Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Cysts

Pancreatic Cyst

Pancreatic Diseases

Gastrointestinal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system

Irving Waxman, MD

Assess the safety and efficacy of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in differentiating benign from malignant and premalignant cysts (e.g. mucinous from non-mucinous cysts)

The primary aim of the study is to define interpretation criteria to differentiate mucinous from non-mucinous cysts and classify more precisely the cysts. Once these criteria have been defined, the diagnostic parameters of nCLE in differentiating the different types of cysts and the reproducibility of these criteria will be assessed.

In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors

Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.

For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.

In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.

Assess the safety of nCLE, by recording any possible adverse event or complications occurring during or shortly after the EUSFNA and nCLE procedure

Mauna Kea Technologies

Institut Paoli-Calmettes

Technical University of Munich

Yale University

University of California, Irvine

Mayo Clinic

University of Washington

Cedars-Sinai Medical Center

University of Chicago

Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).

nCLE System

Age, Continuous

Sex: Female, Male

Dr. Vani J.A. Konda

Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).

nCLE System (Stage 2)

Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.

Spots Global Cancer Trial Database for In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial