Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

NCT00797121 | Unknown Phase 4 DMC

• 4 other identifiers: SUMS-5010CholangiocarcinomaSurgeryDrainage
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholangiocarcinoma; Drainage; Surgery

Keywords

Cholangiocarcinoma; Drainage

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative complication

  30 days after operation

Secondary Outcomes (3)

• Postoperative mortality

  30 days after operation

• Overall survival, OS

  May, 2013

• Disease free survival, DFS

  May, 2013

Study Arms (2)

Preoperative biliary drainage

EXPERIMENTAL

Procedure: Preoperative biliary drainage

Controlled group

NO INTERVENTION

Interventions

Preoperative biliary drainage PROCEDURE

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.

Preoperative biliary drainage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (2)

• 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. doi: 10.1097/00000658-200110000-00010.

  PMID: 11573044 BACKGROUND

• 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. doi: 10.1007/s005340050170.

  PMID: 10982608 BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Lijian Liang

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

  STUDY CHAIR

• Xiaoyu Yin, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lijian Liang

CONTACT

86-20-87755766; lianglj@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2013
• Last Updated: November 25, 2008

Record last verified: 2008-11

Locations

CN (1)