Obstructive JaundiceNCT01675908
Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression
A study testing Stent Dysfunction and Complications in people with Obstructive Jaundice and Pancreatic Cancer, run by AdventHealth at 1 site in United States.
Trial summary
Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Obstructive Jaundice, Pancreatic Cancer
- What is being tested?
- Stent Dysfunction and Complications
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2012to 21 Aug 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.
- Patients 19 yrs of age and older
- Serum bilirubin > 2mg/dl
- CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).
Who cannot join
- Karnofsky score < 60
- Prior (ERCP or PTC) attempts at biliary decompression for the same indication
- Tumor-related gastric outlet obstruction (vomiting and oral intake of < 1L/day)
- Ongoing or planned neoadjuvant therapy
- Cholangitis at presentation or coagulopathy needing reversal medication
- Post-surgical anatomy
- Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum
- Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression
Read the detailed description
Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.
- Conditions
- Obstructive Jaundice, Pancreatic Cancer
- Being tested
- Stent Dysfunction, Complications
- Medical subject headings
- Jaundice, Obstructive, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent DysfunctionProcedure or surgery
Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.
ComplicationsProcedure or surgery
Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Metal stent | Active comparator | Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated. Receives: Procedure: Stent Dysfunction; Procedure: Complications |
| Plastic Stent | Active comparator | At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated. Receives: Procedure: Stent Dysfunction; Procedure: Complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications related to stent dysfunction
Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.
Measured: 30 days
Secondary outcomes (1)
Procedural complications
This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study start22 Aug 2012
- Primary completion21 Aug 2019
- Study completion21 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive JaundiceStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, University of Maryland, Baltimore
- Responsible party
- Sponsor
- Investigators
- shyam varadarajulu, MD, Principal investigator, Florida Hospital Center for Interventional Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675908
- Sponsor's protocol ID
- 356090
- Status last verified
- Feb 2022
- First submitted
- 28 Aug 2012
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: A manuscript will be developed following completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01675908
- Acronym / sponsor ID
- 356090
- Conditions
- Obstructive Jaundice, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- Vanderbilt University, University of Maryland, Baltimore
- Study start
- 22 Aug 2012 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 30 Aug 2012 (estimated)
- 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.
Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression
Detailed description
Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal stent | Active comparator | Procedure: Stent Dysfunction, Procedure: ComplicationsPatients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated. |
| Plastic Stent | Active comparator | Procedure: Stent Dysfunction, Procedure: ComplicationsAt ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.
- Patients 19 yrs of age and older
- Serum bilirubin > 2mg/dl
- CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).
Key exclusion criteria (8 listed)
- Karnofsky score < 60
- Prior (ERCP or PTC) attempts at biliary decompression for the same indication
- Tumor-related gastric outlet obstruction (vomiting and oral intake of < 1L/day)
- Ongoing or planned neoadjuvant therapy
- Cholangitis at presentation or coagulopathy needing reversal medication
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 |
|---|---|---|
| Stent DysfunctionRate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP. | Procedure or surgery | Metal stent, Plastic Stent |
| ComplicationsRates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed. | Procedure or surgery | Metal stent, Plastic Stent |
Primary outcome
Complications related to stent dysfunction
Time frame: 30 days
Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.
1 secondary outcome
Procedural complications
Time frame: 30 days
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 3 Mar 2022.
- Individual participant dataSharing planned: No. A manuscript will be developed following completion of the study.
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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.
shyam varadarajulu, MD principal investigator
Florida Hospital Center for Interventional Endoscopy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent Dysfunction and Complications in people with Obstructive Jaundice and Pancreatic Cancer, run by AdventHealth at 1 site 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 4 inclusion and 8 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 3 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 1 site 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?
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?
Complications related to stent dysfunction (time frame: 30 days). 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 3 Mar 2022; AzTrials last refreshed its copy on 31 Oct 2026.