NCT05825664

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 7, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

April 7, 2023

Last Update Submit

April 20, 2023

Conditions

Colorectal PolypColorectal Neoplasms

Keywords

colorectal polypunderwater endoscopic mucosal resectionconventional endoscopic mucosal resection

Outcome Measures

Primary Outcomes (2)

  • en bloc resection

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

    immediately after the procedure

  • Curative rate

    Curative rate for non-pedunculated colorectal polyps of 10 mm or more

    through study completion, an average of 6 months

Secondary Outcomes (3)

  • Complication rate

    up to 2 weeks

  • Local recurrence rate

    6 months

  • Procedure time

    during the procedure

Study Arms (2)

Underwater endoscopic mucosal resection

EXPERIMENTAL

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.

Procedure: Endoscopic resection

Conventional endoscopic mucosal resection

ACTIVE COMPARATOR

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.

Procedure: Endoscopic resection

Interventions

Endoscopic resectionPROCEDURE

Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR

Conventional endoscopic mucosal resectionUnderwater endoscopic mucosal resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medicine and Pharmacy at Ho Chi Minh city

Ho Chi Minh City, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 7, 2023

First Posted

April 24, 2023

Study Start

April 7, 2023

Primary Completion

December 31, 2023

Study Completion

July 31, 2024

Last Updated

April 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)