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saddle-cross study

A multicenter validative study of endoscopic treatment using fully covered self-expandable metallic stents for benign strictures after hepaticojejunostomy (saddle-cross technique).

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032220556
Enrollment
50
Registered
2023-01-05
Start date
2023-02-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benign strictures after hepaticojejunostomy benign strictures

Interventions

After dilating the anastomotic stenosis with a balloon smaller than 8 mm, FC-SEMS (M-Intraductal, 8 mm x 30 mm) is placed in the left and right bile ducts if both hepatic lobes are present, in the ant
Metallic stent FC-SEMS)

Sponsors

Okusaka Takushi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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).

Design outcomes

Primary

MeasureTime frame
Long-term restenosis-free rate (at 12 months)

Secondary

MeasureTime frame
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.

Contacts

Public ContactSusumu Hijioka

National cancer center hospital, Japan

yukikawa@ncc.go.jp+81-3-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026