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A Multicenter, Single-Arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis with Lumen-Apposing Metal Stents

Study category: Digestive Health

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Description

The purpose of this study is to determine if a newer type of metal stent with a plastic covering, called the AXIOSTM stent, is safe and effective in draining your WON.

Details
Age

Adult

Eligibility

1. Age between 22 and 75 years old 2. Severe or moderately severe acute necrotizing pancreatitis, defined per the 2012 Revised Atlanta Classification [1]. 3. WON resulting from necrotizing pancreatitis per contrast-enhanced CT or MRI with the following characteristics, per the 2012 Revised Atlanta Classification: [1]. • Heterogeneous with liquid and non-liquid density with varying degrees of loculations (some may appear homogeneous) • Well defined wall • Location-intrapancreatic and/or extrapancreatic 4. Infected WON or symptomatic sterile WON

Detailed Eligibility: 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 Normal coagulation Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post imaging study

Phase

IV - Research Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug's safety, efficacy, or optimal use.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Raj Shah,  MD

Raj Shah, MD

Study ID

Protocol Number: 18-0442

ClinicalTrials.gov: NCT03525808

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