NCT03567746

Brief Summary

To analyse the efficacy and safety of two standard methods of endoscopic mucosal resection (EMR) for large non-pedunculated colorectal polyps, the investigators will compare submucosal injection-assisted endoscopic mucosal resection (SEMR) versus underwater endoscopic mucosal resection, without submucosal injection (UEMR).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

1.6 years

First QC Date

June 13, 2018

Last Update Submit

July 23, 2019

Conditions

Colonic Polyp

Keywords

Colonic PolypEndoscopic mucosal resection

Outcome Measures

Primary Outcomes (1)

  • Lesion recurrence rate

    Presence of polyp tissue at the same site as the original lesion (adenoma or sessile serrated polyp)

    1 year

Secondary Outcomes (7)

  • Technical success rate

    1 hour

  • Incidence of Treatment-Emergent Adverse Events

    1 year

  • En bloc Resection rate

    1 hour

  • Procedure time

    1 hour

  • Number of fragments

    1 hour

  • +2 more secondary outcomes

Study Arms (2)

Underwater EMR

EXPERIMENTAL

The patients randomized in this arm will be treated by endoscopic resection assisted by the filling of the colonic lumen using water instead of air and avoiding the formation of a submucosal cushion

Procedure: Underwater EMR

Conventional EMR

ACTIVE COMPARATOR

The patients randomized in this arm will be treated by endoscopic resection following the traditional technique. It means, by assistance of selective submucosal saline injection to create a submucosal cushion below the polyp.

Procedure: Conventional EMR

Interventions

Underwater EMRPROCEDURE

Polypectomy is performed under full water emersion avoiding the use of submucosal injection.

Underwater EMR
Conventional EMRPROCEDURE

It will be performed in a 2-step procedure. First the formation of a submucosal injection underneath the polyp to create a submucosal safety cushion. Then EMR is performed with a polipectomy snare.

Conventional EMR

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients aged \>18 years, diagnosed with a large (\>=20 mm) non-pedunculated colonic polyp, who consent to endoscopic mucosal resection of the polyp and willing to participate in this study.

You may not qualify if:

  • Polyps showing signs of deep submucosal invasion
  • Inflamatory bowel disease with signs of activity
  • Known or suspected pregnancy
  • Patients unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital del Mar. Parc de Salut Mar

Barcelona, 08003, Spain

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

RECRUITING

Related Publications (1)

  • Rodriguez Sanchez J, Alvarez-Gonzalez MA, Pellise M, Coto-Ugarte D, Uchima H, Aranda-Hernandez J, Santiago Garcia J, Marin-Gabriel JC, Riu Pons F, Nogales O, Carreno Macian R, Herreros-de-Tejada A, Hernandez L, Patron GO, Rodriguez-Tellez M, Redondo-Cerezo E, Sanchez Alonso M, Daca M, Valdivielso-Cortazar E, Alvarez Delgado A, Enguita M, Montori S, Albeniz E. Underwater versus conventional EMR of large nonpedunculated colorectal lesions: a multicenter randomized controlled trial. Gastrointest Endosc. 2023 May;97(5):941-951.e2. doi: 10.1016/j.gie.2022.12.013. Epub 2022 Dec 23.

    PMID: 36572129DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Joaquin Rodriguez, MD PhD

CONTACT

926278000joakinrodriguez@gmail.com

Marco A Alvarez-Gonzalez, MD PhD

CONTACT

marcoalgo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2018

First Posted

June 26, 2018

Study Start

June 4, 2018

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

July 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)