Endoscopic balloon dilation followed by steroid injection for anastomotic strictures after hepaticojejunostomy

JRCT ID: jRCTs041190091

Registered date:02/12/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepaticojejunostomy stricture
• Date of first enrollment: 19/12/2019
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Endoscopic steroid injection

Outcome(s)

Primary Outcome

Phase 1: Adverse events rate within 1 week after treatment
Phase 2: Hepaticojejunostomy stricture recurrence rate after 1 year after treatment

Secondary Outcome

Phase2
Adverse events rate within 1 week after treatment
Hepaticojejunostomy stricture recurrence rate after 2 or 3 year after treatment
Late adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patient with suspected hepaticjejunostomy stricture
2) Patient with >= 20 yo
3) Patient with performance status 1-2
4) Patient without organ dysfunction

Exclude criteria

1) Patient with malignant hepaticojejunostomy stricture
2) Patient who cannot stop anti-platelet agent
3) Patient who take steroids or immunosuppressive agents regulary
4) Allergy for triamcinolone
5) Pregnant woman
6) Patient with psychiatric disorder or dementia
7) Patient with severe diabetes mellitus, hypertension, penumonia, digestive tract bleeding, heart failure, angina, or cardial infaction

Related Information

• Primary Sponsor: Sato Junya