AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of the AXIOS™ Stent with Electrocautery Enhanced Delivery System in the management of symptoms of acute cholecystitis as an alternative to percutaneous gallbladder drainage.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient requiring intervention for the management of symptoms associated with acute cholecystitis.
  • Patients referred for percutaneous drainage of the gallbladder who are not surgical candidates because of advanced age, anesthetic risk, significant co-morbidities and/or overall health.
  • Eligible for endoscopic intervention.
  • Acute Cholecystitis (AC) Grade I (mild) or II (moderate) per Tokyo guidelines [3]: -AC Grade I (mild) defined as acute cholecystitis in an otherwise healthy patient with mild local inflammatory changes and without organ dysfunction. Criteria for grade II or III not met. -AC Grade II (moderate) defined by any one of the following characteristics -Leukocytosis (>18,000 cells per mm3) -Palpable, tender mass in right upper quadrant -Symptom duration >72 hours -Marked local inflammation (gangrenous or emphysematous cholecystitis, pericholecystic or hepatic abscess, biliary peritonitis).
  • Pre-drainage imaging confirms sufficient stone-free space to allow AXIOS™ stent deployment and complete flange expansion.
  • 18 years of age or older.
  • Willing and able to comply with the study procedures and provide written informed consent form (ICF) to participate in the study. 

Exclusion Criteria:

  • AC Grade III (severe) per Tokyo guidelines defined by organ dysfunction in any one of the following systems: -Cardiovascular - Hypotension requiring administration of ≥5μg/kg/min of dopamine or any dose of norepinephrine -Neurologic - decreased level of consciousness -Respiratory - PaO2/FiO2 <300 -Renal - Oliguria and Creatinine >2.0 mg/dl (>177 μmol/liter) -Hepatic - International normalized ratio >1.5 -Hematologic - Platelet count <100,000/mm3.
  • Obvious signs on diagnostic imaging of perforated, extensive gangrenous or ischemic gallbladder.
  • Hepatic abscess.
  • Ascites.
  • Advanced liver disease.
  • Subjects with abnormal coagulation or who require ongoing complete anticoagulation.
  • Bleeding diathesis.
  • Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum that might preclude endoscopic drainage.
  • Prior surgical, interventional radiology or endoscopic procedures for the treatment of acute cholecystitis.
  • Distance between gallbladder wall and duodenal or gastric wall > 1cm by US (ultrasound) at the time of drainage.
  • Patients with intervening gastric varices or vessels within a one centimeter radius of the device insertion location.
  • Patients that have allergies or are sensitive to any of the device materials.
  • Patients with contraindications to use of electrical devices.
  • Pregnancy.
  • Prisoners and other vulnerable populations.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrew Storm, M.D.

Open for enrollment

Contact information:

William Winter

(507) 422-5673

Winter.William@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20491074

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