Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

Extrahepatic Cholestasis Clinical Trial

— TransHepatic  

Official title:

Defining the Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05268731
• Other study ID #: PTBD retro 003
• Status: Recruiting
• Start date: March 15, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: August 2023
• Source: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
• Contact: Dr.med. D Schmitz, MD
• Phone: +49491758674415
• Email: s.daniel_427[@]gmx.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• technically successful PTBD

Exclusion Criteria:

• technically not successful PTBD

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis, Extrahepatic
• Extrahepatic Cholestasis

Intervention

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
• 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.
• 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

Locations

Country	Name	City	State
Germany	Helios Kliniken Schwerin	Schwerin

Sponsors (2)

Lead Sponsor	Collaborator
Theresienkrankenhaus und St. Hedwig-Klinik GmbH	Helios Kliniken Schwerin

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Born P, Rosch T, Triptrap A, Frimberger E, Allescher HD, Ott R, Weigert N, Lorenz R, Classen M. Long-term results of percutaneous transhepatic biliary drainage for benign and malignant bile duct strictures. Scand J Gastroenterol. 1998 May;33(5):544-9. doi — View Citation

Tsai CC, Mo LR, Lin RC, Kuo JY, Chang KK, Yeh YH, Yang SC, Yueh SK, Tsai HM, Yu CY. Self-expandable metallic stents in the management of malignant biliary obstruction. J Formos Med Assoc. 1996 Apr;95(4):298-302. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bilirubin value	Change of serum bilirubin value	4 weeks
Primary	GGT value	Change of serum bilirubin value	4 weeks