Status:
TERMINATED
Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology
Lead Sponsor:
IHU Strasbourg
Conditions:
Rectal Cancer
Rectal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This innovative study will involve the use of probe-based confocal laser endomicroscopy, a new medical imaging technology never used for surgical indications to date. Virtual biopsies (pCLE images) wi...
Detailed Description
Defining the limits of resection of rectal tumors is often imprecise. The identification of the banks of a tumor becomes critical when it comes to the decision to potentially sacrifice the sphincter d...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patient, male or female over 18 years old
- Patient with rectal adenocarcinoma :
- stage T1 or T2, N0 (one single evaluation, during resection)
- stage N+ or T3 (pre- and post-radiochemotherapy evaluations)
- Absence of contra-indication to rectoscopy conduct
- Patient able to understand the study and to provide written informed consent
- Patient registered with the French social security regime
- Non-inclusion criteria:
- Absence of written informed consent
- Patient with known or suspected allergy to fluorescein
- Patient with history of reaction jeopardizing the vital prognosis during angiography
- Patient with history of multiple or serious allergic reaction to drugs
- Patient presenting, in the investigator's judgment, a condition or disease preventing their participation to study procedures
- Patient pregnant or breast-feeding
- Patient within exclusion period from other clinical trial
- Patient having forfeited their freedom of an administrative or legal obligation
- Patient being under guardianship
Exclusion
Key Trial Info
Start Date :
November 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2017
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01887509
Start Date
November 7 2013
End Date
October 17 2017
Last Update
May 15 2018
Active Locations (1)
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1
Service de chirurgie digestive et endocrinienne - Nouvel Hôpital Civil
Strasbourg, France, 67000