Pronostic Score of Morbidity to Determine Risk of Complications After Endoscopic Submucosal Dissection for Colorectal Lesions

NCT ID: NCT04647266

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-16

Study Completion Date

2020-11-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%.

Currently, the procedure is realized during a hospitalization with not real recommendation about the time of this.

There is currently no score established for the colo-rectal endoscopic submucosal dissection.

* To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
* Allow to obtain an estimation of number of patients required for a larger study.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polyp of Colon

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Endoscopic Submucosal Dissection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

endoscopic submucosal dissection

endoscopic submucosal dissection

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient suffering of lesion relevant of endoscopic submucosal dissection treatment:
* Lesions for which en bloc resection with snare EMR is difficult to apply i/LST-NG, particularly LST-NG (PD) ii/ Lesions showing a VI-type pit pattern iii/ Carcinoma with shallow T1 (SM) invasion Large depressed-type tumors iv/ Large protruded-type lesions suspected to be carcinoma
* Mucosal tumors with submucosal fibrosis
* Sporadic tumors in conditions of chronic inflammation such as ulcerative colitis
* Local residual or recurrent early carcinomas after endoscopic resection Local res Les lésions de plus
* Male or female patients aged ≥ 18 years old
* Patients able to fill in questionnaires written in French

Exclusion Criteria

* Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris O-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean Baptiste CHEVAUX

Role: STUDY_DIRECTOR

Doctor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHRU Brabois

Nancy, Meurthe ET Moselle, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019PI285

Identifier Type: -

Identifier Source: org_study_id