Metal or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.

NCT ID: NCT02166840

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2015-01-31

Brief Summary

Patients with obstructive jaundice due to periampullary tumor can temporarily be relieved of their jaundice with transpapillary stenting at endoscopic retrograde cholangio-pancreatography (ERCP) prior to operation. Usually plastic stents are used.

Hypothesis: Self expanding metallic stents offer a be a better alternative for preoperative stenting in patients with obstructive jaundice due to periampullary tumour obstruction.

Detailed Description

Patients who present with obstructive jaundice and have a periampullary tumor and where the patient seems to be in good condition for surgical resection are offered the opportunity to become randomized to either endoscopic drainage with self expanding metallic or plastic stents. Before randomization they are informed about the study details and have to give their consent to participate. The metallic as well as plastic stents are standard commercially available stents. Within four weeks after stent placement the patient will be operated and the following parameters will be evaluated: quality of life, clinical symptoms and lab tests. At the operation the surgeon will make an evaluation of the inflammatory reaction in the area of the bile ducts. A culture from the bile is sampled close to the area where the anastomosis will be sutured. A tissue sample is also taken from the bile ducts to evaluate inflammation. A Lymph node is also sampled for the same reason. The surgeon also evaluates the difficulty with which the stent had to be removed. Postoperative complications are monitored in line with the regular routines at the clinic.

Conditions

Obstructive Jaundice; Periampullary Tumour

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Self expanding metal stent

Patients with self expanding metal stent inserted into bile duct.

Group Type: EXPERIMENTAL

Self Expanding Metal Stent

Intervention Type: PROCEDURE

Plastic stent

Patients with obstructive jaundice who got a plastic stent inserted into bile duct.

Group Type: ACTIVE_COMPARATOR

Plastic stent (7-10Fr)

Intervention Type: PROCEDURE

Interventions

Plastic stent (7-10Fr)

Intervention Type: PROCEDURE

Self Expanding Metal Stent

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Obstructive jaundice in periampullary tumor.

Exclusion Criteria

• Not willing to participate.
• Not a resectable tumor.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lars Lundell

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Lundell, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2006/220-31/4

Identifier Type: OTHER

Identifier Source: secondary_id

2006/220-31/4

Identifier Type: -

Identifier Source: org_study_id