Trial record 5 of 84 for:    cholangiocarcinoma | Open Studies

Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00797121
First received: November 24, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Cholangiocarcinoma
Drainage
Surgery
Procedure: Preoperative biliary drainage
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Preoperative Biliary Drainage on Postoperative Complications in Resectable Patients With Hilar Cholangiocarcinoma(Klatskin Tumor)

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Incidence of postoperative complication [ Time Frame: 30 days after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Postoperative mortality [ Time Frame: 30 days after operation ] [ Designated as safety issue: Yes ]
  • Overall survival, OS [ Time Frame: May, 2013 ] [ Designated as safety issue: Yes ]
  • Disease free survival, DFS [ Time Frame: May, 2013 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 82
Study Start Date: May 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preoperative biliary drainage 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.
No Intervention: Controlled group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797121

Contacts
Contact: Lijian Liang 86-20-87755766 ext 8096 lianglj@medmail.com.cn

Locations
China, Guangdong
Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Dong Chen, MD    86-20-87755766 ext 8096    gzbobsums2004@hotmail.com   
Principal Investigator: Lijian Liang         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Lijian Liang Department of hepatobiliary, the first affiliated hospital, Sun Yat-sen University
Principal Investigator: Xiaoyu Yin, MD Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University
  More Information

Publications:
Responsible Party: Liang Li-jian, the First affiliated hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT00797121     History of Changes
Other Study ID Numbers: SUMS-5010, Cholangiocarcinoma, Surgery, Drainage
Study First Received: November 24, 2008
Last Updated: November 24, 2008
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
Cholangiocarcinoma
Drainage

Additional relevant MeSH terms:
Postoperative Complications
Cholangiocarcinoma
Klatskin's Tumor
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 19, 2014