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Using Hot AXIOS™ stent for bile duct drainage in patients with malignant stenosis

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

Not applicable Interventional Boston Scientific Corporation · NCT06750146

This study is testing whether the Hot AXIOS™ stent can help improve the quality of life for patients with bile duct blockages from cancer who haven't had success with standard treatments.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment162 (estimated)
Ages18 Years and up
SexAll
SponsorBoston Scientific Corporation Industry-sponsored
Locations18 sites (Besançon and 17 other locations)
Trial IDNCT06750146 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the Hot AXIOS™ stent for patients suffering from malignant biliary stenosis who have experienced failure with standard ERCP procedures. It focuses on the quality of life improvements, particularly through the reduction of jaundice, after the stent placement via endoscopic ultrasound. The quality of life will be assessed using the EORTC QLQ-BIL21 questionnaire, which addresses symptoms and issues relevant to biliary tract cancer patients. The study aims to provide insights into how effective bile drainage can enhance overall patient well-being.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced failed ERCP for malignant biliary obstruction and are eligible for Hot AXIOS™ stent placement.

Not a fit: Patients who are pregnant, have immediately resectable tumors, or are participating in other conflicting studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for patients with malignant biliary stenosis by effectively managing jaundice.

How similar studies have performed: While the specific use of the Hot AXIOS™ stent is being evaluated, similar studies on bile duct drainage techniques have shown promising results in improving patient outcomes.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Besançon and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Malignant Biliary Stenosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.