COLD SNARE: Cold Snare Endoscopic Resection for Duodenal Adenomas

• Sponsor: Istituto Clinico Humanitas (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04783961
• Collaborator: (none)
• Enrollment: 10
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Duodenal Adenomas	Procedure: Cold snare endoscopic resection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cold Snare Endoscopic Resection for Duodenal Adenomas
• Anticipated Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Mar 1, 2022

Outcome Measures

Primary Outcome Measures

1. Number of patints that will have serious and non-serious adverse events [3 Months]

   endoscopic appearance scar biopsies perforation risk

2. Number of residual adenomas [3 Months]

   endoscopic appearance scar biopsies

Secondary Outcome Measures

1. Duration of endoscopic procedure [3 Months]

2. Hospital stay [3 Months]

3. Hospital readmission [3 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Istituto Clinico Humanitas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istituto Clinico Humanitas
• ClinicalTrials.gov Identifier: NCT04783961
• Other Study ID Numbers: 2248
• First Posted: Mar 5, 2021
• Last Update Posted: Mar 8, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adenoma

Study Results

No Results Posted as of Mar 8, 2021