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A New Screening Strategy for Varices (LSSM-RCT)

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ClinicalTrials.gov Identifier: NCT02024347
Recruitment Status : Completed
First Posted : December 31, 2013
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Prof Wong, Lai Hung Grace, Chinese University of Hong Kong

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.


Condition or disease
Liver Cirrhosis

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.


Study Type : Observational
Actual Enrollment : 548 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Randomized Controlled Trial of a New Screening Strategy for Varices Based on Liver and Spleen Stiffness Measurement (LSSM) in Cirrhotic Patients
Study Start Date : July 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort
LSSM arm
Intervention: upper endoscopy only performed to patients with high LSM (≥12.0kPa) or SSM (≥41.3kPa) values
Control arm
Intervention: upper endoscopy performed to all patients in this group.



Primary Outcome Measures :
  1. Clinically significant esophageal and/or gastric varices [ Time Frame: At time of upper endoscopy, up to 5 years ]

    Number of participants who develop large varices warranting pharmacological and/or endoscopic therapy according to the indications mentioned below:

    • Varices of any size which is actively bleeding;
    • Varices of any size identified in the presence of blood in the esophagus and/or stomach;
    • Varices of any size with the presence of red-wale signs and/or fibrin plugs;


Secondary Outcome Measures :
  1. Variceal bleeding [ Time Frame: At last visit, up to 5 years ]
    Number of participants who develop variceal bleeding, the diagnosis of which is made when diagnostic upper endoscopy shows one of the following: active bleeding from a varix, a "white nipple" overlying a varix, clots overlying a varix, or varices with no other potential source of bleeding.

  2. hepatic events [ Time Frame: At last visit, up to 5 years ]
    Number of participants who develop ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, hepatic decompensation to Child's B or C cirrhosis

  3. Hospitalization [ Time Frame: At last visit, up to 5 years ]
    Number of participants who are admitted to hospital for emergency medical problems. This exclude hospitalizations which are scheduled electively.

  4. Mortality [ Time Frame: At last visit, up to 5 years ]
    Number of participants who die because of any causes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from the medical clinics of Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital. Patients with known chronic liver diseases, radiological evidence of liver cirrhosis and compensated liver function will be invited.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024347


Locations
Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Grace LH Wong, MD Chinese University of Hong Kong

Publications:

Responsible Party: Prof Wong, Lai Hung Grace, Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02024347     History of Changes
Other Study ID Numbers: LSSM-RCT
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases