Prospective study of biliary stent placement for treatment of small common bile duct stones

JRCT ID: jRCT1042200020

Registered date:22/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Choledocholithiasis
• Date of first enrollment: 22/06/2020
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Biliary stent is placed transpapillary. Mainly 7Fr pigtail type stent is placed on the left or right intrahepatic bile duct at the upper end. However, operator can choice any types of plastic stent, for example a straight type stent is used in cases with strong bile duct bending, and a 5Fr stent is used in cases with high risk of post-ERCP pancreatitis. For patients with high risk of post-ERCP pancreatitis, a small endoscopic papillotomy may be performed.

Outcome(s)

• Primary Outcome: The rate of disappearance of common bile duct stones until 6 months after placement of a biliary stent. Disappearance of common bile duct stones is confirmed by endoscopic ultrasonography (EUS) or cholangiography with intraductal ultrasonography (IDUS).

Secondary Outcome

Period from placement of biliary stent to stone disappearance
The rate of recurrence of common bile duct stone, and period from disappearance to recurrence
The rate of adverse events
The rate of asymptomatic migration of stent

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who was placed biliary stent for common bile duct stones.
2) Patients of common bile duct stones which were detected by CT, MRI, abdominal ultrasonography, endoscopic ultrasonography (EUS) , or cholangiography, and the short diameter of bile duct stones was 5 mm or less.
3) Written informed consent is obtained.

Exclude criteria

1) Bile duct malignant tumor
2) History of Bilroth-II reconstruction gastrectomy, Roux-en-Y reconstruction gastrectomy, cholangiojejunostomy, or pancreaticoduodenectomy
3) Benign biliary stricture
4) History of medium or large sphincterotomy
5) Asymptomatic or gallstone pancreatitis
6) A responsible doctor has confirmed the candidate should be excluded from this study.
7) Patients without cholangitis who are expected to have a bile duct stone diameter of 6 mm or more by ERCP after obtaining consent

Related Information

• Primary Sponsor: kawaguchi shinya