NCT01815619

Brief Summary

This study will test two different methods for processing biopsy specimens taken from the bile duct. Patient;s who are asked to participate int his study have a stricture in the bile duct that needs a single operator cholangioscopy-guided biopsies during endoscopic retrograde cholangiopancreatography (ERCP) so that a diagnosis can be made. Standard of care includes performing single operator cholangioscopy-guided biopsies in the bile duct and sending the tissue to the lab for testing to make a diagnosis. Using this method the investigators can establish a diagnosis only about 50% of the time. The investigators believe that if a cytopathologist is available in the endoscopy suite during the procedure to evaluate the biopsy specimens onsite, the investigators can improve the diagnostic accuracy. The purpose of this study is to compare two methods for processing biopsies obtained from the bile duct (Onsite vs. Offsite).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2020

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

7.2 years

First QC Date

February 26, 2013

Last Update Submit

August 2, 2023

Conditions

Bile Duct Stricture

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of cholangioscopy-directed biopsies of bile duct strictures

    The primary endpoint of the study is to compare the diagnostic accuracy rates between two different methods used for processing specimens obtained from the bile duct.

    up to18 months

Secondary Outcomes (4)

  • Specimen evaluation

    up to18 months

  • Operating characteristics

    up to18 months

  • Costs difference between the onsite and offsite procedures

    up to 18 months

  • Number of biopsies to achieve diagnosis

    up to 18 months

Study Arms (2)

on-site evaluation of specimens by cytopathologist

EXPERIMENTAL

The specimen will be evaluated onsite by a cytopathologist during the procedure to render a diagnosis

Other: on-site specimen evaluation

off-site specimen evaluation

ACTIVE COMPARATOR

The specimen will be evaluated offsite by a cytopathologist during the procedure and render a diagnosis

Other: off-site specimen evaluation

Interventions

on-site specimen evaluationOTHER

The specimen will be evaluated on-site by a cytopathologist during the procedure to render a diagnosis

on-site evaluation of specimens by cytopathologist
off-site specimen evaluationOTHER

The specimen will be evaluated off-site by a cytopathologist

off-site specimen evaluation

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Suspected biliary stricture

You may not qualify if:

  • Age \< 18 years
  • Pregnancy
  • Altered surgical anatomy
  • Irreversible elevation in INR \> 1.5 or low platelet count \< 50,000

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Related Publications (2)

  • Bang JY, Navaneethan U, Hasan M, Sutton B, Hawes R, Varadarajulu S. Optimizing Outcomes of Single-Operator Cholangioscopy-Guided Biopsies Based on a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Feb;18(2):441-448.e1. doi: 10.1016/j.cgh.2019.07.035. Epub 2019 Jul 24.

    PMID: 31351135DERIVED

  • Navaneethan U, Hasan MK, Kommaraju K, Zhu X, Hebert-Magee S, Hawes RH, Vargo JJ, Varadarajulu S, Parsi MA. Digital, single-operator cholangiopancreatoscopy in the diagnosis and management of pancreatobiliary disorders: a multicenter clinical experience (with video). Gastrointest Endosc. 2016 Oct;84(4):649-55. doi: 10.1016/j.gie.2016.03.789. Epub 2016 Mar 16.

    PMID: 26995690DERIVED

Study Officials

  • Shyam Varadarajulu, MD

    AdventHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 21, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2020

Study Completion

August 25, 2020

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)