Cold Snare Endoscopic Resection for Duodenal Adenomas

NCT04783961 | Completed

• 1 other identifier: 2248
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Duodenal Adenomas

Outcome Measures

Primary Outcomes (2)

• Number of patints that will have serious and non-serious adverse events

  * endoscopic appearance * scar biopsies * perforation risk

  3 Months

• Number of residual adenomas

  * endoscopic appearance * scar biopsies

  3 Months

Secondary Outcomes (3)

• Duration of endoscopic procedure

  3 Months

• Hospital stay

  3 Months

• Hospital readmission

  3 Months

Interventions

Cold snare endoscopic resection PROCEDURE

Cold snare endoscopic resection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed large duodenal adenomas (\>20 mm)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)