Clinical trial NCT05545787: Cold or Hot Snare Endoscopic Mucosal Resection for 10-19mm Non-pedunculated Colorectal Polyps
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Polyp
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Complete resection rate
timeFrame: Within 14 days
Secondary outcomes:
measure: En-bloc resection rate
timeFrame: Within 1 day
measure: Intraprocedural bleeding
timeFrame: Within 1 day
measure: Intraprocedural perforation
timeFrame: Within 1 day
measure: Delayed bleeding
timeFrame: Within 14 days
measure: Delayed perforation
timeFrame: Within 14 days
measure: Number of clips used
timeFrame: Within 1 day
measure: Resection time
timeFrame: Within 1 day
measure: Total cost
timeFrame: Within 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Seventh Medical Center, General Hospital of the Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Qingwei Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: