Pancreatic Cysts
Conditions
Keywords
Pancreatic cysts
Brief summary
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)
Detailed description
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.
Interventions
DEVICECellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system
Sponsors
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
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| nCLE System Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). | 66 |
| Total | 66 |
Baseline characteristics
| Characteristic | nCLE System |
|---|---|
| Age, Continuous | 63.1 years |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 66 |
| serious Total, serious adverse events | 1 / 66 |
Outcome results
Primary
NPV (Negative Predictive Value)
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.
Time frame: October 2011
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| nCLE System (Stage 2) | NPV (Negative Predictive Value) | 50 percentage of participants |
Primary
PPV (Positive Predictive Value)
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.
Time frame: October 2011
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| nCLE System (Stage 2) | PPV (Positive Predictive Value) | 100 percentage of participants |
Primary
Sensitivity
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.
Time frame: October 2011
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| nCLE System (Stage 2) | Sensitivity | 59 percentage of participants |
Primary
Specificity
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.
Time frame: October 2011
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| nCLE System (Stage 2) | Specificity | 100 percentage of participants |
Secondary
Overall Complication Rate
Assess the safety of nCLE, by recording any possible adverse event or complications occurring during or shortly after the EUSFNA and nCLE procedure
Time frame: August 2011
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| nCLE System (Stage 2) | Overall Complication Rate | 9 percentage of participants |