A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (5-15 mm)

Adenomatous Polyps Clinical Trial

— COLDSNAP-2  

Official title:

A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (5-15 mm) - A Randomized Controlled Trial (COLDSNAP-2)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04816292
• Other study ID #: 90/21 S-EB
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: March 2023

Study information

• Verified date: March 2021
• Source: Technische Universität München
• Contact: Christoph Schlag, MD
• Phone: +49894140
• Email: christoph.schlag[@]mri.tum.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 5-15 mm with CSP and HSP.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 850
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Indication for colonoscopy
• at least 1 adenomatous polyp 5-15 mm
• provided written informed consent

Exclusion Criteria:

• American Society of Anaesthesiologists class IV or higher
• florid inflammatory bowel disease
• emergency indication for colonoscopy
• haemorrhagic diathesis
• continued dual antiplatelet therapy
• continued anticoagulant therapy

Related Conditions & MeSH terms

• Adenomatous Polyps
• Polyps

Intervention

Procedure:
• Active Comparator: Hot Snare Polypectomy
Hot Snare Polypectomy with the use of electrocautery for the resection of polyps.
• Experimental: Cold Snare Polypectomy
Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete resection rate	The histological complete resection rate, determined by pathologically negative margins of the specimen and no residual adenomatous material obtained from two/four biopsies of the resection site.	6 months
Secondary	En-bloc resection rate	Number of additional resections (snare/forceps) needed.	During procedure
Secondary	Rate of immediate bleeding with necessity of haemostasis	Immediate bleeding: Bleeding >30 seconds after snaring.	During procedure
Secondary	Rate of impossible resection by CSP	An impossible resection by CSP needs electrocautery for successful resection.	During procedure
Secondary	Time required for resection	Time required for resection is the time between the insertion of the snare into working channel to the end of polyp resection. In the HSP group, it is defined as the start of submucosal injection until the end of polyp resection.	During procedure
Secondary	Rate of procedure-related adverse events.	Delayed bleeding, defined as haemorrhage after colonoscopy with the necessity of endoscopic haemostasis.	6 months