Colo-rectal CancerNCT04551001
Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy
A study testing Cold forcep polypectomy and Cold snare polypectomy in people with Colo-rectal Cancer and Polyp of Colon, run by Stanford University at 1 site in United States.
Trial summary
The focus of the study is to evaluate impact of cold forcep and cold snare in achieving complete resection during polypectomy of polyps <=3mm during colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyp of Colon
- What is being tested?
- Cold forcep polypectomy and Cold snare polypectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2020to 20 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years or older
- Polyps <=3mm
Who cannot join
- Pregnant
- Inflammatory bowel disease
- Polyposis syndromes
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Official title: Randomized Controlled Trial Investigating Cold Snare aNd Forcep polypectomY Among Small POLYPs in Rates of Complete Resection: the TINYPOLYP Trial.
The focus of the study is to evaluate impact of cold forcep and cold snare in achieving complete resection during polypectomy of polyps <=3mm during colonoscopy.
Read the detailed description
The details of the proposed study are as follows:
- Experimental group: using cold forceps for polyps <=3mm of the colon
- Control group: using cold snare for polyps <=3mm of the colon
- Methods:
- Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
- If polyps <=3mm are identified, the endoscopist is randomized to performing polypectomy with cold forcep or cold snare.
- After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
- The polyp as well as well as the two biopsies are reviewed by a pathologist.
- Being tested
- Cold forcep polypectomy, Cold snare polypectomy
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold forcep polypectomyProcedure or surgery
Removal of appropriate polyps using cold forceps until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.
Cold snare polypectomyProcedure or surgery
Removal of appropriate polyps using cold snare until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.
| Study group | Role | What they receive |
|---|---|---|
| Cold forcep | Experimental | Cold forcep polypectomy performed for polyps <=3mm. Receives: Procedure: Cold forcep polypectomy |
| Cold snare | Experimental | Cold forcep polypectomy performed for polyps <=3mm. Receives: Procedure: Cold snare polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness of resection
The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups.
Measured: 2 weeks
Secondary outcomes (3)
Time to resection
The time between the forceps or snare is introduced till the polyp is removed and retrieved will be compared.
Measured: During the procedure
Number of forcep bites or snare attempts
We will compare the number of bites or snare attempts needed to remove the tissue adequately to the endoscopist's judgment.
Measured: During the procedure
Complications
We will compare rates of complications including perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start16 Sep 2020
- Primary completion15 Oct 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shai Friedland, Stanford University
- Investigators
- Shai Friedland, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551001
- Sponsor's protocol ID
- 15766-1
- Status last verified
- May 2022
- First submitted
- 9 Sep 2020
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wei MT, Louie CY, Chen Y, Pan JY, Quan SY, Wong R, Brown R, Clark M, Jensen K, Lau H, Friedland S. Randomized Controlled Trial Investigating Cold Snare and Forceps Polypectomy Among Small POLYPs in Rates of Complete Resection: The TINYPOLYP Trial. Am J Gastroenterol. 2022 Aug 1;117(8):1305-1310. doi: 10.14309/ajg.0000000000001799. Epub 2022 Apr 25.
PubMed 35467557
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Investigating Cold Snare aNd Forcep polypectomY Among Small POLYPs in Rates of Complete Resection: the TINYPOLYP Trial.
- ClinicalTrials.gov ID
- NCT04551001
- Acronym / sponsor ID
- 15766-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 16 Sep 2020 (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.
The focus of the study is to evaluate impact of cold forcep and cold snare in achieving complete resection during polypectomy of polyps <=3mm during colonoscopy.
Detailed description
The details of the proposed study are as follows:
- Experimental group: using cold forceps for polyps <=3mm of the colon
- Control group: using cold snare for polyps <=3mm of the colon
- Methods:
- Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
- If polyps <=3mm are identified, the endoscopist is randomized to performing polypectomy with cold forcep or cold snare.
- After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
- The polyp as well as well as the two biopsies are reviewed by a pathologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold forcep | Experimental | Procedure: Cold forcep polypectomyCold forcep polypectomy performed for polyps <=3mm. |
| Cold snare | Experimental | Procedure: Cold snare polypectomyCold forcep polypectomy performed for polyps <=3mm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years or older
- Polyps <=3mm
Key exclusion criteria (3 listed)
- Pregnant
- Inflammatory bowel disease
- Polyposis syndromes
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 |
|---|---|---|
| Cold forcep polypectomyRemoval of appropriate polyps using cold forceps until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site. | Procedure or surgery | Cold forcep |
| Cold snare polypectomyRemoval of appropriate polyps using cold snare until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site. | Procedure or surgery | Cold snare |
Primary outcome
Completeness of resection
Time frame: 2 weeks
The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups.
3 secondary outcomes
Time to resection
Time frame: During the procedure
Number of forcep bites or snare attempts
Time frame: During the procedure
Complications
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 35467557Wei MT, Louie CY, Chen Y, Pan JY, Quan SY, Wong R, Brown R, Clark M, Jensen K, Lau H, Friedland S. Randomized Controlled Trial Investigating Cold Snare and Forceps Polypectomy Among Small POLYPs in Rates of Complete Resection: The TINYPOLYP Trial. Am J Gastroenterol. 2022 Aug 1;117(8):1305-1310. doi: 10.14309/ajg.0000000000001799. Epub 2022 Apr 25.
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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. This study is not recruiting at the moment.
Shai Friedland, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold forcep polypectomy and Cold snare polypectomy in people with Colo-rectal Cancer and Polyp of Colon, run by Stanford University at 1 site in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 17 May 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completeness of resection (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04551001, which also lists 1 linked publication.
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 17 May 2022.