Distal Bile Duct ObstructionNCT01905384
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
A study testing Covered Self-expanding metal biliary stents (C-SEMS) and Uncovered Self-expanding metal biliary stents (U-SEMS) in people with Distal Bile Duct Obstruction, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Distal Bile Duct Obstruction
- What is being tested?
- Covered Self-expanding metal biliary stents (C-SEMS) and Uncovered Self-expanding metal biliary stents (U-SEMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2017to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- distal bile obstruction referred for ERCP with intended palliative metal stent placement for palliation of jaundice
- 18 years of age or older
- serum bilirubin > 2mg/dL
Who cannot join
- prior endoscopic or percutaneous biliary drainage
- post-surgical anatomy
- primary site of biliary obstruction involving the common hepatic duct or hilum
- tumor involving gastric outlet, duodenum, or ampulla either precluding endoscopic access to the papilla or otherwise preventing endoscopic biliary cannulation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Mount Sinai Hospital
New York, New York, 10029
About this study
Official title: Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
- Conditions
- Distal Bile Duct Obstruction
- Being tested
- Covered Self-expanding metal biliary stents (C-SEMS), Uncovered Self-expanding metal biliary stents (U-SEMS)
- Keywords
- pancreatic cancer, cholangiocarcinoma, metastatic malignancy, jaundice
- Medical subject headings
- Pancreatic Neoplasms, Cholangiocarcinoma, Neoplasms, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covered Self-expanding metal biliary stents (C-SEMS)Device
Used for palliation of inoperable malignant distal bile duct obstruction.
Uncovered Self-expanding metal biliary stents (U-SEMS)Device
Used for palliation of inoperable malignant distal bile duct obstructions.
| Study group | Role | What they receive |
|---|---|---|
| U-SEMS group | Active comparator | Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific). Receives: Device: Uncovered Self-expanding metal biliary stents (U-SEMS) |
| C-SEMS Group | Active comparator | Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific) Receives: Device: Covered Self-expanding metal biliary stents (C-SEMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Long-term Stent Failure
Compare the rate of long-term stent failure, defined as need for repeat biliary intervention (endoscopic, percutaneous, or surgical) following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
Measured: One year
Secondary outcomes (1)
Rates of Adverse Stent-related or Intervention-related Outcomes
Participants will be monitored for adverse stent-related or intervention-related outcomes such as pancreatitis, cholangitis, cholecystitis, perforation.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study start8 Nov 2017
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Distal Bile Duct ObstructionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Yachimski, Vanderbilt University Medical Center
- Investigators
- Patrick Yachimski, MD, MPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905384
- Sponsor's protocol ID
- 130331
- Status last verified
- Mar 2022
- First submitted
- 29 May 2013
- Last updated
- 31 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
- ClinicalTrials.gov ID
- NCT01905384
- Acronym / sponsor ID
- 130331
- Conditions
- Distal Bile Duct Obstruction
- Keywords
- pancreatic cancer, cholangiocarcinoma, metastatic malignancy, jaundice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Posted 31 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| U-SEMS group | Active comparator | Device: Uncovered Self-expanding metal biliary stents (U-SEMS)Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific). |
| C-SEMS Group | Active comparator | Device: Covered Self-expanding metal biliary stents (C-SEMS)Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- distal bile obstruction referred for ERCP with intended palliative metal stent placement for palliation of jaundice
- 18 years of age or older
- serum bilirubin > 2mg/dL
Key exclusion criteria (4 listed)
- prior endoscopic or percutaneous biliary drainage
- post-surgical anatomy
- primary site of biliary obstruction involving the common hepatic duct or hilum
- tumor involving gastric outlet, duodenum, or ampulla either precluding endoscopic access to the papilla or otherwise preventing endoscopic biliary cannulation
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 |
|---|---|---|
| Covered Self-expanding metal biliary stents (C-SEMS)Used for palliation of inoperable malignant distal bile duct obstruction. | Device | C-SEMS Group |
| Uncovered Self-expanding metal biliary stents (U-SEMS)Used for palliation of inoperable malignant distal bile duct obstructions. | Device | U-SEMS group |
Primary outcome
Rate of Long-term Stent Failure
Time frame: One year
Compare the rate of long-term stent failure, defined as need for repeat biliary intervention (endoscopic, percutaneous, or surgical) following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
1 secondary outcome
Rates of Adverse Stent-related or Intervention-related Outcomes
Time frame: One Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Distal Bile Duct Obstruction
Active, not recruiting
Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents
Pancreatic Cancer Non-resectable, Bile Duct Cancer
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.
Patrick Yachimski, MD, MPH principal investigator
Vanderbilt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Covered Self-expanding metal biliary stents (C-SEMS) and Uncovered Self-expanding metal biliary stents (U-SEMS) in people with Distal Bile Duct Obstruction, run by Vanderbilt University Medical Center at 2 sites in United States.
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 3 inclusion and 4 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Long-term Stent Failure (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2022.