Efficacy of TACE With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma

NCT05017922 | Completed

• 1 other identifier: 2021719-Tao
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Esophagogastric Varices

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

combined group

EXPERIMENTAL

unresectable hepatocellular carcinoma patients who received TACE plus endoscopic therapy

Procedure: transarterial chemoembolization combined with endoscopic therapy

control group

OTHER

unresectable hepatocellular carcinoma patients who only received TACE

Procedure: transarterial chemoembolization combined with endoscopic therapy

Interventions

transarterial chemoembolization combined with endoscopic therapy PROCEDURE

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.

combined group; control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital , Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (1)

• Tao Z, Ruan Y, Peng Z, Zhang K, Gao Y. Transarterial Chemoembolization Combined With Endoscopic Therapy Is Beneficial for Unresectable Hepatocellular Carcinoma With Esophagogastric Varices. Front Oncol. 2021 Dec 2;11:783574. doi: 10.3389/fonc.2021.783574. eCollection 2021.

  PMID: 34926300 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: January 1, 2017
• Primary Completion: January 1, 2021
• Study Completion: August 10, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-07

Locations

CN (1)