Extended Resection After Positive Intraoperative Pathology in Gastric Cancer Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Extension of Resection After Positive Intraoperative Pathology During Surgery of Gastric and Gastroesophageal Junction Adenocarcinoma

Conditions
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Gastric Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 59 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with direct R0 (in primary intraoperative pathology consultation)<br>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)<br>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)<br>patients undergoing (sub)total gastrectomy for gastric or GEJ adenocarcinoma with R1 resection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of R1-resection during oncologic surgery | Rate of incomplete tumour resection (macroscopic: R2; microscopic: R1) during the surgical resection of gastric cancer patients | intraoperative pathology | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-surgical survival | post-surgical survival after radical surgical resection | months (median follow-up: 29 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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excision margin; prognosis; gastric cancer; resection