ACTRN12621001534875
Recruiting
未知
To assess the feasibility and safety performance of the novel bio-degradable stent (ARCHIMEDES) in three patient groups: Duct to duct anastomotic strictures, hepatico-jejunal strictures and those that require post-endoscopy retrograde cholangiopancreatography (ERCP) pancreatitis prophylaxis (PEP).
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Biliary anastomotic stricture
- Sponsor
- Royal Prince Alfred Hospital
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical criteria (1 required)
- •A. Patients with clinical indication for ERCP with a duct to duct anastomotic stricture or Hepaticojejunal stricture
- •B. Those requiring pancreatic duct stent placement for post ERCP pancreatitis prophylaxis.
- •Other criteria:
- •Symptoms or signs: jaundice, cholangitis
- •Age 18 years old and above
- •Able to give informed consent
Exclusion Criteria
- •Contra\-indication for endoscopy
- •Patients who had undergone any treatment to the stricture in the last 6 months
- •Inability to pass a guidewire through stricture
- •Malignant stricture
- •Multiple concomitant bile duct strictures
- •Stricture length \> 8cm
- •Anticoagulant therapy that cannot be discontinued prior to procedure
Outcomes
Primary Outcomes
Not specified
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