HVPG-guided Laparoscopic Versus Endoscopic Therapy for Variceal Rebleeding in Portal Hypertension: A Multicenter Randomized Controlled Trial (CHESS1803)
NCT ID: NCT03783065
Last Updated: 2021-08-17
Study Results
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Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-01-02
2022-10-28
Brief Summary
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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.
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Detailed Description
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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 (Shunde Hospital of Southern Medical University, Xingtai People's Hospital, The Fifth Medical Center of Chinese PLA General Hospital, The First Hospital of Lanzhou University) 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Experimental group
Procedure: Laparoscopic splenectomy and pericardial devascularization Drug: Propranolol
Propranolol
Propranolol was administrated orally while keeping monitoring heart rate and blood pressure daily.
Laparoscopic splenectomy and pericardial devascularization
Including splenectomy and pericardial devascularizaion under laparoscopy
Control group
Procedure: Endoscopic therapy Drug: Propranolol
Propranolol
Propranolol was administrated orally while keeping monitoring heart rate and blood pressure daily.
Endoscopic therapy
Either endoscopic variceal ligation (EVL) or cyanoacrylate injection was applied according to the condition of varices
Interventions
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Propranolol
Propranolol was administrated orally while keeping monitoring heart rate and blood pressure daily.
Laparoscopic splenectomy and pericardial devascularization
Including splenectomy and pericardial devascularizaion under laparoscopy
Endoscopic therapy
Either endoscopic variceal ligation (EVL) or cyanoacrylate injection was applied according to the condition of varices
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Southern Medical University, China
OTHER
Xingtai People's Hospital
OTHER
Beijing 302 Hospital
OTHER
LanZhou University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Xiaolong Qi
Director, Hepatic Hemodynamic Lab
Principal Investigators
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Weidong Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Southern Medical University, China
Changzeng Zuo, MD
Role: PRINCIPAL_INVESTIGATOR
Xingtai People's Hospital
Xun Li, MD
Role: PRINCIPAL_INVESTIGATOR
LanZhou University
Xiaolong Qi, MD
Role: STUDY_CHAIR
Nanfang Hospital, Southern Medical University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Zhiwei Li, MD
Role: primary
Xun Li, M.D.
Role: primary
Weidong Wang, MD
Role: primary
Changzeng Zuo, MD
Role: primary
References
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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.
Cremers 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.
Garcia-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.
Garcia-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.
de 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.
Bosch 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.
Saad 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.
de 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.
Shao 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.
Other Identifiers
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CHESS1803
Identifier Type: -
Identifier Source: org_study_id
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