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

Sponsor

Asian Institute of Gastroenterology, India (Other)

Overall Status

Recruiting

CT.gov ID

NCT06121752

Collaborator

(none)

Enrollment

Location

Arms

11.7

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroendocrine Tumors	Procedure: Endoscopic submucosal dissection Device: EFTR	N/A

Detailed Description

Primary objective:

Rate of R0 resection in both the groups

Secondary outcomes:

Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically
Procedure duration
Adverse Events

Inclusion criteria:

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

Exclusion criteria:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 10, 2023

Anticipated Primary Completion Date :

Aug 30, 2024

Anticipated Study Completion Date :

Oct 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rate of R0 resection in both the groups [7 days]
Endoscopically and pathologically complete resection

Secondary Outcome Measures

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
Adverse Events [7 days]
Adverse events during and after the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asian institute of Gastroenterology	Hyderabad	Telangana	India	500082

Sponsors and Collaborators

Asian Institute of Gastroenterology, India

Investigators

Principal Investigator: Zaheer Dr Nabi, MBBS MD, Asian Institute of Gastroenterology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohan Ramchandani, STUDY DIRECTOR, Asian Institute of Gastroenterology, India

ClinicalTrials.gov Identifier:

NCT06121752

Other Study ID Numbers:

EFTR1

First Posted:

Nov 8, 2023

Last Update Posted:

Nov 14, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neuroendocrine Tumors

Study Results

No Results Posted as of Nov 14, 2023