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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuroendocrine Tumors
• Intervention / Treatment: Device: EFTR; Procedure: Endoscopic submucosal dissection

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 Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zaheer Dr Nabi, MBBS MD DNB; Phone Number: 04023378888; Email: zaheernabi1978@gmail.com
• Study Contact Backup: Name: Ayush Dr Singh, MBBS MD; Phone Number: 04023378888; Email: ayush769@gmail.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Recruiting
      • Asian Institute of Gastroenterology
      • Contact: Zaheer Dr Nabi, MBBS MD DNB; Phone Number: 04023378888; Email: zaheernabi1978@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device assisted endoscopic full thickness resection (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).	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).
Active Comparator: Endoscopic submucosal dissection (ESD); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of R0 resection in both the groups	Endoscopically and pathologically complete resection	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Zaheer Dr Nabi, MBBS MD, Asian Institute of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Actual): August 30, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: EFTR1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No