Duodenal Neuroendocrine TumorDEBLNCT06790056
Efficacy of Endoscopic Band Ligation (DEBL) for Duodenal Neuroendocrine Neoplasms(dNENs)
An observational study of Duodenal Neuroendocrine Tumor, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Primary objective To evaluate the therapeutic efficacy (clinical success) of dEBL at 3 months 2b. Secondary objective To evaluate adverse events, technical success and recurrence on follow-up 50 patients over 1-year duration based on our previous study of Prospective data (2023-2024) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Duodenal Neuroendocrine Tumor
- What is being tested?
- duodenal ndoscopic bind ligation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 29 Feb 2024to 11 Nov 2024
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 patients over 1-year duration .
Who may be able to join
- Patients age >18 years
- Size of lesion less than 15mm
- Site of lesion- duodenum (d1-d4)
- No of lesions- ≤6
Who cannot join
- Age less than 18 years
- Non-duodenal lesion
- Local or distant metastasis
- Lumen occluding lesions
- Uncorrectable coagulopathy
- Not willing for consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Endoscopic Band Ligation (DEBL) for Duodenal Neuroendocrine Neoplasms(dNENs) : A Prospective Study
Primary objective To evaluate the therapeutic efficacy (clinical success) of dEBL at 3 months
2b. Secondary objective
To evaluate adverse events, technical success and recurrence on follow-up
50 patients over 1-year duration based on our previous study of Prospective data (2023-2024)
Read the detailed description
We will collect your basic demographics details like age, Sex, date of admission, Endoscopy (is a test to look inside your body) details of Site, size, number of lesion.
By EUS (Endoscopic ultrasound (EUS) combines two techniques - endoscopy and ultrasound - to help doctors see, evaluate and diagnose conditions in and near the gastrointestinal (GI) tract) details of layer of Duodenum involved, site/size/number of lesions.
We will collect your details of Duodenal endoscopic band ligation procedure to check feasibility, technical success.
You are requested to come for follow up for 3 months for endoscopy prodecure.
- Conditions
- Duodenal Neuroendocrine Tumor
- Being tested
- duodenal ndoscopic bind ligation
- Keywords
- lesion size,, tumour, binding
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duodenal ndoscopic bind ligationProcedure or surgery
We will collect your basic demographics details like age, Sex, date of admission, Endoscopy (is a test to look inside your body) details of Site, size, number of lesion.
By EUS (Endoscopic ultrasound (EUS) combines two techniques - endoscopy and ultrasound - to help doctors see, evaluate and diagnose conditions in and near the gastrointestinal (GI) tract) details of layer of Duodenum involved, site/size/number of lesions.
We will collect your details of Duodenal endoscopic band ligation procedure to check feasibility, technical success.
You are requested to come for follow up for 3 months for endoscopy prodecure.
| Study group | Role | What they receive |
|---|---|---|
| Duodenal endoscopic band ligation group | We will collect your basic demographics details like age, Sex, date of admission, Endoscopy (is a test to look inside your body) details of Site, size, number of lesion.
By EUS (Endoscopic ultrasound (EUS) combines two techniques - endoscopy and ultrasound - to help doctors see, evaluate and diagnose conditions in and near the gastrointestinal (GI) tract) details of layer of Duodenum involved, site/size/number of lesions.
We will collect your details of Duodenal endoscopic band ligation procedure to check feasibility, technical success.
You are requested to come for follow up for 3 months for endoscopy prodecure. Receives: Procedure: duodenal ndoscopic bind ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic efficacy (clinical success) of dEBL at 3 months and 1 year
Therapeutic efficacy (clinical success) of dEBL at 3 months and 1 year
Measured: One year
Secondary outcomes (1)
Adverse events and recurrence on follow up
Univariate and multivariate analysis will be done to determine which are the factors associated with clinical success and clinical recurrence
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start29 Feb 2024
- Primary completion10 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
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
- Hardik Rughwani, Principal investigator, AIG HOSPITALS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790056
- Sponsor's protocol ID
- DEBL- 01
- Acronym
- DEBL
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Endoscopic Band Ligation (DEBL) for Duodenal Neuroendocrine Neoplasms(dNENs) : A Prospective Study
- ClinicalTrials.gov ID
- NCT06790056
- Acronym / sponsor ID
- DEBL / DEBL- 01
- Conditions
- Duodenal Neuroendocrine Tumor
- Keywords
- lesion size,, tumour, binding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 23 Jan 2025 (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.
Primary objective To evaluate the therapeutic efficacy (clinical success) of dEBL at 3 months
2b. Secondary objective
To evaluate adverse events, technical success and recurrence on follow-up
50 patients over 1-year duration based on our previous study of Prospective data (2023-2024)
Detailed description
We will collect your basic demographics details like age, Sex, date of admission, Endoscopy (is a test to look inside your body) details of Site, size, number of lesion.
By EUS (Endoscopic ultrasound (EUS) combines two techniques - endoscopy and ultrasound - to help doctors see, evaluate and diagnose conditions in and near the gastrointestinal (GI) tract) details of layer of Duodenum involved, site/size/number of lesions.
We will collect your details of Duodenal endoscopic band ligation procedure to check feasibility, technical success.
You are requested to come for follow up for 3 months for endoscopy prodecure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duodenal endoscopic band ligation group | – | Procedure: duodenal ndoscopic bind ligationWe will collect your basic demographics details like age, Sex, date of admission, Endoscopy (is a test to look inside your body) details of Site, size, number of lesion. By EUS (Endoscopic ultrasound (EUS) combines two techniques - endoscopy and ultrasound - to help doctors see, evaluate and diagnose conditions in and near the gastrointestinal (GI) tract) details of layer of Duodenum involved, site/size/number of lesions. We will collect your details of Duodenal endoscopic band ligation procedure to check feasibility, technical success. You are requested to come for follow up for 3 months for endoscopy prodecure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients over 1-year duration .
Key inclusion criteria (4 listed)
- Patients age >18 years
- Size of lesion less than 15mm
- Site of lesion- duodenum (d1-d4)
- No of lesions- ≤6
Key exclusion criteria (6 listed)
- Age less than 18 years
- Non-duodenal lesion
- Local or distant metastasis
- Lumen occluding lesions
- Uncorrectable coagulopathy
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 |
|---|---|---|
| duodenal ndoscopic bind ligationWe will collect your basic demographics details like age, Sex, date of admission, Endoscopy (is a test to look inside your body) details of Site, size, number of lesion. By EUS (Endoscopic ultrasound (EUS) combines two techniques - endoscopy and ultrasound - to help doctors see, evaluate and diagnose conditions in and near the gastrointestinal (GI) tract) details of layer of Duodenum involved, site/size/number of lesions. We will collect your details of Duodenal endoscopic band ligation procedure to check feasibility, technical success. You are requested to come for follow up for 3 months for endoscopy prodecure. | Procedure or surgery | Duodenal endoscopic band ligation group |
Primary outcome
Therapeutic efficacy (clinical success) of dEBL at 3 months and 1 year
Time frame: One year
Therapeutic efficacy (clinical success) of dEBL at 3 months and 1 year
1 secondary outcome
Adverse events and recurrence on follow up
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Hardik Rughwani principal investigator
AIG HOSPITALS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duodenal Neuroendocrine Tumor, 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: finished, as of the sponsor's last update on 23 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic efficacy (clinical success) of dEBL at 3 months and 1 year (time frame: One year). 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 23 Jan 2025.