A Phase 2 interventional study of Plastic stent (7-10Fr) and Self Expanding Metal Stent in Obstructive Jaundice and Periampullary Tumour, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-10-22.
Sponsored by Karolinska University Hospital · Phase 2, Interventional, and Prevention
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.
185 studies on the registry are indexed under Jaundice; 33 are open to participants now.
This study's enrollment of 92 is close to the median of 100 across 119 interventional studies indexed under Jaundice.
Browse Jaundice studies →Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with self expanding metal stent inserted into bile duct.
Procedure: Self Expanding Metal Stent
Patients with obstructive jaundice who got a plastic stent inserted into bile duct.
Procedure: Plastic stent (7-10Fr)
Degree and amount of bile bacterial contamination at the time of resection
Time frame: Time at the operation
Degree of inflammation around the bile duct.
Time frame: Time at the operative intervention
General complication rates
Time frame: Time from intervention until day of discharge from hospital (on an average less than 90 days).
Postoperative hospital stay.
Time frame: 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 frame: Time of operative intervention
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Karolinska University Hospital