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.

Sponsors

Lead Sponsor: Karolinska University Hospital

Source Karolinska University Hospital
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.

Overall Status Completed
Start Date March 2007
Completion Date January 2015
Primary Completion Date December 2014
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Degree and amount of bile bacterial contamination at the time of resection Time at the operation
Secondary 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
Enrollment 92
Condition
Intervention

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

Eligibility

Criteria:

Inclusion Criteria:

- Obstructive jaundice in periampullary tumor.

Exclusion Criteria:

- Not willing to participate.

- Not a resectable tumor.

Gender: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Lars Lundell, Professor Principal Investigator Karolinska University Hospital
Location
Facility: Karolinska University Hospital
Location Countries

Sweden

Verification Date

October 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Karolinska University Hospital

Investigator Full Name: Lars Lundell

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Self expanding metal stent

Type: Experimental

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.

Acronym SEMS
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Participant)

Source: ClinicalTrials.gov