Clinical trial NCT04816292: A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm)
Official title: A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm) - a Randomized Controlled Trial (COLDSNAP-2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adenomatous Polyps
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 - 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 criteria: 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 outcomes:
measure: Complete resection rate
timeFrame: 6 months
Secondary outcomes:
measure: En-bloc resection rate
timeFrame: During procedure
measure: Rate of immediate bleeding with necessity of haemostasis
timeFrame: During procedure
measure: Rate of impossible resection by CSP
timeFrame: During procedure
measure: Time required for resection
timeFrame: During procedure
measure: Rate of procedure-related adverse events.
timeFrame: 6 months
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technische Universität München
state: Bavaria
Study officials:
References: