Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

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Bile duct cancer
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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

, ,

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

, ,

Verification Date

June 2014