Safety of laparoscopic surgery for large gastric tumors
A Prospective, Multicenter Cohort Study on the Efficacy and Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors
Fujian Medical University · NCT05938309
This study is testing whether laparoscopic surgery is safe for people with larger gastric tumors compared to those with smaller ones.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 194 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fujian Medical University (other) |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT05938309 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with a confirmed diagnosis of gastric GIST and who are eligible for laparoscopic resection.
Not a fit: Patients who are pregnant, have severe mental disorders, or have a history of significant abdominal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of laparoscopic surgery for patients with larger gastric GISTs, potentially leading to improved surgical outcomes.
How similar studies have performed: While there is limited high-quality evidence specifically for larger gastric GISTs, similar laparoscopic approaches have shown promise in treating smaller tumors, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Fuzhou, Fujian
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrointestinal Stromal Tumors, Gastrectomy, Laparoscopic, gastrointestinal stromal tumor