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Completed

NCT Number: NCT04783961

Cold Snare Endoscopic Resection for Duodenal Adenomas

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.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold snare endoscopic resection

Procedure

Cold snare endoscopic resection

Primary outcomes

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

    Time frame: 3 Months

    • endoscopic appearance
    • scar biopsies
    • perforation risk
  2. Number of residual adenomas

    Time frame: 3 Months

    • endoscopic appearance
    • scar biopsies

Secondary outcomes

  1. Duration of endoscopic procedure

    Time frame: 3 Months

  2. Hospital stay

    Time frame: 3 Months

  3. Hospital readmission

    Time frame: 3 Months

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Acronym: COLD SNARE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2021
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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