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Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02284802
Recruitment Status : Recruiting
First Posted : November 6, 2014
Last Update Posted : August 8, 2018
Information provided by (Responsible Party):
Fauze Maluf Filho, Instituto do Cancer do Estado de São Paulo

Brief Summary:

Confocal endomicroscopy is an emerging technique that allows in vivo imaging of cells and tissue structures of the gastrointestinal mucosa, with a magnification of about 1000 times, guiding optical biopsies in real time. Confocal endomicroscopy represents technique that combines conventional white light image with the confocal microscope probe, thereby allowing examination of the surface epithelium in vivo and histological diagnosis during endoscopy. Among the applications already established for its use, stand out diagnosis of Barrett's esophagus, gastric atrophy and intestinal metaplasia, celiac disease, differentiation of hyperplastic adenomatous polyps of the colon, microscopic colitis and follow-up of patients with inflammatory disease, reducing the need for endoscopic biopsies. The CLE can still detect molecular changes effectively improving the endoscopic diagnosis. This pilot project consists of 07 subprojects which the technology of confocal endomicroscopia will be evaluated and compared with the histological results of biopsy or surgical specimens:

1. confocal endomicroscopy for the diagnosis of high-grade dysplasia and superficial esophageal adenocarcinoma in patients with Barrett's esophagus 2 Diagnosis of superficial esophageal squamous cell carcinoma in patients with head and neck cancer by confocal endomicroscopy 3 Detect the presence of premalignant lesions in the gastric stump in patients with reflux alkaline gastritis after partial gastrectomy 4. detect lesions in the gastric mucosa of patients with familial history of gastric cancer 5 Biliary Strictures: differential diagnosis by confocal endomicroscopia 6 confocal Endomicroscopy of cystic neoplasms of the pancreas 7 Contribution of confocal endomicroscopy for the differential diagnosis of colorectal polyps The project aims to deploy the structure of the Confocal endomicroscopy Endoscopy ICESP, for performing in vivo histological examinations of the digestive tract, biliary tract and pancreas. All research groups involved in the early detection of tumors of the esophagus, stomach, biliary tract, pancreas, colon and rectum may benefit from the implementation of this methodology.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Gastric Antrectomy Partial Biliary Duct Stricture Pancreatic Duct Stricture Colorectal Polyps Esophageal Epidermoid Cancer in Pts With Head and Neck Cancer Procedure: Confocal endomicroscopy Not Applicable

Detailed Description:
Confocal Endomicroscopy procedure: eligible patients which consent to participate in the study will be submitted to endoscopic procedures under conscious or deep sedation. The patients will receive an intravenous injection of 2.5-5 mL of 10% sodium fluorescein at the beginning of the endoscopic procedure. The endoscope will target the area of interest and the confocal probe will be passed through the endoscope biopsy channel. The probe will gently and perpendicularly touch the mucosal surface of the area of the interest. The images will be recorded and a presumptive diagnosis will be made. The area of interest will be biopsied and the histology results will be considered the diagnostic gold standard method. We will calculate the diagnostic accuracy of the presumptive diagnosis provided by the confocal endomicroscopy examination.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy
Study Start Date : September 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Confocal endomicroscopy
Pts will be submitted to confocal endomicroscopy examination of the area of interest during endoscopy. A presumptive diagnosis will be made. This diagnosis will be compared to the definitive histologic diagnosis provided by endoscopic biopsies of the area of interest.
Procedure: Confocal endomicroscopy
Confocal endomicroscopy examination during endoscopy

Primary Outcome Measures :
  1. Diagnostic accuracy of confocal endomicroscopy for the early detection of tumors of the digestive tract [ Time Frame: Less than 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Minimum age of 18 years old
  • Clinical conditions for the proposed endoscopic procedure
  • Sign the informed consent

Exclusion Criteria:

  • History of anaphylactic reactions to fluorescein

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02284802

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Contact: Fauze Maluf-Filho, MD, PHD 5511991919014

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Instituto do Câncer do Estado de São Paulo - ICESP Recruiting
São Paulo, Brazil, 01246-000
Contact: Fauze Fauze-Maluf, MD, PHD    5511991919014   
Principal Investigator: Fauze Maluf-FIlho, MD, PHD         
Sponsors and Collaborators
Fauze Maluf Filho
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Principal Investigator: Fauze Maluf-FIlho, MD, PHD Instituto do Cancer do Estado de São Paulo

Publications of Results:
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Responsible Party: Fauze Maluf Filho, MD, PHD, Instituto do Cancer do Estado de São Paulo Identifier: NCT02284802     History of Changes
Other Study ID Numbers: NP354/13
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Barrett Esophagus
Constriction, Pathologic
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical