Best Biliary Drainage Option in Advanced Klatskin Tumor

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

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).

Study Overview

• Status: Completed
• Conditions: Cholangitis
• Intervention / Treatment: Procedure: ERCP Drainage; Procedure: PTBD Drainage

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Hepatopancreatobiliary Surgery Institute of Gansu Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biliary drainage 1; Patients with advanced hilar cholangiocarcinoma need biliary drainage performed Endoscopic Retrograde Cholangiopancreatography (ERCP) drainage	Procedure: ERCP Drainage; When advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent.
Active Comparator: Biliary drainage 2; Patients with advanced hilar cholangiocarcinoma need biliary drainage performed percutaneous transhepatic biliary drainage(PTBD) drainage	Procedure: PTBD Drainage; When advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Investigators: Study Director: Xun Li, M.D., Ph. D., Hepatopancreatobiliary Surgery Institute of Gansu Province

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): July 14, 2017
• Study Completion (Actual): July 14, 2017

Study Registration Dates

• First Submitted: March 25, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: ERCP; Complication; Cholangitis; Klatskin tumor; PTBD; EBD
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Biliary Tract Diseases; Bile Duct Diseases; Cholangiocarcinoma; Cholangitis; Klatskin Tumor
• Other Study ID Numbers: Biliary drainage in KT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No