A non-inferiority randomized controlled trial of balloon dilatation alone versus balloon dilatation with stenting for stricture of choledochojejunostomy

UMIN ID: UMIN000054052

Registered date:03/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: CholedochojeJunostomy stricture
• Date of first enrollment: 2024/04/05
• Target sample size: 112
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

For cholangiojejunostomy stenosis, the test treatment group will be treated with balloon dilation alone, and the control treatment group will be treated with a combination of balloon dilation and stent placement.
For cholangiojejunostomy stenosis, the test treatment group will be treated with balloon dilation alone, and the control treatment group will be treated with a combination of balloon dilation and stent placement.

Outcome(s)

• Primary Outcome: Cholangitis recurrence-free survival

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Have a history of hypersensitivity to iodine or iodine contrast media. 2) Have poorly controlled hyperthyroidism (thyroid function is not stable despite untreated status or treatment). 3) Have a serious heart disorder (acute myocardial infarction, intractable arrhythmia, or other severe heart disease) 4) Have serious lung disease (with symptoms such as hypoxemia and difficulty breathing). 5) Have active multiple cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free period of 5 years or less). However, this does not include carcinoma in situ, which is considered to be curable with treatment. 6) Concomitant disseminated intravascular coagulation (meeting the diagnostic criteria of the Japanese Society of Thrombosis and Haemostasis DIC diagnostic criteria 2017 edition [12]). 7) Having biliary stricture due to malignant tumor. 8) I am pregnant. 9) A bile duct jejunostomy other than an anastomosis is confirmed by imaging test (ultrasound, CT, or MRI) or ERCP.

Related Information

• Primary Sponsor: Shimane University
• Source(s) of Monetary Support: Non