Colorectal PolypsNCT07764224
Cold Versus Hot Snare Endoscopic Mucosal Resection for Intermediate-Size Flat Nonpedunculated Colorectal Polyps
A study testing Cold snare endoscopic mucosal resection (CS-EMR) and Hot snare endoscopic mucosal resection (HS-EMR) in people with Colorectal Polyps and Endoscopic Mucosal Resection, run by Nanfang Hospital, Southern Medical University.
Trial summary
This multicenter, prospective, randomized, non-inferiority trial aimed to compare the efficacy and safety of cold snare endoscopic mucosal resection (CS-EMR) and hot snare endoscopic mucosal resection (HS-EMR) for resection of intermediate-size (10-20 mm) flat nonpedunculated colorectal polyps. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Polyps, Endoscopic Mucosal Resection
- What is being tested?
- Cold snare endoscopic mucosal resection (CS-EMR) and Hot snare endoscopic mucosal resection (HS-EMR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 968 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Feb 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18-75 years, irrespective of gender;
- Flat sessile colorectal polyps confirmed by colonoscopy, classified as Paris classification 0-Is or 0-IIa, with a measured diameter ranging from 10 to 20 mm;
- Subjects voluntarily agree to receive endoscopic treatment and sign written informed consent.
Who cannot join
- Colonoscopic findings suggestive of submucosal invasion or malignant transformation of colorectal polyps;
- Previous history of colorectal surgery;
- Previous history of inflammatory bowel disease, familial adenomatous polyposis, or colorectal cancer;
- Failure to discontinue anticoagulant and antiplatelet medications for a minimum of 1 week prior to the procedure;
- Known coagulation disorders or bleeding diathesis;
- Pregnant or breastfeeding women;
- Patients complicated with malignant tumors, severe cardiovascular and cerebrovascular diseases, liver cirrhosis, chronic kidney disease, or other severe comorbidities that preclude tolerance to endoscopic resection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cold Versus Hot Snare Endoscopic Mucosal Resection for Intermediate-Size Flat Nonpedunculated Colorectal Polyps: A Multicenter, Prospective, Randomized, Non-Inferiority Clinical Trial
This multicenter, prospective, randomized, non-inferiority trial aimed to compare the efficacy and safety of cold snare endoscopic mucosal resection (CS-EMR) and hot snare endoscopic mucosal resection (HS-EMR) for resection of intermediate-size (10-20 mm) flat nonpedunculated colorectal polyps.
- Conditions
- Colorectal Polyps, Endoscopic Mucosal Resection
- Being tested
- Cold snare endoscopic mucosal resection (CS-EMR), Hot snare endoscopic mucosal resection (HS-EMR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold snare endoscopic mucosal resection (CS-EMR)Procedure or surgery
During CS-EMR, methylene blue-stained epinephrine saline is injected into the submucosa surrounding the lesion to achieve submucosal lifting. The polyp together with 1-2 mm of adjacent mucosa is subsequently tightly snared and mechanically transected.
Hot snare endoscopic mucosal resection (HS-EMR)Procedure or surgery
During HS-EMR, methylene blue-stained epinephrine saline is injected into the submucosa surrounding the lesion to achieve submucosal lifting. The snare is positioned around the lesion, and electrocautery is delivered via the electrosurgical generator for transection.
| Study group | Role | What they receive |
|---|---|---|
| Cold snare endoscopic mucosal resection (CS-EMR) | Experimental | Eligible colorectal polyps measuring 10-20 mm will be resected using CS-EMR. Receives: Procedure: Cold snare endoscopic mucosal resection (CS-EMR) |
| Hot snare endoscopic mucosal resection (HS-EMR) | Active comparator | Eligible colorectal polyps measuring 10-20 mm will be resected using HS-EMR. Receives: Procedure: Hot snare endoscopic mucosal resection (HS-EMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete resection rate
All five biopsy specimens harvested from the resection margins after EMR resection yielded negative pathological findings. These five biopsy samples consisted of four specimens collected from the four quadrants of the resection wound margin and one specimen obtained from the wound base.
Measured: Within 14 days
Secondary outcomes (8)
en bloc resection rate
The lesion was completely excised under endoscope and a single specimen was obtained.
Measured: Within one days
Unresectable rate of CS-EMR
A resection procedure that needed high-frequency electric current.
Measured: Within one day
Intraprocedural bleeding
Intraoperative arterial bleeding or active mucosal oozing lasting more than 30 seconds that requires endoscopic hemostatic intervention.
Measured: Within one day
Intraprocedural perforation
Endoscopic observation of perforation requiring sealing with clips
Measured: Within one day
Procedural time
The duration from the first occurrence of injection needle under endoscope visual field to complete removal of the resected polyp
Measured: Within one day
Delayed bleeding
haemorrhage after colonoscopy requiring endoscopic haemostasis with 14 days.
