Evaluating laparoscopic surgery for gastrointestinal stromal tumors in difficult stomach locations

Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach：a Multicenter Prospective Trial（CLASS-06）

This study is testing if laparoscopic surgery is a safe way to remove gastrointestinal stromal tumors in tricky spots of the stomach for adults aged 18 to 75.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 182 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: RenJi Hospital (other)
• Drugs / interventions: imatinib
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05197933 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the safety of laparoscopic resection for gastrointestinal stromal tumors (GIST) located at unfavorable anatomic sites of the stomach, specifically those tumors measuring between 2cm and 5cm. Unfavorable sites include areas such as the less curvature, posterior wall, and regions adjacent to the cardia and pylorus, as defined by clinical guidelines. The study will involve patients aged 18 to 75 who have confirmed GIST and meet specific preoperative criteria, ensuring that the tumors are resectable and have no evidence of metastasis. The intervention consists of laparoscopic surgical techniques to remove the tumors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with resectable gastrointestinal stromal tumors located at unfavorable anatomic sites of the stomach.

Not a fit: Patients with severe mental disorders, previous upper abdominal surgeries, or those with distant metastasis will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer surgical option for patients with GIST located in challenging areas of the stomach.

How similar studies have performed: While laparoscopic techniques have been successful in other surgical contexts, this specific application for GIST at unfavorable sites is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai

• Renji hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Hui Cao, Professor

Conditions: Gastrointestinal Stromal Tumors, Unfavorable Anatomic Site of Stomach, Laparoscopic Resection