Best Biliary Drainage Option in Advanced Klatskin Tumor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Completed

Conditions: Cholangitis

Treatments: Procedure: ERCP Drainage; Procedure: PTBD Drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT03104582

Biliary drainage in KT

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Biliary drainage 1

Experimental group

Description:

Patients with advanced hilar cholangiocarcinoma need biliary drainage performed Endoscopic Retrograde Cholangiopancreatography (ERCP) drainage

Treatment:

Procedure: ERCP Drainage

Biliary drainage 2

Active Comparator group

Description:

Patients with advanced hilar cholangiocarcinoma need biliary drainage performed percutaneous transhepatic biliary drainage(PTBD) drainage

Treatment:

Procedure: PTBD Drainage