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

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825664
• Other study ID #: 001
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2023
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Polyp
• Polyps

Intervention

Procedure:
• Endoscopic resection
Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR

Locations

Country	Name	City	State
Vietnam	University of Medicine and Pharmacy at Ho Chi Minh city	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	en bloc resection	Rate of en bloc resection for non-pedunculated colorectal polyps of 10 mm or more	immediately after the procedure
Primary	Curative rate	Curative rate for non-pedunculated colorectal polyps of 10 mm or more	through study completion, an average of 6 months
Secondary	Complication rate	Rate of complications including bleeding, perforation	up to 2 weeks
Secondary	Local recurrence rate	Rate of local recurrence	6 months
Secondary	Procedure time	Time for complete resection of polyps	during the procedure