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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054052
Enrollment
112
Registered
2024-04-03
Start date
2024-04-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CholedochojeJunostomy stricture

Interventions

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 sten

Sponsors

Shimane University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Have a history of treatment for bile duct jejunostomy. 2) Elevated hepatobiliary enzymes within 90 days before enrollment. The above was approved. 3) Intrahepatic bile duct dilatation is found on imaging tests. 4) No serious renal disorder (latest serum creatinine value less than 2.0 mg/dl and eGFR 30 ml/min/1.73 m2 or more within 28 days before registration). 5) Do not have severe diabetes (no concurrent diabetes or latest HbA1c less than 10% within 28 days before registration). 6) Be at least 18 years old at the time of consent. 7) Written consent has been obtained from the individual to participate in the research.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Cholangitis recurrence-free survival

Countries

Japan

Contacts

Public ContactNOBUHIKO FUKUBA

Shimane University Internal medicine II

nfukuba@med.shimane-u.ac.jp0853-23-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026