saddle-cross study

Phase 3

Recruiting

• Conditions: benign strictures after hepaticojejunostomy; benign strictures; D002779

• Registration Number: JPRN-jRCTs032220556
• Lead Sponsor: Okusaka Takushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ong-term restenosis-free rate (at 12 months)

Secondary Outcome Measures

Name	Time	Method
1) rate of adverse events, 2) procedural success rate of endoscopic bile duct jejunal anastomosis dilatation with two FC-SEMS, 3) clinical success rate of endoscopic bile duct jejunal anastomosis dilatation with two FC-SEMS, 4) procedure time, 5) time to stenosis recurrence, 6) rate of spontaneous stent deviation, 7) time to stenosis recurrence in cases of spontaneous stent deviation.