Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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 suspected malignant biliary obstruction
- Patients for whom an indication for Hot AXIOS™ stent placement has been determined
Exclusion Criteria:
- Women who are pregnant, nursing or planning to become pregnant during the study
- Patients with immediately resectable tumor or resectable during the two months of the study
- 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
- Persons under guardianship or curatorship