Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

Not Applicable

Completed

• Conditions: Periampullary Cancers With Obstructive Jaundice; Pancreas Head Cancer; Bile Duct Cancer; Ampulla of Vater Cancer
• Interventions: Procedure: biliary drainage

• Registration Number: NCT01134276
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-31
• Study Start: 2010-08
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-04-07
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-07
• Last Update Submitted: 2014-06-07
• Results First Posted: 2014-06-11
• Last Update Posted: 2014-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTBD	biliary drainage	biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer
ERBD	biliary drainage	biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer

Primary Outcome Measures

Name	Time	Method
Incidence of Infectious Complications After Biliary Drainage	within 120 days after drainage	at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)

Secondary Outcome Measures

Name	Time	Method
Change in Total Serum Bilirubin After Drainage	within 14 days after drainage	Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)
Total Hospital Cost During Admission After Biliary Drainage	during hospital stay for biliary drainage procedure	Total hospital cost during admission after Biliary Drainage in US dollars

Trial Locations

Locations (1)

Department of Surgery, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of