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JOURNAL ONKOLOGIE – STUDIE
COLDSNAP-1

Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm

Noch nicht rekrutierend

NCT-Nummer:
NCT04464837

Studienbeginn:
Juli 2020

Letztes Update:
09.07.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Adenoma, Polyps

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technische Universität München

Collaborator:
-

Studienlocations
(1 von 1)

2nd Medical Department, Klinikum rechts der Isar
81675 Munich
(Bayern)
Germany» Google-Maps

Studien-Informationen

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 - 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.
 

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Complete Resection Rate (R0-resection) (Time Frame - 6 month):
Complete resection rate of polyps resected by cold snare polypectomy



Secondary outcome:

1. Required additional attempts for complete resection during surgery (Time Frame - during surgery):
Where there more than one attempts for complete resection of the polyp during surgery?

2. Incidence of immediate and delayed bleeding. (Time Frame - 3 weeks):
Immediate bleeding: Bleeding >30 seconds after snaring. Delayed bleeding: Bleeding during the next 3 weeks.

3. Technical Impossibility of CSP during surgery (Time Frame - during surgery):
Necessity of changing to HSP, if CSP is technically not possible

Geprüfte Regime

  • Cold Snare Polypectomy of intermediate sized polyps (10-15 mm) (Olympus SnareMaster® Plus):
    If an eligible polyp (10-15mm) is found, cold snare polypectomy is performed with the Olympus SnareMaster® Plus Snare

Quelle: ClinicalTrials.gov


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