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Clinical Trials/JPRN-jRCTs032220556
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.

Registry
who.int
Start Date
January 5, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Okusaka Takushi

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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