Comparing two methods for removing duodenal neuroendocrine tumors
Device Assisted Full Thickness Resection Versus Endoscopic Submucosal Dissection for Duodenal Neuroendocrine Tumors
This study is testing two different methods to see which one works better for removing small duodenal neuroendocrine tumors in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Trial ID | NCT06121752 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of device-assisted endoscopic full thickness resection (EFTR) versus endoscopic submucosal dissection (ESD) in achieving complete removal of duodenal neuroendocrine tumors (DNETs) that are 15 mm or smaller. The primary objective is to evaluate the rate of histologically complete resection (R0) in both techniques. Secondary outcomes include assessing technical success, procedure duration, and any adverse events. The study will involve adult patients with biopsy-proven DNETs and will exclude those with larger lesions or other complicating factors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven duodenal neuroendocrine tumors measuring 15 mm or smaller.
Not a fit: Patients with larger lesions, invasion of deeper layers, or other significant gastrointestinal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with small duodenal neuroendocrine tumors.
How similar studies have performed: While there is limited data on EFTR for DNETs, other studies have shown promising results with similar endoscopic techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients (≥18 years) with biopsy proven duodenal neuroendocrine tumors (DNETs) 2. Size of the lesion \<15 mm 3. Absence of local and distant metastases (EUS and DOTANOC scan) 4. Willing to provide informed consent Exclusion Criteria: 1. Large lesions \>15 mm 2. Invasion of muscularis layer and beyond on imaging (EUS) 3. Scarring or deformity in duodenum 4. Active duodenal ulcer 5. History of prior resection 6. Coagulopathy
Where this trial is running
Hyderabad, Telangana
- Asian institute of Gastroenterology — Hyderabad, Telangana, India (Recruiting)
Study contacts
- Principal investigator: Zaheer Dr Nabi, MBBS MD — Asian Institute of Gastroenterology
- Study coordinator: Zaheer Dr Nabi, MBBS MD DNB
- Email: zaheernabi1978@gmail.com
- Phone: 04023378888
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.