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

Completed

• Conditions: Polyp of Colon

• Registration Number: NCT04647266
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-16
• Status Verified: 2020-11
• Primary Completion: 2020-11-20
• Study Completion: 2020-11-20
• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-11-27
• Last Update Submitted: 2020-11-27
• Study First Posted: 2020-11-30
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.	From 2016 to 2020

Secondary Outcome Measures

Name	Time	Method
Allow to obtain an estimation of number of patients required for a larger study	From 2016 to 2020

Trial Locations

Locations (1)

CHRU Brabois; 🇫🇷 Nancy, Meurthe ET Moselle, France