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Optimizing the Role of ERCP in Evaluating Indeterminate Bile Duct Strictures


N/A
18 Years
N/A
Open (Enrolling)
Both
Indeterminate Bile Duct Stricture

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Trial Information

Optimizing the Role of ERCP in Evaluating Indeterminate Bile Duct Strictures


Inclusion Criteria:



- Extrahepatic BDS with no discrete mass on CT/MRI (either or both)

- A BDS is defined as a segmental narrowing of the bile duct > 50% of the proximal or
distal unaffected duct.

- Biochemical evidence of cholestasis (increase in alkaline phosphatase ≥ 2x upper
limit of normal ± total bilirubin ≥2.0mg/dL)

Exclusion Criteria:

- No clinical suspicion for malignancy

- Associated mass seen on CT or MRI

- Age ≤18, pregnancy, incarceration, inability to give informed consent

- Inability to undergo standard ERCP (e.g., postsurgical anatomy)

- Previous ERCP with sampling of BDS, other than a single brushing specimen sent for
routine cytopathology

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Performance characteristics

Outcome Description:

A definite diagnosis of malignancy (i.e., "true positive") will be defined as either 1) a cytological or histological interpretation "positive for malignancy" based on brushing for RC or biopsy; 2) subsequent cytological or histological confirmation of malignancy within one year of the index procedure, via repeat ERCP, surgery, other diagnostic test. If a diagnosis of cancer is not confirmed after one year of follow-up, then the stricture will be classified as non-malignant and the negative cytology, FISH and histology from the index ERCP considered "true negatives."

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Gregory A Cote, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Institutional Review Board

Study ID:

10895519

NCT ID:

NCT01580709

Start Date:

April 2012

Completion Date:

April 2016

Related Keywords:

  • Indeterminate Bile Duct Stricture
  • stricture
  • cholangiocarcinoma
  • pancreatic adenocarcinoma
  • bile duct
  • ERCP
  • Cholestasis
  • Constriction, Pathologic

Name

Location

Indiana University Health University HospitalIndianapolis, Indiana  46202