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Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis (MISER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02084537
Recruitment Status : Completed
First Posted : March 12, 2014
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Florida Hospital

Brief Summary:
Prospective, randomized controlled trial comparing Endoscopic Ultrasound (EUS) Guided cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally invasive surgical necrosectomy, in patients with necrotizing pancreatitis.

Condition or disease Intervention/treatment Phase
Necrosis of Pancreas Infected Pancreatic Necrosis Procedure: Endoscopic treatment Procedure: Minimally invasive surgical necrosectomy Not Applicable

Detailed Description:
Patients will be randomly allocated to either treatment arm in a 1:1 ratio. Following intervention, patients will be assessed at regular intervals until study completion at 6 months post-discharge. Primary outcome is a composite of major complications and/or mortality, measured to 6 months post-discharge.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis
Study Start Date : April 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Endoscopic treatment
Treated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7 French (Fr) double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed.
Procedure: Endoscopic treatment
Treated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7fr double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed.
Other Names:
  • Endoscopic cystogastrostomy
  • Endoscopic cystoduodenostomy
  • Endoscopic necrosectomy

Active Comparator: Minimally invasive surgical necrosectomy
Video-assisted retroperitoneal debridement (VARD) or laparoscopic approach. This includes laparoscopic cystogastrostomy with internal debridement.
Procedure: Minimally invasive surgical necrosectomy
Video-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement.
Other Names:
  • Video-assisted retroperitoneal debridement (VARD)
  • Laparoscopic cystogastrostomy with internal debridement




Primary Outcome Measures :
  1. Major complications [ Time Frame: 6 months post discharge ]
    Composite of major complications and/or mortality (all cause and disease specific), measured to 6 months post discharge



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Necrotic collection

    • Infected (suspected and confirmed): clinical signs of infection (septic, positive cultures, febrile), systemic inflammatory response syndrome, gas within the collection on imaging (not iatrogenic), or positive culture of collection contents
  • Necrotic collection is within 15mm of the lumen of the gastrointestinal tract.
  • 18 years and older
  • Informed consent obtained from the patient or their medical representative.
  • Medically fit for general anesthetic
  • Collection amenable to either endoscopic or minimally invasive surgical necrosectomy and drainage.

Exclusion Criteria:

  • <18 years old
  • Unable to obtain informed consent from the patient or their medical representative.
  • Medically unfit for general anesthesia
  • Pregnant
  • Necrotic collection not accessible by either or both techniques
  • The collection is >15mm from the lumen of the gastrointestinal tract.
  • Irreversible coagulopathy: International Normalized Ratio (INR) >1.5
  • Irreversible thrombocytopenia: platelet count <50 x10^9/L
  • Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
  • Surgical or endoscopic necrosectomy or pseudocyst drainage has been performed within the preceding 12 months
  • Necrotic collection secondary to trauma or other surgical event that requires additional interventions such as management of liver lacerations or vascular injury.
  • Pre-existing percutaneous drain

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): NCT02084537


Locations
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United States, Florida
Florida Hospital Center for Interventional Endoscopy
Orlando, Florida, United States, 34786
Sponsors and Collaborators
Florida Hospital
Investigators
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Principal Investigator: Shyam S Varadarajulu, MD Florida Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT02084537    
Other Study ID Numbers: 577235
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Florida Hospital:
symptomatic
infected
necrotic collection
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Acute Necrotizing
Necrosis
Pancreatic Diseases
Digestive System Diseases
Pathologic Processes