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Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

NCT05268731 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2023-08-29

No results posted yet for this study

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.

Conditions

  • Extrahepatic Cholestasis

Interventions

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

Sponsors & Collaborators

  • Helios Kliniken Schwerin

    collaborator OTHER

  • Theresienkrankenhaus und St. Hedwig-Klinik GmbH

    lead OTHER

Principal Investigators

  • Daniel Schmitz, MD · Theresienkrankenhaus Mannheim, University of Heidelberg

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2023-12-15
Completion
2023-12-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05268731 on ClinicalTrials.gov