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

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.

• Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system (Device)

Primary outcomes

• Sensitivity [October 2011]: 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.
• Specificity [October 2011]: 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.
• PPV (Positive Predictive Value) [October 2011]: 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.
• NPV (Negative Predictive Value) [October 2011]: 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.

Secondary outcomes

• Overall Complication Rate [August 2011]: Assess the safety of nCLE, by recording any possible adverse event or complications occurring during or shortly after the EUSFNA and nCLE procedure

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients scheduled for an EUSFNA procedure of a pancreatic cyst,
* Patients aged 18 years or older,
* Patients is under surgical consideration for management of the cyst
* Patients have provided written informed consent for the study

Exclusion Criteria:

* Allergy to fluorescein
* Pregnancy or breast-feeding

Participant flow

Outcome results

• Sensitivity (Primary), Number, percentage of participants: nCLE System (Stage 2) 59 (36 to 79)
• Overall Complication Rate (Secondary), Number, percentage of participants: nCLE System 9 (3 to 19)
• Specificity (Primary), Number, percentage of participants: nCLE System (Stage 2) 100 (66 to 100)
• PPV (Positive Predictive Value) (Primary), Number, percentage of participants: nCLE System (Stage 2) 100 (75 to 100)
• NPV (Negative Predictive Value) (Primary), Number, percentage of participants: nCLE System (Stage 2) 50 (26 to 74)

Adverse events

Time frame: Patients were contacted one week after procedure by telephone.

Serious adverse events by term

Other adverse events by term

• Irving Waxman, MD, Principal investigator, University of Chicago