Trials Sponsors Conditions Drugs Pricing

Conditions

Bile Duct Obstruction Extrahepatic Cholestasis

Keywords

Bile Duct ObstructionSelf 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 stentDevice

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

PTBD with primary metal stent implantationPTBD with secondary metal stent implantation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Otherlead
Universitätsmedizin Mannheim
Othercollaborator

Study Sites (1)

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

Mannheim, 68165, Germany

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: 28063840BACKGROUND
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: 28287940BACKGROUND

MeSH Terms

Conditions

CholestasisCholestasis, Extrahepatic

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

Daniel Schmitz, MD
Theresienkrankenhaus Mannheim, University of Heidelberg
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

August 1, 2021

First Posted

August 5, 2021

Study Start

March 1, 2011

Actual (reported)

Primary Versus Secondary Metal Stent Implantation in PTBD

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

PTBD with primary metal stent implantation

PTBD with secondary metal stent implantation

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

PTBD with primary metal stent implantation

PTBD with secondary metal stent implantation

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations