Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis
- Conditions
- Malignant Biliary Stenosis
- Registration Number
- NCT06750146
- Lead Sponsor
- Boston Scientific Corporation
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 129
- Patients 18 years or older
- Willing and able to comply with study procedures and provide written informed consent
- Patients with failed ERCP for treatment of malignant biliary obstruction
- Patients for whom an indication for Hot AXIOS™ stent placement has been determined in the context of the study
- Female of childbearing potential with a positive pregnancy test prior to the procedure or who intends to become pregnant during the study
- Patients with immediately resectable tumor
- Patients for whom the placement of a double pigtail prosthesis is planned by the investigator during the index procedure
- Current participation in another investigation drug or device study that could interfere with the endpoints of this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Quality of Life Measurement - Jaundice Dimension 2 months (± 15 days) 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.
- Secondary Outcome Measures
Name Time Method Quality of Life Measurement - Non-Jaundice Dimension 2 months (± 15 days) 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.
Quality of Life Measurement - Global Score 2 months (± 15 days) 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.
Reduction in Bilirubin (Clinical Success) 2 weeks (+ 7 days) and 2 months (± 15 days) Clinical success is defined as a reduction in bilirubin \> 50% at each follow-up compared to baseline.
Rate of Resolution of Clinical Symptoms 2 months (± 15 days) 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
Rate of Reintervention 2 months (± 15 days) 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.
Chemotherapy Status 2 months (± 15 days) Number of days after study stent implantation to start or continuation of chemotherapy (if applicable).
Overall Survival 2 months (± 15 days) 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.
Progression-Free Survival 2 months (± 15 days) 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.
Number of Days Alive after Hospital Discharge 2 months (± 15 days) Number of days alive after hospital discharge within 2 months after the placement of the Hot AXIOS™.
Rate of Technical Success 2 months (± 15 days) Technical success is defined as the successful placement of the Hot AXIOS™ stent during study procedure.
Serious Adverse Events 2 months (± 15 days) Serious adverse events related to the study procedure and/or the Hot AXIOS™ stent.
Trial Locations
- Locations (15)
Santé Atlantique
🇫🇷Saint Herblain, France
Clinique des Cedres, Ramsay Sante
🇫🇷Cornebarrieu, France
CHRU de Nancy
🇫🇷Vandœuvre-lès-Nancy, France
Centre Hospitalier de Vichy
🇫🇷Vichy, France
CHU Limoges
🇫🇷Limoges, France
Hopital Prive Jean Mermoz
🇫🇷Lyon, France
Clinique Jules Verne
🇫🇷Nantes, France
CHU Nice
🇫🇷Nice, France
Hopital Saint Antoine
🇫🇷Paris, France
Hopital Paris Saint Joseph
🇫🇷Paris, France
Hopital Europeen Georges-Pompidou
🇫🇷Paris, France
CHU de Poitiers
🇫🇷Poitiers, France
CHU Reims
🇫🇷Reims, France
CHU de Strasbourg
🇫🇷Strasbourg, France
CHU Rangueil
🇫🇷Toulouse, France