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NCT Number: NCT07764224

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

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.

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Key information

Conditions

Colorectal Polyps Endoscopic Mucosal Resection

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. en bloc resection rate

    Time frame: Within one days

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

  2. Unresectable rate of CS-EMR

    Time frame: Within one day

    A resection procedure that needed high-frequency electric current.

  3. Intraprocedural bleeding

    Time frame: Within one day

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

  4. Intraprocedural perforation

    Time frame: Within one day

    Endoscopic observation of perforation requiring sealing with clips

  5. Procedural time

    Time frame: Within one day

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

  6. Delayed bleeding

    Time frame: Within 14 days

    haemorrhage after colonoscopy requiring endoscopic haemostasis with 14 days.

  7. Delayed perforation

    Time frame: Within 14 days

    Any perforation within 14 days

  8. Number of clips used

    Time frame: Within one day

    The number of clips used for each resected polyp

Study contacts

Contact information is provided by the study sponsor or research team.

Bitao Lin, MD

CONTACT

[email protected]

+86 137-2532-1385

Zelong Han, MD

CONTACT

[email protected]

+86 189-2506-1960

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Anyuan County People's Hospital of Ganzhou
  • Guzhen People's Hospital of Zhongshan
  • Jiangmen Central Hospital
  • Longgang District People's Hospital of Shenzhen
  • Longnan Traditional Chinese Medicine Hospital
  • Shaoguan First People's Hospital
  • Shunde First People's Hospital of Foshan
  • Sihui Wanlong Hospital
  • Suixi People's Hospital of Zhanjiang
  • The Third People's Hospital of Huizhou
  • Yangchun People's Hospital
  • Yangjiang People's Hospital
  • ZhuHai Hospital
  • ZhuZhou Central Hospital

Registry information

Official study title

Cold Versus Hot Snare Endoscopic Mucosal Resection for Intermediate-Size Flat Nonpedunculated Colorectal Polyps: A Multicenter, Prospective, Randomized, Non-Inferiority Clinical Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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