Neuroendocrine TumorsDNETNCT06121752
Device Assisted Full Thickness Resection Versus Endoscopic Submucosal Dissection for Duodenal Neuroendocrine Tumors
A study testing Endoscopic submucosal dissection and EFTR in people with Neuroendocrine Tumors, run by Asian Institute of Gastroenterology, India at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Endoscopic submucosal dissection and EFTR
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndia
- Study dates
- 10 Nov 2023to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian institute of Gastroenterology
Hyderabad, Telangana, 500082
Zaheer Dr Nabi, MBBS MD DNB, 04023378888, zaheernabi1978@gmail.com
About this study
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.
Read the 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
- Conditions
- Neuroendocrine Tumors
- Being tested
- Endoscopic submucosal dissection, EFTR
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic submucosal dissectionProcedure or surgery
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.
EFTRDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Device assisted endoscopic full thickness resection (EFTR) | Experimental | 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). Receives: Device: EFTR |
| Endoscopic submucosal dissection (ESD) | Active comparator | 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. Receives: Procedure: Endoscopic submucosal dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of R0 resection in both the groups
Endoscopically and pathologically complete resection
Measured: 7 days
Secondary outcomes (3)
Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically
Endoscopically complete resection
Measured: 7 days
Procedure duration
Time to complete each procedure in minutes
Measured: 7 days
Adverse Events
Adverse events during and after the procedure
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start10 Nov 2023
- Primary completion30 Aug 2024
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Zaheer Dr Nabi, MBBS MD, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121752
- Sponsor's protocol ID
- EFTR1
- Acronym
- DNET
- Status last verified
- Nov 2023
- First submitted
- 10 Oct 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Device Assisted Full Thickness Resection Versus Endoscopic Submucosal Dissection for Duodenal Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT06121752
- Acronym / sponsor ID
- DNET / EFTR1
- Conditions
- Neuroendocrine Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device assisted endoscopic full thickness resection (EFTR) | Experimental | Device: EFTRThe 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). |
| Endoscopic submucosal dissection (ESD) | Active comparator | Procedure: Endoscopic submucosal dissectionESD 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic submucosal dissectionEndoscopic 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. | Procedure or surgery | Endoscopic submucosal dissection (ESD) |
| EFTRInitially, 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 | Device assisted endoscopic full thickness resection (EFTR) |
Primary outcome
Rate of R0 resection in both the groups
Time frame: 7 days
Endoscopically and pathologically complete resection
3 secondary outcomes
Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically
Time frame: 7 days
Procedure duration
Time frame: 7 days
Adverse Events
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaheer Dr Nabi, MBBS MD principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic submucosal dissection and EFTR in people with Neuroendocrine Tumors, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zaheer Dr Nabi, MBBS MD DNB (04023378888, zaheernabi1978@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of R0 resection in both the groups (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.