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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
First received
Last updated
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
Health authority
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

Study Design


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
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