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Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

Defining the Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05268731
Acronym
TransHepatic
Enrollment
80
Registered
2022-03-07
Start date
2022-03-15
Completion date
2023-12-15
Last updated
2023-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extrahepatic Cholestasis

Keywords

Extrahepatic Cholestasis, Self Expandable Metallic Stents, Drainage

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.

Interventions

PROCEDUREExternal 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

PROCEDURECombined 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.

PROCEDUREPrimary 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

Helios Kliniken Schwerin
CollaboratorOTHER
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* technically successful PTBD

Exclusion criteria

* technically not successful PTBD

Design outcomes

Primary

MeasureTime frameDescription
Bilirubin value4 weeksChange of serum bilirubin value
GGT value4 weeksChange of serum bilirubin value

Countries

Germany

Contacts

Primary ContactDr.med. D Schmitz, MD
s.daniel_427@gmx.de+49491758674415
Backup ContactMartin Kliment, MD
Martin.Kliment@helios-gesundheit.de+49 385 520 - 2601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026