If a patient is on a beta-blocker (selective or non-selective) such as Bisoprolol, Metoprolol, Atenolol, Propranolol (Inderal, InnoPran), Nadolol (Corgard), Pindolol (Visken), etc. they are ineligible for BOPPP.
However, if a patient is on a beta-blocker for managing hypertension that can be replaced with Diuretics e.g. Indapamide; ACE inhibitors e.g. Ramipril; or, Angiotensin II receptor blockers e.g. Losartan, etc. then the beta-blocker should be discontinued for 1 week. After a 7-day washout period, they are eligible for BOPPP providing they meet all other eligibility criteria.
If this six month period has passed, this participant should be re-evaluated at their next annual varices surveillance appointment, unless they receive an endoscopy as an inpatient. Please maintain accurate pre-screening records to keep track of patients like these.
Photo-documentation of oesophogeal varices are recommended in the trial protocol but we accept that there will be times where your image capture software fails for whatever reason. Photos may also not have been taken in OGDs prior to your site being opened for recruitment.
As a minimum, please document on ALL OGD reports:
- Size of OV
- Number of columns of OV
- Presence/absence of red signs – this is important as red signs suggest increased risk of bleeding and exclude the patient.
- Any gastric or duodenal varices present
In this case, very helpful to make a file note around eligibility review to say that patient has been diagnosed endoscopically with small OV although photo-documentation is suboptimal on report. That way, we know there has been PI oversight and discretion, and eligible patients are not barred from appropriate recruitment because of this issue around the photos.
Yes – as the patient has an active malignancy without curative therapy planned. Whilst TACE will delay malignancy development it is not curative therapy.
As long as the patient has a diagnosis of cirrhosis and portal hypertension and small oesophageal varices, then the presence of a portal vein thrombus will not exclude the patient.
If the patient has a thrombus without cirrhosis, then the patient would not be eligible as they do not meet inclusion criteria.
Please liaise with your PI and / or sub-investigators regarding concerns over inclusion / exclusion criteria and email email@example.com if your are not sure.
Any patients on medication for hypertension that do not involve a beta-blocker should be eligible for BOPPP. There are no known drug interactions with the active IMP (Carvedilol) and Lorstan so this patient would be eligible.
If you have any concerns regarding drug interactions – always refer to the Carvedilol Summary of Product Characteristics found in the Site Resources web-page (click Summary of Product Characteristics) and speak with your PI or sub-investigators. Alternative you can always email firstname.lastname@example.org.
At site level, the PI / sub-investigator should do as per standard of care for each patient. If there are clinical concerns regarding a cardiac arrhythmia it might be prudent to determine the presence of 2nd/3rd degree heart block by obtaining an ECG – otherwise the absence of 2nd/3rd degree heart block in the patients medical history is sufficient to confirm that the patient does not have this exclusion criteria.
We should not exclude patients if they are non-English speaking and we will look into translating the PIS and ICF on a case by case basis. In all cases, please contact email@example.com as soon as you find an eligible non-English speaking patient.
When you contact us, please confirm the language required and the support that will be needed for the patient to participate in BOPPP. Consider the use of “language line” that would be used during standard care appointments and if a translator is required in person.
If translators are needed in person you must guarantee that the patients appointment will run on time or in a research focused clinic as this will affect translator availability and time required to complete the visit.
Research nurses can be involved in the consent process but as BOPPP is a CTIMP, the Principal Investigator or a delegated sub-investigator need to confirm eligibility and complete the consent process by signing the consent form.
Your site will be reimbursed up to £30 per patient per visit for three research only visits. These are at Screening, Baseline and the Week 1 up-titration visit. If Screening and Baseline occur during a standard of care appointment, then travel expenses would not be appropriate to pay.
Please contact firstname.lastname@example.org if the patients travel expenses would be in excess of the £30 per patient per visit so we can discuss this with you on a case by case basis.
Procedures and Resources
We recommend that patients are randomised within 28 days of consenting to participate. If this is not possible, please email email@example.com for advice.
Current versions of the PISs and ICFs can be found here
BOPPP medication levels will be monitored by the BOPPP Pharmacist (Angela Cape) in an ongoing manner. The BOPPP Pharmacist is unblinded so they will know if stocks are getting low and may affect trial delivery. Monitoring will include monthly assessment of site screening, recruitment and withdrawal. If you have concerns over stock levels, please email the trial Pharmacist (firstname.lastname@example.org) and BOPPP email account (email@example.com).
Firstly, ascertain what the participant wants to withdraw from as this may refer to not completing the participant questionnaires, not taking the BOPPP medication and/or withdrawing permission from allowing us to analyse the participants Health Episode Statistics (HES) data.
Secondly, contact firstname.lastname@example.org to inform the central trial team so this can be documented and discussed with the BOPPP Statistician. In the case of withdrawing from BOPPP medication, please ask the participant if we can still collect data about their health and ascertain why the participant would like to withdraw. Record the discussion in patients medical notes and email
email@example.com, completing the relevant pages on MACRO.