Endoscopic procedure to remove gastric tumors
Prospective Clinical Study on Safety and Effectiveness of Endoscopic Full Thickness Resection for Treatment of Patients With Gastric Gastrointestinal Stromal Tumors (GIST)
This study is testing a new, less invasive way to remove stomach tumors in adults to see if it works safely and effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, Outside Of US & Canada) |
| Trial ID | NCT04198337 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of endoscopic full thickness resection (EFTR) for treating gastric gastrointestinal stromal tumors (GIST). A total of 30 patients aged between 18 and 80 will be recruited, focusing on submucosal tumors located at specific areas of the stomach. The study aims to determine how well this minimally invasive technique can effectively remove tumors while ensuring patient safety.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with gastric submucosal tumors sized between 10mm and 30mm located at the cardia, lesser curvature, or antrum.
Not a fit: Patients who are unfit for general anesthesia, those with ASA class ≥ IV, or those with tumors located at the greater curvature and fundus will not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could provide a less invasive treatment option for patients with gastric GIST, potentially leading to quicker recovery times and fewer complications.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in minimally invasive techniques for tumor removal, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 18 and ≤ 80 2. Gastric submucosal tumors located at cardia, lesser curvature and antrum 3. Size of the submucosal tumor between 10mm to 30mm as assessed by endoscopic Exclusion Criteria: 1. Patients who are considered as unfit for general anesthesia 2. ASA class ≥ IV or moribund patients 3. Pregnancy 4. Gastric submucosal tumors located at greater curvature and fundus
Where this trial is running
Hong Kong, Outside Of US & Canada
- Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong — Hong Kong, Outside Of US & Canada, China (Recruiting)
Study contacts
- Principal investigator: Philip Wai Yan Chiu, MD, FRCSEd — Chinese University of Hong Kong
- Study coordinator: Philip Wai Yan Y Chiu, MD, FRCSEd
- Email: philipchiu@surgery.cuhk.edu.hk
- Phone: +85235053952
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.