Esophagogastric Varices, Hepatocellular Carcinoma
Conditions
Brief summary
The study is aimed to explore the efficacy of transarterial chemoembolization (TACE) combined with endoscopic therapy for unresectable hepatocellular carcinoma (HCC) complicated with esophagogastric varices (EGV) and seek out predictors associated with survival.
Interventions
PROCEDUREtransarterial chemoembolization combined with endoscopic therapy
TACE: The tip of the catheter was advanced into tumor-feeding artery based on the tumor location and size. 5-Fu was injected. Then the chemolipiodolization was performed, using oxaliplatin, epirubicin and lipiodol. If stagnant flow did not realized, then injected pure lipiodol. If the tumor-feeding artery still cannot be completely embolized, several absorbable gelatin sponge particles would be injected. Endoscopic therapy: After the site of esophageal varices was identified by the gastroscopy, spiral ligation using the EVL device (COOK, MBL-6-F) was performed and ensure the varices were fully inhaled, 1-3 rubber bands were used totally. After EVL, water was sprayed to the ligation sites to check for bleeding. If gastric varices were found, EIS was performed using the 'sandwich method' of hypertonic glucose-tissue adhesive-normal saline. Make sure the needle entered the varieose vein before inject drugs, and repeated the injection if necessary.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. HCC was diagnosed in accordance with the 2017 edition of diagnosis guidelines, all patients were in CNLC stage Ib to IIIa, and treated with TACE; 2. EGV was demonstrated through endoscopic examination; 3. Child-Pugh grade A or B, or grade C patients improved liver function to grade A or B through aggressive treatment; 4. age between 18 and 75 years.
Exclusion criteria
* 1\. HCC with diffuse or distant metastasis, or with other systemic malignancies; 2. severe jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome; 3. severe cardiac, cerebrovascular, lung and renal diseases and cannot tolerate endoscopic treatment; 4. severe coagulation dysfunction; 5. severe infection, bleeding with unstable vital signs; 6. history of liver surgery; 7. cannot or refuse to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of overall survival | In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years | Differences of overall survival between two groups |
| Number of bleeding episodes | In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years | Differences of bleeding episodes between two groups |
Countries
China
Outcome results
None listed