Primary Versus Secondary Metal Stent Implantation in PTBD

NCT ID: NCT04992585

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-01
• Study Completion Date: 2021-03-01

Brief Summary

The aim is to compare percutaneous transhepatic biliary drainage (PTBD) with primary metal stent implantation (one stage-procedure) with PTBD with secondary metal stent implantation in terms of adverse events.

Detailed Description

Percutaneous transhepatic biliary interventions (PBI) are used in biliary tract diseases when endoscopic access was not successful or not possible due to anatomical changes after abdominal surgery. Self-expandible metal stents (SEMS) can be applied percutaneously in patients with malignant extrahepatic bile duct obstruction. In this setting, PTBD is usually performed as a two step-procedure with primary drainage of the accumulated bile fluid by an external or an external/internal plastic stent and a secondary metal stent implantation at an interval of a few days. PTBD with primary metal stent implantation might shorten the hospital stay and is therefore equal to the increasingly used method of endoscopic ultrasound-guided biliary drainage (EUS-BD). EUS-BD offers a one step-procedure with primary metal stent implantation which is probably associated with lesser adverse events (AE) than PTBD with secondary metal stent implantation. However, it is not clear whether PTBD with primary metal stent implantation shows fewer adverse events than PTBD with secondary stent implantation. The aim of this study is to retrospectively analyze the prospectively collected data of PTBDs with primary or secondary metal stent implantation in patients with proximal and distal malignant bile duct obstruction. The focus of this single center study will be to compare the two approaches in terms of adverse events. Adverse events in PTBD might range from very mild to fatal. Therefore, the severity of the adverse events has been considered in the calculation.

Conditions

Bile Duct Obstruction; Extrahepatic Cholestasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PTBD with primary metal stent implantation

PTBD with primary metal stent implantation is performed in the same session as a one step-procedure

Group Type: EXPERIMENTAL

Percutaneous transhepatic implantation of self-expandable metal stent

Intervention Type: DEVICE

A self-expandable metal stent is inserted into the extrahepatic bile duct which is obstructed by malignant disease

PTBD with secondary metal stent implantation

PTBD with secondary metal stent implantation is performed as a two step-procedure with metal stent implantation 3 to 7 days after previous percutaneous transhepatic biliary drainage and insertion of a plastic catheter

Group Type: ACTIVE_COMPARATOR

Percutaneous transhepatic implantation of self-expandable metal stent

Intervention Type: DEVICE

A self-expandable metal stent is inserted into the extrahepatic bile duct which is obstructed by malignant disease

Interventions

Percutaneous transhepatic implantation of self-expandable metal stent

A self-expandable metal stent is inserted into the extrahepatic bile duct which is obstructed by malignant disease

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• PTBD with metal stent implantation into the extrahepatic bile duct
• malignant and non-resectable extrahepatic bile duct obstruction

Exclusion Criteria

• benign extrahepatic bile duct obstruction

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsmedizin Mannheim

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

Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic

Mannheim, , Germany

Countries

Germany

References

Sharaiha RZ, Khan MA, Kamal F, Tyberg A, Tombazzi CR, Ali B, Tombazzi C, Kahaleh M. Efficacy and safety of EUS-guided biliary drainage in comparison with percutaneous biliary drainage when ERCP fails: a systematic review and meta-analysis. Gastrointest Endosc. 2017 May;85(5):904-914. doi: 10.1016/j.gie.2016.12.023. Epub 2017 Jan 4.

Reference Type: BACKGROUND

PMID: 28063840 (View on PubMed)

Venkatanarasimha N, Damodharan K, Gogna A, Leong S, Too CW, Patel A, Tay KH, Tan BS, Lo R, Irani F. Diagnosis and Management of Complications from Percutaneous Biliary Tract Interventions. Radiographics. 2017 Mar-Apr;37(2):665-680. doi: 10.1148/rg.2017160159.

Reference Type: BACKGROUND

PMID: 28287940 (View on PubMed)

Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.

Reference Type: BACKGROUND

PMID: 20189503 (View on PubMed)

Other Identifiers

PTBD retro 002

Identifier Type: -

Identifier Source: org_study_id