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Endoscopic resection of duodenal neuroendocrine tumors: A randomized controlled trial

Device assisted full thickness resection versus endoscopic submucosal dissection for duodenal neuroendocrine tumors: A Randomized controlled trial - Nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060494
Enrollment
54
Registered
2023-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K319- Disease of stomach and duodenum, unspecified

Interventions

Intervention1: Endoscopic sub mucosal dissection: ESD will be performed using the standard technique under general anaesthesia. The steps of the procedure are as follows: a) marking of the lesion usin
Ovesco Endoscopy, Tu¨bingen, Germany) . Gastroduodenal full thickness resection device (FTRD) consists of an application cap with outer diameter 19.5 mm and depth 23 mm, ready to use mounted FTRD clip

Sponsors

Asian institute of Gastroenterology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients (=18 years) with biopsy proven duodenal neuroendocrine tumors (DNETs) 2) Size of the lesion 3) Absence of local and distant metastases (EUS and DOTANOC scan) 4) Willing to provide informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Rate of histologically complete resection in both the armsTimepoint: 7 days

Secondary

MeasureTime frame
Adverse EventsTimepoint: 7 Days;Procedure DurationTimepoint: 7 Days;Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopicallyTimepoint: 7 Days

Countries

India

Contacts

Public ContactDr Ayush Singh

Asian institute of Gastroenterology/AIGH

zaheernabi1978@gmail.com04023378888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026