A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-04-30

Brief Summary

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A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by standard surveillance. This part of the study will recruit 60 patients.

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Detailed Description

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A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by standard surveillance. This part of the study will recruit 60 patients. The study also includes a feasibility study to evaluate the role of intraoperative nCLE in the diagnosis and staging of pancreatic tumours. This part of the study will recruit a further 20 patients.

Primary endpoint:

Assess the diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts, compared to standard diagnostic modalities.

Secondary endpoints:

* Assess the safety and efficacy of EUS-nCLE.
* Assess the impact of the Cellvizio nCLE system on the management of patients with pancreatic cysts.
* Develop and validate interpretation criteria for nCLE in the pancreas.
* Assess the diagnostic performance of nCLE in characterising and staging pancreatic tumours intraoperatively.

Conditions

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Pancreatic Cyst Serous Cystadenoma Intraductal Papillary Mucinous Neoplasm Cystadenoma, Mucinous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EUS guided nCLE

For patients with indeterminate cystic lesions of the pancreas, in addition to routine diagnostic investigations, patients participating in the study will undergo needle based confocal laser endomicroscopy (using the AQ-flex 19 probe - Mauna Kea Technologies, Paris France) at the time of their endoscopic ultrasound.

Group Type EXPERIMENTAL

AQ-Flex 19 probe (Mauna Kea Technologies, Paris)

Intervention Type DEVICE

Needle-based Confocal Laser Endomicroscopy (nCLE)

Interventions

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AQ-Flex 19 probe (Mauna Kea Technologies, Paris)

Needle-based Confocal Laser Endomicroscopy (nCLE)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging for which EUS-FNA is indicated.
2. Pancreatic cystic tumour \>1cm in size.
3. ECOG performance status 0, 1 or 2.
4. Estimated life expectancy of at least 12 weeks.
5. Age \>18 years.
6. Capable of giving written informed consent.
7. Has not has pancreatitis within the previous 3 months.
8. Women of child-bearing potential must have a negative pregnancy test in the week before nCLE, AND be using an adequate contraception method, which must be continued for at least 1 week after nCLE.

Exclusion Criteria

1. Acute pancreatitis in the last 3 months.
2. Subject with multiple cysts
3. Subjects for whom EUS-FNA or surgery are contraindicated
4. Known allergy to fluorescein dye
5. Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial.
6. Any psychiatric disorder making reliable informed consent impossible.
7. Pregnancy or breast-feeding.
8. ECOG performance status 3 or 4

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No