Best Biliary Drainage Option in Advanced Klatskin Tumor

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03104582

Enrollment

180

Registered

2017-04-07

Start date

2011-11-01

Completion date

2017-07-14

Last updated

2019-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangitis

Keywords

ERCP, PTBD, EBD, Cholangitis, Complication, Klatskin tumor

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.

Interventions

PROCEDUREERCP Drainage

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

PROCEDUREPTBD Drainage

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026