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

NCT ID: NCT06790056

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-11-11

Brief Summary

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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

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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

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Duodenal Neuroendocrine Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

duodenal ndoscopic bind ligation

Intervention Type PROCEDURE

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

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duodenal 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Asian Institute of Gastroenterology, India

OTHER

Sponsor Role lead

Responsible Party

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Mohan Ramchandani

Consultant Gastroenterologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hardik Rughwani

Role: PRINCIPAL_INVESTIGATOR

AIG HOSPITALS

Locations

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Hardik Rughwani

Hyderabad, Telangana, India

Site Status

Countries

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India

Other Identifiers

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DEBL- 01

Identifier Type: -

Identifier Source: org_study_id

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