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Prevention and treatment of esophageal and gastric variceal bleeding in patients with chronic liver disease and cirrhosis with portal hypertension

Research and application of comprehensive prevention and treatment of portal hypertension in chronic liver disease and cirrhosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072413
Enrollment
Unknown
Registered
2023-06-13
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic liver disease and cirrhosis with portal hypertension and bleeding from esophageal and gastric varices

Interventions

First group:Eradication of Helicobacter pylori
Second group:Endoscopic treatment
Third group:N/A
Fourth group:TIPS surgery

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 To explore the changes of metabolomics and intestinal macrogenomics in patients with chronic liver disease before and after eradication of Helicobacter pylori (1) Select patients with chronic liver disease diagnosed in our hospital to study; (2) Clinical history, liver function, and abdominal ultrasound can clearly diagnose chronic liver disease. 2 Analysis of risk factors and predictive models for rebleeding after endoscopic treatment of esophageal and gastric varices in patients with liver cirrhosis (1) The study selected patients diagnosed as post hepatitis cirrhosis, esophageal and gastric variceal bleeding from June 2022 to June 2024 in our hospital; (2) Patients treated with endoscopic ligation, sclerotherapy, or tissue glue injection for the first time. 3? To study the impact of endoscopic ligation, TIPS, and endoscopic ligation sequential TIPS on the rebleeding rate of esophageal and gastric varices in patients with liver cirrhosis and evaluate their safety (1) The patient or his legal representative voluntarily signed an informed consent form and was orally informed of the specific trial protocol; (2) Male or female patients aged 18-75 years; (3) Liver cirrhosis (confirmed by medical history, physical examination, laboratory examination, and imaging); (4) Endoscopic confirmed history of bleeding from esophageal and gastric varices 4? To explore the role of the "intestinal liver axis" in the development of esophageal and gastric varices in liver cirrhosis by means of portal blood single cell transcriptome sequencing and microflora macrogenome sequencing (1) Male or female patients aged 18-75 years; (2) Patients undergoing endoscopic ligation, sclerotherapy, or tissue glue injection for the first time; (3) Liver cirrhosis (confirmed by medical history, physical examination, laboratory examination, and imaging); (4) History of endoscopic confirmed bleeding from esophageal and gastric varices; (5) No dementia or disturbance of consciousness; (6) There are no other acute or chronic infectious diseases.

Exclusion criteria

Exclusion criteria: 1.To investigate the changes of metabonomics and intestinal metagenomics in patients with chronic liver disease before and after Helicobacter pylori eradication Exclusion criteria:(1)complicated with serious primary heart and lung diseases, primary kidney disease, hematological diseases, malignant tumors, etc. (2) pregnant or lactating women; (3) patients who were lost to follow-up or had incomplete clinical data. Patients and their family members agreed to undergo relevant examinations and signed informed consent. (4) patients with a history of mental illness or inability to cooperate with treatment. (5) recently or currently participating in other clinical trials. (6) recently or currently participating in other clinical trials. (7) Use of laxatives or drugs for diarrhea within 3 months; (8) recent changes in dietary habits, such as switching to semi-vegetarian or vegan diets. (9) Complicated infections and bacteremia were present. (10) history of other severe organ failure (e.g. epilepsy, acquired immunodeficiency, etc.). (11) history of intestinal surgery within 6 months; (12) previous ileocecal surgery or current stoma. (13) Colonoscopy was performed within 1 month. (14) recently or currently participating in other clinical trials. (15) The investigator considered that he was not suitable to join the study. 2. To explore the risk factors and prediction model of rebleeding after endoscopic treatment of esophagogastric varices in liver cirrhosis Exclusion criteria: (1) complicated with serious primary heart and lung diseases, primary kidney disease, hematological diseases, malignant tumors, etc. (2) patients who underwent surgery or liver transplantation during treatment. (3) patients who were lost to follow-up or had incomplete clinical data. Patients and their family members agreed to undergo relevant examinations and signed informed consent. (4) pregnant women; (5) patients who are unable to cooperate with treatment or have a history of mental illness; (6) recently or currently participating in other clinical trials; (7) The investigator considered that he was not suitable to join the study. 3.to study the effects of endoscopic variceal ligation, TIPS and endoscopic variceal ligation sequential TIPS on the rebleeding rate and safety evaluation of esophageal and gastric varices in liver cirrhosis (1) pregnant or lactating women; (2) Cavernous transformation of portal vein; (3) previous TIPS or surgical shunt; (4) liver cancer or other malignant tumors; (5) Endoscopic therapy, ß-blockers and TIPS contraindications; (6) recently or currently participating in other clinical trials; (7) The investigator considered that he was not suitable to join the study. 4. To explore the role of "gut-liver axis" in the development of esophagogastric varices in liver cirrhosis by single-cell transcriptome sequencing and microbial metagenomic sequencing of portal blood Exclusion criteria:1. Cavernous transformation of the portal vein. 2 had previous TIPS or surgical shunts. Liver cancer or other malignant tumors. 4. Endoscopic therapy, ß-blockers and TIPS contraindications were present. 4. Pregnant or lactating women. Use of laxatives or medications for diarrhea within 5.3 months. 6. Recent changes in eating habits, such as switching to a semi-vegetarian or vegan diet. 7. Complicated infections and bacteremia were present. 8. History of other severe organ failure (e.g., epilepsy, acquired immunodeficiency, etc.). 9. Had underg

Design outcomes

Primary

MeasureTime frame
14C exhalation test;the difference microbiota and small molecular substances;Portal blood single cell transcriptomics;The rate of recurrent bleeding after 1 year;

Secondary

MeasureTime frame
1-year survival rate;Incidence of hepatic encephalopathy;

Countries

China

Contacts

Public ContactFeng Zhijie

The Second Hospital of Hebei Medical University

zhijiefeng6600@163.com+86 158 0321 0958

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026