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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTechnical University of Munich

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Indication for colonoscopy

at least 1 adenomatous polyp 10-15 mm

provided written informed consent

Disqualifiers

American Society of Anaesthesiologists class IV or higher

florid inflammatory bowel disease

emergency indication for colonoscopy

haemorrhagic diathesis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active Comparator: Hot Snare Polypectomy

    Procedure/Surgery

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

  • Experimental: Cold Snare Polypectomy

    Procedure/Surgery

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

Treatment groups

850 Participants
are divided into 2 treatment groups
Group A: Hot Snare PolypectomyActive comparator 1 intervention
Group B: Cold Snare PolypectomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete resection rate

The histological complete resection rate, determined by pathologically negative margins of the specimen and no residual adenomatous material obtained from two/four biopsies of the resection site.

Time frame
6 months

Secondary outcomes

1

En-bloc resection rate

Number of additional resections (snare/forceps) needed.

Time frame
During procedure
2

Rate of immediate bleeding with necessity of haemostasis

Immediate bleeding: Bleeding \>30 seconds after snaring.

Time frame
During procedure
3

Rate of impossible resection by CSP

An impossible resection by CSP needs electrocautery for successful resection.

Time frame
During procedure
4

Time required for resection

Time required for resection is the time between the insertion of the snare into working channel to the end of polyp resection. In the HSP group, it is defined as the start of submucosal injection until the end of polyp resection.

Time frame
During procedure

Other outcomes

Sponsors and contacts

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