NCT02543151

Brief Summary

The purpose of this study is to describe SpyGlass choledochoscopy in patients with post orthotopic liver transplant (OLT) biliary strictures prior to endoscopic therapy and ductal changes after treatment stents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration 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

First Submitted

Initial submission to the registry

September 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

September 2, 2015

Last Update Submit

April 15, 2019

Conditions

Liver Transplant DisorderBiliary Anastomosis Complication

Keywords

Biliary strictureCholangioscopySpyglassLiver transplant

Outcome Measures

Primary Outcomes (1)

  • Documentation of biliary ductal changes in post-liver transplant biliary complications.

    The study aim is to describe biliary ductal changes in post-liver transplant presenting biliary complications

    2 years

Secondary Outcomes (1)

  • Number of Participants with Adverse Events.

    2 years

Other Outcomes (1)

  • Procedural success rate:

    1 year

Study Arms (1)

SpyGlass Choledochoscopy procedure

EXPERIMENTAL

Any patient referred to endoscopic management for biliary post liver transplant complication without previous treatment will be submitted to SpyGlass (direct visualization system) choledochoscopy procedure.

Procedure: SpyGlass (direct visualization system) choledochoscopy

Interventions

SpyGlass (direct visualization system) choledochoscopyPROCEDURE

SpyGlass (direct visualization system) choledochoscopy procedure will be performed pre and post biliary complication treatment

SpyGlass Choledochoscopy procedure

Eligibility Criteria

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

You may qualify if:

  • Patients referred to endoscopic management for biliary post liver transplant complication without previous treatment

You may not qualify if:

  • Patients referred to endoscopic management for biliary post liver transplant complication with any previous treatment.
  • Below 18 years of age
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Location

Related Publications (4)

  • Chen YK, Pleskow DK. SpyGlass single-operator peroral cholangiopancreatoscopy system for the diagnosis and therapy of bile-duct disorders: a clinical feasibility study (with video). Gastrointest Endosc. 2007 May;65(6):832-41. doi: 10.1016/j.gie.2007.01.025.

    PMID: 17466202BACKGROUND

  • Draganov PV, Lin T, Chauhan S, Wagh MS, Hou W, Forsmark CE. Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system. Gastrointest Endosc. 2011 May;73(5):971-9. doi: 10.1016/j.gie.2011.01.003. Epub 2011 Mar 17.

    PMID: 21419408BACKGROUND

  • Tringali A, Lemmers A, Meves V, Terheggen G, Pohl J, Manfredi G, Hafner M, Costamagna G, Deviere J, Neuhaus H, Caillol F, Giovannini M, Hassan C, Dumonceau JM. Intraductal biliopancreatic imaging: European Society of Gastrointestinal Endoscopy (ESGE) technology review. Endoscopy. 2015 Aug;47(8):739-53. doi: 10.1055/s-0034-1392584. Epub 2015 Jul 6.

    PMID: 26147492BACKGROUND

  • Hasan M, Canipe A, Tharian B, Navaneethan U, Varadarajulu S, Hawes R. Digital cholangioscopy-directed removal of a surgical staple from a strictured bile duct. Gastrointest Endosc. 2015 Nov;82(5):958. doi: 10.1016/j.gie.2015.05.035. Epub 2015 Jun 25. No abstract available.

    PMID: 26117180BACKGROUND

Study Officials

  • ANGELO P FERRARI, MD

    Attending physician

    STUDY DIRECTOR

  • FERNANDA P MARTINS, MD

    Attending physician

    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
Attending physician

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 7, 2015

Study Start

March 1, 2016

Primary Completion

June 1, 2017

Study Completion

October 1, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

BR(1)