Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594744
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Endoscopic Variceal Ligation vs Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With HCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial of Endoscopic Variceal Ligation Versus Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P-HCC-CVL
Brief Summary:
The goal of this clinical trial is to evaluate whether endoscopic variceal ligation EVL or carvedilol is more effective at preventing the first esophageal variceal bleeding EVB in patients with hepatocellular carcinoma HCC It will also learn about the safety of EVL and carvedilol in patients with HCC The main questions it aims to answer are
Whether EVL or carvedilol is more effective at preventing initial EVB in patients with HCC with high-risk EVs
What medical problems do participants have when undergoing EVL or taking carvedilol Researchers will compare the efficacy and safety of EVL to carvedilol for the prevention of first EVB in patients with HCC
Participants will
Undergo EVL every 3-4 weeks until variceal eradication and then receive regular endoscopic follow-up according to the protocol or Take carvedilol every day start from 625 mgd and then titrate to 125 mgd if tolerable
Visit the clinic once every 2-3 months for checkups and tests Keep a diary of their vital signs SBP DBP and HR as well as symptoms
Whether EVL or carvedilol is more effective at preventing initial EVB in patients with HCC with high-risk EVs
What medical problems do participants have when undergoing EVL or taking carvedilol Researchers will compare the efficacy and safety of EVL to carvedilol for the prevention of first EVB in patients with HCC
Participants will
Undergo EVL every 3-4 weeks until variceal eradication and then receive regular endoscopic follow-up according to the protocol or Take carvedilol every day start from 625 mgd and then titrate to 125 mgd if tolerable
Visit the clinic once every 2-3 months for checkups and tests Keep a diary of their vital signs SBP DBP and HR as well as symptoms
Detailed Description:
Gastro-esophageal variceal bleeding is a major complication of portal hypertension PHT and carries a high rate of rebleeding and mortality Hepatocellular carcinoma HCC a special subgroup of PHT is the sixth most commonly diagnosed cancer and the third leading cause of cancer death worldwide The presence of esophageal varices EVs in more than half of patients with HCC is associated with poor survival Furthermore without primary prevention strategies nearly half of these HCC patients experience esophageal variceal bleeding EVB The prognosis of HCC patients with EVB is extremely poor with a rebleeding rate of 50 and a six-week mortality rate of 26-48 both of which are higher than those of non-HCC patients
However there is still a lack of evidence on how to prevent first EVB in patients with HCC with high-risk EVs AASLD practice guidance recommends prevention of EVB and hepatic decompensation in patients with HCC should follow the same principles as those for patients without HCC that is nonselective beta-blocker NSBB therapy is recommended in patients with HCC with clinically significant portal hypertension CSPH Endoscopic variceal ligation EVL is recommended for compensated patients with high-risk EVs who have contraindications to NSBBs However this recommendation lacks randomized controlled trial RCT to support it Our recently published RCT showed that EVL is superior to propranolol PPL in the primary prevention of EVB in patients with HCC with high-risk EVs In the subgroup analysis EVL reduces EVB and improves OS in patients with BCLC stage AB but not in those with BCLC stage CD
Carvedilol an NSBB that additionally exerts intrinsic anti-alpha-1-adrenergic activity has been shown to reduce hepatic venous pressure gradient more than propranolol and is currently the first-line treatment for primary prophylaxis in patients with CSPH Nevertheless the superiority of EVL versus carvedilol as a primary prevention strategy in patients with HCC with high-risk EVs is still unknown In this project we will initiate an open-label RCT aiming at comparing the efficacy of EVL and carvedilol in the primary prevention of EVB in patients with HCC with high-risk EVs We will also explore if there is any difference between the two groups in terms of other upper gastrointestinal bleeding nonbleeding liver decompensation such as new onsetworsening ascites hepatic encephalopathy spontaneous bacterial peritonitis and hepatorenal syndrome overall survival adverse events tolerability and safety We will also compare the efficacy of EVL and carvedilol in the primary prevention of EVB in patients with HCC at different BCLC stage
However there is still a lack of evidence on how to prevent first EVB in patients with HCC with high-risk EVs AASLD practice guidance recommends prevention of EVB and hepatic decompensation in patients with HCC should follow the same principles as those for patients without HCC that is nonselective beta-blocker NSBB therapy is recommended in patients with HCC with clinically significant portal hypertension CSPH Endoscopic variceal ligation EVL is recommended for compensated patients with high-risk EVs who have contraindications to NSBBs However this recommendation lacks randomized controlled trial RCT to support it Our recently published RCT showed that EVL is superior to propranolol PPL in the primary prevention of EVB in patients with HCC with high-risk EVs In the subgroup analysis EVL reduces EVB and improves OS in patients with BCLC stage AB but not in those with BCLC stage CD
Carvedilol an NSBB that additionally exerts intrinsic anti-alpha-1-adrenergic activity has been shown to reduce hepatic venous pressure gradient more than propranolol and is currently the first-line treatment for primary prophylaxis in patients with CSPH Nevertheless the superiority of EVL versus carvedilol as a primary prevention strategy in patients with HCC with high-risk EVs is still unknown In this project we will initiate an open-label RCT aiming at comparing the efficacy of EVL and carvedilol in the primary prevention of EVB in patients with HCC with high-risk EVs We will also explore if there is any difference between the two groups in terms of other upper gastrointestinal bleeding nonbleeding liver decompensation such as new onsetworsening ascites hepatic encephalopathy spontaneous bacterial peritonitis and hepatorenal syndrome overall survival adverse events tolerability and safety We will also compare the efficacy of EVL and carvedilol in the primary prevention of EVB in patients with HCC at different BCLC stage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None