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

NCT ID: NCT06121752

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-10
• Study Completion Date: 2025-03-30

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

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

EFTR

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

Endoscopic submucosal dissection

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Mohan Ramchandani

STUDY DIRECTOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zaheer Dr Nabi, MBBS MD

Role: PRINCIPAL_INVESTIGATOR

Asian Institute of Gastroenterology

Locations

Asian institute of Gastroenterology

Hyderabad, Telangana, India

Site Status: RECRUITING

Countries

India

Central Contacts

Zaheer Dr Nabi, MBBS MD DNB

Role: CONTACT

zaheernabi1978@gmail.com

04023378888

Ayush Dr Singh, MBBS MD

Role: CONTACT

ayush769@gmail.com

04023378888

Facility Contacts

Zaheer Dr Nabi, MBBS MD DNB

Role: primary

zaheernabi1978@gmail.com

04023378888

Other Identifiers

EFTR1

Identifier Type: -

Identifier Source: org_study_id