SpyGlass in Post Liver Transplant Biliary Complications.
NCT ID: NCT02543151
Last Updated: 2019-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-03-31
2018-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
SpyGlass (direct visualization system) choledochoscopy
SpyGlass (direct visualization system) choledochoscopy procedure will be performed pre and post biliary complication treatment
Interventions
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SpyGlass (direct visualization system) choledochoscopy
SpyGlass (direct visualization system) choledochoscopy procedure will be performed pre and post biliary complication treatment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Below 18 years of age
* Pregnancy
18 Years
ALL
No
Sponsors
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Hospital Israelita Albert Einstein
OTHER
Responsible Party
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FERNANDA PRATA MARTINS
Attending physician
Principal Investigators
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ANGELO P FERRARI, MD
Role: STUDY_DIRECTOR
Attending physician
FERNANDA P MARTINS, MD
Role: PRINCIPAL_INVESTIGATOR
Attending physician
Locations
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Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Countries
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References
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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.
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.
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.
Other Identifiers
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28005314.5.0000.0071
Identifier Type: OTHER
Identifier Source: secondary_id
1439-11
Identifier Type: -
Identifier Source: org_study_id
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