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

NCT04464837 | Unknown

• 1 other identifier: COLDSNAP-1
• Study Type: interventional
• Target: 35
• 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 - 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.

Conditions

Colorectal Polyp; Colorectal Adenoma

Keywords

coldsnare polypectomy; hotsnare polypectomy; intermediate sized polyps

Outcome Measures

Primary Outcomes (1)

• Complete Resection Rate (R0-resection)

  Complete resection rate of polyps resected by cold snare polypectomy

  6 month

Secondary Outcomes (3)

• Required additional attempts for complete resection during surgery

  during surgery

• Incidence of immediate and delayed bleeding.

  3 weeks

• Technical Impossibility of CSP during surgery

  during surgery

Interventions

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

If an eligible polyp (10-15mm) is found, cold snare polypectomy is performed with the Olympus SnareMaster® Plus Snare

Also known as: Olympus SnareMaster® Plus

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
• signed informed consent
• at least one polyp of the size 10-15mm
• American Society of Anesthesiologists-classification (ASA) I-III

You may not qualify if:

• American Society of Anesthesiologists-classification (ASA) IV-VI
• Inflammatory bowel disease (IBD)
• known/suspected invasive colorectal cancer
• contraindications for polypectomy
• emergency indication for colonoscopy

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

2nd Medical Department, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (1)

• Ulrich JD, Rechberger P, Bachmann J, Herner A, V Figura G, Lahmer T, Phillip V, Mayr U, Haller B, Jesinghaus M, Schmid RM, Abdelhafez M, Schlag C. Efficacy and Safety of Cold Snare Polypectomy of Colorectal Polyps 10-15 mm with a Hybrid Snare: A Prospective Observational Pilot Study. Digestion. 2023;104(5):391-399. doi: 10.1159/000530642. Epub 2023 Jun 16.

  PMID: 37331350 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Proof-Of-Concept

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: July 9, 2020
• Study Start: July 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)