UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps

NCT03833492 | Completed

• 1 other identifier: UEMR-1.0
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (2)

• complete resection rate

  complete resection rate is defined as a complete en bloc resection of a lesion with tumor-free lateral and vertical margins.

  7 days

• En bloc resection rate

  En bloc resection rate was defined as the entire lesion could be removed in 1 piece instead of piecemeal resection.

  immediately

Secondary Outcomes (2)

• Adverse event rate

  14 days

• Procedure time

  24 hours

Study Arms (2)

Underwater EMR

EXPERIMENTAL

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.

Behavioral: Underwater EMR

Traditional EMR

NO INTERVENTION

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.

Interventions

Underwater EMR BEHAVIORAL

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

Underwater EMR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnancy,
• inflammatory bowel disease,
• familial polyposis
• the use of anticoagulant therapy or antiplatelet therapy
• the absence of informed patient consent.
• Polyps showing signs of deep submucosal invasion

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (3)

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

Ningbo, Zhejiang, 315000, China

Location

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

Ningbo, Zhejiang, 315000, China

Location

Ningbo first hospital

Ningbo, Zhejiang, 315010, China

Location

Related Publications (1)

• 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.

  PMID: 32967616 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 7, 2019
• Study Start: May 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 12, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

CN (3)