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Trial Title:
Device Assisted Full Thickness Resection Versus Endoscopic Submucosal Dissection for Duodenal Neuroendocrine Tumors
NCT ID:
NCT06121752
Condition:
Neuroendocrine Tumors
Conditions: Official terms:
Neuroendocrine Tumors
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Endoscopic submucosal dissection
Description:
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 group label:
Endoscopic submucosal dissection (ESD)
Intervention type:
Device
Intervention name:
EFTR
Description:
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).
Arm group label:
Device assisted endoscopic full thickness resection (EFTR)
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Asian institute of Gastroenterology
Address:
City:
Hyderabad
Zip:
500082
Country:
India
Status:
Recruiting
Contact:
Last name:
Zaheer Dr Nabi, MBBS MD DNB
Phone:
04023378888
Email:
zaheernabi1978@gmail.com
Start date:
November 10, 2023
Completion date:
March 30, 2025
Lead sponsor:
Agency:
Asian Institute of Gastroenterology, India
Agency class:
Other
Source:
Asian Institute of Gastroenterology, India
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06121752
