Colorectal PolypNCT05545787
Cold or Hot Snare Endoscopic Mucosal Resection for 10-19mm Non-pedunculated Colorectal Polyps
A study testing Cold snare endoscopic mucosal resection and Hot snare endoscopic mucosal resection in people with Colorectal Polyp, run by Qingwei Jiang at 15 sites in China.
Trial summary
This is a prospective, randomized, open-label, non-inferiority, multiple-center trial. Outpatients who are scheduled to undergo colonoscopy and found eligible polyps will be randomized to receive either cold snare endoscopic mucosal resection (CS-EMR) or hot snare endoscopic mucosal resection (HS-EMR). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Polyp
- What is being tested?
- Cold snare endoscopic mucosal resection and Hot snare endoscopic mucosal resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 15 sitesChina
- Study dates
- 14 Oct 2022to 15 Apr 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
- 18-80 years of age;
- undergo colonoscopy in the Digestive Endoscopy Center of Peking Union Medical College Hospital, Beijing Tsinghua Changgung Hospital or Seventh Medical Center, General Hospital of the Chinese People's Liberation Army;
- volunteer to participate in this study and sign informed consent;
- at least one polyp sized 10-19 mm (Paris classification Is or IIa) by colonoscopy.
Who cannot join
- American Society of Anesthesiologists (ASA) status class 3 or above;
- poor bowel preparation (Boston bowel preparation scale < 6 points);
- known or endoscopic features indicating the submucous infiltration or malignancy;
- oral anti-coagulants, or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency (platelets<50000 cells/mm3 or INR>1.5);
- a history of colorectal resection;
- emergency colonoscopy (hemodynamic instability and/or continued active gastrointestinal bleeding and/or requiring intensive care patients);
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- inflammatory bowel disease, familial polyposis, and colorectal cancer;
- pregnancy or lactation;
- severe cardiopulmonary dysfunction, liver cirrhosis, chronic kidney disease, other malignant tumors, or severe infectious diseases.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Beijing Dongcheng District First People's Hospital
Beijing, Beijing Municipality, 100010
Emergency General Hospital
Beijing, Beijing Municipality, 100028
Beijing Sixth Hospital
Beijing, Beijing Municipality, 100191
Seventh Medical Center, General Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality, 100700
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Beijing Fangshan District Liangxiang Hospital
Beijing, Beijing Municipality, 102401
Beijing Daxing District People's Hospital
Beijing, Beijing Municipality, 102600
West China Longquan Hospital, Sichuan University
Chengdu, Sichuan, 610041
PLA Western Theater General Hospital
Chengdu, Sichuan, 610083
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266005
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
About this study
Official title: A Prospective, Randomized, Non-inferiority Study to Compare Efficacy and Safety of Cold Snare Endoscopic Mucosal Resection and Hot Snare Endoscopic Mucosal Resection in Treatment for 10-19 mm Non-pedunculated Colorectal Polyps
This is a prospective, randomized, open-label, non-inferiority, multiple-center trial. Outpatients who are scheduled to undergo colonoscopy and found eligible polyps will be randomized to receive either cold snare endoscopic mucosal resection (CS-EMR) or hot snare endoscopic mucosal resection (HS-EMR). This study aims to compare the efficacy and safety of CS-EMR or HS-EMR for the resection of non-pedunculated colorectal polyps sized 10-19mm.
- Conditions
- Colorectal Polyp
- Being tested
- Cold snare endoscopic mucosal resection, Hot snare endoscopic mucosal resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold snare endoscopic mucosal resectionProcedure or surgery
During CS-EMR, methylene blue-tinted epinephrine saline will be injected into the submucosal space around the lesion to lift the lesion. The polyp and 1-2mm of surrounding mucosa will then be closely snared and transected mechanically.
Hot snare endoscopic mucosal resectionProcedure or surgery
During HS-EMR, methylene blue-tinted epinephrine saline will be injected into the submucosal space around the lesion to lift the lesion. The snare will be placed around the lesion, and then cautery will be applied using the electrosurgical generator.
| Study group | Role | What they receive |
|---|---|---|
| Cold snare endoscopic mucosal resection (CS-EMR) | Experimental | Eligible colorectal polyps sized 10-19mm will be resected by CS-EMR Receives: Procedure: Cold snare endoscopic mucosal resection |
| Hot snare endoscopic mucosal resection (HS-EMR) | Experimental | Eligible colorectal polyps sized 10-19mm will be resected by HS-EMR Receives: Procedure: Hot snare endoscopic mucosal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection rate
The resection is considered histologically complete if the lateral margins of the resected polyps are surrounded by normal tissue and the vertical margin is free of neoplasia tissue. If en-bloc resection is not achieved, 5 biopsies (4 biopsies obtained in a 4-quadrant fashion from the polypectomy site margins; 1 biopsy from the base) are applied to evaluate histological completeness of resection.
