Role of prophylactic biliary stent in reducing the recurrence of choledocholithiasis and biliary complications after stone clearance in patients awaiting cholecystectomy - a Multicentric randomized controlled trial (stone trial).

Patients with cholelithiasis can have presence of concomitant choledocholithiasis (CDL) in upto 30%. These stones may remain asymptomatic or cause obstructive jaundice and complications like cholangitis and pancreatitis. In situations where there is a failure of CDL clearance during endoscopic retrograde cholangiography (ERC), biliary stenting is recommended to prevent complications. However, the role of prophylactic biliary stenting in situations where CDL clearance has been achieved, and the patient is awaiting cholecystectomy is debatable. One retrospective study showed benefit while a small prospective study and a retrospective study did not show benefit of prophylactic biliary stenting. We conducted a pilot randomized trial to study the role of prophylactic biliary stent in reducing CDl recurrence and biliary/pancreatic complications. In our trial the CDL recurrence rate was similar between the stent and no stent group. However, the total complication rate was significantly higher in the stent group (p-0.024). Three patients developed post ERC pancreatitis and 2 developed cholecystitis. Although, the findings of our trial were significant, however, the trial had several limitations. Amongst them important limitations were that it was single centre and the sample size of inadequate. Also, we realized that the primary outcome should be the development of complications as it is more clinically relevant in real world scenario. While asymptomatic recurrence of CDL during the follow up is just a silent event. Hence, to address the above limitations, we planned this multicenter randomized controlled trial to study the role of a prophylactic biliary stent in prevention of biliary and pancreatic complications and recurrence of stones in patients awaiting cholecystectomy after biliary stone clearance.