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To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of walled off pancreatic necrosis (WONs) in patients with WONs with solid component >30%.
This study is a prospective, single arm, multi-center trial. Treatment of up to 40 patients will take place at up to 6 clinical centers. Patients who meet all eligibility criteria will receive the AXIOS stent for up to 60 days stent indwell and 6 months follow-up after stent removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXIOS | Experimental | Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXIOS | Device | Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Resolution of WON With Endoscopic Drainage | Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI | Up to 60 Days |
| AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events | AXIOS stent related or WON drainage procedure related serious adverse events | Through study completion, average of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Reduction | Reduction of WON-related clinical symptoms. Note: WON-related symptoms as defined in Inclusion Criteria #4 | Through study completion, average of 8 months |
| Technical Success | Technical AXIOS stent placement success, defined as placement in desired location using endoscopic/EUS techniques per standard of practice. Technical AXIOS stent removal success, defined as ability to remove the AXIOS stent using an endoscopic snare or forceps or graspers without AXIOS stent removal related serious adverse events. |
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Inclusion Criteria:
Age between 22 and 75 years old
Severe or moderately severe acute necrotizing pancreatitis, defined per the 2012 Revised Atlanta Classification.
WON resulting from necrotizing pancreatitis per contrast-enhanced CT with the following characteristics, per the 2012 Revised Atlanta Classification:
Infected WON or symptomatic sterile WON Note: WON-related symptoms may include: pain, fever, leukocytosis, failure to thrive or deterioration of overall heath score, gastric outlet obstruction (GOO), weight loss, biliary obstructive symptoms, systemic inflammatory response syndrome (SIRS), deteriorating organ function, chronic nausea, lethargy, and inability to eat or gain weight
Imaging suggestive of greater than 30% necrotic material
WON ≥ 6cm in size
Eligible for endoscopic intervention
Acceptable candidate for endoscopic transluminal drainage
Patient understands the study requirements and the treatment procedures and provides written Informed Consent
Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post imaging study
Exclusion Criteria:
Pseudocyst
Cystic neoplasm
Untreated Pseudoaneurysm > 1cm within the WON
More than one WON clearly separated and requiring drainage
WONs that require dual modality interventions (endoscopic and percutaneous) from the beginning (i.e. deep paracolic space involvement that is inaccessible through the central drainage access)
Prior surgical, interventional radiology or endoscopic procedures for the treatment of the WON
Abnormal coagulation:
Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound)
WON that poorly approximates the GI lumen (≥1cm away)
Pericolic gutter necrosis
Pelvic necrosis
Prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient
Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study
Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
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| Name | Affiliation | Role |
|---|---|---|
| Barham K Abu Dayyeh, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Denver | Aurora | Colorado | 80045 | United States | ||
| Emory University Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35129503 | Derived | Dayyeh BKA, Chandrasekhara V, Shah RJ, Easler JJ, Storm AC, Topazian M, Levy MJ, Martin JA, Petersen BT, Takahashi N, Edmundowicz S, Hammad H, Wagh MS, Wani S, DeWitt J, Bick B, Gromski M, Al Haddad M, Sherman S, Merchant AA, Peetermans JA, Gjata O, McMullen E, Willingham FF. Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial. Ann Surg. 2023 May 1;277(5):e1072-e1080. doi: 10.1097/SLA.0000000000005274. Epub 2023 Apr 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AXIOS Stent and Electrocautery Enhanced Delivery System | Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis. AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AXIOS Stent and Electrocautery Enhanced Delivery System | Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis. AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age between 22 and 75 years old |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Resolution of WON With Endoscopic Drainage | Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI | Posted | Count of Participants | Participants | Up to 60 Days |
|
|
From stent implant to 6-month post-stent removal
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AXIOS | Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis. AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Localised infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ornela Gjata | Boston Scientific | (508)-683-4155 | Ornela.Gjata@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2018 | Oct 5, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2018 | Oct 5, 2021 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D019283 | Pancreatitis, Acute Necrotizing |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| Intraoperative (Stent placement) |