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 1 day
Intraprocedural bleeding
Any immediate episode requiring any form of endoscopic hemostasis or oozing for more than 60s
Measured: Within 1 day
Intraprocedural perforation
Endoscopic observation of perforation requiring sealing with clips
Measured: Within 1 day
Delayed bleeding
Any episode requiring emergency department presentation, hospitalization, or reintervention within 14 days
Measured: Within 14 days
Delayed perforation
Any perforation within 14 days
Measured: Within 14 days
Number of clips used
The number of endoscopic clips used for each resected polyp
Measured: Within 1 day
Resection time
The duration from the first occurrence of injection needle under endoscope visual field to complete removal of the resected polyp
Measured: Within 1 day
Total cost
Total cost including both treatment cost and material cost for polyp resection
Measured: Within 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start14 Oct 2022
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
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 Colorectal PolypStudies 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
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingwei Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qingwei Jiang, Peking Union Medical College Hospital
- Investigators
- Qingwei Jiang, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545787
- Sponsor's protocol ID
- K2203
- Status last verified
- Apr 2026
- First submitted
- 15 Sep 2022
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang Q, Yan X, Wang D, Zhang S, Zhang Y, Feng Y, Yang A, Wu D. Endoscopic mucosal resection using cold snare versus hot snare in treatment for 10-19 mm non-pedunculated colorectal polyps: protocol of a non-inferiority randomised controlled study. BMJ Open. 2023 May 22;13(5):e070321. doi: 10.1136/bmjopen-2022-070321.
PubMed 37217262
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Non-inferiority Study to Compare Efficacy and Safety of Cold Snare Endoscopic Mucosal Resection and Hot Snare Endoscopic Mucosal Resection in Treatment for 10-19 mm Non-pedunculated Colorectal Polyps
- ClinicalTrials.gov ID
- NCT05545787
- Acronym / sponsor ID
- K2203
- Conditions
- Colorectal Polyp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Qingwei JiangUniversity, hospital or other
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 19 Sep 2022 (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 is a prospective, randomized, open-label, non-inferiority, multiple-center trial. Outpatients who are scheduled to undergo colonoscopy and found eligible polyps will be randomized to receive either cold snare endoscopic mucosal resection (CS-EMR) or hot snare endoscopic mucosal resection (HS-EMR). This study aims to compare the efficacy and safety of CS-EMR or HS-EMR for the resection of non-pedunculated colorectal polyps sized 10-19mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold snare endoscopic mucosal resection (CS-EMR) | Experimental | Procedure: Cold snare endoscopic mucosal resectionEligible colorectal polyps sized 10-19mm will be resected by CS-EMR |
| Hot snare endoscopic mucosal resection (HS-EMR) | Experimental | Procedure: Hot snare endoscopic mucosal resectionEligible colorectal polyps sized 10-19mm will be resected by HS-EMR |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-80 years of age;
- undergo colonoscopy in the Digestive Endoscopy Center of Peking Union Medical College Hospital, Beijing Tsinghua Changgung Hospital or Seventh Medical Center, General Hospital of the Chinese People's Liberation Army;
- volunteer to participate in this study and sign informed consent;
- at least one polyp sized 10-19 mm (Paris classification Is or IIa) by colonoscopy.
Key exclusion criteria (9 listed)
- American Society of Anesthesiologists (ASA) status class 3 or above;
- poor bowel preparation (Boston bowel preparation scale < 6 points);
- known or endoscopic features indicating the submucous infiltration or malignancy;
- oral anti-coagulants, or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency (platelets<50000 cells/mm3 or INR>1.5);
- a history of colorectal resection;
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 resectionDuring CS-EMR, methylene blue-tinted epinephrine saline will be injected into the submucosal space around the lesion to lift the lesion. The polyp and 1-2mm of surrounding mucosa will then be closely snared and transected mechanically. | Procedure or surgery | Cold snare endoscopic mucosal resection (CS-EMR) |
| Hot snare endoscopic mucosal resectionDuring HS-EMR, methylene blue-tinted epinephrine saline will be injected into the submucosal space around the lesion to lift the lesion. The snare will be placed around the lesion, and then cautery will be applied using the electrosurgical generator. | Procedure or surgery | Hot snare endoscopic mucosal resection (HS-EMR) |
Primary outcome
Complete resection rate
Time frame: Within 14 days
The resection is considered histologically complete if the lateral margins of the resected polyps are surrounded by normal tissue and the vertical margin is free of neoplasia tissue. If en-bloc resection is not achieved, 5 biopsies (4 biopsies obtained in a 4-quadrant fashion from the polypectomy site margins; 1 biopsy from the base) are applied to evaluate histological completeness of resection.
8 secondary outcomes
En-bloc resection rate
Time frame: Within 1 day
Intraprocedural bleeding
Time frame: Within 1 day
Intraprocedural perforation
Time frame: Within 1 day
Delayed bleeding
Time frame: Within 14 days
Delayed perforation
Time frame: Within 14 days
Number of clips used
Time frame: Within 1 day
Resection time
Time frame: Within 1 day
Total cost
Time frame: Within 1 day
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 1 May 2026.
- Derived from this study: PubMed 37217262Jiang Q, Yan X, Wang D, Zhang S, Zhang Y, Feng Y, Yang A, Wu D. Endoscopic mucosal resection using cold snare versus hot snare in treatment for 10-19 mm non-pedunculated colorectal polyps: protocol of a non-inferiority randomised controlled study. BMJ Open. 2023 May 22;13(5):e070321. doi: 10.1136/bmjopen-2022-070321.
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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.
Qingwei Jiang, MD principal investigator
Peking Union Medical College Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold snare endoscopic mucosal resection and Hot snare endoscopic mucosal resection in people with Colorectal Polyp, run by Qingwei Jiang at 15 sites 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 4 inclusion and 9 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
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?
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?
On the ClinicalTrials.gov record for NCT05545787, 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 1 May 2026.