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

Not Applicable

Recruiting

• Conditions: Neuroendocrine Tumors
• Interventions: Device: EFTR; Procedure: Endoscopic submucosal dissection

• Registration Number: NCT06121752
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief Summary

Introduction :

The incidence of duodenal neuroendocrine tumors (DNETs) is increasing. 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.

In this study, we aim to compare the rate of histologically complete resection (R0) with ESD and EFTR in cases with DNETs.

Detailed Description

Primary objective:

Rate of R0 resection in both the groups

Secondary outcomes:

1. Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically

2. Procedure duration

3. Adverse Events

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

Study Timeline

• Study First Submitted: 2023-10-10
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-08
• Study Start: 2023-11-10
• Primary Completion: 2024-08-30
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-15
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device assisted endoscopic full thickness resection (EFTR)	EFTR	The steps of EFTR are as follows. 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).
Endoscopic submucosal dissection (ESD)	Endoscopic submucosal 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 using closed tip of DualKnife J in soft coagulation mode (Effect 4, 80W), b) submucosal lifting injection using saline mixed with indigocarmine dye, c) circumferential mucosal incision (Dry Cut, Effect 2, 30W), d) submucosal dissection (SwiftCoag, Effect 2, 30W), removal of the lesion using suction or a polypectomy snare, f) closure of the defect using endoclips or loop and endoclips.

Primary Outcome Measures

Name	Time	Method
Rate of R0 resection in both the groups	7 days	Endoscopically and pathologically complete resection

Secondary Outcome Measures

Name	Time	Method
Adverse Events	7 days	Adverse events during and after the procedure
Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically	7 days	Endoscopically complete resection
Procedure duration	7 days	Time to complete each procedure in minutes

Trial Locations

Locations (1)

Asian institute of Gastroenterology; 🇮🇳 Hyderabad, Telangana, India