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

NCT ID: NCT04816292

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 850 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2026-03-31

Brief 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

Adenomatous Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Active Comparator: Hot Snare Polypectomy

Intervention Type: PROCEDURE

Hot Snare Polypectomy with the use of electrocautery for the resection of polyps.

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.

Group Type: EXPERIMENTAL

Experimental: Cold Snare Polypectomy

Intervention Type: PROCEDURE

Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.

Interventions

Active Comparator: Hot Snare Polypectomy

Hot Snare Polypectomy with the use of electrocautery for the resection of polyps.

Intervention Type: PROCEDURE

Experimental: Cold Snare Polypectomy

Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Indication for colonoscopy
• at least 1 adenomatous polyp 10-15 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Veit Phillip

Departement for Interdisciplinary Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technische Universität München

München, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Veit Phillip, MD

Role: CONTACT

veit.phillip@mri.tum.de

+49894140 ext. 9350

Joerg Ulrich, MD

Role: CONTACT

joerg.ulrich@mri.tum.de

+49894140 ext. 8004

Facility Contacts

Jörg Ulrich, MD

Role: primary

joerg.ulrich@mri.tum.de

+498941408004

Veit Phillip, MD

Role: backup

veit.phillip@mri.tum.de

+498941409350

Jörg Ulrich, MD

Role: backup

Other Identifiers

2021-90-S-P

Identifier Type: -

Identifier Source: org_study_id