Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy-A Pilot Study

NCT01447238 | Completed DMC

• 1 other identifier: HS2010-7729
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE).

Conditions

Pancreatic Cysts

Keywords

pancreatic cysts; EUS/FNA; Needle-based Confocal Laser Endomicroscopy (nCLE); fiber optic imaging; EUS/FNA of pancreatic cysts

Outcome Measures

Primary Outcomes (1)

• Assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE)

  Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.

  From the date of imaging until follow up for 6 months to two years.

Interventions

Direct visualization and needle based confocal laser-induced endomicroscopy miniprobe DEVICE

Patients will undergo the EUS-FNA procedure, as per standard of care, plus an additional direct visualization (fiber optic probe) and nCLE procedure with the prototype probes, which will add 10 minutes maximum to the EUS-FNA procedure. The probes will be positioned against the lining of the pancreatic cyst, and images will be acquired. After imaging, fine needle aspiration of the lesion will be performed, as usual.

Also known as: Cellvizio, nCLE, Spyglass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients underoing EUS-FNA procedure for pancreatic cyst.

You may qualify if:

• Patients scheduled for an EUS-FNA procedure of a pancreatic cyst,
• Aged above 18 years
• Granted written informed consent for the study can be included in the study.

You may not qualify if:

• Contraindication for undergoing EUS/FNA procedure (such as unwilling or medically unstable patients, patients with severe coagulopathy, patients with poor visualization on EUS for various reasons, etc)
• Pregnant or breastfeeding
• Allergy to fluorescein
• Renal insufficiency

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (1)

• Nakai Y, Iwashita T, Park DH, Samarasena JB, Lee JG, Chang KJ. Diagnosis of pancreatic cysts: EUS-guided, through-the-needle confocal laser-induced endomicroscopy and cystoscopy trial: DETECT study. Gastrointest Endosc. 2015 May;81(5):1204-14. doi: 10.1016/j.gie.2014.10.025. Epub 2015 Jan 26.

  PMID: 25634486 DERIVED

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Kenneth J Chang, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: October 6, 2011
• Study Start: September 15, 2010
• Primary Completion: September 21, 2018
• Study Completion: September 21, 2018
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

US (1)