Bile Duct ObstructionNCT04992585
Primary Versus Secondary Metal Stent Implantation in PTBD
A study testing Percutaneous transhepatic implantation of self-expandable metal stent in people with Bile Duct Obstruction and Extrahepatic Cholestasis, run by Theresienkrankenhaus und St. Hedwig-Klinik GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bile Duct Obstruction, Extrahepatic Cholestasis
- What is being tested?
- Percutaneous transhepatic implantation of self-expandable metal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2011to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PTBD with metal stent implantation into the extrahepatic bile duct
- malignant and non-resectable extrahepatic bile duct obstruction
Who cannot join
- benign extrahepatic bile duct obstruction
Trial locations and contacts
1 site in 1 country.
Germany1 site
Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic
Mannheim, 68165
About this study
Official title: Primary Versus Secondary Metal Stent Implantation in PTBD in Patients With Extrahepatic Malignant Bile Duct Obstruction
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.
Read the 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
- Being tested
- Percutaneous transhepatic implantation of self-expandable metal stent
- Keywords
- Bile Duct Obstruction, Self Expandable Metallic Stents
- Medical subject headings
- Cholestasis, Cholestasis, Extrahepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| PTBD with primary metal stent implantation | Experimental | PTBD with primary metal stent implantation is performed in the same session as a one step-procedure Receives: 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 Receives: Device: Percutaneous transhepatic implantation of self-expandable metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From the intervention until 30 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Mar 2011
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bile Duct ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Retrospective comparison of two similar interventions with small modification
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsmedizin Mannheim
- Responsible party
- Sponsor
- Investigators
- Daniel Schmitz, MD, Principal investigator, Theresienkrankenhaus Mannheim, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992585
- Sponsor's protocol ID
- PTBD retro 002
- Status last verified
- Aug 2021
- First submitted
- 1 Aug 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28063840Venkatanarasimha 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.
PubMed 28287940Cotton 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.
PubMed 20189503
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Versus Secondary Metal Stent Implantation in PTBD in Patients With Extrahepatic Malignant Bile Duct Obstruction
- ClinicalTrials.gov ID
- NCT04992585
- Acronym / sponsor ID
- PTBD retro 002
- Conditions
- Bile Duct Obstruction, Extrahepatic Cholestasis
- Keywords
- Bile Duct Obstruction, Self Expandable Metallic Stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbHUniversity, hospital or other
- Collaborators
- Universitätsmedizin Mannheim
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Retrospective comparison of two similar interventions with small modification
| Arm | Type | Receives |
|---|---|---|
| PTBD with primary metal stent implantation | Experimental | Device: Percutaneous transhepatic implantation of self-expandable metal stentPTBD with primary metal stent implantation is performed in the same session as a one step-procedure |
| PTBD with secondary metal stent implantation | Active comparator | Device: Percutaneous transhepatic implantation of self-expandable metal stentPTBD 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PTBD with metal stent implantation into the extrahepatic bile duct
- malignant and non-resectable extrahepatic bile duct obstruction
Key exclusion criteria (1 listed)
- benign extrahepatic bile duct obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous transhepatic implantation of self-expandable metal stentA self-expandable metal stent is inserted into the extrahepatic bile duct which is obstructed by malignant disease | Device | PTBD with primary metal stent implantation, PTBD with secondary metal stent implantation |
Primary outcome
Adverse events
Time frame: From the intervention until 30 days after
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Background: PubMed 28063840Sharaiha 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.
- Background: PubMed 28287940Venkatanarasimha 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.
- Background: PubMed 20189503Cotton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Schmitz, MD principal investigator
Theresienkrankenhaus Mannheim, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous transhepatic implantation of self-expandable metal stent in people with Bile Duct Obstruction and Extrahepatic Cholestasis, run by Theresienkrankenhaus und St. Hedwig-Klinik GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: From the intervention until 30 days after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04992585, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.