Health Condition 1: K315- Obstruction of duodenum
Conditions
Interventions
Intervention1: Endoscopic Ultrasound Guided Gastroenterostomy EUS-GE: EUS-guided gastroenterostomy EUS GE using the AXIOSTM lumen apposing Metal Stent also known as LAMS for the management of symptoms
Sponsors
Boston Scientific Corporation
Boston Scientific
Eligibility
Inclusion criteria
Inclusion criteria: Gastric outlet obstruction from unresectable malignant neoplasm Eligible for endoscopic intervention GOOS of 0 or 1 0 no oral intake 1 liquids only 2 soft solids only 3 low-residue or full diet 18 years of age or older Willing and able to comply with the study procedures or legally authorized representative LAR must provide written informed consent form ICF to participate in the study The distance between the gastric lumen and jejunal lumen must be no more than 1 cm
Exclusion criteria
Exclusion criteria: Patients with baseline ECOG greater than 2 and or Karnofsky Performance score less than 30 Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent Abnormal coagulation INR greater than 1.5 and not correctable per the discretion of the physician or who require continuous complete anticoagulation, and or any underlying condition associated with high risk of bleeding Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic drainage Multiple-level bowel obstruction downstream from the intended location of the EUS-guided bypass confirmed by radiography such as small bowel series or computed tomography Presence of intraperitoneal fat between the gastric lumen and jejunal lumen estimated to be larger than 1 cm at the proposed site of AXIOSTM stent insertion Gastric varices located within a 2 cm radius of the device insertion location on the gastric wall Ascites Grade greater than or equal to 2 confirmed by cross-sectional imaging Vessels located within a 2 cm radius of the device insertion location History of multiple abdominal surgeries and/or evidence of small bowel adhesions Allergic to any of the device materials Contraindications to use of electrical devices Pregnancy Prisoners and other vulnerable populations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AXIOS stent related or AXIOS endoscopic and/or study procedure related Serios Adverse Events through 30 days post stent placementTimepoint: At the time of the stent placement through study completion, an average of 1-year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Transmural placement of the AXIOS stent with confirmed stent patency by visualization of the contralateral wall of the small bowel through the AXIOS stent lumen. Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placementTimepoint: During the Procedure;Improvement of GOOS by 1 point from baseline to any point during 14 days after AXIOS stent placement & GOOS remaining at 1 or more without the need for reintervention due to loss of stent function at 30 days post index procedure or death whichever comes first.Timepoint: Through 14 days after procedure;Clinical success over time defined as improvement of GOOS by 1 point from baseline at any time during 14 days after AXIOS stent placement & GOOS remaining at 1 or more. This endpoint will be evaluated at 3 months, 6 months, & 12 months A patient undergoing reintervention for GOO is considered a failure of clinical successTimepoint: Through study completion, an average of 1 year;Time to resumption of oral intake after stent placement.Timepoint: Immediately after the procedure;Time to start or resume chemotherapy after AXIOSTM stent placement (where applicable)Timepoint: Immediately after the procedure;Change in Quality-of-Life score (SF-12 questionnaire) from baseline to 30 days, 3 months, 6 months, & 12 monthsTimepoint: through study completion, an average of 1 year;Incidence of Device Deficiencies. Including but not limited to stent migration & misplacement, stent occlusion, leakage at site of stent placementTimepoint: Immediately after the procedure;Incidence of Reintervention for GOO. Need for repeat treatment for persistent or recurrent GOO symptomsTimepoint: Immediately after the procedure | — |
Countries
Belgium, Brazil, Canada, India, United States of America
Contacts
Public ContactSundeep Lakhtakia
Asian Institute of Gastroenterology
Outcome results
None listed