Cold or Hot Snare Endoscopic Mucosal Resection for 10-19mm Non-pedunculated Colorectal Polyps

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-14

Study Completion Date

2025-12-01

Brief Summary

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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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Detailed Description

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Conditions

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Colorectal Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cold snare endoscopic mucosal resection (CS-EMR)

Eligible colorectal polyps sized 10-19mm will be resected by CS-EMR

Group Type EXPERIMENTAL

Cold snare endoscopic mucosal resection

Intervention Type 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 (HS-EMR)

Eligible colorectal polyps sized 10-19mm will be resected by HS-EMR

Group Type EXPERIMENTAL

Hot snare endoscopic mucosal resection

Intervention Type 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.

Interventions

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Cold snare endoscopic mucosal resection

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.

Intervention Type PROCEDURE

Hot snare endoscopic mucosal resection

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Qingwei Jiang

attending physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Qingwei Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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