| Drainage Procedural Time | Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval. | Intraoperative (Stent placement) |
| Resolution of WON: Radiographic Resolution Evaluated by MRI or CT | Resolution of WON with or without necrosectomy by 6 months post AXIOS stent removal. | Through study completion, average of 8 months |
| Time to WON Resolution | Time to WON resolution using same definition as for primary endpoint, namely:
| Up to 60 Days |
| WON Recurrence | Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal. | Through study completion, average of 8 months |
| Stent Lumen Patency | Stent lumen patency, evaluated via imaging or direct visual inspection with endoscope, and defined as one or both of the following:
| Intraoperative (Stent placement through stent removal) |
| Fluoroscopy | Fluoroscopy (time) per endoscopic procedure. | Intraoperative (Stent placement through stent removal) |
| Incidence of New Organ Failure | Number of participants with new organ failure from drainage procedure to WON resolution. | Up to 60 days |
| Change in SF-12 Score | *Change* in Quality of Life score (SF-12 questionnaire) from *baseline to stent removal*. The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | Difference from baseline to stent removal (up to 60 days) visit |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Etiology of Acute Pancreatitis | Count of Participants | Participants |
|
| Severity of Acute Necrotizing Pancreatitis | -Grades of severity-
Persistent organ failure (>48 h)
| Count of Participants | Participants |
|
| Baseline Imaging | More than one type of imaging, i.e. CT Scan, MRI, EUS, was used for baseline imaging. | Number | participants |
|
| WON Symptom | Number | participants |
|
| Organ Failure, Affected Organ Systems | Count of Participants | Participants |
|
| Organ Failure Score | A score of 2 or more in any organ system defines the presence of organ failure. | Count of Participants | Participants |
|
| Nutrition source/status | Count of Participants | Participants |
|
| SF-12 quality of life score | There were 2 participants whom were missing the SF-12 data. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events | AXIOS stent related or WON drainage procedure related serious adverse events | Posted | Count of Participants | Participants | Through study completion, average of 8 months |
|
|
|
| Secondary | Symptom Reduction | Reduction of WON-related clinical symptoms. Note: WON-related symptoms as defined in Inclusion Criteria #4 | Posted | Count of Participants | Participants | Through study completion, average of 8 months |
|
|
|
| Secondary | Technical Success | Technical AXIOS stent placement success, defined as placement in desired location using endoscopic/EUS techniques per standard of practice. Technical AXIOS stent removal success, defined as ability to remove the AXIOS stent using an endoscopic snare or forceps or graspers without AXIOS stent removal related serious adverse events. | Posted | Count of Participants | Participants | Intraoperative (Stent placement) |
|
|
|
| Secondary | Drainage Procedural Time | Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval. | Posted | Mean | Standard Deviation | minutes | Intraoperative (Stent placement) |
|
|
|
| Secondary | Resolution of WON: Radiographic Resolution Evaluated by MRI or CT | Resolution of WON with or without necrosectomy by 6 months post AXIOS stent removal. | Posted | Count of Participants | Participants | Through study completion, average of 8 months |
|
|
|
| Secondary | Time to WON Resolution | Time to WON resolution using same definition as for primary endpoint, namely:
| Posted | Mean | Standard Deviation | days | Up to 60 Days |
|
|
|
| Secondary | WON Recurrence | Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal. | Posted | Count of Participants | Participants | Through study completion, average of 8 months |
|
|
|
| Secondary | Stent Lumen Patency | Stent lumen patency, evaluated via imaging or direct visual inspection with endoscope, and defined as one or both of the following:
| Posted | Count of Participants | Participants | Intraoperative (Stent placement through stent removal) |
|
|
|
| Secondary | Fluoroscopy | Fluoroscopy (time) per endoscopic procedure. | Posted | Mean | Standard Deviation | minutes | Intraoperative (Stent placement through stent removal) |
|
|
|
| Secondary | Incidence of New Organ Failure | Number of participants with new organ failure from drainage procedure to WON resolution. | Posted | Count of Participants | Participants | Up to 60 days |
|
|
|
| Secondary | Change in SF-12 Score | *Change* in Quality of Life score (SF-12 questionnaire) from *baseline to stent removal*. The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | Posted | Mean | Standard Deviation | score on a scale | Difference from baseline to stent removal (up to 60 days) visit |
|
|
|
| 1 |
| 40 |
| 19 |
| 40 |
| 5 |
| 40 |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Complication associated with device | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Extravasation | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Pancreatic leak | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
|
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