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

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Enrolling

Conditions: Colorectal Polyp; Colorectal Neoplasms

Treatments: Procedure: Endoscopic resection

Study type: Interventional

Funder types: Other

Identifiers

NCT05825664

001

Details and patient eligibility

About

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

Full 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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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228 participants in 2 patient groups

Underwater endoscopic mucosal resection

Experimental group

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.

Treatment:

Procedure: Endoscopic resection

Conventional endoscopic mucosal resection

Active Comparator group

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.

Treatment:

Procedure: Endoscopic resection