NCT03716089Recruiting
Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site
Prospective Controlled Clinical Trial for Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site（FUGES-016）
Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 14 Oct 2018
- Start date
- 11 Oct 2018
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Fujian Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03716089
What you commit to
- Study type: Observational
- Planned participants: 250
- From 11 Oct 2018 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Suffering from a severe mental disorder
- 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
Other
- Pregnant and lactating women
- FEV1\<50% of the predicted values
- Maximum tumor diameter \>10cm
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.