NCT04464837: COLDSNAP-1

Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm

Status unknown NA Last updated 9 July 2020

What this trial tests

NA trial testing Cold Snare Polypectomy of intermediate sized polyps (10-15 mm) in Colorectal Polyp in 35 participants. Status unknown.

Timeline

1 July 2020

Primary endpoint
1 January 2021

1 June 2021

Quick facts

Lead sponsor	Technical University of Munich
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	1 July 2020
Primary completion	1 January 2021
Estimated completion	1 June 2021
Sites	1 location across Germany

Drugs / interventions tested

• Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)

Conditions studied

• Colorectal Polyp — all drugs for Colorectal Polyp →
• Colorectal Adenoma — all drugs for Colorectal Adenoma →

Sponsor

Technical University of Munich

Who can join

Adults 18 to 80, any sex, with Colorectal Polyp or Colorectal Adenoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 - 20 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 feasibility trial, the investigators try to find out if CSP with a new designed polypectomy snare is efficient and safe in terms of complete resection (R0), pathological evaluation and adverse events.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and Safety of Cold Snare Polypectomy of Colorectal Polyps 10-15 mm with a Hybrid Snare: A Prospective Observational Pilot Study.
   Ulrich JD, Rechberger P, Bachmann J, Herner A, et al · · 2023 · cited 1× · PMID 37331350 · DOI 10.1159/000530642