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NCT04647266 Clinical Trial

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

Polyp of Colon Clinical Trial

Official title:
Proof of Concept for the Development of Clinical or Mixed Prognostic Score of Morbidity After Endoscopic Subcostal Dissection for Colorectal Lesions in Nancy's Hospital Since 2016 to Nowadays

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04647266
Other study ID # 2019PI285
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 16, 2016
Est. completion date November 20, 2020

Study information
Verified date November 2020
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 168
Est. completion date November 20, 2020
Est. primary completion date November 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• endoscopic submucosal dissection
endoscopic submucosal dissection

Locations
Country Name City State
France CHRU Brabois Nancy Meurthe ET Moselle

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital. From 2016 to 2020
Secondary Allow to obtain an estimation of number of patients required for a larger study From 2016 to 2020
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