Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711].

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  • Additional Information
    • Corporate Authors:
      Dutch Pancreatitis Study Group
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 100968547 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-230X (Electronic) Linking ISSN: 1471230X NLM ISO Abbreviation: BMC Gastroenterol Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : BioMed Central, [2001-
    • Subject Terms:
      Bacterial Infections/*surgery ; Pancreatitis, Acute Necrotizing/*surgery; Bacterial Infections/complications ; Debridement/methods ; Drainage/methods ; Endoscopy/methods ; Humans ; Minimally Invasive Surgical Procedures/methods ; Netherlands ; Pancreatitis, Acute Necrotizing/complications ; Treatment Outcome
    • Abstract:
      Background: Infected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention. Traditionally, primary open necrosectomy has been the treatment of choice. In recent years, the surgical step-up approach, consisting of percutaneous catheter drainage followed, if necessary, by (minimally invasive) surgical necrosectomy has become the standard of care. A promising minimally invasive alternative is the endoscopic transluminal step-up approach. This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy. We hypothesise that the less invasive endoscopic step-up approach is superior to the surgical step-up approach in terms of clinical and economic outcomes.
      Methods/design: The TENSION trial is a randomised controlled, parallel-group superiority multicenter trial. Patients with (suspected) infected necrotising pancreatitis with an indication for intervention and in whom both treatment modalities are deemed possible, will be randomised to either an endoscopic transluminal or a surgical step-up approach. During a 4 year study period, 98 patients will be enrolled from 24 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of death and major complications within 6 months following randomisation. Secondary endpoints include complications such as pancreaticocutaneous fistula, exocrine or endocrine pancreatic insufficiency, need for additional radiological, endoscopic or surgical intervention, the need for necrosectomy after drainage, the number of (re-)interventions, quality of life, and total direct and indirect costs.
      Discussion: The TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications, as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis.
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    • Contributed Indexing:
      Investigator: S van Brunschot; HC van Santvoort; MG Besselink; OJ Bakker; P Fockens; HG Gooszen; MA Boermeester; MJ Bruno; CH Dejong; R Timmer; BJ Witteman; MA Boermeester; TL Bollen; M Bruno; VC Cappendijk; CH Dejong; C van Eijck; P Fockens; H van Goor; HG Gooszen; JW Haveman; HS Hofker; JS Laméris; KP van Lienden; VB Nieuwenhuijs; JW Poley; AF Schaapherder; R Timmer; JG Tijssen; JF Lange; HJ Bonjer; J Stoker; AA Masclee; KM Tytgat; P Fockens; T Seerden; C Rosman; EJ Schoon; MJ Bruno; GW Erkelens; B Witteman; MA Meijssen; K Bosscha; AF Schaapherder; H Hadithi; RJ de Ridder; JW Straathof; EC Consten; ER Manusama; NG Venneman; JM Jansen; H van Goor; JJ Scheepers; BW Spanier; R Timmer; HS Hofker; FP Vleggaar; CJ Mulder; J van Grinsven; H van der Eng
    • Molecular Sequence:
      ISRCTN ISRCTN09186711
    • Publication Date:
      Date Created: 20131127 Date Completed: 20140401 Latest Revision: 20211021
    • Publication Date:
      20231215
    • Accession Number:
      PMC4222267
    • Accession Number:
      10.1186/1471-230X-13-161
    • Accession Number:
      24274589