Best Biliary Drainage Option in Advanced Klatskin Tumor

Study Overview
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Brief Summary
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To investigate the biliary drainage-related cholangitis and other complications of percutaneous transhepatic biliary drainage (PTBD) in the management of Klatskin tumor (KT) compared with endoscopic biliary drainage (EBD).

Detailed Description
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Operative treatment combined with preoperative biliary drainage (PBD) has been established as a safe management strategy for KT. Preoperative cholangitis was an independent risk factor for patients undergoing resection for KT. However, controversy exists regarding the preferred technique for PBD.

Official Title
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Best Biliary Drainage Option in Type II、III、IV Klatskin Tumor：ERCP or PTBD

Conditions
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Cholangitis

Intervention / Treatment
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* Procedure: ERCP Drainage
* Procedure: PTBD Drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type II、III、IV Klatskin tumor patients; 18-90 years old Exclusion Criteria: Unwillingness or inability to consent for the study; Coagulation dysfunction (INR> 1.3) and low peripheral blood platelet count(<50×109 / L) or using anti-coagulation drugs; Previous endoscopic sphincterectomy (EST) or endoscopic papillary balloon dilatation (EPBD); Any type of GI reconstruction; Combined with Mirizzi syndrome and intrahepatic bile duct stones; Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock; Biliary-duodenal fistula; Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biliary drainage 1<br>Patients with advanced hilar cholangiocarcinoma need biliary drainage performed Endoscopic Retrograde Cholangiopancreatography (ERCP) drainage | Procedure: ERCP Drainage<br>* When advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent.<br>|
| Active Comparator: Biliary drainage 2<br>Patients with advanced hilar cholangiocarcinoma need biliary drainage performed percutaneous transhepatic biliary drainage(PTBD) drainage | Procedure: PTBD Drainage<br>* When advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute cholangitis | Acute cholangitis is defined if patients experienced abdominal pain, high fever, or chill after procedure in 2 weeks | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain | Pain score (scores:1-10) | 2 weeks | 
| Length of hospital stay | The total time of hospital stay | 6 months | 
| Overall procedure related complication rate | Pancreatitis, bleeding, perforation, seeding | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, PTBD, EBD, Cholangitis, Complication, Klatskin tumor