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A Randomized Controlled Trial on the Effects of Omega-3 Polyunsaturated Fatty Acids, Either Alone or in Combination with Ursodeoxycholic Acid (UDCA), on Bile Composition and Inflammatory Markers in Patients with Postoperative T-tube Drainage Following Biliary Tract Stone Surgery

A Randomized Controlled Trial on the Effects of Omega-3 Polyunsaturated Fatty Acids, Either Alone or in Combination with Ursodeoxycholic Acid (UDCA), on Bile Composition and Inflammatory Markers in Patients with Postoperative T-tube Drainage Following Biliary Tract Stone Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122615
Enrollment
Unknown
Registered
2026-04-15
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Bile duct stones

Interventions

Omega-3 Fatty Acid Soft Capsule Group:Omega-3 Fatty Acid Intervention Group
Combination Group (Omega-3 Fatty Acids + UDCA):Combined Intervention
UDCA Standard Group:UDCA Standard Group
Placebo Control Group:Placebo (High-Oleic Sunflower Oil) Capsule)

Sponsors

The Second Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 80 years; 2.Diagnosis of biliary stones confirmed by imaging (e.g., ultrasound, CT, MRCP); 3.Planned for surgical intervention with postoperative T-tube placement and confirmed adequate biliary drainage;

Exclusion criteria

Exclusion criteria: 1.History of allergy to Omega-3 or ursodeoxycholic acid (UDCA); 2.Red blood cell Omega-3 index = 8%; 3.Use of UDCA, Omega-3, or similar supplements within the past 3 months; 4.Long-term use of corticosteroids, immunosuppressants, or lipid-lowering agents; 5.Coagulation disorders or bleeding diathesis; 6.Long-term use of anticoagulant or antiplatelet medications; 7.Pregnancy or lactation; 8.Hepatic or renal insufficiency; 9.Presence of severe comorbidities (e.g., cancer, end-stage renal disease, heart failure NYHA class III-IV);

Design outcomes

Primary

MeasureTime frame
Changes in Bile;CompositionChanges in Bile Cholesterol Saturation Index (CSI);

Secondary

MeasureTime frame
Inflammatory Markers;Adverse Events;Hepatic Function Parameters;

Countries

China

Contacts

Public ContactMiao, Huilai

The Second Affiliated Hospital of Guangdong Medical University

miaohl-gdwk@gdmu.edu.cn+86 759 2372188

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026