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NCT04783961: COLD SNARE
Cold Snare Endoscopic Resection for Duodenal Adenomas
trial testing Cold snare endoscopic resection in Duodenal Adenomas in 10 participants. Completed in 31 December 2021.
31 December 2021
Quick facts
| Lead sponsor | Istituto Clinico Humanitas |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 10 |
| Start date | 1 March 2021 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Cold snare endoscopic resection
Conditions studied
- Duodenal Adenomas — all drugs for Duodenal Adenomas →
Sponsor
Istituto Clinico Humanitas
Who can join
Adults 18 to 99, any sex, with Duodenal Adenomas. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Cold-snare endoscopic mucosal resection of large duodenal laterally spreading tumors: is cold the future gold standard?
Geyl S, Schaefer M, Pioche M, Dahan M, et al · · 2022 · PMID 35777374 · DOI 10.1055/a-1841-5607
Verify or expand the search:
- PubMed search for NCT04783961
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04783961 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Clinico Humanitas
- Last refreshed: 15 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04783961.
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