Brief Title
Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers
Official Title
Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice
Brief Summary
Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. The purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.
Study Type
Interventional
Primary Outcome
Incidence of Infectious Complications After Biliary Drainage
Secondary Outcome
Change in Total Serum Bilirubin After Drainage
Condition
Periampullary Cancers With Obstructive Jaundice
Intervention
biliary drainage
Study Arms / Comparison Groups
PTBD
Description: biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
211
Start Date
August 2010
Completion Date
May 2013
Primary Completion Date
May 2013
Eligibility Criteria
Inclusion Criteria: - patient who have periampullary tumors causing obstructive jaundice - patient age: ≥20 and ≤85 - resectable state of disease - no history of previous chemotherapy or radiotherapy - patients without uncontrollable severe cardiovascular, respiratory disease - Karnofsky performance scale ≥70 - informed consent Exclusion Criteria: - patients with distant metastasis or locally advanced disease with major vascular invasion - duodenal cancer - biliary drainage before randomization - previous chemotherapy or radiotherapy - uncontrollable active infection except cholangitis - severe comorbid disease (cardiac, pulmonary, cerebrovascular)
Gender
All
Ages
20 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01134276
Organization ID
H-1001-047-307
Responsible Party
Principal Investigator
Study Sponsor
Seoul National University Hospital
Study Sponsor
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Verification Date
June 2014