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NCT Number: NCT04816292

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

München, Bavaria, 81675, Germany

Location status: Recruiting

Location contact

Jörg Ulrich, MD

CONTACT

[email protected]

+498941408004

Jörg Ulrich, MD

CONTACT

Veit Phillip, MD

CONTACT

[email protected]

+498941409350

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Comparator: Hot Snare Polypectomy

Procedure

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

Experimental: Cold Snare Polypectomy

Procedure

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

Primary outcomes

  1. Complete resection rate

    Time frame: 6 months

    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.

Secondary outcomes

  1. En-bloc resection rate

    Time frame: During procedure

    Number of additional resections (snare/forceps) needed.

  2. Rate of immediate bleeding with necessity of haemostasis

    Time frame: During procedure

    Immediate bleeding: Bleeding >30 seconds after snaring.

  3. Rate of impossible resection by CSP

    Time frame: During procedure

    An impossible resection by CSP needs electrocautery for successful resection.

  4. Time required for resection

    Time frame: During procedure

    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.

  5. Rate of procedure-related adverse events.

    Time frame: 6 months

    Delayed bleeding, defined as haemorrhage after colonoscopy with the necessity of endoscopic haemostasis.

Study contacts

Contact information is provided by the study sponsor or research team.

Joerg Ulrich, MD

CONTACT

[email protected]

+49894140 ext. 8004

Veit Phillip, MD

CONTACT

[email protected]

+49894140 ext. 9350

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study 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)

Acronym: COLDSNAP-2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2021
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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