Clinical trial NCT02084537: Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis
Official title: Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Necrosis of Pancreas
Infected Pancreatic Necrosis
Keywords: symptomatic
infected
necrotic collection
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Major complications
timeFrame: 6 months post discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital Center for Interventional Endoscopy
state: Florida
Study officials:
affiliation: AdventHealth
name: Shyam S Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.