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临床试验/NCT05663450
NCT05663450已完成不适用

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

University Hospital of Cologne0 个研究点目标入组 679 人开始时间: 1996年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
679
主要终点
Rate of R1-resection during oncologic surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
59 Years 至 66 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • older than 18 years
  • tumor resection via total gastrectomy and subtotal esophagectomy

排除标准

  • no additional other solid or hematological neoplasias in the medical history
  • pregnancy
  • surgical procedures in palliative intention

结局指标

主要结局

Rate of R1-resection during oncologic surgery

时间窗: intraoperative pathology

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

次要结局

  • Post-surgical survival(months (median follow-up: 29 months))

研究者

发起方
University Hospital of Cologne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hakan Alakus

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

University Hospital of Cologne

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