Ignite Creation Date:
2025-12-24 @ 12:59 PM
Ignite Modification Date:
2025-12-27 @ 9:42 PM
Study NCT ID:
NCT04783961
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2021-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cold Snare Endoscopic Resection for Duodenal Adenomas
Sponsor:
Istituto Clinico Humanitas
Organization:
Study Overview
Official Title:
Cold Snare Endoscopic Resection for Duodenal Adenomas
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLD SNARE
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: