Randomized Study Comparing the Effect of Plastic Stents to That of Expandable Metal Stents as Prior to Pancreaticoduodenectomy
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Purpose
Randomized study comparing the effect of plastic stents to that of expandable metal stents as pre-operative drainage of the bile ducts prior to Whipple operation.
| Condition | Intervention |
|---|---|
|
Pancreas Cancer |
Procedure: Plastic and metalic stent inserion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Study Comparing the Effect of Plastic Stents to That of Expandable Metal Stents Prior to Pancreaticoduodenectomy |
- Intra-operative measurement of the Culture from the bile. [ Time Frame: Intraoperativt ] [ Designated as safety issue: No ]
- Intraoperative measurements of inflammatory reaction in the liver, hepatoduodenal ligament and around the bile ducts with biopsies. Stent dysfunction and cholangitis after ERCP and pre-operative bile flow relief. Postoperative analysis. [ Time Frame: Perioperative ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: plastic stent
Stent insertion
|
Procedure: Plastic and metalic stent inserion
Patient randomizes to metal or plastic insertion prior to Whipple procedure
Other Name: Two types of Stent prior to Whipple procedure
|
|
Active Comparator: metalic stent
Stent inserttion
|
Procedure: Plastic and metalic stent inserion
Patient randomizes to metal or plastic insertion prior to Whipple procedure
Other Name: Two types of Stent prior to Whipple procedure
|
Detailed Description:
Patients suffering from a locally invasive tumour process in the Periampullary area usually seek medical attention because of jaundice. Not only do patients suffering from jaundice show significant symptoms of exhaustion and purities, but they are also at higher risk for developing post-operative complications. Experimentally, the liver exhibits a reduced capacity for tolerating ischemia in the presence of jaundice. Several different etiologic factors suggest cause complication such as presence of toxic substances as bilirubin and bile salts, impaired nutritional status, effects of endotoxins, bacterial translocation, modulation of the inflammatory cascade with cytokine release, reduction of cellular immunity and nutritional. These complications primarily consist of septic complications (cholangitis, abscesses, and leakage), haemorrhage, impaired wound healing and renal disorders. Summarily, these issues have motivated pre-operative bile flow drainage by way of stent. Traditionally, pre-operative bile flow drainage has been achieved by insertion of a EP because these are considered easy to remove and cause less tissue reaction in the bile ducts. However, multiple studies have found the disadvantage with the EP is that it provides poorer bile drainage than the SEMS.
In palliative situations, metal stents have been associated with fewer side-effects in the form of fever relapse of jaundice, etc. These effects are likely due to better bile flow through the stent. It remains unclear if metal stents can provide similar advantages in the curative situation.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The primary inclusion criteria are all patients with operable Periampullary cancer and jaundice who have not previously undergone bile flow drainage.
Exclusion Criteria:
- Define as failed ERCP, patients who have previously undergone bile flow drainage or radical surgery is not possible.
Contacts and Locations| Contact: Farshad Frozanpor | farshad.frozanpor@sodersjukhuset.se |
| Sweden | |
| Karolinksa university hospital | Recruiting |
| Stockholm, Sweden, 14186 | |
| Contact: Farshad Frozanpor | |
| Contact: Urban Arnelo | |
| Principal Investigator: Farshad Frozanpor | |
| Principal Investigator: | Farshad Frozanpor | Karolinksa university hospital |
| Study Director: | Urban Arnelo, M.D. | Karolinska institut Huddinge |
| Study Chair: | Lars Lundell, Professor | Karolinska Institutet |
More Information
No publications provided
| Responsible Party: | Farshad Frozanpor, MD, PhD, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT00501176 History of Changes |
| Other Study ID Numbers: | ¨2006/220-31/4 |
| Study First Received: | July 11, 2007 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska Institutet:
|
Pancreas cancer SEMS Plastic |
stent Whipple Jaundicie |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013