Comparing laparoscopic surgery outcomes for gastrointestinal stromal tumors based on tumor location
Prospective Controlled Clinical Trial for Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site（FUGES-016）
This study is testing how well laparoscopic surgery works for people with gastrointestinal stromal tumors based on where the tumors are located in the body.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT03716089 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the postoperative morbidity and mortality rates of laparoscopic resection for gastrointestinal stromal tumors (GIST) based on whether the tumors are located in favorable or unfavorable anatomical sites. Participants aged 18 to 75 with confirmed GIST will undergo laparoscopic surgery, and their outcomes will be monitored to determine the effectiveness of the procedure. The primary endpoint is the 3-year disease-free survival rate, which will help validate the safety and efficacy of this surgical approach in different tumor locations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a primary gastric GIST confirmed by biopsy and suitable for laparoscopic resection.
Not a fit: Patients with a history of severe mental disorders, previous upper abdominal or gastric surgeries, or those who reject laparoscopic resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing surgical approaches for GIST, potentially improving patient outcomes.
How similar studies have performed: While there have been studies on laparoscopic resection for GIST, this specific comparison based on tumor site is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18 and 75 years old 2. 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 3. Written informed consent 4. Expected R0 resection by laparoscopy 5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale 6. ASA (American Society of Anesthesiology) class I to III 7. Maximum tumor diameter ≤10cm Exclusion Criteria: 1. Pregnant and lactating women 2. Suffering from a severe mental disorder 3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) 4. History of previous gastric surgery (including ESD/EMR for gastric cancer) 5. Rejection of laparoscopic resection 6. History of other malignant disease within the past five years 7. History of unstable angina or myocardial infarction within the past six months 8. History of a cerebrovascular accident within the past six months 9. History of continuous systematic administration of corticosteroids within one month 10. Requirement of simultaneous surgery for another disease 11. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer 12. FEV1\<50% of the predicted values 13. Maximum tumor diameter \>10cm
Where this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.