical operations and remote survival is confirmed, supporting multi-center trial feasibility.
    • Pre-trial confirmation of minimal inter-institutional variability is recommended for future survival-endpoint-focused PRCTs in gastric cancer.
    • The study highlights the importance of standardization in multi-center clinical trials for reliable results.