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Synchronous hepatectomy and splenectomy for patients with hepatocellular carcinoma, cirrhosis and hypersplenism: a multicenter, randomized, and positive parallel control clinical study

Synchronous hepatectomy and splenectomy for patients with hepatocellular carcinoma, cirrhosis and hypersplenism: a multicenter, randomized, and positive parallel control clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024695
Enrollment
Unknown
Registered
2019-07-22
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-29

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

Conditions

hepatocellular carcinoma

Interventions

HS group:synchronous hepatectomy and splenectomy
H group:hepatectomy alone

Sponsors

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Clinical diagnosis of hepatocellular carcinoma with posthepatitic cirrhosis hypersplenism: (1) imaging confirmed splenomegaly; (2) 50x10^9/ L< PLT < 100x10^9/ L); 3. Child-pugh liver function was classified as grade A, or grade B but recovered to grade A after treatment; 4. Hepatocellular carcinoma, BCLC stage A; 5. No other antitumor therapy or immunotherapy were performed before surgery; 6. No serious organic diseases of the heart, lungs, brain or other organs; 7. No history of other malignancies; 8. Patient's survival is expected to exceed 3 months; 9. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. A history of organ transplantation; 3. If there is any history of esophageal and gastric varicose vein rupture and bleeding or if there is "red sign" in this gastroscopy; 4. Active bleeding caused by various causes; 5. Suffering from serious acute or chronic diseases; 6. Severe diabetes; 7. Having a serious infectious disease; 8. HIV infection or AIDS related diseases; 9. Substance abuse, or mental or other disorders that may interfere with research compliance.

Design outcomes

Primary

MeasureTime frame
DFS at 3 years after surgery;

Secondary

MeasureTime frame
OS at 3 years after surgery;Postoperative liver function;Postoperative immune function;Postoperative quality of life;Incidence of postoperative complications;Postoperative complication severity;Postoperative morbidity;Postoperative mortality;

Countries

China

Contacts

Public ContactZhang Zhiwei

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

zwzhang@tjh.tjmu.edu.cn+86 13607130969

Outcome results

None listed

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