Preoperative Stent Study

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Randomized Study Comparing the Effect of Plastic Stents to That of Expandable Metal Stents Prior to Pancreaticoduodenectomy

Conditions
-----------------
Pancreas Cancer

Intervention / Treatment
-----------------
* Procedure: Plastic and metalic stent inserion


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: plastic stent<br>Stent insertion | Procedure: Plastic and metalic stent inserion<br>* Patient randomizes to metal or plastic insertion prior to Whipple procedure<br>* Other names: Two types of Stent prior to Whipple procedure;|
| Active Comparator: metalic stent<br>Stent inserttion | Procedure: Plastic and metalic stent inserion<br>* Patient randomizes to metal or plastic insertion prior to Whipple procedure<br>* Other names: Two types of Stent prior to Whipple procedure;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative measurement of the Culture from the bile. |  | Intraoperativt | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Perioperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreas, cancer, SEMS, Plastic, stent, Whipple, Jaundicie