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A randomized clinical trial of oral ursodeoxycholic acid in patients with severe preoperative obstructive jaundice

A randomized clinical trial of oral ursodeoxycholic acid versus plancebo in patients with severe preoperative obstructive jaundice

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16009297
Enrollment
Unknown
Registered
2016-09-29
Start date
2015-04-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver-Obstructive Jaundice

Interventions

Treatment Group:ursodeoxycholic acid capsule, p.o.
Control Group:Plancebo

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Consensus obtained after introducing the study in detail; 2) Obstructive jaundice by tumor compression, serum total bilirubin level > 200 umol/L; 3) The external biliary drainage was established either by percutaneous transhepatic procedure; 4) No history of hepatolithiasis.

Exclusion criteria

Exclusion criteria: 1) Jaundice referred to other reasons than tumor obstruction, (PBS, cirrhosis, et al.); 2) Bile stones detected under ultrasonography; 3) Clinical evidences of cholangitis; 4) Clinical evidences of pancreatitis; 5) Unsatisfied, only small amount of bile outflow after external drainage established; 6) Uncompensated liver or kidney function, or other organ failure; 7) Other contraindications detected against UDCA therapy.

Design outcomes

Primary

MeasureTime frame
Serum Total Bilirubin Concentration;Serum Direct Bilirubin Concentration;

Secondary

MeasureTime frame
serum alanine aminotransferase;serum aspartate aminotransferase;Serum Creatinine;prothrombin time;3-year overall survival;3-year recurrence rates;

Countries

China

Contacts

Public ContactYong Zeng

West China Hospital, Sichuan University

zengyong@medmail.com.cn+86 18980601472

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026