POCS in Liver Transplantation Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03205072|
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : March 29, 2019
|Condition or disease||Intervention/treatment|
|Liver Transplant; Complications||Device: Spy Glass DS|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||66 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Per-Oral Cholangioscopy in Liver Transplantation Patients|
|Actual Study Start Date :||January 25, 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||August 2020|
ERCP & Spy Glass DS
Patients with cadaveric donor or live donor liver transplantation referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct strictures.
Device: Spy Glass DS
The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.
- Impact of Per-Oral Cholangioscopy on Patient Management [ Time Frame: 12 Months ]To evaluate the impact of the addition of POCS to same setting ERCP on the recommended management of post-liver transplantation biliary complications.
- Technical Success [ Time Frame: 12 Months ]Ability to visualize the duct/lesion of interest and, if applicable, ability to obtain POCS-guided biopsy adequate for histopathology.
- Serious Adverse Events [ Time Frame: 12 Months ]Serious Adverse Events (SAEs) including severity, onset, time to resolution, required interventions, relatedness to endoscopic devices and/or procedures and hospitalizations.
- Number of biliary re-interventions [ Time Frame: 12 Months ]Re-interventions may include but are not limited to repeat ERCP, repeat POCS, ultrasonography, stent exchanges, balloon dilations and liver biopsy.
- Patient Management [ Time Frame: 3 and 12 Months ]Confirmation at 3 months and at 12 months that recommended management at the index procedures was adequate.
- Relationship between endoscopic findings on POCS visualization [ Time Frame: 12 Months ]Relationship between endoscopic findings on POCS visualization during index procedure and refractory biliary strictures during follow-up.
- Evaluation [ Time Frame: 12 Months ]Evaluation by surgeon of whether or not POCS impacted patient management post procedure.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205072
|Contact: Srey Yinemail@example.com|
|United States, New York|
|New York Presbyterian Hospital CUMC||Recruiting|
|New York, New York, United States, 10032|
|Contact: Amrita Sethi, MD firstname.lastname@example.org|
|Principal Investigator: Amrita Sethi, MD|
|Sub-Investigator: Jean D Edmond, MD|
|Sub-Investigator: Elizabeth C Verna, MD|
|Sub-Investigator: Amit Sachdev, MD|
|Sub-Investigator: Jeffrey Adler, MD|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Adam Slivka, MD email@example.com|
|Principal Investigator: Adam Slivka, MD, PhD|
|Sub-Investigator: Christopher Hughes, MD|
|Sub-Investigator: Mordechai Rabinovitz, MD|
|Sub-Investigator: Georgios Papachrisou, MD|
|Sub-Investigator: Jennifer Chennat, MD|
|Sub-Investigator: Asif Khalid, MD|
|Hospital das Clinicas||Recruiting|
|São Paulo, Brazil, 05403|
|Contact: Eduardo De Moura, MD firstname.lastname@example.org|
|Principal Investigator: Eduardo De Moura, MD|
|Sub-Investigator: Wellington Andraus, MD|
|Sub-Investigator: Luiz A D'Albuquerque, MD|
|Sub-Investigator: Hugo G Guedes, MD|
|Sub-Investigator: Diogo T.H. De Moura, MD|
|Hospital Clinic de Barcelona||Recruiting|
|Barcelona, Spain, 08036|
|Contact: Andres Cardenas, MD email@example.com|
|Principal Investigator: Andres Cardenas, MD|
|Sub-Investigator: Nidal Mawasi, MD|
|Sub-Investigator: Karina Chavez, MD|
|Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 14186|
|Contact: Urban Arnelo, MD Urban.Arnelo@ki.se|
|Principal Investigator: Urban Arnelo, MD|
|Sub-Investigator: Greg Nowak, MD|
|Sub-Investigator: Karouk Said, MD|
|Principal Investigator:||Amrita Sethi, MD||Columbia University|
|Principal Investigator:||Eduardo De Moura, MD||Hospital das Clinicas University of Sao Paulo|
|Principal Investigator:||Adam Slivka, MD||University of Pittsburgh Medical Center|
|Principal Investigator:||Andres Cardenas, MD||Hospital Clinic of Barcelona|
|Principal Investigator:||Urban Arnelo, MD||Karolinska University Hospital|