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

NCT04816292 | Recruiting

• 1 other identifier: 2021-90-S-P
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• En-bloc resection rate

  During procedure

• Rate of immediate bleeding with necessity of haemostasis

  During procedure

• Rate of impossible resection by CSP

  During procedure

• Time required for resection

  During procedure

• Rate of procedure-related adverse events.

  6 months

Study Arms (2)

Hot Snare Polypectomy

ACTIVE COMPARATOR

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.

Procedure: Active Comparator: Hot Snare Polypectomy

Cold Snare Polypectomy

EXPERIMENTAL

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.

Procedure: Experimental: Cold Snare Polypectomy

Interventions

Active Comparator: Hot Snare Polypectomy PROCEDURE

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

Hot Snare Polypectomy

Experimental: Cold Snare Polypectomy PROCEDURE

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

Cold Snare Polypectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for colonoscopy
• at least 1 adenomatous polyp 10-15 mm
• provided written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

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

München, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Adenomatous Polyps

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Veit Phillip, MD

CONTACT

+49894140; veit.phillip@mri.tum.de

Joerg Ulrich, MD

CONTACT

+49894140; joerg.ulrich@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Departement for Interdisciplinary Endoscopy

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: November 5, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)