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

Neuroendocrine Tumors Clinical Trial

— DNET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06121752
• Other study ID #: EFTR1
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: November 2023
• Source: Asian Institute of Gastroenterology, India
• Contact: Zaheer Dr Nabi, MBBS MD DNB
• Phone: 04023378888
• Email: zaheernabi1978[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: October 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

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.

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).

Locations

Country	Name	City	State
India	Asian institute of Gastroenterology	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of R0 resection in both the groups	Endoscopically and pathologically complete resection	7 days
Secondary	Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically	Endoscopically complete resection	7 days
Secondary	Procedure duration	Time to complete each procedure in minutes	7 days
Secondary	Adverse Events	Adverse events during and after the procedure	7 days