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Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Unknown
Phase 4

Conditions

Surgery
Cholangiocarcinoma
Drainage

Treatments

Procedure: Preoperative biliary drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT00797121
Drainage
Surgery
SUMS-5010
Cholangiocarcinoma

Details and patient eligibility

About

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

Full 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.

Enrollment

82 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

82 participants in 2 patient groups

Preoperative biliary drainage
Experimental group
Treatment:
Procedure: Preoperative biliary drainage
Controlled group
No Intervention group

Trial contacts and locations

1

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Central trial contact

Lijian Liang

Data sourced from clinicaltrials.gov

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