ClinicalTrials.gg
Not yet recruitingNCT07764224Updated Aug 13, 2026

Cold Versus Hot Snare Endoscopic Mucosal Resection for Intermediate-Size Flat Nonpedunculated Colorectal Polyps

An interventional study of Cold snare endoscopic mucosal resection (CS-EMR) and Hot snare endoscopic mucosal resection (HS-EMR) in Colorectal Polyps and Endoscopic Mucosal Resection, sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
968
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Polyps
  • Endoscopic Mucosal Resection

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03

In context

Polyps

312 studies on the registry are indexed under Polyps; 60 are open to participants now.

This study's planned enrollment of 968 is above the median of 150 across 204 interventional studies indexed under Polyps.

Browse Polyps studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects aged 18-75 years, irrespective of gender;
  2. 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;
  3. Subjects voluntarily agree to receive endoscopic treatment and sign written .

Exclusion criteria

Exclusion Criteria:

  1. Colonoscopic findings suggestive of submucosal invasion or malignant transformation of colorectal polyps;
  2. Previous history of colorectal surgery;
  3. Previous history of inflammatory bowel disease, familial adenomatous polyposis, or colorectal cancer;
  4. Failure to discontinue anticoagulant and antiplatelet medications for a minimum of 1 week prior to the procedure;
  5. Known coagulation disorders or bleeding diathesis;
  6. Pregnant or breastfeeding women;
  7. 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
968 participants (estimated)

Study arms

  • Experimental
    Cold snare endoscopic mucosal resection (CS-EMR)

    Eligible colorectal polyps measuring 10-20 mm will be resected using CS-EMR.

    Procedure: Cold snare endoscopic mucosal resection (CS-EMR)

  • Active comparator
    Hot snare endoscopic mucosal resection (HS-EMR)

    Eligible colorectal polyps measuring 10-20 mm will be resected using HS-EMR.

    Procedure: Hot snare endoscopic mucosal resection (HS-EMR)

Interventions

  • ProcedureCold 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.

  • ProcedureHot 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 14 days

Secondary outcomes

  1. en bloc resection rate

    The lesion was completely excised under endoscope and a single specimen was obtained.

    Time frame: Within one days

  2. Unresectable rate of CS-EMR

    A resection procedure that needed high-frequency electric current.

    Time frame: Within one day

  3. Intraprocedural bleeding

    Intraoperative arterial bleeding or active mucosal oozing lasting more than 30 seconds that requires endoscopic hemostatic intervention.

    Time frame: Within one day

  4. Intraprocedural perforation

    Endoscopic observation of perforation requiring sealing with clips

    Time frame: Within one day

  5. Procedural time

    The duration from the first occurrence of injection needle under endoscope visual field to complete removal of the resected polyp

    Time frame: Within one day

  6. Delayed bleeding

    haemorrhage after colonoscopy requiring endoscopic haemostasis with 14 days.

    Time frame: Within 14 days

  7. Delayed perforation

    Any perforation within 14 days

    Time frame: Within 14 days

  8. Number of clips used

    The number of clips used for each resected polyp

    Time frame: Within one day

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Oct 2028, 26 months later.

Of 68 non-industry interventional studies with no phase under Polyps, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 26 months is above that.

Counting every sponsor, half of 79 studies reached it within 23 months; a quarter within 12 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 13, 2026
StartEst.
Aug 2026
Primary completionEst.
Oct 2028
CompletionEst.
Feb 2029
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07764224
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
First posted
Aug 13, 2026
Start date
Aug 2026 (estimated)
Primary completion
Oct 2028 (estimated)
Completion
Feb 2029 (estimated)
Last update
Aug 13, 2026

Study contacts

Zelong Han, MD
Contact
hanzelong2025@163.com
+86 189-2506-1960
Bitao Lin, MD
Contact
linbitao1996@163.com
+86 137-2532-1385

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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