Patients with non-resected distal malignant bile duct obstruction
Conditions
Interventions
Two 10 French plastic stent placement
One fully covered self expandable metallic stent placement
Sponsors
The Jikei University school of medicine
Katsushika Medical Center, The Jikei University School of Medicine, Tokyo, Japan. The Jikei University Kashiwa Hospital. Chiba, Japan Atsugi City Hospital, Kanagawa Japan. Fuji City General Hospital, Shizuoka Japan.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with unresected distal malignant bile duct stenosis who have already undergone initial PS implantation and whose cholangitis and jaundice have been confirmed to have improved. 2. Patients who are 20 years of age or older and have obtained written consent from themselves or a substitute. 3. Patients who can undergo endoscopic papillotomy without antithrombotic medication or with withdrawal of medication. 4. Patients with no history of SEMS placement. 5. The upper margin of the bile duct stenosis has a margin of at least 2 cm above the bifurcation. 6. Performance states 1, 2, 3.
Exclusion criteria
Exclusion criteria: 1. Cases in which endoscopic retrograde cholangiography is difficult. 2. Patients with peri-hilar bile duct obstruction. 3. Patients with altered gastrointestinal anatomy excluding Billroth-I reconstruction. 4. Patients with serious complications in other organs. 5. Performance status 4 6. Cases of pregnancy or possible pregnancy 7. Cases deemed inappropriate by the principal investigator or sub-investigator 8. Underage patients(less than 20 years old)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the duration of recurrent bile duct obstruction between two 10 French PS and one fully covered SEMS for non-resected distal malignant bile duct stenosis. | — |
Countries
Japan
Contacts
Public ContactMasafumi Chiba
The Jikei University School of Medicine, Tokyo, Japan Department of Endoscopy
Outcome results
None listed