Cold Snare ResectionNCT06658561
Efficacy and Safety Research of Cold Snare Polypectomy and Hot Snare Polypectomy in the Treatment of 4-9 mm Diameter Colorectal 0-Isp and 0-Ip Polyps: a Prospective, Multicenter, Randomized Controlled Study(FAST -REST Study)
A study testing cold snare polypectomy and hot snare polypectomy in people with Cold Snare Resection and Hot Snare Resection, run by Ruijin Hospital at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of cold snare polypectomy(CSP) and hot snare polypectomy(HSP) in the treatment of colorectal 4-9mm 0-Isp and 0-Ip polyps, and compare the complete resection rate, postoperative late bleeding rate, intraoperative bleeding rate, en bloc resection rate, operation time and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cold Snare Resection, Hot Snare Resection, Polyps of Colon
- What is being tested?
- cold snare polypectomy and hot snare polypectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 982 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to 1 Mar 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years old, male or female
- At least one polyp with size of 4-9 mm 0-Isp or 0-Ip is found during colonoscopy
- Voluntarily sign informed consent for endoscopic treatment
Who cannot join
- Boston Bowel Preparation Scale<6 points.
- Patients who receive antiplatelet/anticoagulant therapy within 5 days before polypectomy.
- Participants with a contraindication to colonoscopy and polypectomy.
- Patients with inflammatory bowel disease or gastrointestinal polyposis.
- Lesions with submucosal invasion and those suspected of being cancerous at the preprocedural diagnostic evaluation.
- Patients with pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Taojing Ran, MD, 8615601942397, rantaojing@163.com
About this study
This study will evaluate the efficacy and safety of cold snare polypectomy(CSP) and hot snare polypectomy(HSP) in the treatment of colorectal 4-9mm 0-Isp and 0-Ip polyps, and compare the complete resection rate, postoperative late bleeding rate, intraoperative bleeding rate, en bloc resection rate, operation time and the number of metal clips used. The conclusion of this study will help clinical doctor develop more effective resection strategies for colorectal 0-Isp and 0-Ip polyps, and provide more effective treatment for patients.
Read the detailed description
Colorectal polyps are one of the precancerous lesions of colorectal cancer, 60-80% of which eventually become advanced colorectal cancer. Therefore, early resection of colorectal polyps can effectively reduce the incidence of colorectal cancer. Polyps under white light are judged mainly according to the shape, size and color of polyps. At present, the Paris classification is often used to divide 0-I uplifted polyps into sessile polyps (0-Is), sessile-pedunculated polyps (0-Isp) and pedunculated polyps (0-Ip). It is generally believed that there are thick arteries in 0-Ip polyps, especially thick pedunculated polyps, which are prone to uncontrollable bleeding during operation. 0-Is polyps have small scattered blood vessels and low intraoperative bleeding risk, while the morphological and structural characteristics of 0-Isp polyps are between the two. The current guidelines recommend HSP for 0-Isp and 0-Ip polyps \<1 cm, but the internal blood vessels of these polyps are not thick. There is no guidance on whether they can be resected by CSP method, and there is a lack of prospective large sample clinical research. This study will include0-Isp /0-Ip polyps \<1cm, and observe the safety and effectiveness of CSP for the above polyp resection , so as to provide reference for the clinical treatment of colorectal polyps.
- Conditions
- Cold Snare Resection, Hot Snare Resection, Polyps of Colon
- Being tested
- cold snare polypectomy, hot snare polypectomy
- Keywords
- cold snare resection, hot snare resection, colorectal Polyps
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold snare polypectomyProcedure or surgery
Also called CSP
Place the special cold snare in the normal mucosa 1-2mm away from the polyp edge. Tighten the snare at a constant speed and gently lift it up and then excision.
hot snare polypectomyProcedure or surgery
Also called HSP
According to evaluation of the polyps, directly place the snare on the edge of the polyp including a clear margin of normal tissue (1-2 mm) or after submucosal injection. Tighten the snare at a constant speed and gently lift it up.Use the electrocoagulation and electroscission mode, power on for several seconds until the polyp is cut off.
| Study group | Role | What they receive |
|---|---|---|
| cold snare polypectomy group | Other | 1. Rotate the lens body to make the polyp at about 6 o'clock.
2. Place the special cold snare in the normal mucosa 1-2mm away from the polyp edge.
3. Tighten the snare at a constant speed and gently lift it up.
4. Excision.
5. According to the polyp size, use the colonoscope suction channel or directly use the snare to pull out the tissue for further pathological examination.
