Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

NCT ID: NCT05268731

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2023-12-15

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.

Conditions

Extrahepatic Cholestasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

External plastic endoprosthesis

Intervention Type: 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

Combined external internal plastic endoprosthesis

Intervention Type: 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.

Primary metal stent

Intervention Type: 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

Interventions

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

Intervention Type: 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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• technically successful PTBD

Exclusion Criteria

• technically not successful PTBD

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helios Kliniken Schwerin

OTHER

Sponsor Role: collaborator

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Schmitz, MD

Role: PRINCIPAL_INVESTIGATOR

Theresienkrankenhaus Mannheim, University of Heidelberg

Locations

Helios Kliniken Schwerin

Schwerin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Dr.med. D Schmitz, MD

Role: CONTACT

s.daniel_427@gmx.de

+49491758674415

Martin Kliment, MD

Role: CONTACT

Martin.Kliment@helios-gesundheit.de

+49 385 520 - 2601

Facility Contacts

Daniel Schmitz, MD

Role: primary

Daniel.Schmitz@helios-gesundheit.de

+491758674415

Martin Kliment, MD

Role: backup

Martin.Kliment@helios-gesundheit.de

+493855202601

References

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.

Reference Type: RESULT

PMID: 9648997 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8935298 (View on PubMed)

Other Identifiers

PTBD retro 003

Identifier Type: -

Identifier Source: org_study_id