AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03525808
• Collaborator: (none)
• Enrollment: 40
• Locations: 5
• Arm: 1
• Actual Duration (Months): 24.9
• Patients Per Site: 8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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%.

Condition or Disease	Intervention/Treatment	Phase
Walled Off Pancreatic Necrosis	Device: AXIOS	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents
• Actual Study Start Date: Sep 5, 2018
• Actual Primary Completion Date: Mar 31, 2020
• Actual Study Completion Date: Oct 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AXIOS Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.	Device: AXIOS; Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. 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

2. 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.

3. Drainage Procedural Time [Intraoperative (Stent placement)]

   Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval.

4. 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.

5. 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.

6. WON Recurrence [Through study completion, average of 8 months]

   Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal.

7. 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

8. Fluoroscopy [Intraoperative (Stent placement through stent removal)]

   Fluoroscopy (time) per endoscopic procedure.

9. Incidence of New Organ Failure [Up to 60 days]

   Number of participants with new organ failure from drainage procedure to WON resolution.

10. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado, Denver	Aurora	Colorado	United States	80045
2	Emory University Healthcare	Atlanta	Georgia	United States	30322
3	Indiana University Health	Indianapolis	Indiana	United States	46202
4	Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
5	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Barham K Abu Dayyeh, MD, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol - Aug 16, 2018
• Statistical Analysis Plan - May 18, 2018

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT03525808
• Other Study ID Numbers: E7116
• First Posted: May 16, 2018
• Last Update Posted: Dec 20, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Boston Scientific Corporation: Pancreatic necrosis
• Additional relevant MeSH terms: Pancreatitis, Acute Necrotizing; Necrosis

Study Results

Participant Flow

Arm/Group Title	AXIOS Stent and Electrocautery Enhanced Delivery System
Arm/Group Description	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.
Period Title: Overall Study
STARTED	40
COMPLETED	34
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	AXIOS Stent and Electrocautery Enhanced Delivery System
Arm/Group Description	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.
Overall Participants	40
Age, Customized (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	54.5 (12.4)
Sex: Female, Male (Count of Participants)
Female	14 35%
Male	26 65%
Race/Ethnicity, Customized (Count of Participants)
Black or African American	4 10%
Hispanic or Latino	1 2.5%
White (Caucasian)	35 87.5%
Region of Enrollment (participants) [Number]
United States	40 100%
Etiology of Acute Pancreatitis (Count of Participants)
Gallstones	22 55%
Alcohol	4 10%
ERCP	3 7.5%
Hypertriglyceridemia	1 2.5%
Lisinopril/Hydrochlorothiazide	1 2.5%
Unknown	11 27.5%
Severity of Acute Necrotizing Pancreatitis (Count of Participants)
Severe	21 52.5%
Moderately Severe	19 47.5%
Baseline Imaging (participants) [Number]
Type of Imaging Used : Abdominal CT	28 70%
Type of Imaging Used : MRI	12 30%
Type of Imaging Used : EUS	4 10%
WON Symptom (participants) [Number]
Abdominal Pain	36 90%
Weight Loss	23 57.5%
Chronic Nausea	17 42.5%
Leukocytosis	14 35%
Lethargy	12 30%
Deterioration of overall health score	14 35%
Gastric Outlet Obstruction	10 25%
Fever	7 17.5%
Biliary Obstructive Symptoms	4 10%
Systemic Inflammatory Response Syndrome	3 7.5%
Deteriorating Organ Function	3 7.5%
Organ Failure, Affected Organ Systems (Count of Participants)
Respiratory	2 5%
Renal	3 7.5%
Cardiovascular	1 2.5%
Organ Failure Score (Count of Participants)
0	36 90%
1	2 5%
2	1 2.5%
3	1 2.5%
4	0 0%
Nutrition source/status (Count of Participants)
Non-Assisted Feeding/Non-Enteral Feeding	26 65%
Nasoduodenal/Nasojejunal	6 15%
Total Parenteral Nutrition	4 10%
Nasoenteric	2 5%
Nasogastric	1 2.5%
Percutaneous Endoscopic Gastrostomy	1 2.5%
Percutaneous Endoscopic Duodenostomy/Jejunostomy	0 0%
SF-12 quality of life score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	35.1 (19.5)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Resolution of WON With Endoscopic Drainage
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIOS
Arm/Group Description	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.
Measure Participants	40
Count of Participants [Participants]	39 97.5%

2. Primary Outcome

Title	AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events
Description	AXIOS stent related or WON drainage procedure related serious adverse events
Time Frame	Through study completion, average of 8 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIOS
Arm/Group Description	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.
Measure Participants	40
Count of Participants [Participants]	3 7.5%

