Preoperative Stent Study

NCT ID: NCT00501176

Last Updated: 2022-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Pancreas Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

plastic stent

Stent insertion

Group Type: ACTIVE_COMPARATOR

Plastic and metalic stent inserion

Intervention Type: PROCEDURE

Patient randomizes to metal or plastic insertion prior to Whipple procedure

metalic stent

Stent inserttion

Group Type: ACTIVE_COMPARATOR

Plastic and metalic stent inserion

Intervention Type: PROCEDURE

Patient randomizes to metal or plastic insertion prior to Whipple procedure

Interventions

Plastic and metalic stent inserion

Patient randomizes to metal or plastic insertion prior to Whipple procedure

Intervention Type: PROCEDURE

Other Intervention Names

Two types of Stent prior to Whipple procedure

Eligibility Criteria

Exclusion Criteria

• Define as failed ERCP, patients who have previously undergone bile flow drainage or radical surgery is not possible.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars Enochsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinksa Institutet

Urban Arnelo, M.D.

Role: STUDY_DIRECTOR

Karolinska Institutet

Lars Lundell, Professor

Role: STUDY_CHAIR

Karolinska Institutet

Locations

Karolinksa University Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

¨2006/220-31/4

Identifier Type: -

Identifier Source: org_study_id