Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

Phase 4

• Conditions: Cholangiocarcinoma; Drainage; Surgery
• Interventions: Procedure: Preoperative biliary drainage

• Registration Number: NCT00797121
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This study is to investigate whether preoperative biliary drainage can reduce the postoperative morbidity in patients with hilar cholangiocarcinoma.

Detailed Description

Preoperative biliary drainage(PBD) or not, is a Hot Spot issue in the management of Hilar cholangiocarcinoma. Surgeons from Japan tend to perform PTBD(Percutaneous Transhepatic Biliary Drainage) before a definite operation until the total bilirubin(TB) lower than 85μmol/L. For some patients needed to perform extended curative resection, PVE(Portal Vein Embolization) is performed and thus the duration of PBD may be around six weeks and the final TB is lower than 34μmol/L. Some tend to perform a definite curative operation in a short time after diagnosis. There is no RCT research on the effect of PBD for the resectable Hilar Cholangiocarcinoma patients to date.

Study Timeline

• Study Start: 2008-05
• Status Verified: 2008-11
• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Last Update Submitted: 2008-11-24
• Study First Posted: 2008-11-25
• Last Update Posted: 2008-11-25
• Primary Completion: 2011-05
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Patients newly diagnosed
• Resectable patients after imaging assessment and evaluation of general condition of the patient
• TB>85μmol/L
• WBC account more than 1.5×109/L, PLT account more than 100×109/L and HB account more than 100g/L
• No serious disease in heart, lung and kidney
• Written informed consent

Exclusion Criteria

• Unresectable patients.
• Patients have received biliary drainage procedure such as PTBD before admission
• Complicated with chronic hepatitis
• Myocardia infarction record within six months
• Women in pregnancy
• Serious disease in heart, lung or kidney

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative biliary drainage	Preoperative biliary drainage	-

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative complication	30 days after operation

Secondary Outcome Measures

Name	Time	Method
Postoperative mortality	30 days after operation
Overall survival, OS	May, 2013
Disease free survival, DFS	May, 2013

Trial Locations

Locations (1)

Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China