6. Piecemeal resection will be performed if the en-bloc resection fails. Receives: Procedure: cold snare polypectomy |
| hot snare polypectomy group | Other | 1. Rotate the lens body to make the polyp at about 6 o'clock.
2. According to evaluation of the polyps, directly place the snare on the edge of the polyp including a clear margin of normal tissue (1-2 mm) or after submucosal injection.
3. Tighten the snare at a constant speed and gently lift it up.
4. Use the electrocoagulation and electroscission mode, power on for several seconds until the polyp is cut off.
5. According to the polyp size, use the colonoscope suction channel or directly use the snare to pull out the tissue for further pathological examination.
6. Piecemeal resection will be performed if the en-bloc resection fails. Receives: Procedure: hot snare polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection rate
The polyps and the two biopsies from the margin will be sent to the pathologist for further analysis. Two independent experienced pathologists will evaluate the samples separately and both are blinded to the technique performed for polypectomy. Complete resection rate is defined as the negative pathological evaluation of two biopsies obtained from the margin.
Measured: Up to 5-7 days from operation day
Secondary outcomes (6)
Postoperative delayed bleeding rate
Incidence of bleeding requiring endoscopic hemostasis intervention within 14 days after surgery
Measured: Up to 14 days from operation day
Intraoperative bleeding rate
Immediate bleeding is defined as bleeding persists >60s after polypectomy according to the ESGE recommendations (2017) and requires for endoscopic intervention.
Measured: Up to 1 minute from the time the polyp is resected
En bloc resection rate
The lesion is removed at one time, and the integrity of the specimen is maintained
Measured: Up to 7 days when the pathologists finish the evaluations.
Operation time
CSP: the time from the time the snare exits the working channel to leaving the wound. Hsp: time from the injection needle leaving the working channel to leaving the wound
Measured: From the snare/ injection needle exits the working channel to leaving the wound.
Other related postoperative complications
Perforation, infection, electrocoagulation syndrome, etc
Measured: Up to 48 Hours from the time the polyp is resected
Number of metal clips used
Whether metal clips are used for hemostasis, and the number of metal clips
Measured: The time when the operation is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold Snare ResectionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 982 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jinshan Hospital Fudan University, Second Affiliated Hospital of Soochow University, The Third People's Hospital of Yunnan Province, People's Hospital Mojiang, Shanghai Yueyang Integrated Medicine Hospital, Huadong Hospital
- Responsible party
- Principal investigator, ZOU DUOWU, Ruijin Hospital
- Investigators
- Duowu Zou, PHD/MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658561
- Sponsor's protocol ID
- RuijinH20241532
- Status last verified
- Oct 2024
- First submitted
- 18 Jul 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Research of Cold Snare Polypectomy and Hot Snare Polypectomy in the Treatment of 4-9 mm Diameter Colorectal 0-Isp and 0-Ip Polyps: a Prospective, Multicenter, Randomized Controlled Study(FAST -REST Study)
- ClinicalTrials.gov ID
- NCT06658561
- Acronym / sponsor ID
- RuijinH20241532
- Conditions
- Cold Snare Resection, Hot Snare Resection, Polyps of Colon
- Keywords
- cold snare resection, hot snare resection, colorectal Polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 982 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Jinshan Hospital Fudan University, Second Affiliated Hospital of Soochow University, The Third People's Hospital of Yunnan Province, People's Hospital Mojiang, Shanghai Yueyang Integrated Medicine Hospital, Huadong Hospital
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 26 Oct 2024 (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.
This study will evaluate the efficacy and safety of cold snare polypectomy(CSP) and hot snare polypectomy(HSP) in the treatment of colorectal 4-9mm 0-Isp and 0-Ip polyps, and compare the complete resection rate, postoperative late bleeding rate, intraoperative bleeding rate, en bloc resection rate, operation time and the number of metal clips used. The conclusion of this study will help clinical doctor develop more effective resection strategies for colorectal 0-Isp and 0-Ip polyps, and provide more effective treatment for patients.
