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

Primary Purpose

Colorectal Polyp

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cold snare endoscopic mucosal resection
Hot snare endoscopic mucosal resection
Sponsored by
Qingwei Jiang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Polyp

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-80 years of age;
  • undergo colonoscopy in the Digestive Endoscopy Center of PUMCH;
  • 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.

Sites / Locations

  • Seventh Medical Center, General Hospital of the Chinese People's Liberation ArmyRecruiting
  • Peking Union Medical College HospitalRecruiting
  • Beijing Tsinghua Changgung HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cold snare endoscopic mucosal resection (CS-EMR)

Hot snare endoscopic mucosal resection (HS-EMR)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Complete resection rate
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 Outcome Measures

En-bloc resection rate
The lesion was completely excised under endoscope and a single specimen was obtained.
Intraprocedural bleeding
Any immediate episode requiring any form of endoscopic hemostasis or oozing for more than 60s
Intraprocedural perforation
Endoscopic observation of perforation requiring sealing with clips
Delayed bleeding
Any episode requiring emergency department presentation, hospitalization, or reintervention within 14 days
Delayed perforation
Any perforation within 14 days
Number of clips used
The number of endoscopic clips used for each resected polyp
Resection time
The duration from the first occurrence of injection needle under endoscope visual field to complete removal of the resected polyp
Total cost
Total cost including both treatment cost and material cost for polyp resection

Full Information

First Posted
September 15, 2022
Last Updated
August 16, 2023
Sponsor
Qingwei Jiang
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1. Study Identification

Unique Protocol Identification Number
NCT05545787
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qingwei Jiang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyp

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cold snare endoscopic mucosal resection (CS-EMR)
Arm Type
Experimental
Arm Description
Eligible colorectal polyps sized 10-19mm will be resected by CS-EMR
Arm Title
Hot snare endoscopic mucosal resection (HS-EMR)
Arm Type
Experimental
Arm Description
Eligible colorectal polyps sized 10-19mm will be resected by HS-EMR
Intervention Type
Procedure
Intervention Name(s)
Cold snare endoscopic mucosal resection
Intervention Description
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
Intervention Name(s)
Hot snare endoscopic mucosal resection
Intervention Description
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 Outcome Measure Information:
Title
Complete resection rate
Description
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.
Time Frame
Within 14 days
Secondary Outcome Measure Information:
Title
En-bloc resection rate
Description
The lesion was completely excised under endoscope and a single specimen was obtained.
Time Frame
Within 1 day
Title
Intraprocedural bleeding
Description
Any immediate episode requiring any form of endoscopic hemostasis or oozing for more than 60s
Time Frame
Within 1 day
Title
Intraprocedural perforation
Description
Endoscopic observation of perforation requiring sealing with clips
Time Frame
Within 1 day
Title
Delayed bleeding
Description
Any episode requiring emergency department presentation, hospitalization, or reintervention within 14 days
Time Frame
Within 14 days
Title
Delayed perforation
Description
Any perforation within 14 days
Time Frame
Within 14 days
Title
Number of clips used
Description
The number of endoscopic clips used for each resected polyp
Time Frame
Within 1 day
Title
Resection time
Description
The duration from the first occurrence of injection needle under endoscope visual field to complete removal of the resected polyp
Time Frame
Within 1 day
Title
Total cost
Description
Total cost including both treatment cost and material cost for polyp resection
Time Frame
Within 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingwei Jiang, MD
Phone
8610-69151591
Email
flyerj@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingwei Jiang, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seventh Medical Center, General Hospital of the Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Na Li
Phone
15011158690
Email
lina200481@163.com
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingwei Jiang
Phone
8610-69151591
Email
flyerj@sina.com
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102218
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yutang Ren
Phone
8610-56119096
Email
pumcren@126.com

12. IPD Sharing Statement

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

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