NCT02284802

Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy

Completed NA Last updated 23 March 2023

What this trial tests

NA trial testing Confocal endomicroscopy in Barrett Esophagus in 87 participants. Completed in 10 March 2023.

Timeline

10 September 2014

Primary endpoint
10 March 2023

10 March 2023

Quick facts

Lead sponsor	Fauze Maluf Filho
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	87
Start date	10 September 2014
Primary completion	10 March 2023
Estimated completion	10 March 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Confocal endomicroscopy

Conditions studied

• Barrett Esophagus — all drugs for Barrett Esophagus →
• Gastric Antrectomy Partial — all drugs for Gastric Antrectomy Partial →
• Biliary Duct Stricture — all drugs for Biliary Duct Stricture →
• Pancreatic Duct Stricture — all drugs for Pancreatic Duct Stricture →

Sponsor

Fauze Maluf Filho — full company profile →

Who can join

18 and older, any sex, with Barrett Esophagus or Gastric Antrectomy Partial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Role of Probe-Based Confocal Laser Endomicroscopy (pCLE) in the Diagnosis of Sustained Clinical Complete Response Under Watch-and-Wait Strategy After Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Adenocarcinoma: a Score Validation.
   Safatle-Ribeiro AV, Ribeiro U, Lata J, Baba ER, et al · · 2023 · cited 6× · PMID 37291428 · DOI 10.1007/s11605-023-05732-7