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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hot AXIOS™ Recipients | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System | Device | 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Baptiste Chevaux | Central Hospital, Nancy, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Besançon | 25030 | France | |||
| Clinique des Cedres, Ramsay Sante |
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| 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) |
| 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) |
| Cornebarrieu |
| 31700 |
| France |
| CHU Limoges | Limoges | 87042 | France |
| Hopital Prive Jean Mermoz | Lyon | 69008 | France |
| Clinique Jules Verne | Nantes | 44300 | France |
| CHU Nice | Nice | 06202 | France |
| Hopital Saint Antoine | Paris | 75012 | France |
| Hopital Paris Saint-Joseph | Paris | 75014 | France |
| Hopital Europeen Georges-Pompidou | Paris | 75908 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| CHU Reims | Reims | 51092 | France |
| CHRU Hopital Pontchaillou | Rennes | 35033 | France |
| Clinique Saint-Hilaire | Rouen | 76000 | France |
| Santé Atlantique | Saint-Herblain | 44800 | France |
| CHU de Strasbourg | Strasbourg | 67091 | France |
| CHU Rangueil | Toulouse | 31059 | France |
| CHRU de Nancy | Vandœuvre-lès-Nancy | 54500 | France |
| Centre Hospitalier de Vichy | Vichy | 03200 | France |