SpyGlass in Post Liver Transplant Biliary Complications.

Liver Transplant Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543151
• Other study ID #: 1439-11
• Secondary ID: 28005314.5.0000.
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 2018

Study information

• Verified date: April 2019
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Anastomosis Complication
• Liver Transplant Disorder

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Tringali A, Lemmers A, Meves V, Terheggen G, Pohl J, Manfredi G, Häfner M, Costamagna G, Devière 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedural success rate:	defined as the proportion of SpyGlass procedures completed where the diagnostic or therapeutic objectives were achieved.	1 year
Primary	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	Number of Participants with Adverse Events.	Secondary outcomes include the description of adverse events	2 years