UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps

NCT ID: NCT03833492

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-11-12

Brief Summary

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This clinical trial is being conducted to compare the efficacy and safety of two standard methods of polypectomy,Conventional Endoscopic Mucosal Resection(EMR)and Underwater Endoscopic Mucosal Resection(UEMR),for small colorectal polyps.

Detailed Description

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Conditions

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Colonic Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Underwater EMR

The patients who are randomized to the " Underwater EMR" arm polypectomy with water will be performed under full water emersion without the use of submucosal injection.

Group Type EXPERIMENTAL

Underwater EMR

Intervention Type BEHAVIORAL

Polypectomy is performed under full water emersion without the use of submucosal injection.

Traditional EMR

The patients who are randomized to the " Traditional EMR" arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Underwater EMR

Polypectomy is performed under full water emersion without the use of submucosal injection.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Patients age between 18-75 years old with non-pedunculated colonic polyps (measuring between 4 and 9mm), who willing to participate in this study.

Exclusion Criteria

1. pregnancy,
2. inflammatory bowel disease,
3. familial polyposis
4. the use of anticoagulant therapy or antiplatelet therapy
5. the absence of informed patient consent.
6. Polyps showing signs of deep submucosal invasion
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ningbo No. 1 Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Gastroenterology, Haishu No.2 Hospital, Ningbo, China

Ningbo, Zhejiang, China

Site Status

Department of Gastroenterology, Ninghai No.2 Hospital, Ningbo, China

Ningbo, Zhejiang, China

Site Status

Ningbo first hospital

Ningbo, Zhejiang, China

Site Status

Countries

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China

References

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Zhang Z, Xia Y, Cui H, Yuan X, Wang C, Xie J, Tong Y, Wang W, Xu L. Underwater versus conventional endoscopic mucosal resection for small size non-pedunculated colorectal polyps: a randomized controlled trial : (UEMR vs. CEMR for small size non-pedunculated colorectal polyps). BMC Gastroenterol. 2020 Sep 23;20(1):311. doi: 10.1186/s12876-020-01457-y.

Reference Type DERIVED
PMID: 32967616 (View on PubMed)

Other Identifiers

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UEMR-1.0

Identifier Type: -

Identifier Source: org_study_id