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OpenTrials
Completed

NCT Number: NCT06790056

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

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)

Completed

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Key information

Conditions

Duodenal Neuroendocrine Tumor Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hardik Rughwani

Hyderabad, Telangana, 500082, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

duodenal ndoscopic bind ligation

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Adverse events and recurrence on follow up

    Time frame: One year

    Univariate and multivariate analysis will be done to determine which are the factors associated with clinical success and clinical recurrence

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

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

Acronym: DEBL

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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