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

Not Applicable

• Conditions: D041781; obstructive jaundice

• Registration Number: JPRN-jRCT1052210158
• Lead Sponsor: Shiomi Hideyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

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

(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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical success rate

Secondary Outcome Measures

Name	Time	Method
Duration of stent patency, clinical procedure success rate, incidence of complications, incidence of postoperative pancreatitis and cholecystitis, and outcome after biliary drainage