Clinical trial NCT02543151: SpyGlass in Post Liver Transplant Biliary Complications.
Official title: Prospective Evaluation of SpyGlass Direct Visualization System in Post Liver Transplant Biliary Stricture.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant Disorder
Biliary Anastomosis Complication
Keywords: Biliary stricture
Cholangioscopy
Spyglass
Liver transplant
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Documentation of biliary ductal changes in post-liver transplant biliary complications.
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants with Adverse Events.
timeFrame: 2 years
Other outcomes:
measure: Procedural success rate:
timeFrame: 1 year
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
Study officials:
affiliation: Attending physician
name: ANGELO P FERRARI, MD
role: STUDY_DIRECTOR
affiliation: Attending physician
name: FERNANDA P MARTINS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
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. No abstract available.