Best Biliary Drainage Option in Advanced Klatskin Tumor

Hepatopancreatobiliary Surgery Institute of Gansu Province180 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Cholangitis

Interventions

ERCP DrainagePROCEDURE

When advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent.

PTBD DrainagePROCEDURE

When advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, China

Outcomes

Primary Outcomes

Acute cholangitis

Acute cholangitis is defined if patients experienced abdominal pain, high fever, or chill after procedure in 2 weeks

Time frame: 2 weeks

Secondary Outcomes

Abdominal pain

Pain score (scores:1-10)

Time frame: 2 weeks

Length of hospital stay

The total time of hospital stay

Time frame: 6 months

Overall procedure related complication rate

Pancreatitis, bleeding, perforation, seeding

Time frame: 6 months

Data from ClinicalTrials.gov

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