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
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Colonic Polyps
• Polyp of Colon

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