Clinical trial · Interventional
Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach
Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach:a Multicenter Prospective Trial(CLASS-06)
NCT05197933CI-TRIAL-00056043unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Laparoscopic resection
- description
- laparoscopic resection for GIST at unfavorable anatomic sites of stomach
- interventionNames
- Procedure: Laparoscopic resection
Primary outcomes (1)
- measure
- 3-year disease-free survival rate (DFS)
- timeFrame
- until the date of first documented progression, assessed up to 3 years
- description
- The number of patients with DFS \> 3 years was used as the numerator and the number of all patients was used as the denominator to calculate the ratio value.
Secondary outcomes (6)
- measure
- Success rate of laparoscopic surgery
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.