NCT02935049

Brief Summary

For tough colic resection, evaluation of our practice for these lesions unresectable in monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy dissection) /ESD (submucosal dissection)

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

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

October 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

October 13, 2016

Last Update Submit

October 25, 2017

Conditions

Colorectal AdenomaIntramucinous Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Relapse rate

    Medical follow-up

    From surgery to 1 year

Secondary Outcomes (1)

  • Complications rate

    From surgery to 6 months

Interventions

Endoscopic resectionPROCEDURE

Endoscopic resection with technique EMR piecemeal or hybrid technique EMR/ESD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with colorectal adenoma or intramucinous adenocarcinoma

You may qualify if:

  • Age \> 18 years,
  • Patient with colorectal adenoma or intramucinous adenocarcinoma

You may not qualify if:

  • Contraindication surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GENRE

Marseille, 13273, France

RECRUITING

Related Links

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • RATONE Jean Philippe, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GENRE Dominique, MD

CONTACT

+33 (4) 91 22 37 78drci.up@ipc.unicancer.fr

COURNIER Sandra, Project Manager

CONTACT

+33 (4) 91 22 37 78drci.up@ipc.unicancer.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 17, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

October 1, 2018

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)