Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

Overview

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

Full Title of Study: “Effect of Preoperative Biliary Drainage on Postoperative Complications in Resectable Patients With Hilar Cholangiocarcinoma(Klatskin Tumor)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2011

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

  • Procedure: Preoperative 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.

Arms, Groups and Cohorts

  • Experimental: Preoperative biliary drainage
  • No Intervention: Controlled group

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of postoperative complication
    • Time Frame: 30 days after operation

Secondary Measures

  • Postoperative mortality
    • Time Frame: 30 days after operation
  • Overall survival, OS
    • Time Frame: May, 2013
  • Disease free survival, DFS
    • Time Frame: May, 2013

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Liang Li-jian, the First affiliated hospital, Sun Yat-Sen University
  • Overall Official(s)
    • Lijian Liang, Study Chair, Department of hepatobiliary, the first affiliated hospital, Sun Yat-sen University
    • Xiaoyu Yin, MD, Principal Investigator, Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University
  • Overall Contact(s)
    • Lijian Liang, 86-20-87755766, lianglj@medmail.com.cn

References

Jarnagin WR, Fong Y, DeMatteo RP, Gonen M, Burke EC, Bodniewicz BS J, Youssef BA M, Klimstra D, Blumgart LH. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg. 2001 Oct;234(4):507-17; discussion 517-9.

Nimura Y, Kamiya J, Kondo S, Nagino M, Uesaka K, Oda K, Sano T, Yamamoto H, Hayakawa N. Aggressive preoperative management and extended surgery for hilar cholangiocarcinoma: Nagoya experience. J Hepatobiliary Pancreat Surg. 2000;7(2):155-62.

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