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A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

Recruiting
18-75 years
All
Phase N/A

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Overview

The purpose of this study is to explore the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors

Description

There is a lack of high-quality evidence on the efficacy and safety of laparoscopic resection of gastric GIST over 5cm. A multicenter, prospective cohort study was conducted to evaluate the clinical efficacy of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors (GIST) compared to laparoscopic resection of GIST of less than 5cm. The primary evaluation parameter is overall postoperative morbidity.

Eligibility

Inclusion Criteria:

  1. 18 years < age < 75 years
  2. Primary gastric lesion diagnosed as gastric GSIT by endoscopic biopsy histopathology or suspected gastric GIST by preoperative endoscopy, ultrasound endoscopy, or CT or MR, and confirmed as primary gastric GIST by postoperative pathology
  3. Patient informed consent and willingness to undergo laparoscopic resection
  4. Expected laparoscopic outcome of R0 resection
  5. Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative American Society of Anesthesiologists(ASA) score I-III

Exclusion Criteria:

  1. Women during pregnancy or breast-feeding
  2. Severe mental disorder
  3. History of upper abdominal surgery (except the history of laparoscopic cholecystectomy)
  4. History of gastric surgery (except ESD/EMR for gastric cancer)
  5. History of other malignant diseases within the past five years
  6. History of unstable angina or myocardial infarction within the past six months
  7. History of a cerebrovascular accident within the past six months
  8. History of continuous systematic administration of corticosteroids within one month
  9. Requirement of simultaneous surgery for other diseases
  10. Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer

Study details
    Gastrointestinal Stromal Tumors

NCT05938309

Fujian Medical University

28 January 2024

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