Primary Versus Secondary Metal Stent Implantation in PTBD

NCT04992585 | Completed

• 1 other identifier: PTBD retro 002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bile Duct Obstruction; Extrahepatic Cholestasis

Keywords

Bile Duct Obstruction; Self Expandable Metallic Stents

Outcome Measures

Primary Outcomes (1)

• Adverse events

  All adverse events which have been documented in the medical record were analyzed and classified as mild, moderate, severe or fatal/death according to the AE severity grading system of the American Society of Gastrointestinal Endoscopy (ASGE)

  From the intervention until 30 days after

Study Arms (2)

PTBD with primary metal stent implantation

EXPERIMENTAL

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

Device: Percutaneous transhepatic implantation of self-expandable metal stent

PTBD with secondary metal stent implantation

ACTIVE COMPARATOR

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

Device: Percutaneous transhepatic implantation of self-expandable metal stent

Interventions

Percutaneous transhepatic implantation of self-expandable metal stent DEVICE

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

PTBD with primary metal stent implantation; PTBD with secondary metal stent implantation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• benign extrahepatic bile duct obstruction

Sponsors & Collaborators

• Theresienkrankenhaus und St. Hedwig-Klinik GmbH: lead
• Universitätsmedizin Mannheim: collaborator

Study Sites (1)

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

Mannheim, 68165, Germany

Location

Related Publications (3)

• 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.

  PMID: 28063840 BACKGROUND

• 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.

  PMID: 28287940 BACKGROUND

• 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.

  PMID: 20189503 BACKGROUND

MeSH Terms

Conditions

Cholestasis; Cholestasis, Extrahepatic

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Daniel Schmitz, MD

  Theresienkrankenhaus Mannheim, University of Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Retrospective comparison of two similar interventions with small modification

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 5, 2021
• Study Start: March 1, 2011
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)