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

NCT04647266 | Completed

• 1 other identifier: 2019PI285
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Polyp of Colon

Keywords

Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (1)

• To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.

  From 2016 to 2020

Secondary Outcomes (1)

• Allow to obtain an estimation of number of patients required for a larger study

  From 2016 to 2020

Interventions

endoscopic submucosal dissection PROCEDURE

endoscopic submucosal dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient, more than 18 years old with no contra indication of the general anesthesia suffering of lesion relevant of endoscopic submucosal dissection treatment.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Brabois

Nancy, Meurthe ET Moselle, 54000, France

Location

MeSH Terms

Conditions

Colonic Polyps

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jean Baptiste CHEVAUX

  Doctor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: November 30, 2020
• Study Start: June 16, 2016
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

FR (1)