Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy
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|ClinicalTrials.gov Identifier: NCT02284802|
Recruitment Status : Unknown
Verified September 2015 by Fauze Maluf Filho, Instituto do Cancer do Estado de São Paulo.
Recruitment status was: Recruiting
First Posted : November 6, 2014
Last Update Posted : November 30, 2015
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||February 2017|
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
- Diagnostic accuracy of confocal endomicroscopy for the early detection of tumors of the digestive tract [ Time Frame: Less than 7 days ]
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 ClinicalTrials.gov identifier (NCT number): NCT02284802
|Contact: Fauze Maluf-Filho, MD, PHDfirstname.lastname@example.org|
|Instituto do Câncer do Estado de São Paulo - ICESP||Recruiting|
|São Paulo, Brazil, 01246-000|
|Contact: Fauze Fauze-Maluf, MD, PHD 5511991919014 email@example.com|
|Principal Investigator: Fauze Maluf-FIlho, MD, PHD|
|Principal Investigator:||Fauze Maluf-FIlho, MD, PHD||Instituto do Cancer do Estado de São Paulo|