Best Biliary Drainage Option in Advanced Klatskin Tumor

Not Applicable

Completed

• Conditions: Cholangitis
• Interventions: Procedure: ERCP Drainage; Procedure: PTBD Drainage

• Registration Number: NCT03104582
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief Summary

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

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 Timeline

• Study Start: 2011-11-01
• Study First Submitted: 2017-03-25
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-07
• Primary Completion: 2017-07-14
• Study Completion: 2017-07-14
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Biliary drainage 1	ERCP Drainage	Patients with advanced hilar cholangiocarcinoma need biliary drainage performed Endoscopic Retrograde Cholangiopancreatography (ERCP) drainage
Biliary drainage 2	PTBD Drainage	Patients with advanced hilar cholangiocarcinoma need biliary drainage performed percutaneous transhepatic biliary drainage(PTBD) drainage

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province; 🇨🇳 Lanzhou, Gansu, China