Clinical trial NCT04464837: Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm
Official title: Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm With a Newly Designed Polypectomy Snare - A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Polyp
Colorectal Adenoma
Keywords: coldsnare polypectomy
hotsnare polypectomy
intermediate sized polyps
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Proof-Of-Concept
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Complete Resection Rate (R0-resection)
timeFrame: 6 month
Secondary outcomes:
measure: Required additional attempts for complete resection during surgery
timeFrame: during surgery
measure: Incidence of immediate and delayed bleeding.
timeFrame: 3 weeks
measure: Technical Impossibility of CSP during surgery
timeFrame: during surgery
Other outcomes:
Locations:
city: Munich
country: Germany
facility: 2nd Medical Department, Klinikum rechts der Isar
Study officials:
References: