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]

Abstract

BackgroundInfected 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/DesignThe 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.DiscussionThe 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.

Diagnostic strategy and timing of intervention in infected necrotizing pancreatitis: an international expert survey and case vignette study

“…Consensus regarding the timing of intervention is lacking as shown by an almost equal division between respondents awaiting the full effect of antibiotics or those immediately proceeding to intervention in infected necrosis. This discrepancy in timing of intervention was most apparent in the early case vignettes, before the stage of walled-off necrosis (day [7][8][9][10][11][12][13][14][15][16][17][18][19][20]. This implies that some pancreatologists feel that a non-invasive approach with antibiotics alone is an effective treatment for infected necrosis.…”

“…The selection was based on recent participation in collaborative publications on invasive interventions in necrotizing pancreatitis cohorts, 17,18 collaborative projects such as participation in an Individual Patient Data Meta-Analysis about necrosectomy in severe acute pancreatitis (unpublished data), the development of recent evidenced-based guidelines 6 and the Dutch Online Pancreatitis Expert Panel 19 (excluding members of the writing committee of the present study).…”

A demarkált pancreasnecrosis kezelése. Irodalmi áttekintés

“…Másrészről a szervezetdetoxikálásban is jelentős szerepet játszik [30,38]. Az akut folyadékgyü-lemek és a necrosis felülfertőződése esetén a kezelést ki kell egészíteni empirikus, illetve célzott antibiotikum-kezeléssel [1, 7,10,14,18,22,26,34,36,[38][39][40]. A necrosis és/vagy a folyadékgyülemek bakteriális transzloká-cióját megelőzendő az enteralis táplálást minél korábban el kell kezdeni [7,22,26,38].…”

Treatment of pancreatic necrosis – the Multimodal Glasgow Algorithm

“…There is an acceptance that due to the complexity of presentation, no single technique will be suitable for all patients, and the aim should be to provide a multimodal multi-disciplinary approach. Our current management algorithm has emerged from a process of continuous evolution based on increased experience of the "step-up" concepts, the approach in the last decade being for solid predominant or infected necrotic collections to be managed percutaneously by MIRP or VARD, and for late, well-organized and predominantly fluid collections to be managed by endoscopic or laparoscopic transgastric drainage, but these concepts are now being assessed in randomized trials (2,39).…”

“…The use of CO2 insufflation is therefore now recommended. A persistent problem is the lack of availability of suitable endoscopic devices to facilitate necrosectomy and although endoscopic access to the cyst cavity is now facilitated by metallic stents, piecemeal necrosectomy using standard graspers, baskets and snares is a time consuming and painstaking process (39). One possible modification is the use of intra-cavity hydrogen peroxide to facilitate necrosectomy although further experience is required before this can be recommended for routine practice (36).…”