Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site
Recruiting now
Conditions studied: GIST of Stomach, Gastric Cancer, Surgery, Complication
In brief
Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy.
Key facts
- Study ID
- NCT03716089
- Run by
- Fujian Medical University
- People needed
- 250
- Starts
- 2018-10-11
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2025-04-08
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 18 and 75 years old
- Primary gastric lesion confirmed pathologically GIST by endoscopic biopsy. Preoperative endoscopy, ultrasound endoscopy or computer tomography, Magnetic resonance suspected GIST, and then postoperative pathology confirmed as the original GIST
- Written informed consent
- Expected R0 resection by laparoscopy
- Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Maximum tumor diameter ≤10cm
You may not qualify if…
- Pregnant and lactating women
- Suffering from a severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR for gastric cancer)
- Rejection of laparoscopic resection
- History of other malignant disease 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 another disease
- Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of the predicted values
- Maximum tumor diameter >10cm
Where it is running
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
Full record on ClinicalTrials.gov
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