Status:
RECRUITING
A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors
Lead Sponsor:
Fujian Medical University
Collaborating Sponsors:
Fujian Provincial Hospital
Fujian Cancer Hospital
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is to explore the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors
Detailed 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 e...
Eligibility Criteria
Inclusion Criteria:
- 18 years < age < 75 years
- 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
- Patient informed consent and willingness to undergo laparoscopic resection
- Expected laparoscopic outcome of R0 resection
- Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative American Society of Anesthesiologists（ASA） score I-III
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of upper abdominal surgery (except the history of laparoscopic cholecystectomy)
- History of gastric surgery (except ESD/EMR for gastric cancer)
- History of other malignant diseases within the past five years
- History of unstable angina or myocardial infarction within the past six months
- History of a cerebrovascular accident within the past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other diseases
- Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer
Key Trial Info
Start Date :
May 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT05938309
Start Date
May 1 2023
End Date
May 1 2028
Last Update
July 10 2023
Active Locations (1)
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1
Department of Gastric Surgery， Fujian Medical University Union Hospital
Fuzhou, Fujian, China