Device Assisted Full Thickness Resection Versus Endoscopic Submucosal Dissection for Duodenal Neuroendocrine Tumors

NARecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

November 10, 2023

Primary Completion Date

August 30, 2024

Study Completion Date

March 30, 2025

Conditions
Neuroendocrine Tumors
Interventions
PROCEDURE

Endoscopic submucosal dissection

Endoscopic resection is recommended for the management of small DNETs measuring ≤10 mm. Various endoscopic techniques have been utilized for the resection of DNETs including endoscopic mucosal resection (EMR), band ligation assisted EMR, endoscopic submucosal dissection (ESD). However, the published studies report a high rate of histologically incomplete resection even with ESD. More recently, device assisted endoscopic full thickness resection (EFTR) has emerged as a safe and effective resection modality in cases with upper and lower gastrointestinal (GI) mucosal as well as submucosal lesions. There is limited data on the outcomes of EFTR in cases with DNETs.

DEVICE

EFTR

"Initially, the lesion will be marked circumferentially using the FTRD probe available with the device (Forced Coag, E1, 20W). Subsequently, wire guided balloon dilatation of the pyloric channel will be performed.~The device will be mounted over a therapeutic channel gastroscope and negotiated across the cricopharynx over the guidewire with or without assistance of dilating balloon available with the device.~After reaching the target site, the lesion will be pulled withing the FTRD cap with the help of grasping forceps and gentle suctioning.~The clip will be fired after ensuring the entry of the lesion inside the cap, the premounted snare closed and electrocautery activated to cut the grasped tissue (HighCut 200W, Effect 4)."

Trial Locations (1)

500082

RECRUITING

Asian institute of Gastroenterology, Hyderabad

All Listed Sponsors
lead

Asian Institute of Gastroenterology, India

OTHER