NCT02523170

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

2.3 years

First QC Date

June 22, 2015

Last Update Submit

September 30, 2019

Conditions

Pancreatic CystSerous CystadenomaIntraductal Papillary Mucinous NeoplasmCystadenoma, Mucinous

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Assess the diagnostic accuracy of the Cellvizio nCLE system for diagnosing cystic lesions of the pancreas, compared to standard diagnostic modalities

    3 years

Secondary Outcomes (3)

  • Adverse events

    3 years

  • Interpretation criteria

    3 years

  • Assess margins

    3 years

Study Arms (1)

EUS guided nCLE

EXPERIMENTAL

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.

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

Interventions

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

Needle-based Confocal Laser Endomicroscopy (nCLE)

EUS guided nCLE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging for which EUS-FNA is indicated.
  • Pancreatic cystic tumour \>1cm in size.
  • ECOG performance status 0, 1 or 2.
  • Estimated life expectancy of at least 12 weeks.
  • Age \>18 years.
  • Capable of giving written informed consent.
  • Has not has pancreatitis within the previous 3 months.
  • 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.

You may not qualify if:

  • Acute pancreatitis in the last 3 months.
  • Subject with multiple cysts
  • Subjects for whom EUS-FNA or surgery are contraindicated
  • Known allergy to fluorescein dye
  • 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.
  • Any psychiatric disorder making reliable informed consent impossible.
  • Pregnancy or breast-feeding.
  • ECOG performance status 3 or 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Addenbrookes Hospital

Cambridge, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

University College London Hospitals

London, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Related Publications (1)

  • Keane MG, Wehnert N, Perez-Machado M, Fusai GK, Thorburn D, Oppong KW, Carroll N, Metz AJ, Pereira SP. A prospective trial of CONfocal endomicroscopy in CYSTic lesions of the pancreas: CONCYST-01. Endosc Int Open. 2019 Sep;7(9):E1117-E1122. doi: 10.1055/a-0957-2976. Epub 2019 Aug 29.

    PMID: 31475228BACKGROUND

Related Links

MeSH Terms

Conditions

Pancreatic CystCystadenoma, SerousCystadenoma, Mucinous

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System DiseasesCystadenomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Cystic, Mucinous, and Serous

Study Officials

  • Steve Pereira, PhD FRCP

    University College, London

    PRINCIPAL INVESTIGATOR

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

June 22, 2015

First Posted

August 14, 2015

Study Start

July 1, 2014

Primary Completion

October 1, 2016

Study Completion

April 1, 2018

Last Updated

October 2, 2019

Record last verified: 2019-09

Locations

GB(4)