Measured: Within 14 days
Delayed perforation
Any perforation within 14 days
Measured: Within 14 days
Number of clips used
The number of clips used for each resected polyp
Measured: Within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- 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
- 968 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shunde First People's Hospital of Foshan, Jiangmen Central Hospital, ZhuHai Hospital, Longgang District People's Hospital of Shenzhen, Yangjiang People's Hospital, The Third People's Hospital of Huizhou, Longnan Traditional Chinese Medicine Hospital, Sihui Wanlong Hospital, Suixi People's Hospital of Zhanjiang, Guzhen People's Hospital of Zhongshan, Anyuan County People's Hospital of Ganzhou, Shaoguan First People's Hospital, Yangchun People's Hospital, ZhuZhou Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764224
- Sponsor's protocol ID
- NFEC-2026-545
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Versus Hot Snare Endoscopic Mucosal Resection for Intermediate-Size Flat Nonpedunculated Colorectal Polyps: A Multicenter, Prospective, Randomized, Non-Inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT07764224
- Acronym / sponsor ID
- NFEC-2026-545
- Conditions
- Colorectal Polyps, Endoscopic Mucosal Resection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 968 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Shunde First People's Hospital of Foshan, Jiangmen Central Hospital, ZhuHai Hospital, Longgang District People's Hospital of Shenzhen, Yangjiang People's Hospital, The Third People's Hospital of Huizhou, Longnan Traditional Chinese Medicine Hospital, Sihui Wanlong Hospital, Suixi People's Hospital of Zhanjiang, Guzhen People's Hospital of Zhongshan, Anyuan County People's Hospital of Ganzhou, Shaoguan First People's Hospital, Yangchun People's Hospital, ZhuZhou Central Hospital
- Study start
- Aug 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 13 Aug 2026 (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 multicenter, prospective, randomized, non-inferiority trial aimed to compare the efficacy and safety of cold snare endoscopic mucosal resection (CS-EMR) and hot snare endoscopic mucosal resection (HS-EMR) for resection of intermediate-size (10-20 mm) flat nonpedunculated 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 endoscopic mucosal resection (CS-EMR) | Experimental | Procedure: Cold snare endoscopic mucosal resection (CS-EMR)Eligible colorectal polyps measuring 10-20 mm will be resected using CS-EMR. |
| Hot snare endoscopic mucosal resection (HS-EMR) | Active comparator | Procedure: Hot snare endoscopic mucosal resection (HS-EMR)Eligible colorectal polyps measuring 10-20 mm will be resected using HS-EMR. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged 18-75 years, irrespective of gender;
- Flat sessile colorectal polyps confirmed by colonoscopy, classified as Paris classification 0-Is or 0-IIa, with a measured diameter ranging from 10 to 20 mm;
- Subjects voluntarily agree to receive endoscopic treatment and sign written informed consent.
Key exclusion criteria (7 listed)
- Colonoscopic findings suggestive of submucosal invasion or malignant transformation of colorectal polyps;
- Previous history of colorectal surgery;
- Previous history of inflammatory bowel disease, familial adenomatous polyposis, or colorectal cancer;
- Failure to discontinue anticoagulant and antiplatelet medications for a minimum of 1 week prior to the procedure;
- Known coagulation disorders or bleeding diathesis;
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 endoscopic mucosal resection (CS-EMR)During CS-EMR, methylene blue-stained epinephrine saline is injected into the submucosa surrounding the lesion to achieve submucosal lifting. The polyp together with 1-2 mm of adjacent mucosa is subsequently tightly snared and mechanically transected. | Procedure or surgery | Cold snare endoscopic mucosal resection (CS-EMR) |
| Hot snare endoscopic mucosal resection (HS-EMR)During HS-EMR, methylene blue-stained epinephrine saline is injected into the submucosa surrounding the lesion to achieve submucosal lifting. The snare is positioned around the lesion, and electrocautery is delivered via the electrosurgical generator for transection. | Procedure or surgery | Hot snare endoscopic mucosal resection (HS-EMR) |
Primary outcome
complete resection rate
Time frame: Within 14 days
All five biopsy specimens harvested from the resection margins after EMR resection yielded negative pathological findings. These five biopsy samples consisted of four specimens collected from the four quadrants of the resection wound margin and one specimen obtained from the wound base.
8 secondary outcomes
en bloc resection rate
Time frame: Within one days
Unresectable rate of CS-EMR
Time frame: Within one day
Intraprocedural bleeding
Time frame: Within one day
Intraprocedural perforation
Time frame: Within one day
Procedural time
Time frame: Within one day
Delayed bleeding
Time frame: Within 14 days
Delayed perforation
Time frame: Within 14 days
Number of clips used
Time frame: Within one day
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 13 Aug 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Cold snare endoscopic mucosal resection (CS-EMR) and Hot snare endoscopic mucosal resection (HS-EMR) in people with Colorectal Polyps and Endoscopic Mucosal Resection, run by Nanfang Hospital, Southern Medical University.
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 7 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: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Zelong Han, MD (+86 189-2506-1960, hanzelong2025@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: Within 14 days). 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 13 Aug 2026.