Adenomatous PolypsCOLDSNAP-2NCT04816292
A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm)
A study testing Active Comparator: Hot Snare Polypectomy and Experimental: Cold Snare Polypectomy in people with Adenomatous Polyps, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenomatous Polyps
- What is being tested?
- Active Comparator: Hot Snare Polypectomy and Experimental: Cold Snare Polypectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteGermany
- Study dates
- 5 Nov 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for colonoscopy
- at least 1 adenomatous polyp 10-15 mm
- provided written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technische Universität München
München, Bavaria, 81675
Jörg Ulrich, MD, +498941408004, joerg.ulrich@mri.tum.de
Veit Phillip, MD, +498941409350, veit.phillip@mri.tum.de
About this study
Official 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)
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.
- Conditions
- Adenomatous Polyps
- Being tested
- Active Comparator: Hot Snare Polypectomy, Experimental: Cold Snare Polypectomy
- Medical subject headings
- Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Hot Snare PolypectomyProcedure or surgery
Hot Snare Polypectomy with the use of electrocautery for the resection of polyps.
Experimental: Cold Snare PolypectomyProcedure or surgery
Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.
| Study group | Role | What they receive |
|---|---|---|
| Hot Snare Polypectomy | Active comparator | 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. Receives: Procedure: Active Comparator: Hot Snare Polypectomy |
| Cold Snare Polypectomy | Experimental | 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. Receives: Procedure: Experimental: Cold Snare Polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
En-bloc resection rate
Number of additional resections (snare/forceps) needed.
Measured: During procedure
Rate of immediate bleeding with necessity of haemostasis
Immediate bleeding: Bleeding >30 seconds after snaring.
Measured: During procedure
Rate of impossible resection by CSP
An impossible resection by CSP needs electrocautery for successful resection.
Measured: 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.
Measured: During procedure
Rate of procedure-related adverse events.
Delayed bleeding, defined as haemorrhage after colonoscopy with the necessity of endoscopic haemostasis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start5 Nov 2024
- Primary completion1 Jan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomatous PolypsStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veit Phillip, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816292
- Sponsor's protocol ID
- 2021-90-S-P
- Acronym
- COLDSNAP-2
- Status last verified
- Nov 2024
- First submitted
- 23 Mar 2021
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04816292
- Acronym / sponsor ID
- COLDSNAP-2 / 2021-90-S-P
- Conditions
- Adenomatous Polyps
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot Snare Polypectomy | Active comparator | Procedure: Active Comparator: Hot Snare PolypectomyIf 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. |
| Cold Snare Polypectomy | Experimental | Procedure: Experimental: Cold Snare PolypectomyIf 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for colonoscopy
- at least 1 adenomatous polyp 10-15 mm
- provided written informed consent
Key exclusion criteria (6 listed)
- American Society of Anaesthesiologists class IV or higher
- florid inflammatory bowel disease
- emergency indication for colonoscopy
- haemorrhagic diathesis
- continued dual antiplatelet therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: Hot Snare PolypectomyHot Snare Polypectomy with the use of electrocautery for the resection of polyps. | Procedure or surgery | Hot Snare Polypectomy |
| Experimental: Cold Snare PolypectomyCold Snare Polypectomy without the use of electrocautery for the resection of polyps. | Procedure or surgery | Cold Snare Polypectomy |
Primary outcome
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.
5 secondary outcomes
En-bloc resection rate
Time frame: During procedure
Rate of immediate bleeding with necessity of haemostasis
Time frame: During procedure
Rate of impossible resection by CSP
Time frame: During procedure
Time required for resection
Time frame: During procedure
Rate of procedure-related adverse events.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Hot Snare Polypectomy and Experimental: Cold Snare Polypectomy in people with Adenomatous Polyps, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veit Phillip, MD (+49894140 ext. 9350, veit.phillip@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resection rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.