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

Asian Institute of Gastroenterology, India

Status: Enrolling

Conditions: Neuroendocrine Tumors

Treatments: Device: EFTR; Procedure: Endoscopic submucosal dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT06121752

EFTR1

Details and patient eligibility

About

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.

Full 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

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Device assisted endoscopic full thickness resection (EFTR)

Experimental group

Description:

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).

Treatment:

Device: EFTR

Endoscopic submucosal dissection (ESD)

Active Comparator group

Description:

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.

Treatment:

Procedure: Endoscopic submucosal dissection