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Underwater Versus Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps

Primary Purpose

Colorectal Polyp, Colorectal Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Endoscopic resection
Sponsored by
University of Medicine and Pharmacy at Ho Chi Minh City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Polyp focused on measuring colorectal polyp, underwater endoscopic mucosal resection, conventional endoscopic mucosal resection

Eligibility Criteria

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

Inclusion Criteria: Age > 18 years Non-pedunculated polyps of 10 mm or more in size Type 1 or 2 according to NBI International Colorectal Endoscopy (NICE) classification Patients must sign an informed consent form prior to registration in study Exclusion Criteria: Lesions with signs of deep invasion (hard, friable tissue, poor mobility, positive "non-lifting" sign) Type 3 according to NICE classification Colorectal cancer Patients with unstable chronic disease (melitus diabetes, hypertension, heart failure, kidney failure, liver failure, chronic obstructive pulmonary disease) Hemostasis disorder (INR > 1.5; platelets < 100000/mm3)

Sites / Locations

  • University of Medicine and Pharmacy at Ho Chi Minh cityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Underwater endoscopic mucosal resection

Conventional endoscopic mucosal resection

Arm Description

Intervention: Non-pedunculated polyps will be removed by underwater endoscopic mucosal resection. The UEMR procedure included the following: (1) complete deflation of the colorectal lumen; (2) total immersion of the lesion in normal saline using a mechanical water pump; (3) snaring the lesion and the surrounding mucosa; and (4) resection using electrocautery.

Intervention: Non-pedunculated polyps will be removed by conventional endoscopic mucosal resection. The CEMR procedure included the following: (1) needle injection of normal saline into the submucosa; (2) entrapment of the mucosal protrusion with a snare; and (3) resection applying the same electrocautery setting as was used for UEMR.

Outcomes

Primary Outcome Measures

en bloc resection
Rate of en bloc resection for non-pedunculated colorectal polyps of 10 mm or more
Curative rate
Curative rate for non-pedunculated colorectal polyps of 10 mm or more

Secondary Outcome Measures

Complication rate
Rate of complications including bleeding, perforation
Local recurrence rate
Rate of local recurrence
Procedure time
Time for complete resection of polyps

Full Information

First Posted
April 7, 2023
Last Updated
April 20, 2023
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
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1. Study Identification

Unique Protocol Identification Number
NCT05825664
Brief Title
Underwater Versus Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps
Official Title
Comparison of the Efficiency and Safety of Underwater Endoscopic Mucosal Resection and Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A prospective, randomized, controlled study to compare the efficacy and safety of underwater endoscopic mucosal resection and conventional endoscopic mucosal resection in removal of non-pedunculated colorectal polyps
Detailed Description
Patients are undergone colonoscopy at the Endoscopy department of Ho Chi Minh City University Medical Center. Randomize patients with non-pedunculated polyp of 10mm or larger in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Underwater endoscopic mucosal resection (UEMR) and (2) Group 2: Conventional endoscopic mucosal resection (CEMR). The time of local recurrence assessment depends on the histopathology of polyps. Polyps with low grade dysplasia are followed up at 6 months, while polyps with high grade dysplasia are followed at 3 months. Collecting variables which consist of primary and secodary outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyp, Colorectal Neoplasms
Keywords
colorectal polyp, underwater endoscopic mucosal resection, conventional endoscopic mucosal resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Underwater endoscopic mucosal resection
Arm Type
Experimental
Arm Description
Intervention: Non-pedunculated polyps will be removed by underwater endoscopic mucosal resection. The UEMR procedure included the following: (1) complete deflation of the colorectal lumen; (2) total immersion of the lesion in normal saline using a mechanical water pump; (3) snaring the lesion and the surrounding mucosa; and (4) resection using electrocautery.
Arm Title
Conventional endoscopic mucosal resection
Arm Type
Active Comparator
Arm Description
Intervention: Non-pedunculated polyps will be removed by conventional endoscopic mucosal resection. The CEMR procedure included the following: (1) needle injection of normal saline into the submucosa; (2) entrapment of the mucosal protrusion with a snare; and (3) resection applying the same electrocautery setting as was used for UEMR.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic resection
Intervention Description
Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR
Primary Outcome Measure Information:
Title
en bloc resection
Description
Rate of en bloc resection for non-pedunculated colorectal polyps of 10 mm or more
Time Frame
immediately after the procedure
Title
Curative rate
Description
Curative rate for non-pedunculated colorectal polyps of 10 mm or more
Time Frame
through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Complication rate
Description
Rate of complications including bleeding, perforation
Time Frame
up to 2 weeks
Title
Local recurrence rate
Description
Rate of local recurrence
Time Frame
6 months
Title
Procedure time
Description
Time for complete resection of polyps
Time Frame
during the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Non-pedunculated polyps of 10 mm or more in size Type 1 or 2 according to NBI International Colorectal Endoscopy (NICE) classification Patients must sign an informed consent form prior to registration in study Exclusion Criteria: Lesions with signs of deep invasion (hard, friable tissue, poor mobility, positive "non-lifting" sign) Type 3 according to NICE classification Colorectal cancer Patients with unstable chronic disease (melitus diabetes, hypertension, heart failure, kidney failure, liver failure, chronic obstructive pulmonary disease) Hemostasis disorder (INR > 1.5; platelets < 100000/mm3)
Facility Information:
Facility Name
University of Medicine and Pharmacy at Ho Chi Minh city
City
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quang D Le, MD
Phone
+84985938040
Email
quangledinh@ump.edu.vn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Underwater Versus Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps

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