Cold Snare Endoscopic Resection for Duodenal Adenomas

Duodenal Adenomas Clinical Trial

— COLD SNARE  

Official title:

Cold Snare Endoscopic Resection for Duodenal Adenomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783961
• Other study ID #: 2248
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Duodenal Adenomas

Intervention

Procedure:
• Cold snare endoscopic resection
Cold snare endoscopic resection

Locations

Country	Name	City	State
Italy	Endoscopy Unit, Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patints that will have serious and non-serious adverse events	endoscopic appearance; scar biopsies; perforation risk	3 Months
Primary	Number of residual adenomas	endoscopic appearance; scar biopsies	3 Months
Secondary	Duration of endoscopic procedure		3 Months
Secondary	Hospital stay		3 Months
Secondary	Hospital readmission		3 Months