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Status unknownNCT00797121Updated Nov 25, 2008

Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

A Phase 4 interventional study of Preoperative biliary drainage in Cholangiocarcinoma, Drainage and Surgery, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-11-25.

Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Cholangiocarcinoma
  • Drainage
  • Surgery

Keywords

  • Cholangiocarcinoma
  • Drainage
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In context

Cholangiocarcinoma

914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.

This study's planned enrollment of 82 is above the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
82 participants (estimated)

Study arms

  • Experimental
    Preoperative biliary drainage

    Procedure: Preoperative biliary drainage

  • No intervention
    Controlled group

Interventions

  • ProcedurePreoperative 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.

06

What researchers measure

Primary outcomes

  1. Incidence of postoperative complication

    Time frame: 30 days after operation

Secondary outcomes

  1. Postoperative mortality

    Time frame: 30 days after operation

  2. Overall survival, OS

    Time frame: May, 2013

  3. Disease free survival, DFS

    Time frame: May, 2013

07

Study locations

1 of 1 sites recruiting
  • Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 11573044 ↗
  • 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. PubMed 10982608 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00797121
Lead sponsor
Sun Yat-sen University
First posted
Nov 25, 2008
Start date
May 2008
Primary completion
May 2011 (estimated)
Completion
May 2013 (estimated)
Last update
Nov 25, 2008

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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