Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology

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) will be compared to histopathology analysis.

This study focuses on the evaluation of rectal tumor margins. The hypothesis is that pCLE will allow identification of rectal tumor margin, comparable to that of histopathology. In the future, decision of resection margin could rely on intraoperative pCLE exam.

The proposed study is a feasibility study, first in the indication of rectal cancer.

Conditions

• Rectal Cancer
• Rectal Adenocarcinoma

Interventions

DEVICE

Probe-based confocal laser endomicroscopy

Patients will undergo: * Conventional rectoscopy * pCLE exam following injection of fluorescein, fluorescent contrast agent * EUS : echoendoscopy * Biopsies for histopathology : location identical to those of pCLE * Tumor resection will be performed according to standard oncologic principles. All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view. Biopsies will be harvested in both healthy and tumor tissue as well. After all procedures are complete, a second assessment of pCLE images by a third party will be performed.

PROCEDURE

Rectoscopy

Patients will undergo: * Conventional rectoscopy * pCLE exam following injection of fluorescein, fluorescent contrast agent * EUS : echoendoscopy * Biopsies for histopathology : location identical to those of pCLE - Tumor resection will be performed according to standard oncologic principles. All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view. Both healthy and tumor tissue will be examined.

PROCEDURE

EUS

Patients will undergo: * Conventional rectoscopy * pCLE exam following injection of fluorescein, fluorescent contrast agent * EUS : echoendoscopy * Biopsies for histopathology : location identical to those of pCLE - Tumor resection will be performed according to standard oncologic principles. All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view.

PROCEDURE

Biopsy and resection

Patients will undergo: * Conventional rectoscopy * pCLE exam following injection of fluorescein, fluorescent contrast agent * EUS : echoendoscopy * Biopsies for histopathology : location identical to those of pCLE * Tumor resection will be performed according to standard oncologic principles. All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view. Biopsies will be harvested in both healthy and tumor tissue as well.

Sponsors & Collaborators

• IHU Strasbourg

  lead OTHER

Principal Investigators

• Joël Leroy, Pr · Service de Chirurgie Disgestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-07

Primary Completion

2017-10-17

Completion

2017-10-17

Countries

• France

Study Locations