A non-inferiority randomized controlled trial of balloon dilatation alone versus balloon dilatation with stenting for stricture of choledochojejunostomy
- Conditions
- CholedochojeJunostomy stricture
- Registration Number
- JPRN-UMIN000054052
- Lead Sponsor
- Shimane University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 112
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method