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

Self Expanding Metal Stents (SEMS) or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Jaundice; Periampullary Tumour
• Intervention / Treatment: Procedure: Self Expanding Metal Stent; Procedure: Plastic stent (7-10Fr)

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 141 86
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Obstructive jaundice in periampullary tumor.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self expanding metal stent; Patients with self expanding metal stent inserted into bile duct.	Procedure: Self Expanding Metal Stent
Active Comparator: Plastic stent; Patients with obstructive jaundice who got a plastic stent inserted into bile duct.	Procedure: Plastic stent (7-10Fr)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Degree and amount of bile bacterial contamination at the time of resection	Time at the operation

Secondary Outcome Measures

Outcome Measure	Time Frame
Degree of inflammation around the bile duct.	Time at the operative intervention
General complication rates	Time from intervention until day of discharge from hospital (on an average less than 90 days).
Postoperative hospital stay.	Time from intervention until day of discharge from hospital (on an average less than 90 days).
Bacterial culture of lymph nodes in the hepatoduodenal ligament.	Time of operative intervention

Collaborators and Investigators

• Sponsor: Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: March 3, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Estimate): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 21, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Manifestations; Hyperbilirubinemia; Jaundice; Jaundice, Obstructive
• Other Study ID Numbers: 2006/220-31/4 (Other Identifier: Regional ethics committee (EPN, Stockholm))