NCT05268731

Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

Defining the Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Extrahepatic Cholestasis

Interventions

Type	Name	Description
PROCEDURE	External plastic endoprosthesis	Ultrasound- or fluoroscopy-guided bile duct puncture with insertion of an external plastic endoprosthesis if the duodenum or jejunum cannot be accessed by a guide wire
PROCEDURE	Combined external internal plastic endoprosthesis	Ultrasound- or fluoroscopy-guided bile duct puncture with insertion of an external/internal plastic endoprosthesis if the duodenum or jejunum can be accessed by a guide wire. No definitive drainage intended in initial procedure.
PROCEDURE	Primary metal stent	Ultrasound- or fluoroscopy-guided bile duct puncture with insertion of a self-expanding metal stent if the duodenum or jejunum can be accessed by a guide wire. A definitive drainage is intended in the initial procedure, for example in patients with malign bile duct obstruction

Timeline

• Start date: 2022-03-15
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2022-03-07
• Last updated: 2023-08-29

Locations

1 site across 1 country: Germany