Metal or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.
Self Expanding Metal Stents (SEMS) or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.
Lead Sponsor: Karolinska University Hospital
|Source||Karolinska University Hospital|
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.
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.
|Start Date||March 2007|
|Completion Date||January 2015|
|Primary Completion Date||December 2014|
Intervention Type: Procedure
Intervention Name: Plastic stent (7-10Fr)
Arm Group Label: Plastic stent
Intervention Type: Procedure
Intervention Name: Self Expanding Metal Stent
Arm Group Label: Self expanding metal stent
Inclusion Criteria: - Obstructive jaundice in periampullary tumor. Exclusion Criteria: - Not willing to participate. - Not a resectable tumor.
- Obstructive jaundice in periampullary tumor.
- Not willing to participate.
- Not a resectable tumor.
Minimum Age: 18 Years
Maximum Age: 90 Years
Healthy Volunteers: No
Type: Principal Investigator
Investigator Affiliation: Karolinska University Hospital
Investigator Full Name: Lars Lundell
Investigator Title: Professor
|Has Expanded Access||No|
|Number Of Arms||2|
Label: Self expanding metal stent
Description: Patients with self expanding metal stent inserted into bile duct.
Label: Plastic stent
Type: Active Comparator
Description: Patients with obstructive jaundice who got a plastic stent inserted into bile duct.
|Study Design Info||
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: Single (Participant)