Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures (TransHepatic)

Defining the Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

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.

Study Overview

• Status: Recruiting
• Conditions: Extrahepatic Cholestasis
• Intervention / Treatment: Procedure: External plastic endoprosthesis; Procedure: Combined external internal plastic endoprosthesis; Procedure: Primary metal stent

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Dr.med. D Schmitz, MD; Phone Number: +49491758674415; Email: s.daniel_427@gmx.de
• Study Contact Backup: Name: Martin Kliment, MD; Phone Number: +49 385 520 - 2601; Email: Martin.Kliment@helios-gesundheit.de

Study Locations

• Germany
  • Schwerin, Germany, 19055
    • Recruiting
    • HELIOS Kliniken Schwerin
    • Contact: Daniel Schmitz, MD; Phone Number: +491758674415; Email: Daniel.Schmitz@helios-gesundheit.de
    • Contact: Martin Kliment, MD; Phone Number: +493855202601; Email: Martin.Kliment@helios-gesundheit.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with extrahepatic bile duct obstruction and failed or impossible ERCP

Description

Inclusion Criteria:

• technically successful PTBD

Exclusion Criteria:

• technically not successful PTBD

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bilirubin value	Change of serum bilirubin value	4 weeks
GGT value	Change of serum bilirubin value	4 weeks

Collaborators and Investigators

• Sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
• Collaborators: Helios Kliniken Schwerin
• Investigators: Principal Investigator: Daniel Schmitz, MD, Theresienkrankenhaus Mannheim, University of Heidelberg

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 27, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Drainage; Self Expandable Metallic Stents; Extrahepatic Cholestasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis; Cholestasis, Extrahepatic
• Other Study ID Numbers: PTBD retro 003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data of the study will be available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No