Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04816292

A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm)

A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm) - a Randomized Controlled Trial (COLDSNAP-2)

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
850 (estimated)
Sponsor
Technical University of Munich · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 19 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps \<5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen. In this randomized controlled trial, the investigators want to compare the complete resection rates of small and intermediate sized colorectal polyps 10-15 mm with CSP and HSP.

Conditions

Interventions

TypeNameDescription
PROCEDUREActive Comparator: Hot Snare PolypectomyHot Snare Polypectomy with the use of electrocautery for the resection of polyps.
PROCEDUREExperimental: Cold Snare PolypectomyCold Snare Polypectomy without the use of electrocautery for the resection of polyps.

Timeline

Start date
2024-11-05
Primary completion
2026-01-01
Completion
2026-03-01
First posted
2021-03-25
Last updated
2024-11-12

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT04816292. Inclusion in this directory is not an endorsement.