NCT06790056 - Efficacy of Endoscopic Band Ligation (DEBL) for Duodenal Neuroendocrine Neoplasms(dNENs) | Crick

Overview

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)

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 Type

OBSERVATIONAL

Enrollment

50

Conditions

Duodenal Neuroendocrine Tumor

Interventions

duodenal ndoscopic bind ligationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hardik Rughwani

Hyderabad, Telangana, India

Outcomes

Primary Outcomes

Therapeutic efficacy (clinical success) of dEBL at 3 months and 1 year

Time frame: One year

Secondary Outcomes

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

Time frame: One year