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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


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
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