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

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05825664
• Collaborator: (none)
• Enrollment: 228
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.8
• Patients Per Site Per Month: 14.4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Polyp; Colorectal Neoplasms	Procedure: Endoscopic resection	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 228 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 7, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jul 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. en bloc resection [immediately after the procedure]

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

2. Curative rate [through study completion, an average of 6 months]

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

Secondary Outcome Measures

1. Complication rate [up to 2 weeks]

   Rate of complications including bleeding, perforation

2. Local recurrence rate [6 months]

   Rate of local recurrence

3. Procedure time [during the procedure]

   Time for complete resection of polyps

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Medicine and Pharmacy at Ho Chi Minh city	Ho Chi Minh City		Vietnam	700000

Sponsors and Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Le Dinh Quang, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
• ClinicalTrials.gov Identifier: NCT05825664
• Other Study ID Numbers: 001
• First Posted: Apr 24, 2023
• Last Update Posted: Apr 24, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Le Dinh Quang, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City: colorectal polyp; underwater endoscopic mucosal resection; conventional endoscopic mucosal resection
• Additional relevant MeSH terms: Colorectal Neoplasms; Polyps

Study Results

No Results Posted as of Apr 24, 2023