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A randomized controlled trial of prognostic influence of hepatectomy combined with splenectomy on hepatocellular carcinoma patients with cirrhosis

A randomized controlled trial of prognostic influence of hepatectomy combined with splenectomy on hepatocellular carcinoma patients with cirrhosis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000578
Enrollment
Unknown
Registered
2009-10-22
Start date
2009-11-01
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

Hepatocellular carcinoma and cirrhosis

Interventions

B:Hepatectomy combined with splenectomy

Sponsors

Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Liver cirrhosis diagnosed by fibration grade F3 or F4 by means of puncture biopsy or postoperative pathology; 2. Primary hepatocellular carcinoma by means of postoperative pathology; 3. Liver function: Child-A or Child-B, ICG-R15<14%; 4. Technically radical neoplasm excision; 5. Portal hypertension: splenomegaly (the thickness of spleen is more than 4.1cm by means of percataneous ultrasonography or computerized tomography) and hypersplenism (WBC<4.0*10^9/L or PLT<100*10^9/L); 6. Patients with slight or moderate grade of esophageal and gastric varices by means of endoscopy, without hematemesis, and never received endoscopic varicose vein ligation or variceal sclerotherapy.

Exclusion criteria

Exclusion criteria: 1. Preoperative examinations show tumor thrombus in main portal vein and its first branches, common hepatic duct and its first branches, main hepatic veins, and hepatic veins; 2. Neoplasm metastasis out of liver or in lymph nodes; 3. Pathology shows active hepatitis; 4. Chemotherapy or interventional therapy or any other adjunctive therapy before operation; 5. Patients complicated with diabetes mellitus or heart diseases or any other organ diseases, can't tolerate the surgery; 6. Obstructive jaundice; 7. Postoperative recurrence in 2 months.

Design outcomes

Primary

MeasureTime frame
Disease free survival;Overall survival rate;

Secondary

MeasureTime frame
Peri-operative complication, biochemical indices of liver function (0d, 1d, 3d,7d, 14d), AFP (7d,14d);

Countries

China

Contacts

Public ContactFeng Xia
frankfxia@gmail.com+86 023 68765797

Outcome results

None listed

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