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Study of a Lumen- Apposing, Covered, Self-Expanding Metal Stent (Axios™) Versus Multiple Double Pigtail Stents

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ClinicalTrials.gov Identifier: NCT02673541
Recruitment Status : Terminated (lack of recruitment)
First Posted : February 4, 2016
Results First Posted : January 29, 2019
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Timothy Gardner, Dartmouth-Hitchcock Medical Center

Brief Summary:
The present study aims to compare the clinical efficacy and cost effectiveness of the AXIOS™ stent versus the "conventional" approach using double pigtail plastic stents in the treatment of patients with walled-off pancreatic necrosis.

Condition or disease Intervention/treatment Phase
Pancreatic Necrosis Device: AXIOS™ stent Device: Double Pigtail Stents Not Applicable

Detailed Description:

Acute pancreatitis (AP) is responsible for nearly a quarter million hospital admissions annually and will affect around 40 per 100,000 persons per year (1). The majority of patients experience a clinically mild course; however, as many as one in five patients develop a severe illness associated with a high mortality (2). In early phases of the disease, there is an acute inflammatory process that may involve necrosis of the pancreatic or peri-pancreatic tissues (3). There are also delayed complications that may develop locally, usually over a period of weeks, which include the formation of walled-off fluid collections. These are sometimes composed of simple fluid and termed pseudocysts, while in other cases they represent organization and encapsulation of sterile or infected necrosis and are termed walled-off pancreatic necrosis (WOPN) (4). The indication to drain or debride these collections usually depends upon on a number of factors, but principally on whether they are symptomatic, infected, or responsible for other local or systemic complications.

The contemporary management strategy for walled-off pancreatic fluid collections has shifted in recent years. Surgery, and even percutaneous catheter drainage, should no longer be considered the initial mainstay of therapy in place of endoscopic drainage for simple pseudocysts (5) (6). In addition there is good evidence to support an endoscopic approach for patients with infected necrosis (7). There are now numerous publications reporting the success of direct endoscopic transmural drainage or necrosectomy (ETD/N) for a variety of indications including infected and sterile walled-off collections (8).

The issue that now deserves attention is a matter of selecting the best technique to accomplish ETD/N. The current process involves first creating a cystenterostomy to gain access to the walled-off collection, dilating the tract, and then inserting a drainage device. However, there are a variety of available devices and methods in use for drainage, and to our knowledge, none to date have been directly compared in a randomized controlled trial.

The conventional approach involves inserting either a pair or more of plastic double pigtail stents or a self-expanding metal stent (SEMS) through a cystenterostomy: both approaches have limitations, and may require multiple endoscopic sessions before definitive resolution (9). One, the pigtail stents have a narrow lumen (7F-10F) and often migrate or become occluded (10). Two, the SEMS also have a tendency occlude, cause local trauma with bleeding and infection, and migrate, which has led some to also use double pigtails to help anchor the SEMS in place (11) (12).

These challenges have led to the innovation of large caliber covered stents with flanges on either end to facilitate apposition of the cyst wall and enteral tissues, preventing migration, and allowing for necrosectomy through their wide lumen. To our knowledge there are at least two designs in production; the AXIOS™ stent and the Nagi stent (13) (14). There is now a fair amount of experience, particularly using the AXIOS™ stent (with or without a novel NAVIX access system) for both WOPN and pseudocysts, with the majority of reports showing it to be safe and effective (15) (16) (17) (18) (19) (20). The device has also been successfully used for novel indications including access and drainage of the gallbladder and an intrathoracic fluid collection (21) (22) (23). The AXIOS™ stent is FDA approved for the indication of draining walled off pancreatic necrosis.

The present study aims to compare the clinical efficacy and cost effectiveness of the AXIOS™ stent versus the "conventional" approach using double pigtail plastic stents in the treatment of patients with walled-off pancreatic necrosis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized, Multi-Center, Comparative and Cost Effectiveness Study of a Lumen- Apposing, Covered, Self-Expanding Metal Stent (Axios™) Versus Multiple Double Pigtail Stents in the Management of Walled Off Pancreatic Necrosis
Study Start Date : February 2016
Actual Primary Completion Date : December 18, 2017
Actual Study Completion Date : December 18, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: AXIOS™ stent
1. Arm 1 will undergo EUS-guided cystogastrostomy/enterostomy and placement of the AXIOS™ stent 10-15mm (saddled diameter; choice at the discretion of the treating gastroenterologist) though the tract into the collection cavity, and correct positioning of the inner flange confirmed by EUS prior to deploying within the stomach or duodenum. Necrosectomy will be performed at the discretion of the attending gastroenterologist. Repeat endoscopy will be performed for stent removal at or before 60 days at the discretion of the attending gastroenterologist
Device: AXIOS™ stent
Arm 1 will undergo EUS-guided cystogastrostomy/enterostomy and placement of the AXIOS™ stent 10-15mm (saddled diameter; choice at the discretion of the treating gastroenterologist) though the tract into the collection cavity, and correct positioning of the inner flange confirmed by EUS prior to deploying within the stomach or duodenum.

Active Comparator: double pigtail stents
2. Arm 2 will undergo EUS-guided cystogastrostomy/enterostomy and placement of multiple double pigtail stents (i.e. ≥2) through the tract into the collection cavity. Necrosectomy will be performed at the discretion of the attending gastroenterologist. Routine repeat treating gastroenterologist for stent removal will not be necessary, but left to the discretion of the attending gastroenterologist.
Device: Double Pigtail Stents
Arm 2 will undergo EUS-guided cystogastrostomy/enterostomy and placement of multiple double pigtail stents (i.e. ≥2) through the tract into the collection cavity.




Primary Outcome Measures :
  1. Cost Differences [ Time Frame: Subject followed for an average of one year ]
    To compare the cost differences of the AXIOS™ stent vs. multiple double pigtail stents in the management of walled-off pancreatic necrosis.


Secondary Outcome Measures :
  1. Number of Participants With Definitive Resolution [ Time Frame: Subject followed for an average of one year ]
    1. To compare the relative efficacy in terms of definitive resolution of walled off pancreatic necrosis using the AXIOS™ stent vs. multiple double pigtail stents.

  2. Number of Endoscopic Sessions [ Time Frame: Subject followed for an average of one year ]
    2. To compare the number of endoscopic sessions required to achieve definitive resolution of walled-off pancreatic fluid necrosis using the AXIOS™ stent vs. multiple double pigtail stents.

  3. Number of Additional Procedures [ Time Frame: Subject followed for an average of one year ]
    3. To compare the number of additional procedures (surgical, percutaneous, or nasocystic) required to achieve definitive resolution of walled-off pancreatic necrosis using the AXIOS™ stent vs. multiple double pigtail stents.

  4. Frequency of Stent Migration [ Time Frame: Subject followed for an average of one year ]
    4. To compare the frequency of stent migration using the AXIOS™ stent vs. multiple double pigtail stents in the management of walled-off pancreatic necrosis.

  5. Number of Participants With Adverse Events [ Time Frame: Subject followed for an average of one year ]
    5. To compare the safety and tolerability of the AXIOS™ stent vs. multiple double pigtail stents in the management of walled-off pancreatic necrosis as assessed by the collected of adverse events over the course of the study, including but not limited to: bleeding, infections, stent migration, surgery and pain.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female between 18-80 years old (including patients aged 18 and 80)
  2. Subjects capable of giving informed consent
  3. Patients carrying the diagnosis or symptomatic sterile or infected walled-off pancreatic necrosis (WOPN) based upon Atlanta Classification (4) ≥ 4cm in largest diameter, deemed to require and amenable to endoscopic transmural drainage with or without necrosectomy by attending gastroenterologist
  4. Fluid collection size ≥ 4cm in largest diameter (based on CT, MRI, transabdominal or endoscopic ultrasound within 30days)
  5. Fluid collection that is adherent to the stomach/bowel wall allowing for fistula tract creation
  6. Fluid collection containing significant amount of necrotic material (defined as >30% of echogenic material by ultrasound/EUS, or necrotic debris by CT/MRI)

Exclusion Criteria:

  1. Inability to provide written informed consent
  2. Contraindications to endoscopic treatment as determined by the gastroenterologist attending
  3. Pregnant or nursing mothers
  4. Bleeding or coagulation disorder
  5. Previous surgical or endoscopic cystogastrostomy/enterostomy or necrosectomy
  6. Shock
  7. Cystic neoplasms or pancreatic malignancy
  8. Pseudocysts
  9. Subjects cannot be homeless or incarcerated
  10. Age younger than 18 or older than 80
  11. More than one pancreatic/peri-pancreatic fluid collection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673541


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Timothy Gardner, MD Dartmouth-Hitchcock Medical Center
  Study Documents (Full-Text)

Documents provided by Timothy Gardner, Dartmouth-Hitchcock Medical Center:
Publications:
Paradigm shift away from open surgical necrosectomy toward endoscopic interventions for necrotizing pancreatitis. Jae Hee Cho, Yoon Jae Kim, and Yeon Suk Kim. s.l. : Gastrointestinal Intervention 2014; 3(2): 84-88.
141 EUS-Guided Drainage of Pancreatic Pseudocysts (PP) Utilizing a Novel Anchoring, Covered Self-Expanding Metal Stent (Acsems): Results From a Prospective, Multi-Center Study. Shah, Raj J. et al. s.l. : Gastrointestinal Endoscopy , Volume 77 , Issue 5 , AB128 .

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Responsible Party: Timothy Gardner, Associate Professor of Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02673541    
Other Study ID Numbers: D16030
First Posted: February 4, 2016    Key Record Dates
Results First Posted: January 29, 2019
Last Update Posted: April 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Pancreatitis, Acute Necrotizing
Necrosis
Pathologic Processes
Pancreatitis
Pancreatic Diseases
Digestive System Diseases