Clinical Trial Record

Return to Clinical Trials

Preoperative Stent Study


2006-12


2014-11


2014-12


92

Study Overview

Preoperative Stent Study

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.

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.

  • Pancreas Cancer
  • PROCEDURE: Plastic and metalic stent inserion
  • ¨2006/220-31/4

Study Record Dates

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

2007-07-11  

N/A  

2022-06-22  

2007-07-12  

N/A  

2022-06-29  

2007-07-13  

N/A  

2022-06  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Randomized


Interventional Model:
Crossover


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: plastic stent

Stent insertion

PROCEDURE: Plastic and metalic stent inserion

  • Patient randomizes to metal or plastic insertion 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
Primary Outcome MeasuresMeasure DescriptionTime Frame
Intra-operative measurement of the Culture from the bile.Intraoperativt
Secondary Outcome MeasuresMeasure DescriptionTime 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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

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:
20 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Lars Enochsson, MD, PhD, Karolinksa Institutet

    Publications

    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