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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic treatment | Active Comparator | 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. |
|
| Minimally invasive surgical necrosectomy | Active Comparator | Video-assisted retroperitoneal debridement (VARD) or laparoscopic approach. This includes laparoscopic cystogastrostomy with internal debridement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic treatment | Procedure | 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. |
| 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 |
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Inclusion Criteria:
Necrotic collection
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:
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| Name | Affiliation | Role |
|---|---|---|
| Shyam S Varadarajulu, MD | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital Center for Interventional Endoscopy | Orlando | Florida | 34786 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30452918 | Derived | 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. |
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| ID | Term |
|---|---|
| D019283 | Pancreatitis, Acute Necrotizing |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| Minimally invasive surgical necrosectomy | Procedure | Video-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement. |
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