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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adenomatous Polyps
• Intervention / Treatment: Procedure: Active Comparator: Hot Snare Polypectomy; Procedure: Experimental: Cold Snare Polypectomy

• Study Type: Interventional
• Enrollment (Anticipated): 850
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christoph Schlag, MD; Phone Number: 4781 +49894140; Email: christoph.schlag@mri.tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hot Snare Polypectomy; If an eligible polyp 5-15 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 2 biopsies (polyps 5-9mm) or 4 biopsies (polyps 10-15mm) are performed from the resection margin to reveal presence or absence of residual neoplastic tissue.	Procedure: Active Comparator: Hot Snare Polypectomy; Hot Snare Polypectomy with the use of electrocautery for the resection of polyps.
Experimental: Cold Snare Polypectomy; If an eligible polyp 5-15 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 2 biopsies (polyps 5-9mm) or 4 biopsies (polyps 10-15mm) are performed from the resection margin to reveal presence or absence of residual neoplastic tissue.	Procedure: Experimental: Cold Snare Polypectomy; Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
En-bloc resection rate	Number of additional resections (snare/forceps) needed.	During procedure
Rate of immediate bleeding with necessity of haemostasis	Immediate bleeding: Bleeding >30 seconds after snaring.	During procedure
Rate of impossible resection by CSP	An impossible resection by CSP needs electrocautery for successful resection.	During procedure
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
Rate of procedure-related adverse events.	Delayed bleeding, defined as haemorrhage after colonoscopy with the necessity of endoscopic haemostasis.	6 months

Collaborators and Investigators

• Sponsor: Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Adenoma; Polyps; Adenomatous Polyps
• Other Study ID Numbers: 90/21 S-EB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No