SpyGlass in Post Liver Transplant Biliary Complications.

Prospective Evaluation of SpyGlass Direct Visualization System in Post Liver Transplant Biliary Stricture.

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.

Study Overview

• Status: Completed
• Conditions: Liver Transplant Disorder; Biliary Anastomosis Complication
• Intervention / Treatment: Procedure: SpyGlass (direct visualization system) choledochoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil
      • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; SpyGlass (direct visualization system) choledochoscopy procedure will be performed pre and post biliary complication treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events.	Secondary outcomes include the description of adverse events	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success rate:	defined as the proportion of SpyGlass procedures completed where the diagnostic or therapeutic objectives were achieved.	1 year

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Study Director: ANGELO P FERRARI, MD, Attending Physician; Principal Investigator: FERNANDA P MARTINS, MD, Attending Physician

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Liver transplant; Spyglass; Cholangioscopy; Biliary stricture
• Other Study ID Numbers: 1439-11; 28005314.5.0000.0071 (Other Identifier: CONEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided