Efficacy of TACE With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Efficacy of TACE Combined With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma With Esophagogastric Varices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017922
• Other study ID #: 2021719-Tao
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: August 10, 2021

Study information

• Verified date: July 2021
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 10, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• transarterial 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.

Locations

Country	Name	City	State
China	Qilu Hospital , Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of overall survival	Differences of overall survival between two groups	In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years
Primary	Number of bleeding episodes	Differences of bleeding episodes between two groups	In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years