None listed
Conditions
Brief summary
This study is looking to assess whether alternative treatment to prevent variceal bleeding (variceal banding involving multiple endoscopic procedures) is required if you are on a suboptimal dose of a beta-blocker (Propranolol or Carvedilol); a medication that reduces your heart rate and blood pressure, with the aim of reducing the pressure gradient in the liver. Suboptimal dose suggests this is not the highest dose possible reaching the target of a heart rate less than 60. Reasons for being unable to increase the dose may include side effects such as low blood pressure. The aim of the medication is to reduce portal hypertension (portal vein pressure gradient in the liver, causing higher risk of varices and bleeding). If your portal pressure gradient measurement is adequate (<12mmHg) then you would not require alternative prophylaxis with variceal banding. The aim of this study is to assess the effectiveness of suboptimal doses of beta-blockers in patients unable to tolerate higher doses. Liver inflammation and pressure can be assessed through blood tests, ultrasound and liver elastography (fibroscan) as well as splenic elastography, all of which are non-invasive however these investigations do not measure portal pressure gradient. We are doing this study in the hope that we can optimise treatment management of patients with cirrhosis. Our overall hypothesis is that directly measuring portal pressure gradient via endoscopic ultrasound (EUS-PPG) can identify patients on suboptimal doses of beta-blockers who do or do not require variceal band ligation for primary prophylaxis.
Interventions
SUBJECTS
Thirty patients on beta-blockers for primary prophylaxis for variceal bleeding (as per conventional guidelines) but have failed to tolerate up-titration to maximal dose of beta blocker (320mg propranolol daily or carvedilol 12.5mg daily with HR of 50-55bpm).
DESIGN AND PLAN OF STUDY
1.Clinicians identify patients on sub-optimal doses of beta-blocker for variceal bleeding primary variceal banding prophylaxis
2. Patient Consent
3. Enter into study for Endoscopic Ultrasound (EUS) Portal P
SUBJECTS Thirty patients on beta-blockers for primary prophylaxis for variceal bleeding (as per conventional guidelines) but have failed to tolerate up-titration to maximal dose of beta blocker (320mg propranolol daily or carvedilol 12.5mg daily with HR of 50-55bpm). DESIGN AND PLAN OF STUDY 1.Clinicians identify patients on sub-optimal doses of beta-blocker for variceal bleeding primary variceal banding prophylaxis 2. Patient Consent 3. Enter into study for Endoscopic Ultrasound (EUS) Portal Pressure Gradient (PPG) once patient has had 12 weeks of beta-blocker therapy at current suboptimal dose. ‘EUS-PPGM’ PROCEDURE DETAILS For the patient, this requires an endoscopic procedure with use of sedation (via anaesthetic support). A forward viewing endoscope is used to record any evidence of oesophageal varices. A linear echoendoscope is then inserted and a 25G fine needle is used to puncture the hepatic vein via a transgastric and transhepatic approach. Three pressure readings will be recorded from the compact manometer. The portal vein will then be punctured also with a 25G fine needle. Three pressure readings will then again be recorded. It will be performed by a consultant gastroenterologist at Royal Adelaide Hospital. The procedure takes approximately 30min. ‘LIVER AND SPLENIC TRANSIENT ELASTOGRAPHY’ PROCEDURE DETAILS This is a non-invasive test and can be performed in clinic or bedside. The patient lies in supine position, and an ultrasound-like probe is placed over the liver and spleen. Multiple recordings will be taken for liver stiffness and splenic stiffness. It is performed by either a liver nurse trained in fibroscans, gastroenterology registrar or consultant gastroenterologist. This will be performed prior to beta-blocker commencement and 6 months post. The test takes approximately 10-15 minutes. The overall duration of the study participation including follow-up is 6 months.
Sponsors
Royal Adelaide Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1 - Ability to give informed consent 2 - Patient with Child A or B cirrhosis - on suboptimal doses of a beta-blocker for variceal primary prophylaxis: (i) HR > 55bpm (ii) Propranolol dose < 320mg daily but >= 80mg daily or Carvedilol < 12.5mg daily but >= 6.25mg daily
Exclusion criteria
1 - Ischaemic heart disease or congestive cardiac failure 2 - Concurrent diagnosis of hepatocellular cancer 3 - Pregnant or breastfeeding women 4 - Creatinine clearance <60 mL/min 5 - Those whom investigators believe are unlikely to have more than 12 month’s life expectancy
Outcome results
None listed