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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Colorectal Polyp, Colorectal Neoplasms

Intervention / Treatment
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* Procedure: Endoscopic resection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Underwater endoscopic mucosal resection<br>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<br>* Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR<br>|
| Active Comparator: Conventional endoscopic mucosal resection<br>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<br>* Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal polyp, underwater endoscopic mucosal resection, conventional endoscopic mucosal resection