SpyGlass in Post Liver Transplant Biliary Complications.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Documentation of biliary ductal changes in post-liver transplant biliary complications. [2 years]
The study aim is to describe biliary ductal changes in post-liver transplant presenting biliary complications
Secondary Outcome Measures
- Number of Participants with Adverse Events. [2 years]
Secondary outcomes include the description of adverse events
Other Outcome Measures
- Procedural success rate: [1 year]
defined as the proportion of SpyGlass procedures completed where the diagnostic or therapeutic objectives were achieved.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Israelita Albert Einstein | Sao Paulo | SP | Brazil |
Sponsors and Collaborators
- Hospital Israelita Albert Einstein
Investigators
- Study Director: ANGELO P FERRARI, MD, Attending physician
- Principal Investigator: FERNANDA P MARTINS, MD, Attending physician
Study Documents (Full-Text)
None provided.More Information
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.
- 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.
- 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.
- 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.
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