Extended Resection After Positive Intraoperative Pathology in Gastric Cancer Surgery

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT05663450
• Lead Sponsor: University Hospital of Cologne

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.

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 Timeline

• Study Start: 1996-05-01
• Primary Completion: 2019-12-31
• Study Completion: 2022-03-31
• Status Verified: 2022-12
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-20
• Last Update Submitted: 2022-12-20
• Study First Posted: 2022-12-23
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 679

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Post-surgical survival	months (median follow-up: 29 months)	post-surgical survival after radical surgical resection