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Extended Resection After Positive Intraoperative Pathology in Gastric Cancer Surgery

Sponsor
University Hospital of Cologne (Other)
Overall Status
Completed
CT.gov ID
NCT05663450
Collaborator
(none)
679
Enrollment
311
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Of 737 consecutive patients undergoing (sub)total gastrectomy for gastric or GEJ adenocarcinoma, 679 cases with curative intent surgery between 05/1996 and 03/2019 were included. Patients were categorized into: i) R0 without further resection (direct R0), ii) R0 after positive IOC and extension of resection (converted R0) and iii) R1.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This retrospective cohort study was performed at our tertiary referral center at the University Hospital of Cologne, Germany. Since 1st May 1996 medical charts of patients who undergo surgery for gastric or GEJ adenocarcinomas are collected in a department internal database for research analyses (Chairman since 05/2016 CJ Bruns, from 5/1996-4/2016 AH Hölscher).

    In this study, patients undergoing curative surgery between 1st May 1996 and 31st March 2019 with (sub)total gastrectomy for gastric or GEJ adenocarcinoma were included. Palliative resections and resections with transthoracic esophagectomy and gastric pull-up were excluded.

    Demographics, perioperative treatment, survival and clinicopathologic data were obtained. Medical records were reviewed and complications were categorized according to Clavien-Dindo classification.

    Depending on IOCs, extended resection and final pathology report a treatment flow-chart was created (Figure 1): Patients were grouped on a) IOC received (yes/no), b) IOC positive (yes/no), c) extended resection (yes/no), d) second IOC (IOC2; yes/no), e) IOC2 positive (yes/no) and final pathology results (R0/R1). The decision to perform IOC and to carry out extended resection in case of positive IOC was at the discretion of the treating surgeon. Patients were then categorized into 3 subgroups according to final R status: R0 after extended resection (i.e. converted R0), R0 without extended resection (i.e. direct R0) and R1.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    679 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Extension of Resection After Positive Intraoperative Pathology During Surgery of Gastric and Gastroesophageal Junction Adenocarcinoma
    Actual Study Start Date :
    May 1, 1996
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Mar 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    patients with direct R0 (in primary intraoperative pathology consultation)

    patients undergoing (sub)total gastrectomy for gastric or GEJ adenocarcinoma with R0 without further resection (direct R0)
    patients with converted R0 (in second intraoperative pathology consultation)

    patients undergoing (sub)total gastrectomy for gastric or GEJ adenocarcinoma with R0 after positive IOC and extension of resection (converted R0)
    patients with remaining R1 (after final intraoperative pathology consultation)

    patients undergoing (sub)total gastrectomy for gastric or GEJ adenocarcinoma with R1 resection.

    Outcome Measures

    Primary Outcome Measures

    1. Rate of R1-resection during oncologic surgery [intraoperative pathology]

      Rate of incomplete tumour resection (macroscopic: R2; microscopic: R1) during the surgical resection of gastric cancer patients

    Secondary Outcome Measures

    1. Post-surgical survival [months (median follow-up: 29 months)]

      post-surgical survival after radical surgical resection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    59 Years to 66 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • older than 18 years

    • tumor resection via total gastrectomy and subtotal esophagectomy

    Exclusion Criteria:

    • no additional other solid or hematological neoplasias in the medical history

    • pregnancy

    • surgical procedures in palliative intention

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital of Cologne

    Investigators

    • Principal Investigator: Hakan Alakus, MD, University Hospital of Cologne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hakan Alakus, Clinical Professor and Senior Physician; Department of General, Visceral, Cancer and Transplantation Surgery, University Hospital of Cologne
    ClinicalTrials.gov Identifier:
    NCT05663450
    Other Study ID Numbers:
    • HA_Pos_Margins_Gastrectomy
    First Posted:
    Dec 23, 2022
    Last Update Posted:
    Dec 23, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hakan Alakus, Clinical Professor and Senior Physician; Department of General, Visceral, Cancer and Transplantation Surgery, University Hospital of Cologne
    excision margin; prognosis; gastric cancer; resection
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Dec 23, 2022