When Juliet Stone was admitted to the hospital multiple times due to complications from gallstones, including severe pancreatitis and life-threatening sepsis, she experienced excruciating pain. Juliet aged 33 underwent a surgical procedure to remove gallstones from the bile duct, followed by gallbladder removal surgery.
Juliet said, “The procedure was life-changing. It relieved the excruciating pain and ultimately saved my life. The idea of a trial that might show some patients do not need surgery after gallstone removal from the bile duct is incredibly exciting—it could spare many from the risks of additional surgery and lead to quicker recovery.”
This experience shows the importance of ROSIER (Requirement for Surgical Intervention after ERCP) a clinical trial aimed at improving treatment for patients with gallstones in their bile duct. The trial, led by ĢtvƵ and the Clinical Trials Research Unit at the University of ĢtvƵ, seeks to resolve the clinical uncertainty surrounding whether patients benefit from gallbladder removal following successful gallstone removal from the bile duct.
This £2.7million research is funded by the National Institute for Health and Care Research (NIHR), will be conducted over three years, and involve 1,318 patients across more than 30 hospitals in the UK. Participants will be randomly assigned to one of two groups: one will undergo gallbladder removal surgery, while the other will be closely monitored without surgery.
Gallstones are solid deposits that form in the gallbladder, a small organ beneath the liver responsible for storing bile, a digestive fluid. When these stones migrate into the bile duct, they can cause severe complications, including jaundice, sepsis, and pancreatitis, often requiring urgent medical intervention. Each year, approximately 20,000 surgical procedures to remove gallstones from the bile duct are performed in England. These surgical procedures are not without risk and are not for all patients.
Following removal of gallstones from the bile duct, patients are typically advised to consult a surgeon about the potential removal of their gallbladder to prevent future complications. Although national guidelines from the National Institute for Health and Care Excellence (NICE) recommend this surgery, there is significant variability in practice, with nearly half of eligible patients not undergoing the procedure. This inconsistency highlights the need for more definitive research, which the ROSIER trial will provide.
Professor Giles Toogood, Professor of Hepatobiliary and Emergency General Surgery at ĢtvƵ Teaching Hospitals and the University of ĢtvƵ, Mr. Andrew Smith, Consultant Pancreatic Surgeon at ĢtvƵ Teaching Hospitals, and Professor Deborah Stocken, Professor of Clinical Trials Research, University of ĢtvƵ are leading the trial.
They said:
“We are delighted to be awarded this significant grant. It has taken a lot of effort over the past three years to be successful. The results of this trial will influence the treatment of these patient in the future both in the UK and across the world.”
This trial builds on the success of previous research, including the SUNFLOWER study, which has recruited over 7,500 patients from 60 centres across the UK over the past six years. The ROSIER trial represents a crucial step forward in understanding the best management strategies for patients with gallstones in the bile duct. The findings will shape future clinical guidelines and improve care for thousands of patients across the UK.