NCT07764224

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
968

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Aug 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Feb 2029

Study Start

First participant enrolled

August 1, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

2.2 years

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Colorectal PolypsEndoscopic Mucosal Resection

Outcome Measures

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.

    Within 14 days

Secondary Outcomes (8)

  • en bloc resection rate

    Within one days

  • Unresectable rate of CS-EMR

    Within one day

  • Intraprocedural bleeding

    Within one day

  • Intraprocedural perforation

    Within one day

  • Procedural time

    Within one day

  • +3 more secondary outcomes

Study Arms (2)

Cold snare endoscopic mucosal resection (CS-EMR)

EXPERIMENTAL

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

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.

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

Interventions

Cold snare endoscopic mucosal resection (CS-EMR)PROCEDURE

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.

Cold snare endoscopic mucosal resection (CS-EMR)
Hot snare endoscopic mucosal resection (HS-EMR)PROCEDURE

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.

Hot snare endoscopic mucosal resection (HS-EMR)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Zelong Han, MD

CONTACT

+86 189-2506-1960hanzelong2025@163.com

Bitao Lin, MD

CONTACT

+86 137-2532-1385linbitao1996@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 13, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

August 13, 2026

Record last verified: 2026-08