Clinical trial NCT06121752: Device Assisted Full Thickness Resection Versus Endoscopic Submucosal Dissection for Duodenal Neuroendocrine Tumors
Official title: Device Assisted Full Thickness Resection Versus Endoscopic Submucosal Dissection for Duodenal Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuroendocrine Tumors
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Rate of R0 resection in both the groups
timeFrame: 7 days
Secondary outcomes:
measure: Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically
timeFrame: 7 days
measure: Procedure duration
timeFrame: 7 days
measure: Adverse Events
timeFrame: 7 days
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian institute of Gastroenterology
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Zaheer Dr Nabi, MBBS MD
role: PRINCIPAL_INVESTIGATOR
References: