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

NCT02673541 | Terminated Results DMC

• 1 other identifier: D16030
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Necrosis

Outcome Measures

Primary Outcomes (1)

• Cost Differences

  To compare the cost differences of the AXIOS™ stent vs. multiple double pigtail stents in the management of walled-off pancreatic necrosis.

  Subject followed for an average of one year

Secondary Outcomes (5)

• Number of Participants With Definitive Resolution

  Subject followed for an average of one year

• Number of Endoscopic Sessions

  Subject followed for an average of one year

• Number of Additional Procedures

  Subject followed for an average of one year

• Frequency of Stent Migration

  Subject followed for an average of one year

• Number of Participants With Adverse Events

  Subject followed for an average of one year

Study Arms (2)

AXIOS™ stent

ACTIVE COMPARATOR

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

double pigtail stents

ACTIVE COMPARATOR

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

Interventions

AXIOS™ stent DEVICE

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.

AXIOS™ stent

Double Pigtail Stents DEVICE

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.

double pigtail stents

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 18-80 years old (including patients aged 18 and 80)
• Subjects capable of giving informed consent
• 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
• Fluid collection size ≥ 4cm in largest diameter (based on CT, MRI, transabdominal or endoscopic ultrasound within 30days)
• Fluid collection that is adherent to the stomach/bowel wall allowing for fistula tract creation
• Fluid collection containing significant amount of necrotic material (defined as \>30% of echogenic material by ultrasound/EUS, or necrotic debris by CT/MRI)

You may not qualify if:

• Inability to provide written informed consent
• Contraindications to endoscopic treatment as determined by the gastroenterologist attending
• Pregnant or nursing mothers
• Bleeding or coagulation disorder
• Previous surgical or endoscopic cystogastrostomy/enterostomy or necrosectomy
• Shock
• Cystic neoplasms or pancreatic malignancy
• Pseudocysts
• Subjects cannot be homeless or incarcerated
• Age younger than 18 or older than 80
• More than one pancreatic/peri-pancreatic fluid collection

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (20)

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  PMID: 23732774 BACKGROUND

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  PMID: 19077728 BACKGROUND

• Bakker OJ, van Santvoort HC, van Brunschot S, Geskus RB, Besselink MG, Bollen TL, van Eijck CH, Fockens P, Hazebroek EJ, Nijmeijer RM, Poley JW, van Ramshorst B, Vleggaar FP, Boermeester MA, Gooszen HG, Weusten BL, Timmer R; Dutch Pancreatitis Study Group. Endoscopic transgastric vs surgical necrosectomy for infected necrotizing pancreatitis: a randomized trial. JAMA. 2012 Mar 14;307(10):1053-61. doi: 10.1001/jama.2012.276.

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  PMID: 19028232 BACKGROUND

• Wrobel PS, Kaplan J, Siddiqui AA. A new lumen-apposing metal stent for endoscopic transluminal drainage of peripancreatic fluid collections. Endosc Ultrasound. 2014 Oct;3(4):203-4. doi: 10.4103/2303-9027.144508. No abstract available.

  PMID: 25485266 BACKGROUND

• 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.

  BACKGROUND

• Chaves DM, Monkemuller K, Carneiro F, Medrado B, Dos Santos M, Wodak S, Reimao S, Sakai P, de Moura E. Endoscopic treatment of large pancreatic fluid collections (PFC) using self-expanding metallic stents (SEMS) - a two-center experience. Endosc Int Open. 2014 Dec;2(4):E224-9. doi: 10.1055/s-0034-1390796. Epub 2014 Oct 29.

  PMID: 26135097 BACKGROUND

• Yamamoto N, Isayama H, Kawakami H, Sasahira N, Hamada T, Ito Y, Takahara N, Uchino R, Miyabayashi K, Mizuno S, Kogure H, Sasaki T, Nakai Y, Kuwatani M, Hirano K, Tada M, Koike K. Preliminary report on a new, fully covered, metal stent designed for the treatment of pancreatic fluid collections. Gastrointest Endosc. 2013 May;77(5):809-14. doi: 10.1016/j.gie.2013.01.009. Epub 2013 Feb 26.

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  BACKGROUND

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MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr Jeffrey Adler
• Organization: Dartmouth-Hitchcock Medical Center

Jeffrey.m.adler@hitchcock.org

603-650-5261

Study Officials

• Timothy Gardner, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: February 4, 2016
• Study Start: February 1, 2016
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2017
• Last Updated: April 6, 2020
• Results First Posted: January 29, 2019

Record last verified: 2020-03

Locations

US (1)