Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in Cystic Tumors of the Pancreas
1 other identifier
interventional
40
1 country
1
Brief Summary
This study focuses on pancreatic cysts, especially malignant pancreatic cysts. The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by: Ruling out malignancy for patients with benign appearing nCLE images. Characterizing more malignant tumors in the pancreas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 19, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 14, 2020
June 1, 2020
5.4 years
May 19, 2017
July 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts
Diagnostic performance of the Cellvizio nCLE system compared with pathological results or consensus review at a multidisciplinary tumor board meeting
Within 6 months after the end of Follow-up period
Secondary Outcomes (2)
Safety data on nCLE during EUS-FNA procedure (rate of procedure related complication)
Within 3 months after the end of the enrollment period
Feasibility data on nCLE during EUS-FNA procedure (rate of successful nCLE procedure)
Within 3 months after the end of the enrollment period
Study Arms (1)
pancreatic cysts
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female \> 18 years of age.
- Patient indicated for a first EUS-FNA for a pancreatic cyst or
- Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for pancreatic cyst more than three months ago.
- Patient with known pancreatic cyst detected at cross-sectional imaging
- Willing and able to comply with study procedures and provide written informed consent to participate in the study.
You may not qualify if:
- Subjects for whom EUS-FNA procedures are contraindicated
- Known allergy to fluorescein dye
- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Study Officials
- PRINCIPAL INVESTIGATOR
Aiming Yang, M.D.
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2017
First Posted
June 9, 2017
Study Start
July 1, 2016
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
July 14, 2020
Record last verified: 2020-06