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


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Cholangiocarcinoma, Drainage, Surgery

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Incidence of postoperative complication

Outcome Time Frame:

30 days after operation

Safety Issue:

Yes

Principal Investigator

Lijian Liang

Investigator Role:

Study Chair

Investigator Affiliation:

Department of hepatobiliary, the first affiliated hospital, Sun Yat-sen University

Authority:

China: Ministry of Health

Study ID:

SUMS-5010

NCT ID:

NCT00797121

Start Date:

May 2008

Completion Date:

May 2013

Related Keywords:

  • Cholangiocarcinoma
  • Drainage
  • Surgery
  • Cholangiocarcinoma
  • Drainage
  • Postoperative Complications
  • Cholangiocarcinoma
  • Klatskin's Tumor

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