Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

NCT05268731 | Unknown

• 1 other identifier: PTBD retro 003
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Extrahepatic Cholestasis

Keywords

Extrahepatic Cholestasis; Self Expandable Metallic Stents; Drainage

Outcome Measures

Primary Outcomes (2)

• Bilirubin value

  Change of serum bilirubin value

  4 weeks

• GGT value

  Change of serum bilirubin value

  4 weeks

Study Arms (1)

Extrahepatic bile duct obstruction and failed ERCP

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

Interventions

External plastic endoprosthesis PROCEDURE

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

Extrahepatic bile duct obstruction and failed ERCP

Combined external internal plastic endoprosthesis PROCEDURE

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.

Extrahepatic bile duct obstruction and failed ERCP

Primary metal stent 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

Extrahepatic bile duct obstruction and failed ERCP

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with extrahepatic bile duct obstruction and failed or impossible ERCP

You may qualify if:

• technically successful PTBD

You may not qualify if:

• technically not successful PTBD

Sponsors & Collaborators

• Theresienkrankenhaus und St. Hedwig-Klinik GmbH: lead
• Helios Kliniken Schwerin: collaborator

Study Sites (1)

Helios Kliniken Schwerin

Schwerin, 19055, Germany

RECRUITING

Related 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: 10.1080/00365529850172142.

  PMID: 9648997 RESULT

• 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.

  PMID: 8935298 RESULT

MeSH Terms

Conditions

Cholestasis, Extrahepatic

Condition Hierarchy (Ancestors)

Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Daniel Schmitz, MD

  Theresienkrankenhaus Mannheim, University of Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.med. D Schmitz, MD

CONTACT

+49491758674415; s.daniel_427@gmx.de

Martin Kliment, MD

CONTACT

+49 385 520 - 2601; Martin.Kliment@helios-gesundheit.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 7, 2022
• Study Start: March 15, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)