Underwater Versus Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps
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 |
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N/A |
Detailed Description
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Patients are undergone colonoscopy at the Endoscopy department of Ho Chi Minh City University Medical Center.
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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).
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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.
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Collecting variables which consist of primary and secodary outcomes.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
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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
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Outcome Measures
Primary Outcome Measures
- en bloc resection [immediately after the procedure]
Rate of en bloc resection for non-pedunculated colorectal polyps of 10 mm or more
- 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
- Complication rate [up to 2 weeks]
Rate of complications including bleeding, perforation
- Local recurrence rate [6 months]
Rate of local recurrence
- Procedure time [during the procedure]
Time for complete resection of polyps
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years
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Non-pedunculated polyps of 10 mm or more in size
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Type 1 or 2 according to NBI International Colorectal Endoscopy (NICE) classification
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Patients must sign an informed consent form prior to registration in study
Exclusion Criteria:
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Lesions with signs of deep invasion (hard, friable tissue, poor mobility, positive "non-lifting" sign)
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Type 3 according to NICE classification
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Colorectal cancer
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Patients with unstable chronic disease (melitus diabetes, hypertension, heart failure, kidney failure, liver failure, chronic obstructive pulmonary disease)
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Hemostasis disorder (INR > 1.5; platelets < 100000/mm3)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- 001