Primary Versus Secondary Metal Stent Implantation in PTBD
Primary Purpose
Bile Duct Obstruction, Extrahepatic Cholestasis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Percutaneous transhepatic implantation of self-expandable metal stent
Sponsored by
About this trial
This is an interventional treatment trial for Bile Duct Obstruction focused on measuring Bile Duct Obstruction, Self Expandable Metallic Stents
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
Sites / Locations
- Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PTBD with primary metal stent implantation
PTBD with secondary metal stent implantation
Arm Description
PTBD with primary metal stent implantation is performed in the same session as a one step-procedure
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04992585
First Posted
August 1, 2021
Last Updated
August 5, 2021
Sponsor
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Collaborators
Universitätsmedizin Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT04992585
Brief Title
Primary Versus Secondary Metal Stent Implantation in PTBD
Official Title
Primary Versus Secondary Metal Stent Implantation in PTBD in Patients With Extrahepatic Malignant Bile Duct Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2011 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Collaborators
Universitätsmedizin Mannheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Obstruction, Extrahepatic Cholestasis
Keywords
Bile Duct Obstruction, Self Expandable Metallic Stents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Retrospective comparison of two similar interventions with small modification
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTBD with primary metal stent implantation
Arm Type
Experimental
Arm Description
PTBD with primary metal stent implantation is performed in the same session as a one step-procedure
Arm Title
PTBD with secondary metal stent implantation
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Percutaneous transhepatic implantation of self-expandable metal stent
Intervention Description
A self-expandable metal stent is inserted into the extrahepatic bile duct which is obstructed by malignant disease
Primary Outcome Measure Information:
Title
Adverse events
Description
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)
Time Frame
From the intervention until 30 days after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Schmitz, MD
Organizational Affiliation
Theresienkrankenhaus Mannheim, University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic
City
Mannheim
ZIP/Postal Code
68165
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28063840
Citation
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.
Results Reference
background
PubMed Identifier
28287940
Citation
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. Erratum In: Radiographics. 2017 May-Jun;37(3):1004. Damodharan, Karthik [corrected to Damodharan, Karthikeyan].
Results Reference
background
PubMed Identifier
20189503
Citation
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.
Results Reference
background
Learn more about this trial
Primary Versus Secondary Metal Stent Implantation in PTBD
We'll reach out to this number within 24 hrs