Evaluating laparoscopic surgery for gastrointestinal stromal tumors in difficult stomach locations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Renji hospital
  Shanghai, Shanghai, China Recruiting

Study contacts

• Study coordinator: Hui Cao, Professor
• Email: caohuishcn@hotmail.com
• Phone: 13918141425

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.