Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

Seoul National University

Status

Completed

Conditions

Ampulla of Vater Cancer

Pancreas Head Cancer

Bile Duct Cancer

Periampullary Cancers With Obstructive Jaundice

Treatments

Procedure: biliary drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT01134276

H-1001-047-307

Details and patient eligibility

About

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.

Enrollment

211 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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)