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

Karolinska University Hospital

Status and phase: Completed; Phase 2

Conditions: Obstructive Jaundice; Periampullary Tumour

Treatments: Procedure: Plastic stent (7-10Fr); Procedure: Self Expanding Metal Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02166840

2006/220-31/4 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obstructive jaundice in periampullary tumor.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Self expanding metal stent

Experimental group

Description:

Patients with self expanding metal stent inserted into bile duct.

Treatment:

Procedure: Self Expanding Metal Stent

Plastic stent

Active Comparator group

Description:

Patients with obstructive jaundice who got a plastic stent inserted into bile duct.

Treatment:

Procedure: Plastic stent (7-10Fr)