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A prospective study on the efficacy and safety of double stenting with a narrow covered self-expandable metallic stent (SEMS) for malignant distal bile duct stenosis

A prospective study on the efficacy and safety of double stenting with a narrow covered self-expandable metallic stent (SEMS) for malignant distal bile duct stenosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052210158
Enrollment
20
Registered
2022-01-22
Start date
2022-01-22
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

obstructive jaundice

Interventions

Endoscopic biliary drainage for malignant biliary stenosis by double stenting with a narrow diameter cSEMS.

Sponsors

Shiomi Hideyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with obstructive jaundice caused by malignant biliary stenosis associated with biliary tract cancer, pancreatic cancer, or other malignant tumors, and requiring bile duct drainage (2) Patients who have been fully informed about participation in the study and have given written consent of their own free will with sufficient understanding. (However, this study includes elderly patients, and there is a possibility that patients who lack the capacity to make decisions about the study will be included. In such cases, the selection criteria will be met if written consent is obtained after sufficient explanation to the substitute relative.) (3) 20 years old or older at the time of obtaining informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with difficulty in endoscopic approach (2) Patients with serious complications in other organs (3) Patients without Informed Consent. (4) Other patients deemed inappropriate as subjects by the principal researcher.

Design outcomes

Primary

MeasureTime frame
Clinical success rate

Secondary

MeasureTime frame
Duration of stent patency, clinical procedure success rate, incidence of complications, incidence of postoperative pancreatitis and cholecystitis, and outcome after biliary drainage

Contacts

Public ContactRyota Nakano

Hyogo College of Medicine

ri-nakano@hyo-med.ac.jp+81-798-45-6472

Outcome results

None listed

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