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Extended Resection After Positive Intraoperative Pathology in Gastric Cancer Surgery

NCT ID: NCT05663450

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

679 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-05-01

Study Completion Date

2022-03-31

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.

Conditions

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Gastric Cancer

Keywords

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excision margin; prognosis; gastric cancer; resection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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)

No interventions assigned to this group

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)

No interventions assigned to this group

patients with remaining R1 (after final intraoperative pathology consultation)

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

No interventions assigned to this group

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
Minimum Eligible Age

59 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Hakan Alakus

Clinical Professor and Senior Physician; Department of General, Visceral, Cancer and Transplantation Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hakan Alakus, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Cologne

References

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Plum PS, Barutcu AG, Pamuk A, Mallmann C, Chon SH, Chiapponi C, Dubbers M, Hellmich M, Moenig SP, Quaas A, Hoelscher AH, Bruns CJ, Alakus H. Extension of resection after positive intraoperative pathology during surgery for gastric and gastroesophageal junction adenocarcinoma: a retrospective cohort study. Int J Surg. 2023 Aug 1;109(8):2324-2333. doi: 10.1097/JS9.0000000000000484.

Reference Type DERIVED
PMID: 37222663 (View on PubMed)

Other Identifiers

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HA_Pos_Margins_Gastrectomy

Identifier Type: -

Identifier Source: org_study_id