Cold Snare Endoscopic Resection for Duodenal Adenomas

Study Overview
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Brief Summary
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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.

Official Title
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Cold Snare Endoscopic Resection for Duodenal Adenomas

Conditions
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Duodenal Adenomas

Intervention / Treatment
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* Procedure: Cold snare endoscopic resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cold snare endoscopic resection|Cold snare endoscopic resection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of endoscopic procedure |  | 3 Months | 
| Hospital stay |  | 3 Months | 
| Hospital readmission |  | 3 Months |