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

French Prospective Study on Biliary Tract Drainage Guided by Endoscopic Ultrasound in Patients With Malignant Biliary Stenosis (RAINBOW)

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.

Study Overview

• Status: Suspended
• Conditions: Malignant Biliary Stenosis
• Intervention / Treatment: Device: Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System

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.

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • CHU de Besançon
  • Cornebarrieu, France, 31700
    • Clinique des Cedres, Ramsay Sante
  • Limoges, France, 87042
    • CHU Limoges
  • Lyon, France, 69008
    • Hopital Prive Jean Mermoz
  • Nantes, France, 44300
    • Clinique Jules Verne
  • Nice, France, 06202
    • CHU Nice
  • Paris, France, 75012
    • Hôpital Saint Antoine
  • Paris, France, 75014
    • Hopital Paris Saint-Joseph
  • Paris, France, 75908
    • Hôpital Européen Georges-Pompidou
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Reims, France, 51092
    • CHU Reims
  • Rennes, France, 35033
    • CHRU Hopital Pontchaillou
  • Rouen, France, 76000
    • Clinique Saint-Hilaire
  • Saint-Herblain, France, 44800
    • Santé Atlantique
  • Strasbourg, France, 67091
    • CHU de Strasbourg
  • Toulouse, France, 31059
    • CHU Rangueil
  • Vandœuvre-lès-Nancy, France, 54500
    • CHRU de Nancy
  • Vichy, France, 03200
    • Centre Hospitalier de Vichy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hot AXIOS™ Recipients; 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.

Device: Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System; The Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System is commercially available and can be used to bridge two lumens or organs to create an internal drain, so as to drain the bile ducts in case of failure of ERCP.; Other Names: Hot AXIOS™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Measurement - Jaundice Dimension	The primary outcome is the difference between the measurement taken at 2 months of follow-up (± 15 days) and the baseline measurement of quality of life assessed by the jaundice dimension of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-BIL21). The QLQ-BIL21 consists of 21 questions to which respondents rate their experience with various symptoms or problems on a scale from 1 (Not at All) to 4 (Very Much); the jaundice dimension consists of three of those questions. A lower score correlates to fewer symptoms or problems.	2 months (± 15 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Resolution of Clinical Symptoms	Resolution of GOO-related clinical symptoms such as jaundice, nausea/vomiting, fever/chills, weight loss and abdominal pain following implant of Hot AXIOS™ at 2 months of follow-up	2 months (± 15 days)
Rate of Reintervention	Reintervention is defined as endoscopic, radiological or surgical intervention for the management of recurrent biliary obstruction due to stent dysfunction (e.g., obstruction or migration) at 2 months of follow-up. This criterion will be measured within the population for whom the placement of the Hot AXIOS™ stent was a technical success.	2 months (± 15 days)
Chemotherapy Status	Number of days after study stent implantation to start or continuation of chemotherapy (if applicable).	2 months (± 15 days)
Overall Survival	Time from the placement of the Hot AXIOS™ to the date of death from any cause or to the end of follow-up (end of study participation or lost to follow-up) to assess summary measure overall survival.	2 months (± 15 days)
Progression-Free Survival	Time from the placement of the Hot AXIOS™ to the earliest date of either disease progression or death from any cause or to the end of follow-up (end of study participation or lost to follow-up) to assess summary measure progression-free survival.	2 months (± 15 days)
Number of Days Alive after Hospital Discharge	Number of days alive after hospital discharge within 2 months after the placement of the Hot AXIOS™.	2 months (± 15 days)
Rate of Technical Success	Technical success is defined as the successful placement of the Hot AXIOS™ stent during study procedure.	2 months (± 15 days)
Serious Adverse Events	Serious adverse events related to the study procedure and/or the Hot AXIOS™ stent.	2 months (± 15 days)
Quality of Life Measurement - Non-Jaundice Dimension	The absolute difference between the measurement taken at 2 months of follow-up (± 15 days) and the baseline measurement of quality of life assessed by the non-jaundice dimension of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-BIL21). The QLQ-BIL21 consists of 21 questions to which respondents rate their experience with various symptoms or problems on a scale from 1 (Not at All) to 4 (Very Much); the non-jaundice dimension consists of 18 of those questions. A lower score correlates to fewer symptoms or problems.	2 months (± 15 days)
Quality of Life Measurement - Global Score	The absolute difference between the measurement taken at 2 months of follow-up (± 15 days) and the baseline measurement of quality of life assessed by the global score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-BIL21). The QLQ-BIL21 consists of 21 questions to which respondents rate their experience with various symptoms or problems on a scale from 1 (Not at All) to 4 (Very Much). A lower score correlates to fewer symptoms or problems.	2 months (± 15 days)
Reduction in Bilirubin (Clinical Success)	Clinical success is defined as a reduction in bilirubin > 50% at each follow-up compared to baseline.	2 weeks (+ 7 days) and 2 months (± 15 days)

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Jean-Baptiste Chevaux, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: E7209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No