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

JRCT ID: jRCT1052210158

Registered date:22/01/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: obstructive jaundice
• Date of first enrollment: 22/01/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Endoscopic biliary drainage for malignant biliary stenosis by double stenting with a narrow diameter cSEMS.

Outcome(s)

• Primary Outcome: Clinical success rate
• Secondary Outcome: Duration of stent patency, clinical procedure success rate, incidence of complications, incidence of postoperative pancreatitis and cholecystitis, and outcome after biliary drainage

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Shiomi Hideyuki