NL-OMON38023
Completed
Not Applicable
Transluminal Endoscopic step-up approach versus miNimally invasive SurgIcal step-up apprOach in patients with infected pancreatic Necrosis: TENSION, a randomized controlled parallel-group superiority multicenter trial. Dutch Pancreatitis Study Group. - TENSIO
niversitair Medisch Centrum Sint Radboud0 sites98 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- infected necrotizing pancreatitis
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 98
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Pancreatic necrosis and/or peripancreatic necrosis with (suspected or confirmed) infection. (See protocol, page 15\-16 for definitions)
- •\* The peripancreatic collection is amenable to the endoscopic transluminal step\-up approach as well as the surgical step\-up approach.
- •\* Age \* 18 years and informed consent.
Exclusion Criteria
- •\* Previous surgical, endoscopic or percutaneous intervention for pancreatic necrosis and/or peripancreatic necrosis and/or peripancreatic collections. (See protocol, page 16 for definition)
- •\* Acute flare up of chronic pancreatitis.
- •\* Concomitant indication for laparotomy because of suspected abdominal compartment syndrome, bleeding or perforation of a visceral organ.
Outcomes
Primary Outcomes
Not specified
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Phase 1
Intensive endoscopic therapy compared with standard endoscopic therapy for newly diagnosed benign strictures in the esophagus that developed after esophageal resectioBenign esophagogastric anastomotic strictures after esophagectomyMedDRA version: 20.0Level: LLTClassification code 10030199Term: Oesophageal strictureSystem Organ Class: 100000004856MedDRA version: 20.0Level: LLTClassification code 10015449Term: Esophageal strictureSystem Organ Class: 100000004856MedDRA version: 20.0Level: PTClassification code 10030215Term: OesophagectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10015460Term: EsophagectomySystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Digestive System Diseases [C06]EUCTR2016-001853-41-NLAcademic Medical Center89