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CompletedNCT03833492Updated Dec 11, 2019

UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps

An interventional study of Underwater EMR in Colonic Polyps, sponsored by Ningbo No. 1 Hospital. Completed at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-11.

Sponsored by Ningbo No. 1 Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Colonic Polyps
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In context

Polyps

385 studies on the registry are indexed under Polyps; 59 are open to participants now.

This study's enrollment of 130 is below the median of 160 across 250 interventional studies indexed under Polyps.

Browse Polyps studies →

Lead sponsor

Ningbo No. 1 Hospital is the lead sponsor of 56 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Underwater EMR

  • No intervention
    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.

Interventions

  • BehavioralUnderwater EMR

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

06

What researchers measure

Primary outcomes

  1. complete resection rate

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

    Time frame: 7 days

  2. En bloc resection rate

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

    Time frame: immediately

Secondary outcomes

  1. Adverse event rate

    Including bleeding and perforation , etc.

    Time frame: 14 days

  2. Procedure time

    Time to execute the program

    Time frame: 24 hours

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Study locations

3 sites
  • Department of Gastroenterology, Haishu No.2 Hospital, Ningbo, China
    Ningbo, Zhejiang 315000, China
  • Department of Gastroenterology, Ninghai No.2 Hospital, Ningbo, China
    Ningbo, Zhejiang 315000, China
  • Ningbo first hospital
    Ningbo, Zhejiang 315010, China
08

References and documents

Publications

  • 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. PubMed 32967616 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03833492
Lead sponsor
Ningbo No. 1 Hospital
Responsible party
Sponsor
First posted
Feb 7, 2019
Start date
May 1, 2019
Primary completion
Nov 1, 2019
Completion
Nov 12, 2019
Last update
Dec 11, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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