Skip to content

Temporary Extrahepatic Bile Duct Occlusion Versus the Traditional Gauze Test for the Prevention of Bile Leaks After Hepatectomy: A Prospective Randomized Controlled Trial

Temporary Extrahepatic Bile Duct Occlusion Versus the Traditional Gauze Test for the Prevention of Bile Leaks After Hepatectomy: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120731
Enrollment
Unknown
Registered
2026-03-19
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Liver Neoplasms

Interventions

Experimental group:Temporary Extrahepatic Bile Duct Occlusion: After completing the liver resection and hemostasis of the liver resection surface, rinse away any blood clots or eschar from the surface
if it shows signs of yellow staining, suture the corresponding bleeding site on the liver resection surface. Repeat the inspection until the gauze pad no longer shows yellow staining.
Control group:Traditional Gauze Test: After completing the liver resection and hemostasis of the liver resection surface, rinse away any blood clots or eschar from the surface with distilled water. Co
if it shows yellow staining, suture the corresponding bleeding site on the liver resection surface. Repeat the check until the gauze pad no longer shows yellow staining.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who require elective liver resection for any reason (whether laparoscopic or open surgery) and meet the surgical criteria; 2. Patients aged >=18 and <=80 years; 3. Child-Pugh Class A liver function; 4. No severe comorbidities; 5. Complete clinical data; 6. Have received a comprehensive explanation of the study from the principal investigator, understand the study objectives, and have voluntarily provided a written informed consent form to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Age 80 years; 2. Patients undergoing emergency hepatectomy due to traumatic liver rupture; 3. Patients requiring biliary reconstruction and hepaticoenteric anastomosis; 4. Patients with preoperative biliary obstruction; 5. Patients with Child-Pugh Class B or C liver function; 6. Pregnant women, women who may become pregnant, or women who are currently breastfeeding; 7. Patients with immunosuppression; 8. Patients who have participated in other clinical trials or used unapproved or uninsured medicinal products within 3 months prior to enrollment; 9. Patients deemed unsuitable for participation in this study by the principal investigator or co-investigator due to clinical or ethical issues (e.g., unstable general condition or cognitive impairment affecting informed consent); 10. Patients with incomplete clinical data; 11. Patients unable to undergo follow-up.

Design outcomes

Primary

MeasureTime frame
The incidence of bile leakage following liver resection;

Secondary

MeasureTime frame
Grading of Bile Leak Severity;Postoperative Changes in Liver Function;Length of hospital stay;Timing for removal of the drainage tube;Postoperative complications;

Countries

China

Contacts

Public ContactLi Jiang

West China Hospital, Sichuan University

jl339@126.com+86 189 8060 6338

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026