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Suprapapillary stent-by-stent deployment with slim-fully covered metal stents versus plastic stens for unresectable malignant hilar biliary obstruction (SBSFLUX Trial)

Suprapapillary stent-by-stent deployment with slim-fully covered metal stents versus plastic stens for unresectable malignant hilar biliary obstruction
(SBSFLUX Trial)

Inoue Tadahisa

Aichi Medical University

1-1 Yazakokarimata, Nagakute, Aichi

tinoue-tag@umin.ac.jp

Inoue Tadahisa

Aichi Medical University

1-1 Yazakokarimata, Nagakute, Aichi

+81-561623311

tinoue-tag@umin.ac.jp

Recruiting

Aug. 05, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Patients diagnosed with malignant hilar bile duct stricture by histopathology, cytology or imaging studies.
2. Bismuth classification type II or higher.
3. Unresectable cases.
4. Patients with abnormal values in serum total bilirubin, AST, ALT, GTP, or ALP requiring endoscopic biliary drainage.
5. Patients aged 18 years or older at the time of consent, regardless of gender.
6. Patients who have received sufficient explanation about the study, fully understood the content, and provided written informed consent of their own free will.

1. Patients who have already undergone metal stent placement.
2. Patients undergoing re-intervention for RBO.
3. Patients with surgically altered anatomy other than Billroth-I reconstruction.
4. Patients with a history of biliary reconstruction.
5. Patients with a history of chronic cholangitis such as primary sclerosing cholangitis or IgG4-related sclerosing cholangitis.
6. Cases where the stricture extends near the duodenal papilla, making intraductal stent placement difficult.
7. Cases in which placement of two or more stents is either difficult or unnecessary due to prior hepatic resection or intrahepatic tumors.
8. Cases with severely separated intrahepatic bile ducts where drainage is unlikely to improve the condition.
9. Cases where most of the liver is occupied by tumor and improvement through bile duct drainage is not expected.
10. Patients with an expected prognosis of less than three months.
11. Patients judged to be unsuitable for safe endoscopic procedures.
12. Cases where access to the duodenal papilla is difficult.
13. Pregnant women or those who may be pregnant.
14. Patients deemed unsuitable for this study by the principal investigator or sub-investigators.

Both

Malignant hilar biliary obstruction

The current first-line treatment for unresectable malignant hilar biliary stricture at many institutions in Japan is the placement of multiple intraductal plastic stents (SBS placement). This study aims to evaluate a novel drainage method using small-caliber FCMS placed SBS within the bile duct for unresectable malignant hilar biliary stricture. The conventional SBS placement using PS will serve as the control. Patients will be randomly assigned in a 1:1 ratio to either the small-caliber FCMS group or the PS group, and outcomes will be compared between the two groups.

6-month RBO-free Rate

1. Time to RBO (TRBO)
2. Overall survival
3. Rate of RBO
4. Causes of RBO
5. Technical success rate
6. Clinical success rate
7. Procedure time
8. Incidence and types of adverse events other than RBO
9. Technical success rate and details of reintervention for RBO
10. Success rate of stent removal during reintervention for RBO
11. Clinical success rate of reintervention for RBO
12. Procedure time for reintervention for RBO
13. Incidence and types of adverse events during reintervention for RBO
14. TRBO after reintervention for RBO
15. Total number of reinterventions and total number of RBO occurrences

+81-561623311

July. 15, 2025

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