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2010-07
2022-10-13
2022-10-13
61
NCT01191814
AdventHealth
AdventHealth
INTERVENTIONAL
Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2010-08-12 | N/A | 2023-07-11 |
2010-08-30 | N/A | 2023-07-12 |
2010-08-31 | N/A | 2023-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Metal stent Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent. | PROCEDURE: Metal stent
|
| ACTIVE_COMPARATOR: Plastic Stent Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a plastic stent | PROCEDURE: Plastic stent
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Complications related to stent dysfunction | Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by ERCP) | 30 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Procedural complications | Complications related to the procedure which includes pancreatitis, perforation or hemorrhage. | 30 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
