Status:
UNKNOWN
Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
Peking University Cancer Hospital & Institute
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this trial is to evaluate the safety of laparoscopic resection for GIST whose diameter is ≥2cm and ≤5cm at unfavorable anatomic sites of stomach.
Detailed Description
The aim of this trial is to evaluate the safety of laparoscopic resection for GIST whose diameter is ≥2cm and ≤5cm at unfavorable anatomic sites of stomach. Unfavorable anatomic sites are defined by s...
Eligibility Criteria
Inclusion
- Age from over 18 to under 75 years;
- Gastrointestinal stromal tumor at unfavorable anatomic sites of stomach preoperatively confirmed by endoscopy, ultrasound endoscopy, CT or MRI;
- Diameter of tumor size is ≥2cm and ≤5cm confirmed by contrast CT or MRI;
- Patients whose tumor is resectable by laparoscopic technique at preoperative assessment;
- No evidence of distant metastasis and tumor invading nearby organs at preoperative assessment;
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
- ASA (American Society of Anesthesiology) score I, II, or III;
- Written informed consent.
Exclusion
- Women during pregnancy or breast-feeding;
- Severe mental disorder;
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy);
- History of other malignant disease within the past five years;
- History of previous neoadjuvant imatinib therapy;
- History of unstable angina or myocardial infarction within the past six months;
- History of cerebrovascular accident within the past six months;
- History of continuous systematic administration of corticosteroids within the past month;
- Requirement of simultaneous surgery for other disease;
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastrointestinal stromal tumor;
- FEV1\<50% of predicted value;
- Patients with GIST locates at favorable anatomic sites detected by contrast CT, MRI or ultrasound endoscopy at preoperative assessment;
- Patients with GIST diameter\<2cm or\>5cm detected by contrast CT or MRI;
- Presence of distant metastasis or tumor invading nearby organs at preoperative assessment.
- Withdrawal Criteria:
- Patients postoperatively confirmed as non-GIST case by pathology (These cases are enrolled in safe group for future statistic analysis);
- GIST at unfavorable anatomic site diagnosed before operation, while GIST at favorable anatomic site determined by intraoperative exploration;
- Patients confirmed as tumor rupture , metastasis or invading nearby organs intraoperately;
- Patients requiring simultaneous surgical treatment of other diseases;
- Sudden severe complications during the perioperative period (intolerable surgery or anesthesia), which renders it unsuitable or unfeasible to implement the study treatment protocol as scheduled;
- Patients confirmed to require emergency surgery by attending physicians due to changes in the patient's condition after inclusion in this study;
- Patients who voluntarily quit or discontinue treatment for personal reasons at any stage after inclusion in this study;
- Treatment implemented is proven to violate study protocol.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT05197933
Start Date
October 1 2020
End Date
September 30 2025
Last Update
January 20 2022
Active Locations (1)
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1
Renji hospital
Shanghai, Shanghai Municipality, China, 200127