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

Not Applicable

Completed

• Conditions: Necrosis of Pancreas; Infected Pancreatic Necrosis
• Interventions: Procedure: Minimally invasive surgical necrosectomy; Procedure: Endoscopic treatment

• Registration Number: NCT02084537
• Lead Sponsor: AdventHealth

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.

Study Timeline

• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-12
• Study Start: 2014-04
• Primary Completion: 2017-12-31
• Study Completion: 2018-09-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimally invasive surgical necrosectomy	Minimally invasive surgical necrosectomy	Video-assisted retroperitoneal debridement (VARD) or laparoscopic approach. This includes laparoscopic cystogastrostomy with internal debridement.
Endoscopic treatment	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Florida Hospital Center for Interventional Endoscopy; 🇺🇸 Orlando, Florida, United States