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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
162
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.
CHU de Besançon
Besançon, France
Clinique des Cedres, Ramsay Sante
Cornebarrieu, France
CHU Limoges
Limoges, France
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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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
...and 8 more locations
Time frame: 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
Time frame: 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.
Time frame: 2 months (± 15 days)
Chemotherapy Status
Number of days after study stent implantation to start or continuation of chemotherapy (if applicable).
Time frame: 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.
Time frame: 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.
Time frame: 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™.
Time frame: 2 months (± 15 days)
Rate of Technical Success
Technical success is defined as the successful placement of the Hot AXIOS™ stent during study procedure.
Time frame: 2 months (± 15 days)
Serious Adverse Events
Serious adverse events related to the study procedure and/or the Hot AXIOS™ stent.
Time frame: 2 months (± 15 days)