Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

Recruiting

• Conditions: Extrahepatic Cholestasis
• Interventions: Procedure: External plastic endoprosthesis; Procedure: Combined external internal plastic endoprosthesis; Procedure: Primary metal stent

• Registration Number: NCT05268731
• Lead Sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Brief 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.

Study Timeline

• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-03-07
• Study Start: 2022-03-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-27
• Last Update Posted: 2023-08-29
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• technically successful PTBD

Exclusion Criteria

• technically not successful PTBD

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extrahepatic bile duct obstruction and failed ERCP	External plastic endoprosthesis	Patients with extrahepatic bile duct obstruction and obstructive jaundice have received a percutaneous transhepatic biliary drainage. The choice between an insertion of an external or an external/internal drainage has been made during the procedure depending on whether the guide wire could be accessed to the jejunum/duodenum or not. The choice between internal/external drainage or a primary metal stent has been made by the investigators preference or was made on the basis of an existing malign bile duct obstruction or not.
Extrahepatic bile duct obstruction and failed ERCP	Combined external internal plastic endoprosthesis	Patients with extrahepatic bile duct obstruction and obstructive jaundice have received a percutaneous transhepatic biliary drainage. The choice between an insertion of an external or an external/internal drainage has been made during the procedure depending on whether the guide wire could be accessed to the jejunum/duodenum or not. The choice between internal/external drainage or a primary metal stent has been made by the investigators preference or was made on the basis of an existing malign bile duct obstruction or not.
Extrahepatic bile duct obstruction and failed ERCP	Primary metal stent	Patients with extrahepatic bile duct obstruction and obstructive jaundice have received a percutaneous transhepatic biliary drainage. The choice between an insertion of an external or an external/internal drainage has been made during the procedure depending on whether the guide wire could be accessed to the jejunum/duodenum or not. The choice between internal/external drainage or a primary metal stent has been made by the investigators preference or was made on the basis of an existing malign bile duct obstruction or not.

Primary Outcome Measures

Name	Time	Method
Bilirubin value	4 weeks	Change of serum bilirubin value
GGT value	4 weeks	Change of serum bilirubin value

Trial Locations

Locations (1)

Helios Kliniken Schwerin; 🇩🇪 Schwerin, Germany