Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

Study Overview
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Brief Summary
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This study is to investigate whether preoperative biliary drainage can reduce the postoperative morbidity in patients with hilar cholangiocarcinoma.

Detailed Description
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Preoperative biliary drainage(PBD) or not, is a Hot Spot issue in the management of Hilar cholangiocarcinoma. Surgeons from Japan tend to perform PTBD(Percutaneous Transhepatic Biliary Drainage) before a definite operation until the total bilirubin(TB) lower than 85μmol/L. For some patients needed to perform extended curative resection, PVE(Portal Vein Embolization) is performed and thus the duration of PBD may be around six weeks and the final TB is lower than 34μmol/L. Some tend to perform a definite curative operation in a short time after diagnosis. There is no RCT research on the effect of PBD for the resectable Hilar Cholangiocarcinoma patients to date.

Official Title
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Effect of Preoperative Biliary Drainage on Postoperative Complications in Resectable Patients With Hilar Cholangiocarcinoma(Klatskin Tumor)

Conditions
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Cholangiocarcinoma, Drainage, Surgery

Intervention / Treatment
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* Procedure: Preoperative biliary drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients newly diagnosed Resectable patients after imaging assessment and evaluation of general condition of the patient TB>85μmol/L WBC account more than 1.5×109/L, PLT account more than 100×109/L and HB account more than 100g/L No serious disease in heart, lung and kidney Written informed consent Exclusion Criteria: Unresectable patients. Patients have received biliary drainage procedure such as PTBD before admission Complicated with chronic hepatitis Myocardia infarction record within six months Women in pregnancy Serious disease in heart, lung or kidney

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative biliary drainage<br> | Procedure: Preoperative biliary drainage<br>* Percutaneous transhepatic biliary drainage(PTBD) is performed under the guidance of ultrasound. The duration may be around four weeks to make the total bilirubin of patients lower than 85μmol/L.<br>|
| No Intervention: Controlled group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative complication |  | 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative mortality |  | 30 days after operation | 
| Overall survival, OS |  | May, 2013 | 
| Disease free survival, DFS |  | May, 2013 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangiocarcinoma, Drainage