Cold Snare Endoscopic Resection for Duodenal Adenomas

Completed

• Conditions: Duodenal Adenomas

• Registration Number: NCT04783961
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

Non-ampullary sporadic duodenal adenomas (SDA) are rare lesions, incidentally discovered in up to only 5% of patients during routine endoscopy. In any case, these lesions require treatment due to their potential malignant transformation because of the adenoma-carcinoma sequence, occurring in 30-85% of cases. Endoscopic resection (ER) of SDA represents an attractive alternative to surgical resection in appropriately selected patients, with lower morbidity and mortality rates.

However, most endoscopists are not keen to resect larger lesions due to the risk of complications. Indeed, endoscopic resection in the duodenum has unique challenges: thin wall, high vascularity, very limited space and harmful effects of bile and acid both acting on the ER defect.

Cold snare endoscopic resection has been shown to be a viable method for removing colorectal lesions with comparable efficacy outcomes compared to conventional polypectomy/endoscopic mucosal resection (EMR) and a promising safety profile. As a matter of fact, adverse events associated with hot snare resection technique such as delayed bleeding, post-polypectomy syndrome, and perforation are all related to electrocautery-induced injury.

Performing cold snare piece-meal resection and avoiding the need of thermal therapy, may have a major impact in the duodenum where the risk of delayed bleeding and perforation is consistent.

The aim of this pilot study is to prospectively evaluate the feasibility and the efficacy in term of safety and efficacy of cold snare endoscopic resection.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-05
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients able to give informed consent to involvement in trial.

Exclusion Criteria

• Patient's with known strictures/stenosis
• Pregnancy
• Patients who did not consent to study
• Bleeding diathesis
• Anticoagulants

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patints that will have serious and non-serious adverse events	3 Months	* endoscopic appearance; * scar biopsies; * perforation risk
Number of residual adenomas	3 Months	* endoscopic appearance; * scar biopsies

Secondary Outcome Measures

Name	Time	Method
Duration of endoscopic procedure	3 Months
Hospital stay	3 Months
Hospital readmission	3 Months

Trial Locations

Locations (1)

Endoscopy Unit, Humanitas Research Hospital; 🇮🇹 Rozzano, Milano, Italy