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
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Indication for colonoscopy

• at least 1 adenomatous polyp 10-15 mm

• provided written informed consent

Locations
Other Locations
Germany
Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technische Universität München
RECRUITING
München
Contact Information
Primary
Veit Phillip, MD
veit.phillip@mri.tum.de
+49894140
Backup
Joerg Ulrich, MD
joerg.ulrich@mri.tum.de
+49894140
Time Frame
Start Date: 2024-11-05
Estimated Completion Date: 2026-03
Participants
Target number of participants: 850
Treatments
Active_comparator: Hot Snare Polypectomy
If an eligible polyp 10-15 mm (as compared by the size of the snare) is found, according to the randomized group, HSP is performed for the removal of all eligible polyps in this patient. After polypectomy, the resection site is washed thoroughly with saline water. After the endoscopist carefully examines the resection site for residual adenomatous tissue, eventually another resection with the same method is indicated. Afterwards 4 biopsies (polyps 10-15mm) are performed from the resection margin to reveal presence or absence of residual neoplastic tissue.
Experimental: Cold Snare Polypectomy
If an eligible polyp 10-15 mm (as compared by the size of the snare) is found, according to the randomized group, CSP is performed for the removal of all eligible polyps in this patient. After polypectomy, the resection site is washed thoroughly with saline water. After the endoscopist carefully examines the resection site for residual adenomatous tissue, eventually another resection with the same method is indicated. Afterwards 4 biopsies (polyps 10-15mm) are performed from the resection margin to reveal presence or absence of residual neoplastic tissue.
Sponsors
Leads: Technical University of Munich

This content was sourced from clinicaltrials.gov