NCT02765022

Brief Summary

An simple-blind, randomized study, to evaluate the efficacy and safety of complete closure with clips of mucosal defects after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 29, 2019

Status Verified

August 1, 2018

Enrollment Period

2.1 years

First QC Date

May 3, 2016

Last Update Submit

January 28, 2019

Conditions

Endoscopic ResectionClipHaemorrhageNon-pedunculated Lesions

Outcome Measures

Primary Outcomes (1)

  • Delayed hemorrhage

    15 days post-EMR

Study Arms (2)

Clip

EXPERIMENTAL

Clip closure of mucosal defects after endoscopic mucosal resection.

Device: Clip closure

No clip

ACTIVE COMPARATOR

No clip closure of mucosal defects after endoscopic mucosal resection. Observation.

Procedure: No clip closure

Interventions

Clip closureDEVICE

Complete clip closure of secondary lesions after the endoscopic mucosal resection

Clip
No clip closurePROCEDURE

Observation: no clip closure of secondary lesions after the endoscopic mucosal resection

No clip

Eligibility Criteria

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

You may qualify if:

  • years and older
  • Clinical indication of endoscopic mucosal resection for large-sized (≥ 2cm) non-pedunculated colorectal lesions.
  • Medium-high risk of delayed bleeding (DB risk score ≥ 4)
  • Informed consent.

You may not qualify if:

  • Patients with colorectal non-pedunculated lesions without endoscopic mucosal resection indication.
  • Lesions resected by endoscopic submucosal resection.
  • Incomplete resections.
  • Resections with suspected deep submucosal invasion.
  • Mucosal defects treated with clips for known or suspected damage to the muscle layer.
  • Lesions with low risk of delayed bleeding (DB risk score ≤3).
  • Patients with any other medical, geographic or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eduardo Albeniz Arbizu

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

  • Albeniz E, Alvarez MA, Espinos JC, Nogales O, Guarner C, Alonso P, Rodriguez-Tellez M, Herreros de Tejada A, Santiago J, Bustamante-Balen M, Rodriguez Sanchez J, Ramos-Zabala F, Valdivielso E, Martinez-Alcala F, Fraile M, Elosua A, Guerra Veloz MF, Ibanez Beroiz B, Capdevila F, Enguita-German M. Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding. Gastroenterology. 2019 Nov;157(5):1213-1221.e4. doi: 10.1053/j.gastro.2019.07.037. Epub 2019 Jul 27.

    PMID: 31362007DERIVED

Related Links

MeSH Terms

Conditions

Hemorrhage

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Design

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

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 6, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2018

Study Completion

October 1, 2018

Last Updated

January 29, 2019

Record last verified: 2018-08

Locations

ES(1)