Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis (NCT02084537) | Clinical Trial Compass
CompletedNot Applicable
Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis
United States69 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.