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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Necrosis of Pancreas, Infected Pancreatic Necrosis

Intervention / Treatment
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* Procedure: Endoscopic treatment
* Procedure: Minimally invasive surgical necrosectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic treatment<br>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<br>* 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.<br>* Other names: Endoscopic necrosectomy;|
| Active Comparator: Minimally invasive surgical necrosectomy<br>Video-assisted retroperitoneal debridement (VARD) or laparoscopic approach. This includes laparoscopic cystogastrostomy with internal debridement. | Procedure: Minimally invasive surgical necrosectomy<br>* Video-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement.<br>* Other names: Laparoscopic cystogastrostomy with internal debridement;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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symptomatic, infected, necrotic collection