HVPG-guided Laparoscopic Versus Endoscopic Therapy for Variceal Rebleeding in Portal Hypertension: A Multicenter Randomized Controlled Trial (CHESS1803)
1 other identifier
interventional
40
1 country
4
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 patients with hemorrhagic shock and/or liver failure caused by variceal bleeding face a mortality of 5-20%. Hepatic venous pressure gradient (HVPG) is the recommended golden standard for portal pressure assessment globally with favorable consistency and repeatability. Reducing the HVPG to levels of 12mmHg or below is associated with protection of variceal hemorrhage. An HVPG\> 16mmHg indicates a higher risk of death and HVPG ≥ 20mmHg predicts failure to control bleeding, early rebleeding, and death during acute variceal hemorrhage. The management of portal hypertension has showed a trend of diversification with the development of medication, endoscopy, radiological intervention and liver transplantation. Although medication and endoscopic therapy have achieved preferable effects and are recommended as standard of care for the prevention of variceal rebleeding, patients with HVPG≥ 16mmHg still have a high risk of treatment failure and a high rate of rebleeding. Recent years, early TIPS is recommended as the first-line therapy for the prevention of rebleeding in cirrhotic patients with HVPG≥ 20mmHg. However, for those with HVPG values between 16 to 20mmHg, there is still lack of strong evidence to demonstrate the best practice for the management. With the rapid advancement of laparoscopic device and technique, the utility of laparoscopic splenectomy and pericardial devascularization showed less surgical trauma, bleeding and complications while retaining dependable effects compared to traditional open surgery, especially for portal hypertension with hypersplenism. In the study, the investigators aim to conduct a multicenter randomized controlled trial to compare the safety and effectiveness of HVPG-guided (16 to 20mmHg) laparoscopic versus endoscopic therapy for variceal rebleeding in patients with portal hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2018
CompletedFirst Posted
Study publicly available on registry
December 20, 2018
CompletedStudy Start
First participant enrolled
January 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2022
CompletedAugust 17, 2021
August 1, 2021
10 months
December 19, 2018
August 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Variceal rebleeding
The occurrence rate of gastroesophageal varices rebleeding within 1-year follow-up
1 year
Secondary Outcomes (5)
Overall survival
1 year
Hepatocellular carcinoma occurrence
1 year
Venous thrombosis
1 year
Quality of life score
1 year
Karnofsky score
1 year
Study Arms (2)
Experimental group
EXPERIMENTALProcedure: Laparoscopic splenectomy and pericardial devascularization Drug: Propranolol
Control group
ACTIVE COMPARATORProcedure: Endoscopic therapy Drug: Propranolol
Interventions
Propranolol was administrated orally while keeping monitoring heart rate and blood pressure daily.
Including splenectomy and pericardial devascularizaion under laparoscopy
Either endoscopic variceal ligation (EVL) or cyanoacrylate injection was applied according to the condition of varices
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Southern Medical University, Chinacollaborator
- Xingtai People's Hospitalcollaborator
- Beijing 302 Hospitalcollaborator
- LanZhou Universitycollaborator
Study Sites (4)
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Shunde Hospital, Southern Medical University
Shunde, Guangdong, China
Xingtai People's Hospital
Xingtai, Hebei, China
Related Publications (9)
Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
PMID: 30215362BACKGROUNDCremers I, Ribeiro S. Management of variceal and nonvariceal upper gastrointestinal bleeding in patients with cirrhosis. Therap Adv Gastroenterol. 2014 Sep;7(5):206-16. doi: 10.1177/1756283X14538688.
PMID: 25177367BACKGROUNDGarcia-Tsao G, Bosch J. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010 Mar 4;362(9):823-32. doi: 10.1056/NEJMra0901512. No abstract available.
PMID: 20200386BACKGROUNDGarcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
PMID: 27786365BACKGROUNDde Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
PMID: 26047908BACKGROUNDBosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1.
PMID: 19724251BACKGROUNDSaad WE. Endovascular management of gastric varices. Clin Liver Dis. 2014 Nov;18(4):829-51. doi: 10.1016/j.cld.2014.07.005. Epub 2014 Oct 16.
PMID: 25438286BACKGROUNDde Souza AR, La Mura V, Reverter E, Seijo S, Berzigotti A, Ashkenazi E, Garcia-Pagan JC, Abraldes JG, Bosch J. Patients whose first episode of bleeding occurs while taking a beta-blocker have high long-term risks of rebleeding and death. Clin Gastroenterol Hepatol. 2012 Jun;10(6):670-6; quiz e58. doi: 10.1016/j.cgh.2012.02.011. Epub 2012 Feb 22.
PMID: 22366180BACKGROUNDShao R, Li Z, Wang J, Qi R, Liu Q, Zhang W, Mao X, Song X, Li L, Liu Y, Zhao X, Liu C, Li X, Zuo C, Wang W, Qi X. Hepatic venous pressure gradient-guided laparoscopic splenectomy and pericardial devascularisation versus endoscopic therapy for secondary prophylaxis for variceal rebleeding in portal hypertension (CHESS1803): study protocol of a multicenter randomised controlled trial in China. BMJ Open. 2020 Jun 23;10(6):e030960. doi: 10.1136/bmjopen-2019-030960.
PMID: 32580978DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weidong Wang, MD
Southern Medical University, China
- PRINCIPAL INVESTIGATOR
Changzeng Zuo, MD
Xingtai People's Hospital
- PRINCIPAL INVESTIGATOR
Xun Li, MD
LanZhou University
- STUDY CHAIR
Xiaolong Qi, MD
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Hepatic Hemodynamic Lab
Study Record Dates
First Submitted
December 19, 2018
First Posted
December 20, 2018
Study Start
January 2, 2019
Primary Completion
October 28, 2019
Study Completion
October 28, 2022
Last Updated
August 17, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- The data will become available upon publication of this study for 2 years.
- Access Criteria
- Access application is approved by principal investigators.
IPD data including age, gender, height, weight, ethnic, past history (including time of bleeding), dignosis, co-morbidity, medication, labortory test results (including blood routine, blood ammonia, clotting time, liver function and renal function), ultrasonic results (including spleen diameter, portal vein diameter, portal vein velocity, splenic vein velocity, etc.), transient elastography results (including liver and spleen stiffness), esophagogastroduodenoscopy results, Child-pugh score, QOL and KPS scores and time of all outcome events will be shared upon publication of this study.