Best Biliary Drainage Option in Advanced Klatskin Tumor

Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104582
• Other study ID #: Biliary drainage in KT
• Status: Completed
• Phase: N/A
• Start date: November 1, 2011
• Est. completion date: July 14, 2017

Study information

• Verified date: July 2019
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 14, 2017
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Klatskin Tumor

Intervention

Procedure:
• ERCP Drainage
When advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent.
• PTBD Drainage
When advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent.

Locations

Country	Name	City	State
China	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute cholangitis	Acute cholangitis is defined if patients experienced abdominal pain, high fever, or chill after procedure in 2 weeks	2 weeks
Secondary	Abdominal pain	Pain score (scores:1-10)	2 weeks
Secondary	Length of hospital stay	The total time of hospital stay	6 months
Secondary	Overall procedure related complication rate	Pancreatitis, bleeding, perforation, seeding	6 months