JPRN-jRCTs032220556
Recruiting
Phase 3
A multicenter validative study of endoscopic treatment using fully covered self-expandable metallic stents for benign strictures after hepaticojejunostomy (saddle-cross technique).
Okusaka Takushi0 sites50 target enrollmentJanuary 5, 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- benign strictures after hepaticojejunostomy
- Sponsor
- Okusaka Takushi
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) no tumor is found at the anastomotic site by imaging, no hepatic duct stone is found, and benign bile duct jejunal anastomotic stricture is suspected. 2\) Cholangitis is consistent. 3\) The patient satisfies the conditions for the procedure of the saddle\-cross technique. 4\) No bleeding tendency. 5\) Performance status (ECOG): 0, 1, 2\. 6\) Age \> 20 years. 7\) Patient's free written consent to participate in the study has been obtained.
Exclusion Criteria
- •1\) The physician deems the patient ineligible for enrollment in this study.
- •2\) The patient is severely ill in the severity classification of acute cholangitis (diagnostic criteria and severity follow Tokyo Guidelines 2018 \[21]).
- •3\) Intrahepatic stones evident on CT or MRI (Patients with bile duct stones on CT or MRI will be considered for enrollment in the study after stone removal treatment).
Outcomes
Primary Outcomes
Not specified
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