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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mr
Stephen
Palmer
+44 (0)7929 771395
sunflower-study@bristol.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Symptomatic gallbladder disease, requiring gallbladder surgery
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Surgery to remove the gallbladder is required if it contains gallstones that cause problems. About 70,000 operations are performed annually in England. Sometimes, gallstones cause other problems if they pass from the gallbladder into the nearby bile duct (e.g. jaundice/inflammation of the pancreas). If this happens, it is necessary to remove the bile duct stones before or during the gallbladder operation. Because of this, patients requiring gallbladder surgery are assessed for any risk of bile duct stones. If the risk is high, further tests are done to identify if bile duct stones are present. If the risk is moderate or low (although it can be difficult to distinguish between the two), then it is uncertain whether further tests to look for bile duct stones are necessary. As a result, some surgeons choose to perform tests and others don’t. A UK-wide research study found that a third of patients undergoing gallbladder surgery were tested, usually before surgery using an MRI scanner. This test, called a Magnetic Resonance Cholangiopancreatography (MRCP), involves a 1-hour visit to hospital and costs the NHS about £365. The MRCP identifies bile duct stones but may delay gallbladder surgery which can lead to increased problems with gallstones whilst waiting. There are other uncertainties about the need for testing using MRCP. Even if the MRCP shows bile duct stones, the stones can pass into the bowel spontaneously; and removing the stones can cause complications. Not having the MRCP avoids these risks, but can lead to bile duct stones being left behind after surgery, which may also cause complications. Research to establish if going straight to gallbladder surgery without testing the bile duct beforehand is needed.
The Sunflower Study will find out whether testing for bile duct stones with MRCP before gallbladder surgery is worthwhile or not in patients with a low or moderate risk of having stones.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34187817/ (added 13/08/2021)
You can take part if:
Current inclusion criteria as of 15/01/2020:
1. Aged 18 years or older
2. Symptomatic gallbladder disease, confirmed by trans-abdominal ultrasound scan (USS) or computed tomography (CT) scan, including, for example:
2.1. Biliary colic
2.2. Cholecystitis
2.3. Mild and severe gallstone pancreatitis
2.4. Gallbladder polyps
2.5. Gallbladder dyskinesia, etc
3. Scheduled and fit for laparoscopic cholecystectomy (LC) as an elective or urgent procedure
4. Low or moderate risk of common bile duct (CBD) stones, including all of the following:
4.1. CBD diameter ≤8 mm on USS
4.2. Bilirubin ≤ 50umol/l
4.3. Alanine transferase less than three times the upper limit of normal (≤3 x ULN) and/or alkaline phosphatase ≤3 x ULN
If a patient does not meet the definition of low or moderate risk of CBD stones solely because both alanine transferase and alkaline phosphatase are > 3 x ULN, if repeat blood tests are carried out and at least one of the second or subsequent test results is within range (i.e. ≤ 3 x ULN) the patient may be recruited at that time.
If a patient does not meet the definition of low or moderate risk of CBD stones solely because bilirubin > 50umol/l, if repeat blood tests are carried out and at least one of the second or subsequent test results is within range the patient may be recruited at that time.
If CBD cannot be seen on USS or CT scan, the patient may be recruited as long as all the other inclusion criteria are met and there i
You may not be able to take part if:
Current exclusion criteria as of 15/01/2020:1. Unable to undergo MRCP2. Evidence of empyema or perforated gallbladder requiring urgent intervention3. Previous gastric bypass4. Previous MRCP or endoscopic ultrasound (EUS) within last 3 months5. Any previous ERCP6. Haemolytic disease7. Pregnancy8. Unwilling to participate in follow up9. Unable to provide written informed consent10. Prisoner
Previous exclusion criteria:1. Unable to undergo MRCP2. Evidence of empyema or perforated gallbladder requiring urgent intervention3. Previous duodenal bypass4. Previous MRCP within last 3 months5. Haemolytic disease6. Pregnancy7. Unwilling to participate in follow up8. Unable to provide written informed consent9. Prisoner
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mr
Stephen
Palmer
+44 (0)7929 771395
sunflower-study@bristol.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Leeds Teaching Hospitals NHS Trust and funded by Health Technology Assessment Programme.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
