An interventional study of Active Comparator: Hot Snare Polypectomy and Experimental: Cold Snare Polypectomy in Adenomatous Polyps, sponsored by Technical University of Munich. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Diagnostic
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.
66 studies on the registry are indexed under Adenomatous Polyps; 8 are open to participants now.
This study's planned enrollment of 850 is above the median of 216 across 47 interventional studies indexed under Adenomatous Polyps.
Browse Adenomatous Polyps studies →Technical University of Munich is the lead sponsor of 320 studies on the registry; 58 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
If an eligible polyp 10-15 mm (as compared by the size of the snare) is found, according to the randomized group, HSP is performed for the removal of all eligible polyps in this patient. After polypectomy, the resection site is washed thoroughly with saline water. After the endoscopist carefully examines the resection site for residual adenomatous tissue, eventually another resection with the same method is indicated. Afterwards 4 biopsies (polyps 10-15mm) are performed from the resection margin to reveal presence or absence of residual neoplastic tissue.
Procedure: Active Comparator: Hot Snare Polypectomy
If an eligible polyp 10-15 mm (as compared by the size of the snare) is found, according to the randomized group, CSP is performed for the removal of all eligible polyps in this patient. After polypectomy, the resection site is washed thoroughly with saline water. After the endoscopist carefully examines the resection site for residual adenomatous tissue, eventually another resection with the same method is indicated. Afterwards 4 biopsies (polyps 10-15mm) are performed from the resection margin to reveal presence or absence of residual neoplastic tissue.
Procedure: Experimental: Cold Snare Polypectomy
Hot Snare Polypectomy with the use of electrocautery for the resection of polyps.
Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.
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
En-bloc resection rate
Number of additional resections (snare/forceps) needed.
Time frame: During procedure
Rate of immediate bleeding with necessity of haemostasis
Immediate bleeding: Bleeding \>30 seconds after snaring.
Time frame: During procedure
Rate of impossible resection by CSP
An impossible resection by CSP needs electrocautery for successful resection.
Time frame: During procedure
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
Rate of procedure-related adverse events.
Delayed bleeding, defined as haemorrhage after colonoscopy with the necessity of endoscopic haemostasis.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Jan 2026, 13 months after the start.
Of 13 interventional studies with no phase under Adenomatous Polyps, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's planned 13 months is close to that.
How these figures are worked out, and which studies are left out of them.
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