NHS Forth Valley First in Scotland to Undertake Gallbladder Study

The call is out for 50 patients requiring gallbladder surgery to take part in a clinical trial in Forth Valley Royal Hospital, the first hospital in Scotland to be involved in what is known as the Sunflower Study.

Gallstones sometimes pass from the gallbladder into the nearby bile duct causing problems such as jaundice and severe inflammation of the pancreas. The Sunflower study aims to find out whether testing for bile duct stones is worthwhile or not in patients with a low to moderate risk, as removal of bile duct stones prior to surgery can lead to a delay in the gallbladder operation itself and increased pain and problems whilst waiting.

NHS Forth Valley Consultant Surgeon and Principal Investigator, Mr Michael Wilson, explained: “Around 400 gallbladder operations are carried out in NHS Forth Valley every year and there are no definitive guidelines about whether tests should be carried out. Even if the one hour test does identify bile duct stones they can pass into the bowel spontaneously and removing them before surgery can cause significant complications.

Not having the test avoids these risks but can lead to bile duct stones being left behind after surgery, which may also cause complications. More research is definitely required to establish if going straight to gallbladder surgery without testing is the best way forward.”

Patients who consent to participate will be divided into two groups. One group will go straight to surgery; the other will be tested ahead of their operation. The ‘straight to surgery’ group will have twice as many people in as the ‘tested’ group. Both groups will be followed up for 18 months and information will be collected about the need for treatment of bile duct stones and any complications of surgery.

The target population is adults over the age of l8 deemed to be at low or moderate risk who have been referred for laparoscopic surgery following an ultrasound or CT scan. Around 50 hospitals across the UK are involved in the Sunflower Study.

Anyone interested in taking part of finding out more about the clinical trial should contact Joanne Donnachie, NHS Forth Valley Research Nurse, by emailing fv-uhb.fvgenerictrialsteam@nhs.net or calling 01324 567670/566316.

For more information on the study visit: http://cteu.bris.ac.uk/sunflower