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NCT02935049 Clinical Trial

Evaluation of the Resection of Adenoma and Colic Adenocarcinoma by EMR Piecemeal or EMR/ESD Hybrid Technique

Colorectal Adenoma Clinical Trial

— HYBRID ESD  

Official title:
Evaluation of the Resection of Adenoma and Colic Adenocarcinoma by EMR Piecemeal or EMR/ESD Hybrid Technique

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02935049
Other study ID # HYBRID ESD-IPC 2016-015
Secondary ID
Status Recruiting
Phase N/A
First received October 13, 2016
Last updated October 25, 2017
Start date October 2016
Est. completion date October 2018

Study information
Verified date October 2017
Source Institut Paoli-Calmettes
Contact GENRE Dominique, MD
Phone +33 (4) 91 22 37 78
Email drci.up@ipc.unicancer.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

For tough colic resection, evaluation of our practice for these lesions unresectable in monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy dissection) /ESD (submucosal dissection)

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date October 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 years,

- Patient with colorectal adenoma or intramucinous adenocarcinoma

Exclusion Criteria:

- Contraindication surgery

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endoscopic resection
Endoscopic resection with technique EMR piecemeal or hybrid technique EMR/ESD

Locations
Country Name City State
France GENRE Marseille

Sponsors (1)
Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relapse rate Medical follow-up From surgery to 1 year
Secondary Complications rate haemorrhage or perforation From surgery to 6 months
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