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

Phase 2

Completed

• Conditions: Obstructive Jaundice; Periampullary Tumour
• Interventions: Procedure: Self Expanding Metal Stent; Procedure: Plastic stent (7-10Fr)

• Registration Number: NCT02166840
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-18
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Obstructive jaundice in periampullary tumor.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self expanding metal stent	Self Expanding Metal Stent	Patients with self expanding metal stent inserted into bile duct.
Plastic stent	Plastic stent (7-10Fr)	Patients with obstructive jaundice who got a plastic stent inserted into bile duct.

Primary Outcome Measures

Name	Time	Method
Degree and amount of bile bacterial contamination at the time of resection	Time at the operation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden