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Efficacy of Endoscopic Band Ligation (DEBL) for Duodenal Neuroendocrine Neoplasms(dNENs)

Efficacy of Endoscopic Band Ligation (DEBL) for Duodenal Neuroendocrine Neoplasms(dNENs) : A Prospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06790056
Acronym
DEBL
Enrollment
50
Registered
2025-01-23
Start date
2024-02-29
Completion date
2024-11-11
Last updated
2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenal Neuroendocrine Tumor

Keywords

lesion size,, tumour, binding

Brief 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)

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.

Interventions

PROCEDUREduodenal ndoscopic bind ligation

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.

Sponsors

Asian Institute of Gastroenterology, India
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients age \>18 years * Size of lesion less than 15mm * Site of lesion- duodenum (d1-d4) * No of lesions- ≤6

Exclusion criteria

* Age less than 18 years * Non-duodenal lesion * Local or distant metastasis * Lumen occluding lesions * Uncorrectable coagulopathy * Not willing for consent

Design outcomes

Primary

MeasureTime frameDescription
Therapeutic efficacy (clinical success) of dEBL at 3 months and 1 yearOne yearTherapeutic efficacy (clinical success) of dEBL at 3 months and 1 year

Secondary

MeasureTime frameDescription
Adverse events and recurrence on follow upOne yearUnivariate and multivariate analysis will be done to determine which are the factors associated with clinical success and clinical recurrence

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026