Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis (RAINBOW)

Boston Scientific

Status: Suspended

Conditions: Malignant Biliary Stenosis

Treatments: Device: Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06750146

E7209

Details and patient eligibility

About

The study is designed to highlight the effectiveness of the Hot AXIOS™ stent when used in accordance with standard medical practice on the evolution of the quality of life of patients with malignant biliary stenosis requiring drainage of the bile ducts after failure of ERCP, in the two months after stent placement.

Full description

The study will evaluate the quality of life in patients with malignant biliary obstruction after the placement of a lumen-apposing metal stent via endoscopic ultrasound, with an emphasis on the improvement of quality of life measured as a reduction in jaundice. Improvement in jaundice is a direct indicator of effective bile drainage and is expected to correlate with an enhancement in overall quality of life. Quality of life will be measured by means of subject response to the EORTC QLQ-BIL21, a component of the European Organization for Research and Treatment of Cancer (EORTC) designed specifically to assess the quality of life in patients with biliary tract cancer. The QLQ-BIL21 consists of 21 questions which aim to evaluate specific symptoms and issues relevant to patients with biliary tract cancer, such as jaundice, pain, digestive problems and the psychosocial impact of the disease.

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients 18 years or older
2. Willing and able to comply with study procedures and provide written informed consent
3. Patients with failed ERCP for treatment of suspected malignant biliary obstruction
4. Patients for whom an indication for Hot AXIOS™ stent placement has been determined

Exclusion criteria

1. Women who are pregnant, nursing or planning to become pregnant during the study
2. Patients with immediately resectable tumor or resectable during the two months of the study
3. Patients for whom the placement of a double pigtail prosthesis is planned by the investigator during the index procedure
4. Current participation in another investigation drug or device study that could interfere with the endpoints of this study
5. Persons under guardianship or curatorship

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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162 participants in 1 patient group

Hot AXIOS™ Recipients

Experimental group

Description:

The Hot AXIOS™ Stent is a flexible, fully covered self-expanding metal stent that is preloaded within the Electrocautery Enhanced Delivery System. Patients who meet all eligibility criteria will receive the Hot AXIOS™stent and their quality of life will be measured at baseline, two weeks after stent placement and two months after stent placement by the jaundice dimension of the EORTC QLQ-BIL21 questionnaire. A patient is considered enrolled after signing the study-specific Informed Consent Form (ICF). Patients who sign the ICF but subsequently do not meet one or more of the selection criteria will be considered screen failures and excluded from the study.

Treatment:

Device: Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System