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Cold Snare Endoscopic Resection for Duodenal Adenomas

Cold Snare Endoscopic Resection for Duodenal Adenomas

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04783961
Acronym
COLD SNARE
Enrollment
10
Registered
2021-03-05
Start date
2021-03-01
Completion date
2021-12-31
Last updated
2022-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenal Adenomas

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.

Interventions

PROCEDURECold snare endoscopic resection

Cold snare endoscopic resection

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Number of patints that will have serious and non-serious adverse events3 Months* endoscopic appearance * scar biopsies * perforation risk
Number of residual adenomas3 Months* endoscopic appearance * scar biopsies

Secondary

MeasureTime frame
Duration of endoscopic procedure3 Months
Hospital stay3 Months
Hospital readmission3 Months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026