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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04464837
Other study ID # COLDSNAP-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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