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

Infected Pancreatic Necrosis Clinical Trial

— MISER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084537
• Other study ID #: 577235
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: September 30, 2018

Study information

• Verified date: February 2019
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infected Pancreatic Necrosis
• Necrosis
• Necrosis of Pancreas
• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

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.
• Minimally invasive surgical necrosectomy
Video-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement.

Locations

Country	Name	City	State
United States	Florida Hospital Center for Interventional Endoscopy	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major complications	Composite of major complications and/or mortality (all cause and disease specific), measured to 6 months post discharge	6 months post discharge