Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05624229
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-28
First Post:
2022-11-12
Brief Title:
Efficacy of Proton Pump Inhibitors in Cirrhotic Patients With Acute Variceal Bleeding
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Efficacy of Proton Pump Inhibitors in Cirrhotic Patients With Acute Variceal Bleeding
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute Variceal Bleeding AVB in patients with liver cirrhosis is a common clinical critical disease There is little evidence for the effect of proton pump inhibitor PPI use in patients with AVB and there is no study on the efficacy of PPI combined with standard therapy in patients with AVB
Detailed Description:
AVB in patients with liver cirrhosis is a common clinical critical disease with a 6-week mortality rate as high as 20 Currently many guidelines recommend the use of vasoactive drugs terlipressin somatostatin or octreotide combined with endoscopic therapy Endoscopic Variceal Ligation EVL endoscopic injection sclerotherapy EIS and the use of prophylactic antibiotics for patients with AVB
PPI is a commonly used antacid agent which has a significant antacid effect protects the gastrointestinal mucosa promotes blood coagulation healing ulcers effectively stops bleeding and prevents rebleeding There is a consensus that PPI should be used before and after endoscopic therapy in patients with non-variceal acute bleeding However studies on the efficacy of PPI after EVL are still limited and lack of sufficient convincing In a randomized controlled study pantoprazole treatment was found to be associated with significantly smaller ulcers 10 days after elective EVL in secondary prevention patients with cirrhosis Another randomized controlled study in 2013 found that patients with cirrhosis and AVB treated with PPI for 19 days after endoscopic hemostasis had smaller ulcers and fewer overall side-effects but there was no statistically significant difference in rate of 5-day treatment failure 6-week rebleeding rate and 6-week mortality In 2017 a study included 637 patients with acute bleeding from liver cirrhosis 80 of whom were treated with acid suppression therapy and the study found that acid suppression therapy had no significant effect on long-term bleeding rate and mortality However negative effects of PPI have been reported in patients with cirrhosis such as spontaneous bacterial peritonitis and hepatic encephalopathy It is found that patients with cirrhosis and ascites had an increased risk of first hepatic encephalopathy with PPI use and also found that patients with cirrhosis had an increased risk of hepatic encephalopathy and death with PPI use Therefore PPI use in patients with cirrhosis should be more cautious However the duration of PPI use in these studies was long and there are no data to clarify the effect of short-term PPI use
At present there is no consensus among the major guidelines on the use of PPI in patients with acute AVB in liver cirrhosis and the UK guidelines do not recommend the use of PPI unless accompanied by gastrointestinal ulcer The use of PPI was not mentioned in the guidelines of the American Endoscopic Society and the European Endoscopic Society The 2021 Baveno 7 guideline clearly proposes that PPI should be stopped immediately once AVB is identified as cirrhosis The latest meta-analysis in 2022 showed that the use of PPI before endoscopy may reduce the need for endoscopic hemostasis in patients with upper gastrointestinal tract but there was no sufficient evidence to confirm the effect on clinical outcomes including 30-day mortality and rebleeding It can be concluded that there is no consensus on the use of PPI in patients with AVB in cirrhosis and the recommendations of guidelines lack high-quality studies to improve the convincing
In summary there is little evidence for the effect of PPI use in patients with AVB in liver cirrhosis and there is no study on the efficacy of PPI combined with endoscopic therapy in patients with AVB in liver cirrhosis Therefore the investigators planned to design a multicenter prospective randomized controlled trial to explore the efficacy of PPI in cirrhotic patients with AVB In this study the following questions were investigated 1 Can PPI reduce the 5-day treatment failure rate in cirrhotic patients with AVB 2 Can it reduce the 6-week rebleeding rate mortality and complications in patients with liver cirrhosis and AVB
PPI is a commonly used antacid agent which has a significant antacid effect protects the gastrointestinal mucosa promotes blood coagulation healing ulcers effectively stops bleeding and prevents rebleeding There is a consensus that PPI should be used before and after endoscopic therapy in patients with non-variceal acute bleeding However studies on the efficacy of PPI after EVL are still limited and lack of sufficient convincing In a randomized controlled study pantoprazole treatment was found to be associated with significantly smaller ulcers 10 days after elective EVL in secondary prevention patients with cirrhosis Another randomized controlled study in 2013 found that patients with cirrhosis and AVB treated with PPI for 19 days after endoscopic hemostasis had smaller ulcers and fewer overall side-effects but there was no statistically significant difference in rate of 5-day treatment failure 6-week rebleeding rate and 6-week mortality In 2017 a study included 637 patients with acute bleeding from liver cirrhosis 80 of whom were treated with acid suppression therapy and the study found that acid suppression therapy had no significant effect on long-term bleeding rate and mortality However negative effects of PPI have been reported in patients with cirrhosis such as spontaneous bacterial peritonitis and hepatic encephalopathy It is found that patients with cirrhosis and ascites had an increased risk of first hepatic encephalopathy with PPI use and also found that patients with cirrhosis had an increased risk of hepatic encephalopathy and death with PPI use Therefore PPI use in patients with cirrhosis should be more cautious However the duration of PPI use in these studies was long and there are no data to clarify the effect of short-term PPI use
At present there is no consensus among the major guidelines on the use of PPI in patients with acute AVB in liver cirrhosis and the UK guidelines do not recommend the use of PPI unless accompanied by gastrointestinal ulcer The use of PPI was not mentioned in the guidelines of the American Endoscopic Society and the European Endoscopic Society The 2021 Baveno 7 guideline clearly proposes that PPI should be stopped immediately once AVB is identified as cirrhosis The latest meta-analysis in 2022 showed that the use of PPI before endoscopy may reduce the need for endoscopic hemostasis in patients with upper gastrointestinal tract but there was no sufficient evidence to confirm the effect on clinical outcomes including 30-day mortality and rebleeding It can be concluded that there is no consensus on the use of PPI in patients with AVB in cirrhosis and the recommendations of guidelines lack high-quality studies to improve the convincing
In summary there is little evidence for the effect of PPI use in patients with AVB in liver cirrhosis and there is no study on the efficacy of PPI combined with endoscopic therapy in patients with AVB in liver cirrhosis Therefore the investigators planned to design a multicenter prospective randomized controlled trial to explore the efficacy of PPI in cirrhotic patients with AVB In this study the following questions were investigated 1 Can PPI reduce the 5-day treatment failure rate in cirrhotic patients with AVB 2 Can it reduce the 6-week rebleeding rate mortality and complications in patients with liver cirrhosis and AVB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None