Obstructive JaundiceNCT01191814
Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression
A study testing Metal stent and Plastic stent in people with Obstructive Jaundice and Pancreatic Cancer, run by AdventHealth at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Obstructive Jaundice, Pancreatic Cancer
- What is being tested?
- Metal stent and Plastic stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to 13 Oct 2022
- 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 to 85 years
- 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: A Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
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.
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 as there will be better drainage of the obstructed biliary system with fewer adverse events.
- Conditions
- Obstructive Jaundice, Pancreatic Cancer
- Being tested
- Metal stent, Plastic stent
- Keywords
- pancreatic cancer, obstructive jaundice, Obstructive jaundice secondary to pancreatic cancer
- 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.
Metal stentProcedure or surgery
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
Plastic stentProcedure or surgery
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent.
| Study group | Role | What they receive |
|---|---|---|
| Metal stent | Active comparator | Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent. Receives: Procedure: Metal stent |
| Plastic Stent | Active comparator | Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a plastic stent Receives: Procedure: Plastic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications related to stent dysfunction
Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by ERCP)
Measured: 30 days
Secondary outcomes (1)
Procedural complications
Complications related to the procedure which 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 posted31 Aug 2010 (estimated)
- Study startJul 2010
- Primary completion13 Oct 2022
- Study completion13 Oct 2022
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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
- Investigators
- Muhammad Hasan, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191814
- Sponsor's protocol ID
- FT356090
- Status last verified
- Jul 2023
- First submitted
- 12 Aug 2010
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: A manuscript will be developed following the closure of the study.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01191814
- Acronym / sponsor ID
- FT356090
- Conditions
- Obstructive Jaundice, Pancreatic Cancer
- Keywords
- pancreatic cancer, obstructive jaundice, Obstructive jaundice secondary to pancreatic cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- University of Virginia
- Study start
- Jul 2010
- Primary completion
- 13 Oct 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 31 Aug 2010 (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.
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.
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 as there will be better drainage of the obstructed biliary system with fewer adverse events.
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: Metal stentPatients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent. |
| Plastic Stent | Active comparator | Procedure: Plastic stentPatients with pancreatic cancer causing bile duct obstruction will be treated by placement of a plastic stent |
Who may qualify
- Ages
- 19 to 85 years
- 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 |
|---|---|---|
| Metal stentPatients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent. | Procedure or surgery | Metal stent |
| Plastic stentPatients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent. | Procedure or surgery | Plastic Stent |
Primary outcome
Complications related to stent dysfunction
Time frame: 30 days
Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by 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 12 Jul 2023.
- Individual participant dataSharing planned: No. A manuscript will be developed following the closure of the study.
Related trials for Obstructive Jaundice
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Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
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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.
Muhammad Hasan, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metal stent and Plastic stent 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 12 Jul 2023. 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 12 Jul 2023.