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

Primary Purpose

Necrosis of Pancreas, Infected Pancreatic Necrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic treatment
Minimally invasive surgical necrosectomy
Sponsored by
AdventHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrosis of Pancreas focused on measuring symptomatic, infected, necrotic collection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida Hospital Center for Interventional Endoscopy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Endoscopic treatment

Minimally invasive surgical necrosectomy

Arm Description

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.

Video-assisted retroperitoneal debridement (VARD) or laparoscopic approach. This includes laparoscopic cystogastrostomy with internal debridement.

Outcomes

Primary Outcome Measures

Major complications
Composite of major complications and/or mortality (all cause and disease specific), measured to 6 months post discharge

Secondary Outcome Measures

Full Information

First Posted
March 10, 2014
Last Updated
February 8, 2019
Sponsor
AdventHealth
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1. Study Identification

Unique Protocol Identification Number
NCT02084537
Brief Title
Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis
Acronym
MISER
Official Title
Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrosis of Pancreas, Infected Pancreatic Necrosis
Keywords
symptomatic, infected, necrotic collection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Minimally invasive surgical necrosectomy
Arm Type
Active Comparator
Arm Description
Video-assisted retroperitoneal debridement (VARD) or laparoscopic approach. This includes laparoscopic cystogastrostomy with internal debridement.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic treatment
Other Intervention Name(s)
Endoscopic cystogastrostomy, Endoscopic cystoduodenostomy, Endoscopic necrosectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive surgical necrosectomy
Other Intervention Name(s)
Video-assisted retroperitoneal debridement (VARD), Laparoscopic cystogastrostomy with internal debridement
Intervention Description
Video-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement.
Primary Outcome Measure Information:
Title
Major complications
Description
Composite of major complications and/or mortality (all cause and disease specific), measured to 6 months post discharge
Time Frame
6 months post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shyam S Varadarajulu, MD
Organizational Affiliation
AdventHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital Center for Interventional Endoscopy
City
Orlando
State/Province
Florida
ZIP/Postal Code
34786
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30452918
Citation
Bang JY, Arnoletti JP, Holt BA, Sutton B, Hasan MK, Navaneethan U, Feranec N, Wilcox CM, Tharian B, Hawes RH, Varadarajulu S. An Endoscopic Transluminal Approach, Compared With Minimally Invasive Surgery, Reduces Complications and Costs for Patients With Necrotizing Pancreatitis. Gastroenterology. 2019 Mar;156(4):1027-1040.e3. doi: 10.1053/j.gastro.2018.11.031. Epub 2018 Nov 16.
Results Reference
derived

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

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