Confocal Endomicroscopy for Biliary Strictures -Phase I

NCT00892632 | Terminated DMC

• 1 other identifier: 08-008669
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that the confocal endomicroscopy imaging of the biliary strictures during ERCP will differentiate between benign and malignant strictures in vivo and has increased sensitivity compared to biliary brushing/biopsy, and that direct cholangioscopic guidance of pCLE is more accurate than fluoroscopic guidance.

Conditions

Biliary Stricture

Keywords

Biliary Strictures; Cholangiocarcinoma; ERCP

Outcome Measures

Primary Outcomes (1)

• Primary Aim: 1. To compare confocal image characteristics of benign vs. malignant biliary strictures.

  one year

Secondary Outcomes (1)

• Secondary Aim: 1. To compare the technical feasibility (percentage of images rated as adequate or better) and the quality of the images obtained via fluoroscopy-guided pCLE versus cholangioscopy-guided pCLE.

  One year

Study Arms (1)

1

EXPERIMENTAL

1\. To compare confocal image characteristics of benign vs. malignant biliary strictures

Procedure: ERCP and Confocal imaging

Interventions

ERCP and Confocal imaging PROCEDURE

A major new advancement in cancer imaging is the development of a probe-based confocal endomicroscopy (pCLE) system capable of cellular and sub-cellular imaging of the biliary tree.

1

Eligibility Criteria

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

You may qualify if:

• Pre-ERCP: Age above 18; imaging consistent with stenosis/mass of the hilum/extra-hepatic bile duct with abnormal liver chemistry, or painless jaundice referred for ERCP.
• Evidence of biliary obstruction as defined by elevated direct bilirubin (\> 1.5ULN) and dilation of the common or hepatic ducts \> 8mm) on imaging studies.

You may not qualify if:

• Unwilling/unable to consent.
• Definite pancreatic mass on CT/MR.
• Allergy to Fluorescein.
• Pregnancy (patient who could be pregnant will undergo pregnancy testing as per routine care)
• Indwelling metal biliary stent.

Sponsors & Collaborators

• Mayo Clinic: lead
• Leadiant Biosciences, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Michael B. Wallace, M.D.

  Mayo Clinic

  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: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: May 4, 2009
• Study Start: April 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 24, 2012

Record last verified: 2012-02

Locations

US (1)