Cell-Surface Plectin in the Diagnosis of Cholangiocarcinoma from ERCP-directed Biliary Samples

Not yet recruiting

• Conditions: Cholangiocarcinoma

• Registration Number: NCT06651346
• Lead Sponsor: University of Virginia

Brief Summary

Cholangiocarcinoma is a malignancy that is most-often diagnosed with ERCP-directed cytology brushings of the biliary tree, but the yield on this cytology has been previously shown to only be 5%-40%. Additionally, the vast majority (approximately 80%) of patients are not diagnosed until they are surgically unresectable (due to late stage at time of diagnosis), at which point there is no chance for cure and their only options are palliative. Therefore, better diagnostic modalities are needed. Plectin is a structural protein located inside of most cells, but it has been shown to be expressed on the cell surface of malignant cells in the pancreaticobiliary tract. The investigators hypothesize that ERCP-guided biliary samples can provide cells and immunohistochemical staining can detect cell surface plectin in patients with cholangiocarcinoma. This would be a novel diagnostic tool which could greatly reduce the time to diagnosis. A previously performed study pilot study at the University of Virginia (unpublished) showed that ERCP-directed biliary biopsies in patients with known cholangiocarcinoma had positive plectin immunohistochemistry, thus showing this is possible. In this current study, patients with a biliary stricture or tumor who are already undergoing ERCP as part of their routine clinical care (i.e. no procedures will be done exclusively for this research study) will undergo an additional biopsy and/or brushing to be assessed for cell-surface plectin expression via immunohistochemistry. The investigators hypothesize that plectin immunohistochemistry will have a higher sensitivity for cholangiocarcinoma than biopsies and/or brushings (cytology) alone.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-18
• Study First Posted: 2024-10-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Study Start: 2025-02-01
• Primary Completion: 2026-10-31
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Biliary stricture or mass seen on imaging; already undergoing ERCP as part of their routine clinical care

Exclusion Criteria

• Age < 18 years old; inability to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive plectin staining on IHC from ERCP-directed biliary samples	2 years	Positive plectin staining on IHC from ERCP-directed biliary samples

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States