A New Screening Strategy for Varices

NCT ID: NCT02024347

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 548 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-06-30

Brief Summary

Liver cirrhosis is an advanced stage of chronic liver diseases, which is often associated with various complications, namely esophageal and/or gastric varices, ascites, hepatocellular carcinoma (HCC). It is well known that the risk of complications varies even among cirrhotic patients, as those with more advanced disease would have more complications and poorer survival rates. Liver stiffness measurement (LSM) with transient elastography is found useful to identify cirrhotic patients with higher risk of portal hypertension and presence of varices . Recently, spleen stiffness measurement (SSM) with the same machine was found accurate to predict portal hypertension and esophageal varices.

Investigators hypothesized that a new screening strategy guided by LSM and SSM (LSSM) values (LSSM-guided) is non-inferior to conventional strategy in terms of detection rate of clinically significant esophageal and/or gastric varices for patients with liver cirrhosis in an open-labeled randomized controlled trial.

Consecutive patients with compensated liver cirrhosis will be invited for the study. Patients fulfilling the study criteria will be randomized into LSSM arm (upper endoscopy only performed to patients with high LSM or SSM values), and control arm (upper endoscopy performed to all patients). Patients randomized into LSSM arm will undergo transient elastography examination; those with high LSM or SSM results will be referred for upper endoscopy examination for to screen varices. Patients randomized into control arm will be directly referred for upper endoscopy examination.

Detailed Description

Liver cirrhosis is an advanced stage of chronic liver diseases, which is often associated with various complications, namely esophageal and/or gastric varices, ascites, hepatocellular carcinoma (HCC). It is well known that the risk of complications varies even among cirrhotic patients, as those with more advanced disease would have more complications and poorer survival rates. Liver stiffness measurement (LSM) with transient elastography is found useful to identify cirrhotic patients with higher risk of portal hypertension and presence of varices at cross-sectional basis. LSM cutoff values of 17.6 kPa and 21.0 kPa would have the sensitivity ≥ 90% in order to detect patients with hepatic venous pressure gradient (HVPG) above 10-12mmHg , while the presence of varices could be confidently excluded with a liver stiffness below 12.5-19.8 kPa. However, these suggested cutoff values overlap with those for detecting histologic cirrhosis in most chronic liver diseases. Hence there seems no significant additional information provided by LSM regarding screening endoscopy for varices among cirrhotic patients.

Recently, spleen stiffness measurement (SSM) with the same machine was found accurate to predict portal hypertension and esophageal varices. An SSM cutoff value <41.3 kPa is sensitive and seems able to accurately rule out the presence of varices. This supports a possible screening strategy, reserving upper endoscopy only for patients with an SSM ≥41.3kPa.

Conditions

Liver Cirrhosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

LSSM arm

Intervention: upper endoscopy only performed to patients with high LSM (≥12.0kPa) or SSM (≥41.3kPa) values

No interventions assigned to this group

Control arm

Intervention: upper endoscopy performed to all patients in this group.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age 18 years or above
• Known chronic liver diseases
• Radiological evidence of liver cirrhosis, defined as coarse liver echotexture and/or nodularity & small liver size noted on liver imaging
• Informed written consent obtained

Exclusion Criteria

• Absence of chronic liver diseases (i.e. acute liver diseases in the absence of chronic components e.g. acute hepatitis A)
• Decompensated liver cirrhosis, i.e. Child's B or C liver cirrhosis
• Hepatocellular carcinoma
• Portal vein thrombosis
• Previous liver surgery
• Liver transplantation
• Recent upper endoscopy within last 36 months
• Recent transient elastography within last 24 months
• Current use of beta-blockers
• Known varices of grade II or above diagnosed from previous endoscopic examination, and/or previous history of variceal bleeding
• Previous endoscopic treatment to varices (e.g. banding ligation, sclerotherapy)
• Serious concurrent illness (e.g. malignancy) leading to a life expectancy shorter than 6 months
• Contraindications to transient elastography (e.g. pregnancy, previous pacemaker implantation)
• Refusal to consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof Wong, Lai Hung Grace

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grace LH Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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Reference Type: DERIVED

PMID: 30681726 (View on PubMed)

Wong GLH, Kwok R, Hui AJ, Tse YK, Ho KT, Lo AOS, Lam KLY, Chan HCH, Lui RA, Au KHD, Chan HLY, Wong VWS. A new screening strategy for varices by liver and spleen stiffness measurement (LSSM) in cirrhotic patients: A randomized trial. Liver Int. 2018 Apr;38(4):636-644. doi: 10.1111/liv.13560. Epub 2017 Sep 10.

Reference Type: DERIVED

PMID: 28853196 (View on PubMed)

Other Identifiers

LSSM-RCT

Identifier Type: -

Identifier Source: org_study_id