Preoperative Stent Study

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT00501176

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer	Procedure: Plastic and metalic stent inserion	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: plastic stent Stent insertion	Procedure: Plastic and metalic stent inserion Patient randomizes to metal or plastic insertion prior to Whipple procedure Other Names: 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 Names: Two types of Stent prior to Whipple procedure

Arm

Intervention/Treatment

Active Comparator: plastic stent

Stent insertion

Procedure: Plastic and metalic stent inserion

Patient randomizes to metal or plastic insertion prior to Whipple procedure

Other Names:

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 Names:

Two types of Stent prior to Whipple procedure

Outcome Measures

Primary Outcome Measures

Intra-operative measurement of the Culture from the bile. [Intraoperativt]

Secondary Outcome Measures

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]