An observational study in Extrahepatic Cholestasis, sponsored by Theresienkrankenhaus und St. Hedwig-Klinik GmbH. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Theresienkrankenhaus und St. Hedwig-Klinik GmbH · Observational
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.
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.
Theresienkrankenhaus und St. Hedwig-Klinik GmbH is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Patients with extrahepatic bile duct obstruction and failed or impossible ERCP
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Exclusion Criteria:
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.
Procedure: External plastic endoprosthesis · Procedure: Combined external internal plastic endoprosthesis · Procedure: Primary metal stent
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
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.
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
Bilirubin value
Change of serum bilirubin value
Time frame: 4 weeks
GGT value
Change of serum bilirubin value
Time frame: 4 weeks
Plan to share: No — All data of the study will be available on request
Started Mar 2022 (actual). Primary completion is estimated for Dec 2023, 21 months after the start.
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Cholestasis, Extrahepatic
Theresienkrankenhaus und St. Hedwig-Klinik GmbH