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| ID | Type | Description | Link |
|---|---|---|---|
| 28005314.5.0000.0071 | Other Identifier | CONEP |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpyGlass Choledochoscopy procedure | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpyGlass (direct visualization system) choledochoscopy | Procedure | SpyGlass (direct visualization system) choledochoscopy procedure will be performed pre and post biliary complication treatment |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events. | Secondary outcomes include the description of adverse events | 2 years |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ANGELO P FERRARI, MD | Attending physician | Study Director |
| FERNANDA P MARTINS, MD | Attending physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17466202 | Background | 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. | |
| 21419408 | Background | 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. |
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| 26147492 | Background | 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. |
| 26117180 | Background | 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. |