Back to resultsMetal or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors. (SEMS)
Primary Purpose
Obstructive Jaundice, Periampullary Tumour
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Plastic stent (7-10Fr)
Self Expanding Metal Stent
Sponsored by
About this trial
This is an interventional prevention trial for Obstructive Jaundice
Eligibility Criteria
Inclusion Criteria:
- Obstructive jaundice in periampullary tumor.
Exclusion Criteria:
- Not willing to participate.
- Not a resectable tumor.
Sites / Locations
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Self expanding metal stent
Plastic stent
Arm Description
Patients with self expanding metal stent inserted into bile duct.
Patients with obstructive jaundice who got a plastic stent inserted into bile duct.
Outcomes
Primary Outcome Measures
Degree and amount of bile bacterial contamination at the time of resection
Secondary Outcome Measures
Degree of inflammation around the bile duct.
General complication rates
Postoperative hospital stay.
Bacterial culture of lymph nodes in the hepatoduodenal ligament.
Full Information
NCT ID
NCT02166840
First Posted
March 3, 2014
Last Updated
October 21, 2015
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02166840
Brief Title
Metal or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.
Acronym
SEMS
Official Title
Self Expanding Metal Stents (SEMS) or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Jaundice, Periampullary Tumour
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self expanding metal stent
Arm Type
Experimental
Arm Description
Patients with self expanding metal stent inserted into bile duct.
Arm Title
Plastic stent
Arm Type
Active Comparator
Arm Description
Patients with obstructive jaundice who got a plastic stent inserted into bile duct.
Intervention Type
Procedure
Intervention Name(s)
Plastic stent (7-10Fr)
Intervention Type
Procedure
Intervention Name(s)
Self Expanding Metal Stent
Primary Outcome Measure Information:
Title
Degree and amount of bile bacterial contamination at the time of resection
Time Frame
Time at the operation
Secondary Outcome Measure Information:
Title
Degree of inflammation around the bile duct.
Time Frame
Time at the operative intervention
Title
General complication rates
Time Frame
Time from intervention until day of discharge from hospital (on an average less than 90 days).
Title
Postoperative hospital stay.
Time Frame
Time from intervention until day of discharge from hospital (on an average less than 90 days).
Title
Bacterial culture of lymph nodes in the hepatoduodenal ligament.
Time Frame
Time of operative intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obstructive jaundice in periampullary tumor.
Exclusion Criteria:
Not willing to participate.
Not a resectable tumor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Lundell, Professor
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Metal or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.
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