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

NCT06121752 | Unknown DMC

• 1 other identifier: EFTR1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• Rate of R0 resection in both the groups

  Endoscopically and pathologically complete resection

  7 days

Secondary Outcomes (3)

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

  7 days

• Procedure duration

  7 days

• Adverse Events

  7 days

Study Arms (2)

Device assisted endoscopic full thickness resection (EFTR)

EXPERIMENTAL

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).

Device: EFTR

Endoscopic submucosal dissection (ESD)

ACTIVE COMPARATOR

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.

Procedure: Endoscopic submucosal dissection

Interventions

Endoscopic submucosal dissection PROCEDURE

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.

Endoscopic submucosal dissection (ESD)

EFTR DEVICE

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).

Device assisted endoscopic full thickness resection (EFTR)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years) with biopsy proven duodenal neuroendocrine tumors (DNETs)
• Size of the lesion \<15 mm
• Absence of local and distant metastases (EUS and DOTANOC scan)
• Willing to provide informed consent

You may not qualify if:

• Large lesions \>15 mm
• Invasion of muscularis layer and beyond on imaging (EUS)
• Scarring or deformity in duodenum
• Active duodenal ulcer
• History of prior resection
• Coagulopathy

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian institute of Gastroenterology

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Zaheer Dr Nabi, MBBS MD

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zaheer Dr Nabi, MBBS MD DNB

CONTACT

04023378888; zaheernabi1978@gmail.com

Ayush Dr Singh, MBBS MD

CONTACT

04023378888; ayush769@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: STUDY DIRECTOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: November 8, 2023
• Study Start: November 10, 2023
• Primary Completion: August 30, 2024
• Study Completion: March 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2023-11

Locations

IN (1)