3. Secondary Outcome

Title	Symptom Reduction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIOS
Arm/Group Description	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.
Measure Participants	34
Count of Participants [Participants]	29 72.5%

4. Secondary Outcome

Title	Technical Success
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIOS
Arm/Group Description	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.
Measure Participants	40
Placement Success	40 100%
Removal Success	40 100%

5. Secondary Outcome

Title	Drainage Procedural Time
Description	Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval.
Time Frame	Intraoperative (Stent placement)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIOS
Arm/Group Description	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.
Measure Participants	40
Mean (Standard Deviation) [minutes]	22.6 (11.3)

6. Secondary Outcome

Title	Resolution of WON: Radiographic Resolution Evaluated by MRI or CT
Description	Resolution of WON with or without necrosectomy by 6 months post AXIOS stent removal.
Time Frame	Through study completion, average of 8 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIOS
Arm/Group Description	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.
Measure Participants	40
Count of Participants [Participants]	40 100%

7. Secondary Outcome

Title	Time to WON Resolution
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIOS
Arm/Group Description	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.
Measure Participants	40
Mean (Standard Deviation) [days]	34.1 (16.8)

8. Secondary Outcome

Title	WON Recurrence
Description	Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal.
Time Frame	Through study completion, average of 8 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIOS
Arm/Group Description	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.
Measure Participants	34
Count of Participants [Participants]	0 0%

9. Secondary Outcome

Title	Stent Lumen Patency
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIOS
Arm/Group Description	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.
Measure Participants	40
Count of Participants [Participants]	40 100%

10. Secondary Outcome

Title	Fluoroscopy
Description	Fluoroscopy (time) per endoscopic procedure.
Time Frame	Intraoperative (Stent placement through stent removal)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIOS
Arm/Group Description	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.
Measure Participants	38
Mean (Standard Deviation) [minutes]	4.6 (6.1)

11. Secondary Outcome

Title	Incidence of New Organ Failure
Description	Number of participants with new organ failure from drainage procedure to WON resolution.
Time Frame	Up to 60 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIOS
Arm/Group Description	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.
Measure Participants	39
Count of Participants [Participants]	1 2.5%

12. Secondary Outcome

Title	Change in SF-12 Score
Description	*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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AXIOS
Arm/Group Description	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.
Measure Participants	37
Mean (Standard Deviation) [score on a scale]	23.6 (20.5)

Adverse Events

Time Frame	From stent implant to 6-month post-stent removal
Arm/Group Title	AXIOS
Arm/Group Description	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.
All Cause Mortality
	AXIOS
	Affected / at Risk (%)	# Events
Total	1/40 (2.5%)
Serious Adverse Events
	AXIOS
	Affected / at Risk (%)	# Events
Total	19/40 (47.5%)
Cardiac disorders
Cardiac arrest	1/40 (2.5%)	1
Endocrine disorders
Hyperparathyroidism	1/40 (2.5%)	1
Gastrointestinal disorders
Pancreatitis acute	2/40 (5%)	3
Pancreatitis	3/40 (7.5%)	3
Abdominal pain upper	2/40 (5%)	2
Abdominal pain	1/40 (2.5%)	1
Gastrointestinal haemorrhage	1/40 (2.5%)	1
Upper gastrointestinal haemorrhage	1/40 (2.5%)	1
Pneumatosis intestinalis	1/40 (2.5%)	1
General disorders
Complication associated with device	2/40 (5%)	2
Extravasation	1/40 (2.5%)	1
Chest pain	1/40 (2.5%)	1
Hepatobiliary disorders
Cholecystitis acute	1/40 (2.5%)	1
Infections and infestations
Sepsis	5/40 (12.5%)	5
Bacteraemia	1/40 (2.5%)	1
Gastrointestinal infection	1/40 (2.5%)	1
Injury, poisoning and procedural complications
Pancreatic leak	1/40 (2.5%)	1
Metabolism and nutrition disorders
Malnutrition	1/40 (2.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma	1/40 (2.5%)	1
Nervous system disorders
Monoplegia	1/40 (2.5%)	1
Renal and urinary disorders
Acute kidney injury	1/40 (2.5%)	1
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/40 (2.5%)	3
Acute respiratory failure	1/40 (2.5%)	1
Vascular disorders
Shock	1/40 (2.5%)	1
Other (Not Including Serious) Adverse Events
	AXIOS
	Affected / at Risk (%)	# Events
Total	5/40 (12.5%)
Infections and infestations
Localised infection	3/40 (7.5%)	3
Injury, poisoning and procedural complications
Post procedural haemorrhage	2/40 (5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.