ISRCTN09186711
Completed
Not Applicable
Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected pancreatic necrosis: TENSION, a randomised controlled parallel-group superiority multicentre trial (Dutch Pancreatitis Study Group)
Academic Medical Centre (AMC) (Netherlands)0 sites98 target enrollmentSeptember 6, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infected necrotising pancreatitis
- Sponsor
- Academic Medical Centre (AMC) (Netherlands)
- Enrollment
- 98
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Pancreatic necrosis and/or peripancreatic necrosis with (suspected or confirmed) infection
- •2\. The peripancreatic collection is amenable to the endoscopic transluminal 'step\-up' approach as well as the surgical 'step\-up' approach
- •3\. Aged greater than or equal to 18 years (either sex) and informed consent
Exclusion Criteria
- •1\. Previous surgical, endoscopic or percutaneous intervention for pancreatic necrosis and/or peripancreatic necrosis and/or peripancreatic collections
- •2\. Acute flare up of chronic pancreatitis
- •3\. Concomitant indication for laparotomy because of suspected abdominal compartment syndrome, bleeding or perforation of a visceral organ
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
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Completed
Not Applicable
Transluminal Endoscopic step-up approach versus miNimally invasive SurgIcal step-up apprOach in patients with infected pancreatic Necrosis (TENSION). Long-term outcomes of a step-up endoscopic versus surgical step-up approachinfected necrotizing pancreatitispancreatitis10017966NL-OMON49170Academisch Medisch Centrum98
Recruiting
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ExTENSION. Long-term outcomes of a step-up endoscopic versus a surgical step-up approach in patients with infected pancreatic necrosis.Infected necrotizing pancreatitisNL-OMON22403Amsterdam UMC – location AMC, Dutch pancreatitis study group (PWN)60
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Active, not recruiting
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