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

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.

Study Overview

• Status: Completed
• Conditions: Necrosis of Pancreas; Infected Pancreatic Necrosis
• Intervention / Treatment: Procedure: Endoscopic treatment; Procedure: Minimally invasive surgical necrosectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 34786
      • Florida Hospital Center for Interventional Endoscopy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AdventHealth
• Investigators: Principal Investigator: Shyam S Varadarajulu, MD, AdventHealth

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: symptomatic; infected; necrotic collection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pancreatic Diseases; Necrosis; Pancreatitis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: 577235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No