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

Pancreatic Cyst Clinical Trial

— CONCYST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523170
• Other study ID #: 13/0572
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: April 2018

Study information

• Verified date: September 2019
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystadenoma, Mucinous
• Intraductal Papillary Mucinous Neoplasm
• Pancreatic Cyst
• Pancreatic Neoplasms
• Serous Cystadenoma

Intervention

Device:
• AQ-Flex 19 probe (Mauna Kea Technologies, Paris)
Needle-based Confocal Laser Endomicroscopy (nCLE)

Locations

Country	Name	City	State
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Royal Free Hospital	London
United Kingdom	University College London Hospitals	London
United Kingdom	Freeman Hospital	Newcastle

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events	Record the number of participants with an adverse event due to EUS-nCLE	3 years
Secondary	Interpretation criteria	Develop and validate interpretation criteria for nCLE in the pancreas	3 years
Secondary	Assess margins	Assess the diagnostic accuracy of nCLE in defining the margins and extent of pancreatic tumours intraoperatively	3 years

External Links

•   Publication