HVPG-guided Laparoscopic Versus Endoscopic Therapy for Variceal Rebleeding in Portal Hypertension: A Multicenter Randomized Controlled Trial (CHESS1803)

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.

Conditions

• Portal Hypertension
• Variceal Rebleeding

Interventions

DRUG

Propranolol

Propranolol was administrated orally while keeping monitoring heart rate and blood pressure daily.

PROCEDURE

Laparoscopic splenectomy and pericardial devascularization

Including splenectomy and pericardial devascularizaion under laparoscopy

PROCEDURE

Endoscopic therapy

Either endoscopic variceal ligation (EVL) or cyanoacrylate injection was applied according to the condition of varices

Sponsors & Collaborators

• Southern Medical University, China

  collaborator OTHER

• Xingtai People's Hospital

  collaborator OTHER

• Beijing 302 Hospital

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Weidong Wang, MD · Southern Medical University, China

• Changzeng Zuo, MD · Xingtai People's Hospital

• Xun Li, MD · LanZhou University

• Xiaolong Qi, MD · Nanfang Hospital, Southern Medical University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-02

Primary Completion

2019-10-28

Completion

2022-10-28

Countries

• China

Study Locations