Safety of laparoscopic surgery for large gastric tumors

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 study investigates the safety of laparoscopic resection for gastric gastrointestinal stromal tumors (GIST) that are 5cm or larger. It is a multicenter, prospective cohort study comparing the outcomes of laparoscopic surgery for larger GISTs to those smaller than 5cm. The primary focus is on evaluating overall postoperative morbidity to establish the efficacy and safety of this surgical approach. The study aims to fill the gap in high-quality evidence regarding the treatment of larger gastric GISTs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years \< age \< 75 years
2. Primary gastric lesion diagnosed as gastric GSIT by endoscopic biopsy histopathology or suspected gastric GIST by preoperative endoscopy, ultrasound endoscopy, or CT or MR, and confirmed as primary gastric GIST by postoperative pathology
3. Patient informed consent and willingness to undergo laparoscopic resection
4. Expected laparoscopic outcome of R0 resection
5. Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative American Society of Anesthesiologists（ASA） score I-III

Exclusion Criteria:

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of upper abdominal surgery (except the history of laparoscopic cholecystectomy)
4. History of gastric surgery (except ESD/EMR for gastric cancer)
5. History of other malignant diseases within the past five years
6. History of unstable angina or myocardial infarction within the past six months
7. History of a cerebrovascular accident within the past six months
8. History of continuous systematic administration of corticosteroids within one month
9. Requirement of simultaneous surgery for other diseases
10. Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer

Where it's running

• Department of Gastric Surgery， Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Ping Li, MD，PhD
• Email: Pingli811002@163.com
• Phone: +8613365918502

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

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• Combining radiotherapy with ripretinib for advanced GIST treatment

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• Oral Liporaxel (paclitaxel) treatment for gastrointestinal stromal tumors

  This study will test whether taking oral Liporaxel (a form of paclitaxel) can help people with advanced GIST who stopped responding to imatinib, sunitinib, and regorafenib and whose tumors have low P‑glycoprotein levels.

  Recruiting Phase 2 Asan Medical Center · Seoul, Songpagu · NCT06326346

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.