Walled Off Pancreatic Necrosis
Conditions
Keywords
Pancreatic necrosis
Brief summary
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%.
Detailed description
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.
Interventions
DEVICEAXIOS
Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
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: * Heterogeneous with liquid and non-liquid density with varying degrees of loculations (some may appear homogeneous) * Well defined wall * Location-intrapancreatic and/or extrapancreatic * 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: * INR \> 1.5 and not correctable * presence of a bleeding disorder * platelets \< 50,000/mm3 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Resolution of WON With Endoscopic Drainage | Up to 60 Days | Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI |
| AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events | Through study completion, average of 8 months | AXIOS stent related or WON drainage procedure related serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drainage Procedural Time | Intraoperative (Stent placement) | Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval. |
| Resolution of WON: Radiographic Resolution Evaluated by MRI or CT | Through study completion, average of 8 months | Resolution of WON with or without necrosectomy by 6 months post AXIOS stent removal. |
| Time to WON Resolution | Up to 60 Days | Time to WON resolution using same definition as for primary endpoint, namely: * Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI. |
| WON Recurrence | Through study completion, average of 8 months | Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal. |
| Symptom Reduction | Through study completion, average of 8 months | Reduction of WON-related clinical symptoms. Note: WON-related symptoms as defined in Inclusion Criteria #4 |
| Fluoroscopy | Intraoperative (Stent placement through stent removal) | Fluoroscopy (time) per endoscopic procedure. |
| Incidence of New Organ Failure | Up to 60 days | Number of participants with new organ failure from drainage procedure to WON resolution. |
| Change in SF-12 Score | Difference from baseline to stent removal (up to 60 days) visit | \*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 |
| Stent Lumen Patency | Intraoperative (Stent placement through stent removal) | Stent lumen patency, evaluated via imaging or direct visual inspection with endoscope, and defined as one or both of the following: * Drainage through AXIOS stent visualized from the stomach or bowel, and/or * Visual confirmation of AXIOS stent lumen patency |
| Technical Success | Intraoperative (Stent placement) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | AXIOS Stent and Electrocautery Enhanced Delivery System |
|---|---|
| Age, Customized | 54.5 Years STANDARD_DEVIATION 12.4 |
| Baseline Imaging Type of Imaging Used : Abdominal CT | 28 participants |
| Baseline Imaging Type of Imaging Used : EUS | 4 participants |
| Baseline Imaging Type of Imaging Used : MRI | 12 participants |
| Etiology of Acute Pancreatitis Alcohol | 4 Participants |
| Etiology of Acute Pancreatitis ERCP | 3 Participants |
| Etiology of Acute Pancreatitis Gallstones | 22 Participants |
| Etiology of Acute Pancreatitis Hypertriglyceridemia | 1 Participants |
| Etiology of Acute Pancreatitis Lisinopril/Hydrochlorothiazide | 1 Participants |
| Etiology of Acute Pancreatitis Unknown | 11 Participants |
| Nutrition source/status Nasoduodenal/Nasojejunal | 6 Participants |
| Nutrition source/status Nasoenteric | 2 Participants |
| Nutrition source/status Nasogastric | 1 Participants |
| Nutrition source/status Non-Assisted Feeding/Non-Enteral Feeding | 26 Participants |
| Nutrition source/status Percutaneous Endoscopic Duodenostomy/Jejunostomy | 0 Participants |
| Nutrition source/status Percutaneous Endoscopic Gastrostomy | 1 Participants |
| Nutrition source/status Total Parenteral Nutrition | 4 Participants |
| Organ Failure, Affected Organ Systems Cardiovascular | 1 Participants |
| Organ Failure, Affected Organ Systems Renal | 3 Participants |
| Organ Failure, Affected Organ Systems Respiratory | 2 Participants |
| Organ Failure Score 0 | 36 Participants |
| Organ Failure Score 1 | 2 Participants |
| Organ Failure Score 2 | 1 Participants |
| Organ Failure Score 3 | 1 Participants |
| Organ Failure Score 4 | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized White (Caucasian) | 35 Participants |
| Region of Enrollment United States | 40 participants |
| Severity of Acute Necrotizing Pancreatitis Moderately Severe | 19 Participants |
| Severity of Acute Necrotizing Pancreatitis Severe | 21 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 26 Participants |
| SF-12 quality of life score | 35.1 units on a scale STANDARD_DEVIATION 19.5 |
| WON Symptom Abdominal Pain | 36 participants |
| WON Symptom Biliary Obstructive Symptoms | 4 participants |
| WON Symptom Chronic Nausea | 17 participants |
| WON Symptom Deteriorating Organ Function | 3 participants |
| WON Symptom Deterioration of overall health score | 14 participants |
| WON Symptom Fever | 7 participants |
| WON Symptom Gastric Outlet Obstruction | 10 participants |
| WON Symptom Lethargy | 12 participants |
| WON Symptom Leukocytosis | 14 participants |
| WON Symptom Systemic Inflammatory Response Syndrome | 3 participants |
| WON Symptom Weight Loss | 23 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 40 |
| other Total, other adverse events | 5 / 40 |
| serious Total, serious adverse events | 19 / 40 |
Outcome results
Primary
AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events
AXIOS stent related or WON drainage procedure related serious adverse events
Time frame: Through study completion, average of 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXIOS | AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events | 3 Participants |
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
Time frame: Up to 60 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXIOS | Number of Participants With Resolution of WON With Endoscopic Drainage | 39 Participants |
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
Time frame: Difference from baseline to stent removal (up to 60 days) visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AXIOS | Change in SF-12 Score | 23.6 score on a scale | Standard Deviation 20.5 |
Secondary
Drainage Procedural Time
Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval.
Time frame: Intraoperative (Stent placement)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AXIOS | Drainage Procedural Time | 22.6 minutes | Standard Deviation 11.3 |
Secondary
Fluoroscopy
Fluoroscopy (time) per endoscopic procedure.
Time frame: Intraoperative (Stent placement through stent removal)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AXIOS | Fluoroscopy | 4.6 minutes | Standard Deviation 6.1 |
Secondary
Incidence of New Organ Failure
Number of participants with new organ failure from drainage procedure to WON resolution.
Time frame: Up to 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXIOS | Incidence of New Organ Failure | 1 Participants |
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.
Time frame: Through study completion, average of 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXIOS | Resolution of WON: Radiographic Resolution Evaluated by MRI or CT | 40 Participants |
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: * Drainage through AXIOS stent visualized from the stomach or bowel, and/or * Visual confirmation of AXIOS stent lumen patency
Time frame: Intraoperative (Stent placement through stent removal)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXIOS | Stent Lumen Patency | 40 Participants |
Secondary
Symptom Reduction
Reduction of WON-related clinical symptoms. Note: WON-related symptoms as defined in Inclusion Criteria #4
Time frame: Through study completion, average of 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXIOS | Symptom Reduction | 29 Participants |
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.
Time frame: Intraoperative (Stent placement)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AXIOS | Technical Success | Placement Success | 40 Participants |
| AXIOS | Technical Success | Removal Success | 40 Participants |
Secondary
Time to WON Resolution
Time to WON resolution using same definition as for primary endpoint, namely: * Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI.
Time frame: Up to 60 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AXIOS | Time to WON Resolution | 34.1 days | Standard Deviation 16.8 |
Secondary
WON Recurrence
Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal.
Time frame: Through study completion, average of 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXIOS | WON Recurrence | 0 Participants |