Esophageal Varices, Gastric Varices, Gastroesophageal Varices Hemorrhage, Portal Hypertension
Conditions
Brief summary
This study aims to evaluate the impact of high-risk factors-such as elevated portal venous pressure, concurrent large extra-luminal vessels, portal vein thrombosis, and prominent portosystemic shunts-on the efficacy of endoscopic therapy. By comparing with interventional treatment, the goal is to optimize the clinical management protocol for esophageal and gastric varices, enhance the therapeutic outcomes of portal hypertension-related esophageal and gastric varices, and improve patient prognosis.
Interventions
None listed
Sponsors
Shanghai Zhongshan Hospital
RenJi Hospital
Shandong Provincial Hospital
Qilu Hospital of Shandong University
Third Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital, Southern Medical University
The First Affiliated Hospital of Nanchang University
Shanghai East Hospital
Shanghai Changzheng Hospital
Second Military Medical University
The General Hospital of Northern Theater Command
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admitted due to gastrointestinal bleeding and clinically diagnosed with portal hypertension * Underwent imaging examinations and gastroscopy within one week after admission * Gastroscopy revealed the presence of esophageal and/or gastric varices * Age over 18 years
Exclusion criteria
* Previous history of liver transplantation * Imaging or gastroscopy findings indicated ulcers or other causes of gastrointestinal bleeding * Concurrent severe life-threatening diseases involving the circulatory, hematological, or respiratory systems * Difficulty in follow-up, or lack of essential medical history information, imaging data, or other necessary records
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year gastrointestinal rebleeding rate | 1 year after the treatment. | Time from initial variceal bleeding treated with endoscopy or TIPS to recurrent variceal rupture and bleeding due to portal hypertension (at least 120 hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-month and 6-month gastrointestinal rebleeding rates | 2 months and 6 months after the treatment | Time from initial variceal bleeding treated with endoscopy or TIPS to recurrent variceal rupture and bleeding due to portal hypertension (at least 120 hours) |
| Indicators in the Child-Pugh classification include the progression of ascites and changes in bilirubin levels. | 1, 2, 6, and 12 months after the treatment. | Depth of abdominal fluid dark area detected by abdominal ultrasound; changes in serum bilirubin levels in liver function tests. |
| Changes of portal vein thrombosis | 6 and 12 months after the treatment. | Evaluate the occurrence, recanalization, and other changes in thrombosis every 6 months using portal CTA and ultrasound. |
| Liver cancer | Up to 12 months after the treatment. | Hepatocellular carcinoma or cholangiocarcinoma |
| Liver transplantation | Up to 12 months after the treatment. | Based on comprehensive clinical evaluation, liver transplantation is required. |
| Variceal bleeding-related mortality | Up to 12 months after the treatment. | During the follow-up period, deaths caused by variceal rupture and bleeding that occurred within 6 weeks after the bleeding episode and were clearly related to the bleeding, including hemorrhagic shock and multiple organ failure. |
| Liver-related mortality | Up to 12 months after the treatment. | Deaths resulting from variceal rupture and bleeding, liver failure, hepatic encephalopathy, infection, hepatorenal syndrome, etc., excluding deaths due to extrahepatic causes, including: accidental death, cardiovascular events, and deaths caused by other systemic cancers. |
Outcome results
None listed