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

Conditions

Infected necrotising pancreatitis Digestive System Necrotising pancreatitis

Charlotte Garret, Marion Douillard, Arthur David, Morgane Péré, Lucille Quenehervé et al. (14 authors)

Annals of Intensive Care2022-08-026 citations

Endoscopic or surgical step-up approach for infected necrotising pancreatitis: a multicentre randomised trial.

van Brunschot S, van Grinsven J, van Santvoort HC, Bakker OJ, Besselink MG, Boermeester MA, Bollen TL, Bosscha K, Bouwense SA, Bruno MJ, Cappendijk VC, Consten EC, Dejong CH, van Eijck CH, Erkelens WG, van Goor H, van Grevenstein WMU, Haveman JW, Hofker SH, Jansen JM, Laméris JS, van Lienden KP, Meijssen MA, Mulder CJ, Nieuwenhuijs VB, Poley JW, Quispel R, de Ridder RJ, Römkens TE, Scheepers JJ, Schepers NJ, Schwartz MP, Seerden T, Spanier BWM, Straathof JWA, Strijker M, Timmer R, Venneman NG, Vleggaar FP, Voermans RP, Witteman BJ, Gooszen HG, Dijkgraaf MG, Fockens P, Dutch Pancreatitis Study Group.

2017-11-03442 citations

10.1016/s0140-6736(17)32404-2

Interventions

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

Eligibility

Sex/Gender

All

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 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

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

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 (except for the stomach in ETN) requiring intervention, enterocutaneous fistula requiring intervention and incisional hernia (including burst abdomen). Measured at 6 months.	—

Secondary

Measure	Time frame
Measured at 6 months: 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

Measured at 6 months: 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

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Countries

Netherlands

Outcome results

None listed