Obstructive Jaundice Clinical Trial
— SEMSOfficial title:
Self Expanding Metal Stents (SEMS) or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital |
Sweden,
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 |
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