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

Not Applicable

• Conditions: Colorectal Adenoma; Colorectal Polyp

• Registration Number: NCT04464837
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-11
• Status Verified: 2020-07
• Study Start: 2020-07-01
• Study First Submitted QC: 2020-07-06
• Last Update Submitted: 2020-07-06
• Study First Posted: 2020-07-09
• Last Update Posted: 2020-07-09
• Primary Completion: 2021-01-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complete Resection Rate (R0-resection)	6 month	Complete resection rate of polyps resected by cold snare polypectomy

Secondary Outcome Measures

Name	Time	Method
Required additional attempts for complete resection during surgery	during surgery	Where there more than one attempts for complete resection of the polyp during surgery?
Incidence of immediate and delayed bleeding.	3 weeks	Immediate bleeding: Bleeding \>30 seconds after snaring. Delayed bleeding: Bleeding during the next 3 weeks.
Technical Impossibility of CSP during surgery	during surgery	Necessity of changing to HSP, if CSP is technically not possible

Trial Locations

Locations (1)

2nd Medical Department, Klinikum rechts der Isar; 🇩🇪 Munich, Germany