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

Obstructive Jaundice Clinical Trial

— SEMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166840
• Other study ID #: 2006/220-31/4
• Secondary ID: 2006/220-31/4
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2014
• Last updated: October 21, 2015
• Start date: March 2007
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Obstructive jaundice in periampullary tumor.

Exclusion Criteria:

• Not willing to participate.

• Not a resectable tumor.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Obstructive
• Obstructive Jaundice
• Periampullary Tumour

Intervention

Procedure:
• Plastic stent (7-10Fr)

• Self Expanding Metal Stent

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree and amount of bile bacterial contamination at the time of resection		Time at the operation	No
Secondary	Degree of inflammation around the bile duct.		Time at the operative intervention	Yes
Secondary	General complication rates		Time from intervention until day of discharge from hospital (on an average less than 90 days).	Yes
Secondary	Postoperative hospital stay.		Time from intervention until day of discharge from hospital (on an average less than 90 days).	Yes
Secondary	Bacterial culture of lymph nodes in the hepatoduodenal ligament.		Time of operative intervention	Yes