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

Colorectal Adenoma Clinical Trial

— COLDSNAP-1  

Official title:

Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm With a Newly Designed Polypectomy Snare - A Feasibility Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04464837
• Other study ID #: COLDSNAP-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2020
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: June 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Polyp
• Polyps

Intervention

Device:
• Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)
If an eligible polyp (10-15mm) is found, cold snare polypectomy is performed with the Olympus SnareMaster® Plus Snare

Locations

Country	Name	City	State
Germany	2nd Medical Department, Klinikum rechts der Isar	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Resection Rate (R0-resection)	Complete resection rate of polyps resected by cold snare polypectomy	6 month
Secondary	Required additional attempts for complete resection during surgery	Where there more than one attempts for complete resection of the polyp during surgery?	during surgery
Secondary	Incidence of immediate and delayed bleeding.	Immediate bleeding: Bleeding >30 seconds after snaring. Delayed bleeding: Bleeding during the next 3 weeks.	3 weeks
Secondary	Technical Impossibility of CSP during surgery	Necessity of changing to HSP, if CSP is technically not possible	during surgery