Status:
UNKNOWN
HVPG-guided Laparoscopic Versus Endoscopic Therapy for Variceal Rebleeding in Portal Hypertension: A Multicenter Randomized Controlled Trial (CHESS1803)
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
Southern Medical University, China
Xingtai People's Hospital
Conditions:
Portal Hypertension
Variceal Rebleeding
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The development of portal hypertension is a vital event in the natural progression of cirrhosis and is associated with severe complications including gastroesophageal varices bleeding. Cirrhotic patie...
Detailed Description
The development of portal hypertension is a vital event in the natural progression of cirrhosis and is associated with severe complications including gastroesophageal varices bleeding. Cirrhotic patie...
Eligibility Criteria
Inclusion
- Clinically and/or pathologically diagnosed cirrhosis with portal hypertension
- History of varicial bleeding without receiving endoscopic treatment
- HVPG values between 16-20 mmHg
- ECOG score ≤ 2 or KPS score ≥ 60 during screening
- Voluntarily participated in the study and able to provide written informed consent, understand and willing to comply with the requirements of the study
- Child-Pugh class A or B
Exclusion
- Pregnant or breastfeeding women
- Prior known or suspected malignancy (hepatocellular carcinoma, cholangiocarcinoma etc.)
- Limited coagulation situation (Quick\< 50%, PTT\> 50 sec, thrombocyte count \<50000 / μl or disturbed thrombocyte function)
- Massive ascites
- Child-Pugh class C
- Refuse or inadequate for HVPG measurement
- Other situations whose existence judged inadequate for participation by the investigators
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 28 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03783065
Start Date
January 2 2019
End Date
October 28 2022
Last Update
August 17 2021
Active Locations (4)
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1
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
2
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
3
Shunde Hospital, Southern Medical University
Shunde, Guangdong, China
4
Xingtai People's Hospital
Xingtai, Hebei, China