Clinical trial NCT06750146: Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis
Official title: French Prospective Study on Biliary Tract Drainage Guided by Endoscopic Ultrasound in Patients With Malignant Biliary Stenosis (RAINBOW)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Biliary Stenosis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2024-12-27
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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 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
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

Primary outcomes:
measure: Quality of Life Measurement - Jaundice Dimension
timeFrame: 2 months (± 15 days)
Secondary outcomes:
measure: Quality of Life Measurement - Non-Jaundice Dimension
timeFrame: 2 months (± 15 days)
measure: Quality of Life Measurement - Global Score
timeFrame: 2 months (± 15 days)
measure: Reduction in Bilirubin (Clinical Success)
timeFrame: 2 weeks (+ 7 days) and 2 months (± 15 days)
measure: Rate of Resolution of Clinical Symptoms
timeFrame: 2 months (± 15 days)
measure: Rate of Reintervention
timeFrame: 2 months (± 15 days)
measure: Chemotherapy Status
timeFrame: 2 months (± 15 days)
measure: Overall Survival
timeFrame: 2 months (± 15 days)
measure: Progression-Free Survival
timeFrame: 2 months (± 15 days)
measure: Number of Days Alive after Hospital Discharge
timeFrame: 2 months (± 15 days)
measure: Rate of Technical Success
timeFrame: 2 months (± 15 days)
measure: Serious Adverse Events
timeFrame: 2 months (± 15 days)
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Cornebarrieu
country: France
facility: Clinique des Cedres, Ramsay Sante
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz
city: Nantes
country: France
facility: Clinique Jules Verne
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Paris Saint Joseph
city: Paris
country: France
facility: Hopital Europeen Georges-Pompidou
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: CHRU Hopital Pontchaillou
city: Rouen
country: France
facility: Clinique Saint-Hilaire
city: Saint Herblain
country: France
facility: Santé Atlantique
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU Rangueil
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy
city: Vichy
country: France
facility: Centre Hospitalier de Vichy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Jean-Baptiste Chevaux
role: PRINCIPAL_INVESTIGATOR
References: