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

NCT01887509 | Terminated

• 2 other identifiers: 12-0052013-A00406-39
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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) 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

Keywords

Rectal cancer; Tumor margin; Confocal endomicroscopy; Virtual biopsy; Fluorescein

Outcome Measures

Primary Outcomes (1)

• Concordance in identification of lower pole of tumor

  Identification of lower pole of tumor will be compared between pCLE (optical images, virtual biopsies) and conventional histopathology (biopsies, postoperative analysis of resected piece). Samples of tumor tissue and closest tissue thought to be disease-free. Conventional biopsies and virtual biopsies prior to radiochemotherapy start (if applicable) and during surgery.

  Up to 9 months

Secondary Outcomes (5)

• Identification of tissue characteristics

  Up to 9 months

• Concordance of techniques (pCLE and histopathology)

  Up to 9 months

• Comparison of pCLE results to EUS (echoendoscopy) results

  Upon surgery

• Creation of an image bank

  Up to 9 months

• Assessment of predictive value of interpretation criteria

  Up to 9 months

Interventions

Probe-based confocal laser endomicroscopy DEVICE

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.

Also known as: Cellvizio® with ColoFlex probe

Rectoscopy PROCEDURE

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.

EUS PROCEDURE

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.

Also known as: Echoendoscopy

Biopsy and resection PROCEDURE

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.

Eligibility Criteria

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

You may qualify if:

• 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
• 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 having forfeited their freedom of an administrative or legal obligation
• Patient being under guardianship

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de chirurgie digestive et endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67000, France

Location

Related Publications (1)

• Wijsmuller AR, Ghnassia JP, Varatharajah S, Schaeffer M, Leroy J, Marescaux J, Ignat M, Mutter D. Prospective Trial on Probe-Based Confocal Laser Endomicroscopy for the Identification of the Distal Limit in Rectal Adenocarcinoma. Surg Innov. 2018 Aug;25(4):313-322. doi: 10.1177/1553350618773011. Epub 2018 May 7.

  PMID: 29732957 RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Proctoscopy; Biopsy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

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; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques

Study Officials

• Joël Leroy, Pr

  Service de Chirurgie Disgestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 27, 2013
• Study Start: November 7, 2013
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

FR (1)