Adenomatous Polyps
Conditions
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.
Interventions
PROCEDUREActive Comparator: Hot Snare Polypectomy
Hot Snare Polypectomy with the use of electrocautery for the resection of polyps.
PROCEDUREExperimental: Cold Snare Polypectomy
Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete resection rate | 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
| Measure | Time frame | Description |
|---|---|---|
| En-bloc resection rate | During procedure | Number of additional resections (snare/forceps) needed. |
| Rate of immediate bleeding with necessity of haemostasis | During procedure | Immediate bleeding: Bleeding \>30 seconds after snaring. |
| Rate of impossible resection by CSP | During procedure | An impossible resection by CSP needs electrocautery for successful resection. |
| Time required for resection | 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. |
| Rate of procedure-related adverse events. | 6 months | Delayed bleeding, defined as haemorrhage after colonoscopy with the necessity of endoscopic haemostasis. |
Countries
Germany
Contacts
Primary ContactVeit Phillip, MD
Backup ContactJoerg Ulrich, MD
Outcome results
None listed