Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice

Conditions
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Periampullary Cancers With Obstructive Jaundice, Pancreas Head Cancer, Bile Duct Cancer, Ampulla of Vater Cancer

Intervention / Treatment
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* Procedure: biliary drainage


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PTBD<br>biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer | Procedure: biliary drainage<br>* biliary drainage via PTBD or ERBD/ENBD<br>|
| Active Comparator: ERBD<br>biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer | Procedure: biliary drainage<br>* biliary drainage via PTBD or ERBD/ENBD<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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