Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected pancreatic necrosis

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)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28869

Enrollment

Registered

2013-08-05

Start date

2011-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infected necrotising pancreatitis Minimally invasive Endoscopic drainage Endoscopic necrosectomy Percutaneous drainage Surgical necrosectomy Geinfecteerde necrotiserende pancreatitis Minimaal invasief Endoscopische drainage Endoscopische necrosectomie Percutane drainage Percutane necrosectomie

Interventions

1. Intervention group: endoscopic step-up approach, consisting of endoscopic catheter drainage (ETD) and endoscopic necrosectomy (ETN) 2. Control group: surgical step-up approach, consisting of percu

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pancreatic necrosis and/or peripancreatic necrosis with (suspected or confirmed) infection 2. The peripancreatic collection is amenable to the endoscopic 'step-up' approach as well as the surgical 'step-up' approach 3. Age greater than or equal to 18 years (either sex) and informed consent

Exclusion criteria

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 emergency laparotomy because of suspected abdominal compartment syndrome, bleeding or perforation of a visceral organ

Design outcomes

Primary

Measure	Time frame
Composite of mortality and major morbidity. Major morbidity is defined as new onset organ failure (cardiac, pulmonary or renal), bleeding requiring intervention, perforation of a visceral organ requiring intervention, enterocutaneous fistula requiring intervention and incisional hernia (including burst abdomen).	—

Secondary

Measure	Time frame
1. Individual components of primary composite endpoint 2. Other morbidity such as pancreaticocutaneous fistula 3. Exocrine and/or endocrine pancreatic insufficiency 4. Development of additional fluid collections requiring intervention 5. Biliary strictures 6. Wound infections 7. The need for necrosectomy (either endoscopically or surgically) 8. The total number of surgical, endoscopic or radiological (re-) interventions 9. Total length of intensive care and hospital stay 10. Quality of life 11. Costs per patient with poor outcome 12. Costs per quality adjusted life year (QALY) 13. Total direct and indirect medical costs 14. Total number of cross-overs between groups	—

Measure

Time frame

1. Individual components of primary composite endpoint 2. Other morbidity such as pancreaticocutaneous fistula 3. Exocrine and/or endocrine pancreatic insufficiency 4. Development of additional fluid collections requiring intervention 5. Biliary strictures 6. Wound infections 7. The need for necrosectomy (either endoscopically or surgically) 8. The total number of surgical, endoscopic or radiological (re-) interventions 9. Total length of intensive care and hospital stay 10. Quality of life 11. Costs per patient with poor outcome 12. Costs per quality adjusted life year (QALY) 13. Total direct and indirect medical costs 14. Total number of cross-overs between groups

—

Contacts

Public ContactS. Brunschot, van

UMC St Radboud, HP 690, Postbus 9101,

s.vanbrunschot@pancreatitis.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)