ClinicalTrials.gg
Sign In
CompletedNCT02543151Updated Apr 17, 2019

SpyGlass in Post Liver Transplant Biliary Complications.

An interventional study of SpyGlass (direct visualization system) choledochoscopy in Liver Transplant Disorder and Biliary Anastomosis Complication, sponsored by Hospital Israelita Albert Einstein. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by Hospital Israelita Albert Einstein · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

A prospective observational clinical study to be conducted in Hospital Israelita Albert Einstein, a large open-access, private tertiary referral center.

Consecutive eligible patients with suspected post OLT biliary complications referred to endoscopic retrograde cholangiopancreatography (ERCP) will be considered to SpyGlass as follows.

In those patients with confirmed biliary stricture, SpyGlass direct choledochoscopy will be performed prior to endoscopic treatment with stents.

After final stent removal, choledochoscopy will be repeated to evaluate biliary ductal mucosa.

02

Conditions studied

  • Liver Transplant Disorder
  • Biliary Anastomosis Complication

Keywords

  • Biliary stricture
  • Cholangioscopy
  • Spyglass
  • Liver transplant
03

In context

Lead sponsor

Hospital Israelita Albert Einstein is the lead sponsor of 147 studies on the registry; 32 are open to participants now.

Browse Hospital Israelita Albert Einstein studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients referred to endoscopic management for biliary post liver transplant complication with any previous treatment.
  • Below 18 years of age
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    SpyGlass Choledochoscopy procedure

    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

  • ProcedureSpyGlass (direct visualization system) choledochoscopy

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

06

What researchers measure

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

    Time frame: 2 years

Secondary outcomes

  1. Number of Participants with Adverse Events.

    Secondary outcomes include the description of adverse events

    Time frame: 2 years

Other outcomes

  1. Procedural success rate:

    defined as the proportion of SpyGlass procedures completed where the diagnostic or therapeutic objectives were achieved.

    Time frame: 1 year

07

Study locations

1 site
  • Hospital Israelita Albert Einstein
    São Paulo, São Paulo, Brazil
08

References and documents

Publications

  • 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. PubMed 17466202 ↗
  • 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. PubMed 21419408 ↗
  • 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. PubMed 26147492 ↗
  • 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. PubMed 26117180 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02543151
Lead sponsor
Hospital Israelita Albert Einstein
Responsible party
FERNANDA PRATA MARTINS (Attending physician, Hospital Israelita Albert Einstein) — Principal investigator
First posted
Sep 7, 2015
Start date
Mar 2016
Primary completion
Jun 2017
Completion
Oct 2018
Last update
Apr 17, 2019

Study contacts

ANGELO P FERRARI, MD
study director · Attending physician
FERNANDA P MARTINS, MD
principal investigator · Attending physician

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Hospital Israelita Albert Einstein →

Start the discussion