Detailed description
Colorectal polyps are one of the precancerous lesions of colorectal cancer, 60-80% of which eventually become advanced colorectal cancer. Therefore, early resection of colorectal polyps can effectively reduce the incidence of colorectal cancer. Polyps under white light are judged mainly according to the shape, size and color of polyps. At present, the Paris classification is often used to divide 0-I uplifted polyps into sessile polyps (0-Is), sessile-pedunculated polyps (0-Isp) and pedunculated polyps (0-Ip). It is generally believed that there are thick arteries in 0-Ip polyps, especially thick pedunculated polyps, which are prone to uncontrollable bleeding during operation. 0-Is polyps have small scattered blood vessels and low intraoperative bleeding risk, while the morphological and structural characteristics of 0-Isp polyps are between the two. The current guidelines recommend HSP for 0-Isp and 0-Ip polyps \<1 cm, but the internal blood vessels of these polyps are not thick. There is no guidance on whether they can be resected by CSP method, and there is a lack of prospective large sample clinical research. This study will include0-Isp /0-Ip polyps \<1cm, and observe the safety and effectiveness of CSP for the above polyp resection , so as to provide reference for the clinical treatment of colorectal polyps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold snare polypectomy group | Other | Procedure: cold snare polypectomy1. Rotate the lens body to make the polyp at about 6 o'clock. 2. Place the special cold snare in the normal mucosa 1-2mm away from the polyp edge. 3. Tighten the snare at a constant speed and gently lift it up. 4. Excision. 5. According to the polyp size, use the colonoscope suction channel or directly use the snare to pull out the tissue for further pathological examination. 6. Piecemeal resection will be performed if the en-bloc resection fails. |
| hot snare polypectomy group | Other | Procedure: hot snare polypectomy1. Rotate the lens body to make the polyp at about 6 o'clock. 2. According to evaluation of the polyps, directly place the snare on the edge of the polyp including a clear margin of normal tissue (1-2 mm) or after submucosal injection. 3. Tighten the snare at a constant speed and gently lift it up. 4. Use the electrocoagulation and electroscission mode, power on for several seconds until the polyp is cut off. 5. According to the polyp size, use the colonoscope suction channel or directly use the snare to pull out the tissue for further pathological examination. 6. Piecemeal resection will be performed if the en-bloc resection fails. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18-80 years old, male or female
- At least one polyp with size of 4-9 mm 0-Isp or 0-Ip is found during colonoscopy
- Voluntarily sign informed consent for endoscopic treatment
Key exclusion criteria (6 listed)
- Boston Bowel Preparation Scale<6 points.
- Patients who receive antiplatelet/anticoagulant therapy within 5 days before polypectomy.
- Participants with a contraindication to colonoscopy and polypectomy.
- Patients with inflammatory bowel disease or gastrointestinal polyposis.
- Lesions with submucosal invasion and those suspected of being cancerous at the preprocedural diagnostic evaluation.
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 snare polypectomyAlso: CSPPlace the special cold snare in the normal mucosa 1-2mm away from the polyp edge. Tighten the snare at a constant speed and gently lift it up and then excision. | Procedure or surgery | cold snare polypectomy group |
| hot snare polypectomyAlso: HSPAccording to evaluation of the polyps, directly place the snare on the edge of the polyp including a clear margin of normal tissue (1-2 mm) or after submucosal injection. Tighten the snare at a constant speed and gently lift it up.Use the electrocoagulation and electroscission mode, power on for several seconds until the polyp is cut off. | Procedure or surgery | hot snare polypectomy group |
Primary outcome
Complete resection rate
Time frame: Up to 5-7 days from operation day
The polyps and the two biopsies from the margin will be sent to the pathologist for further analysis. Two independent experienced pathologists will evaluate the samples separately and both are blinded to the technique performed for polypectomy. Complete resection rate is defined as the negative pathological evaluation of two biopsies obtained from the margin.
6 secondary outcomes
Postoperative delayed bleeding rate
Time frame: Up to 14 days from operation day
Intraoperative bleeding rate
Time frame: Up to 1 minute from the time the polyp is resected
En bloc resection rate
Time frame: Up to 7 days when the pathologists finish the evaluations.
Operation time
Time frame: From the snare/ injection needle exits the working channel to leaving the wound.
Other related postoperative complications
Time frame: Up to 48 Hours from the time the polyp is resected
Number of metal clips used
Time frame: The time when the operation is completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Cold Snare Resection
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Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
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Cold Versus Hot Snare Endoscopic Mucosal Resection for Intermediate-Size Flat Nonpedunculated Colorectal Polyps
Colorectal Polyps, Endoscopic Mucosal Resection
Active, not recruiting
Injured Submucosal Arteries After CSP for 10-19 mm Nonpedunculated Colorectal Polyps.
Colonic Polyp
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Comparison of Cold and Hot Loop Resection Techniques for the Removal of Medium-sized Benign Colon Tumors
Benign Colon Tumors
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Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps
Colorectal Polyps
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.
Duowu Zou, PHD/MD principal investigator
Ruijin Hospital
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 snare polypectomy and hot snare polypectomy in people with Cold Snare Resection and Hot Snare Resection, run by Ruijin Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 26 Oct 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taojing Ran, MD (8615601942397, rantaojing@163.com), 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: Up to 5-7 days from operation day). 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 26 Oct 2024.