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Clinical Trial Summary

The clinical success of percutaneous transhepatic biliary drainage procedures (PTBDs) is usually measured by the the decrease of the serum bilirubin value. However, the bilirubin value can be biased by other disease conditions. Furthermore, the time course of the decrease of the bilirubin value after technically successful PTBD is not well known. Serum gamma-glutamyl transferase (GGT), a liver enzyme which is typically elevated in cholestatic liver diseases, might be a good alternative to bilirubin as an indicator for the clinical success of PTBDs. The aim of this study is to analyse the bilirubin level and the GGT level in patients with technically successful PTBD.


Clinical Trial Description

The medical records of adult patients who have received a technically successful PTBD will be screened sytematically in terms of bilirubin and GGT values in the follow up of 4 weeks after the intervention. Bilirubin and GGT values have been routinely examinated every 1 to 3 days. PTBD comprises external plastic endoprosthesis, combined external and internal endoprosthesis and primary metal stent insertion. The respective three procedures are considered separately. As PTBD is a rare intervention which is used after failed or impossible endoscopic retrograde cholangiopancreaticography (ERCP) medical records will be screened from 2002 to 2022 (20 years). It is expected that for example a decrease of GGT after three days might indicate a successful procedure. This in turn might has an impact on the early demission of the patient. On the other side, the precise definition of successful PTBD by bilirubin or GGT value might help to make this procedure better comparable to other alternative biliary drainage procedures such as endoscopic ultrasound-guided biliary drainage. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05268731
Study type Observational
Source Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Contact Dr.med. D Schmitz, MD
Phone +49491758674415
Email s.daniel_427@gmx.de
Status Recruiting
Phase
Start date March 15, 2022
Completion date December 15, 2023

See also
  Status Clinical Trial Phase
Completed NCT03237247 - Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis N/A
Completed NCT04992585 - Primary Versus Secondary Metal Stent Implantation in PTBD N/A