Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

Effect of Preoperative Biliary Drainage on Postoperative Complications in Resectable Patients With Hilar Cholangiocarcinoma(Klatskin Tumor)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00797121

Enrollment

Registered

2008-11-25

Start date

2008-05-31

Completion date

2013-05-31

Last updated

2008-11-25

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

Conditions

Cholangiocarcinoma, Drainage, Surgery

Keywords

Cholangiocarcinoma, Drainage

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.

Interventions

PROCEDUREPreoperative biliary drainage

Percutaneous transhepatic biliary drainage(PTBD) is performed under the guidance of ultrasound. The duration may be around four weeks to make the total bilirubin of patients lower than 85μmol/L.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative complication	30 days after operation

Secondary

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

Countries

China

Contacts

Primary ContactLijian Liang

lianglj@medmail.com.cn86-20-87755766

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026