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Clinical Trials in Germany / NCT04816292
Recruiting Not applicable

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

NCT04816292 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-11-05
Last updated
2024-11-12

Condition(s) studied

Adenomatous Polyps

Investigational drug(s) / intervention(s)

Active Comparator: Hot Snare PolypectomyExperimental: Cold Snare Polypectomy

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Indication for colonoscopy * at least 1 adenomatous polyp 10-15 mm * provided written informed consent Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

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

More Technical University of Munich trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04816292 on ClinicalTrials.gov ↗ ← All trials in Germany