Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors

Completed

• Conditions: Superficial Colorectal Tumors
• Interventions: Other: Evaluation of the long-term complete remission rate (> 12 months)

• Registration Number: NCT03470883
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

To evaluate the long-term complete remission rate (\> 12 months) after endoscopic treatment of early neoplastic colorectal lesions.

Detailed Description

Intra-mucous colorectal neoplasia lesions (or even with minimal mucosal infiltration), formerly treated surgically, are increasingly treated endoscopically.

The IPC as a center for interventional endoscopy has been taking care of these lesions for several years.

Resection techniques have diversified since the 2000s (polypectomy, monobloc or piecemeal mucosectomy, submucosal dissection ... etc) and the endoscopy team has developed its various techniques within the institute ; Practice has evolved and has not been studied or evaluated in recent years. The purpose of this study is to evaluate practices and to compare results with the literature, and to identify predictive factors for the failure or success of endoscopic treatment of these early neoplastic lesions.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2017-11-02
• Status Verified: 2018-03
• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-20
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification during the last 5 years at the institute.

Exclusion Criteria

• Adenomas with low grade dysplasia
• Endoscopic control not available

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
endoscopic resection of a colorectal lesion	Evaluation of the long-term complete remission rate (> 12 months)	Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification during the last 5 years at the institute.

Primary Outcome Measures

Name	Time	Method
Complete long-term remission (> 12 months)	13 months	Evaluation of the long-term complete remission rate (\> 12 months)

Secondary Outcome Measures

Name	Time	Method
Rates of medium and long-term recurrence	13 months	Recurrence rate in the medium and long term
Endoscopic description and anatomopathological results	1 day	Endoscopic and / or anatomopathological predictive factors of success (complete long-term remission)
Absence of residual lesion on early control (3 to 6 months)	3 to 6 months	Medium-term response rate (3 to 6 months)
Management of medium and long-term recurrence	13 months	Management of recurrence (endoscopic revision or surgery)
Morbidity and mortality rates	13 months	Morbidity and mortality rate of endoscopic resection
Lymph node or visceral metastatic evolution rate	13 months	Rate of pejorative lymph node or metastatic evolution (especially for lesions with microinfiltration of the submucosa)

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, Bouches Du Rhone, France