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Completed

NCT Number: NCT05545787

Cold or Hot Snare Endoscopic Mucosal Resection for 10-19mm 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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Daxing District People's Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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);
  • 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.

Treatment and study plan

Cold Snare Endoscopic Mucosal Resection

Procedure

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 resection

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. En-bloc resection rate

    Time frame: Within 1 day

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

  2. Intraprocedural bleeding

    Time frame: Within 1 day

    Any immediate episode requiring any form of endoscopic hemostasis or oozing for more than 60s

  3. Intraprocedural perforation

    Time frame: Within 1 day

    Endoscopic observation of perforation requiring sealing with clips

  4. Delayed bleeding

    Time frame: Within 14 days

    Any episode requiring emergency department presentation, hospitalization, or reintervention within 14 days

  5. Delayed perforation

    Time frame: Within 14 days

    Any perforation within 14 days

  6. Number of clips used

    Time frame: Within 1 day

    The number of endoscopic clips used for each resected polyp

  7. Resection time

    Time frame: Within 1 day

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

  8. Total cost

    Time frame: Within 1 day

    Total cost including both treatment cost and material cost for polyp resection

Sponsors and collaborators

Lead sponsor

Qingwei Jiang

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2022
Registry last updated
May 1, 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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