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

Comparison of the Efficiency and Safety of Underwater Endoscopic Mucosal Resection and Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Neoplasms; Colorectal Polyp
• Intervention / Treatment: Procedure: Endoscopic resection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • Recruiting
    • University of Medicine and Pharmacy at Ho Chi Minh City
    • Contact: Quang D Le, MD; Phone Number: +84985938040; Email: quangledinh@ump.edu.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Underwater endoscopic mucosal resection; 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; Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR
Active Comparator: Conventional endoscopic mucosal resection; 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; Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Rate of complications including bleeding, perforation	up to 2 weeks
Local recurrence rate	Rate of local recurrence	6 months
Procedure time	Time for complete resection of polyps	during the procedure

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: colorectal polyp; conventional endoscopic mucosal resection; underwater endoscopic mucosal resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Polyps
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No