Comparing cold and hot snare techniques for removing colorectal polyps

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 study is testing whether a cold method or a hot method for removing certain types of colorectal polyps works better and is safer for patients during colonoscopy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 232 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 3 sites (Beijing, Beijing and 2 other locations)
• Trial ID: NCT05545787 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, randomized, open-label, non-inferiority trial that aims to evaluate the efficacy and safety of cold snare endoscopic mucosal resection (CS-EMR) versus hot snare endoscopic mucosal resection (HS-EMR) for the removal of non-pedunculated colorectal polyps measuring 10-19mm. Eligible outpatients scheduled for colonoscopy will be randomly assigned to one of the two intervention groups. The study is conducted across multiple centers in Beijing, focusing on patients with specific polyp characteristics identified during colonoscopy.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-80 who are scheduled for a colonoscopy and have at least one eligible colorectal polyp sized 10-19mm.

Not a fit: Patients with significant comorbidities, poor bowel preparation, or those with known malignancies or bleeding disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective method for the removal of colorectal polyps, potentially reducing complications and improving patient outcomes.

How similar studies have performed: While this approach is being compared in a non-inferiority framework, similar studies have shown promising results with both cold and hot snare techniques in polyp removal.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing and 2 other locations

• Seventh Medical Center, General Hospital of the Chinese People's Liberation Army — Beijing, Beijing, China (Recruiting)
• Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
• Beijing Tsinghua Changgung Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Qingwei Jiang, MD — Peking Union Medical College Hospital
• Study coordinator: Qingwei Jiang, MD

Conditions Colorectal Polyp