Best Biliary Drainage Option in Advanced Klatskin Tumor

NCT ID: NCT03104582

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-01
• Study Completion Date: 2017-07-14

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.

Conditions

Cholangitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biliary drainage 1

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

Group Type: EXPERIMENTAL

ERCP Drainage

Intervention Type: PROCEDURE

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

Biliary drainage 2

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

Group Type: ACTIVE_COMPARATOR

PTBD Drainage

Intervention Type: PROCEDURE

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

Interventions

ERCP Drainage

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

Intervention Type: PROCEDURE

PTBD Drainage

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role: lead

Responsible Party

Wenbo Meng

M.D., Ph. D,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xun Li, M.D., Ph. D.

Role: STUDY_DIRECTOR

Hepatopancreatobiliary Surgery Institute of Gansu Province

Locations

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, China

Countries

China

References

Ba Y, Yue P, Leung JW, Wang H, Lin Y, Bai B, Zhu X, Zhang L, Zhu K, Wang W, Meng W, Zhou W, Liu Y, Li X. Percutaneous transhepatic biliary drainage may be the preferred preoperative drainage method in hilar cholangiocarcinoma. Endosc Int Open. 2020 Feb;8(2):E203-E210. doi: 10.1055/a-0990-9114. Epub 2020 Jan 22.

Reference Type: DERIVED

PMID: 32010755 (View on PubMed)

Other Identifiers

Biliary drainage in KT

Identifier Type: -

Identifier Source: org_study_id