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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].

van Brunschot S, van Grinsven J, Voermans RP, Bakker OJ, Besselink MG, Boermeester MA, Bollen TL, Bosscha K, Bouwense SA, Bruno MJ, Cappendijk VC, Consten EC, Dejong CH, Dijkgraaf MG, van Eijck CH, Erkelens GW, van Goor H, Hadithi M, Haveman JW, Hofker SH, Jansen JJ, Laméris JS, van Lienden KP, Manusama ER, Meijssen MA, Mulder CJ, Nieuwenhuis VB, Poley JW, de Ridder RJ, Rosman C, Schaapherder AF, Scheepers JJ, Schoon EJ, Seerden T, Spanier BW, Straathof JW, Timmer R, Venneman NG, Vleggaar FP, Witteman BJ, Gooszen HG, van Santvoort HC, Fockens P, Dutch Pancreatitis Study Gro - BMC Gastroenterol (2013)

Bottom Line: This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Gastroenterology and Hepatology, University of Amsterdam, Amsterdam, The Netherlands. s.vanbrunschot@pancreatitis.nl.

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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Flowchart treatment protocol TENSION trial.
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Figure 4: Flowchart treatment protocol TENSION trial.

Mentions: If a patient with pancreatic and/or extrapancreatic necrosis shows clinical deterioration and has reached the stage to decide on invasive intervention for (suspected) infected necrosis, the Dutch nationwide expert panel is consulted. This panel, consisting of 17 experts (9 surgeons, 4 gastroenterologists and 4 radiologists) is available 24 hours a day, 7 days a week, to assess the indication for intervention, the feasibility of both treatment options and advises on timing of intervention. In general, intervention is delayed to a phase of the disease at which necrosis is walled-off, usually 3–4 weeks after onset. A similar expert panel has already proven to be of value during the previous Dutch PANTER and PENGUIN trials [2,10]. After consultation of the expert panel, patients eligible for inclusion are randomly assigned to group A (endoscopic step-up approach, see Figure 1) or B (surgical step-up approach, see Figure 2) as shown in the flowcharts (Figures 3 and 4). Randomisation is performed by the study coordinator using an internet-based randomisation program (Academic Medical Center) ensuring allocation concealment between groups. Randomisation is stratified according to hospital.


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].

van Brunschot S, van Grinsven J, Voermans RP, Bakker OJ, Besselink MG, Boermeester MA, Bollen TL, Bosscha K, Bouwense SA, Bruno MJ, Cappendijk VC, Consten EC, Dejong CH, Dijkgraaf MG, van Eijck CH, Erkelens GW, van Goor H, Hadithi M, Haveman JW, Hofker SH, Jansen JJ, Laméris JS, van Lienden KP, Manusama ER, Meijssen MA, Mulder CJ, Nieuwenhuis VB, Poley JW, de Ridder RJ, Rosman C, Schaapherder AF, Scheepers JJ, Schoon EJ, Seerden T, Spanier BW, Straathof JW, Timmer R, Venneman NG, Vleggaar FP, Witteman BJ, Gooszen HG, van Santvoort HC, Fockens P, Dutch Pancreatitis Study Gro - BMC Gastroenterol (2013)

Flowchart treatment protocol TENSION trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4222267&req=5

Figure 4: Flowchart treatment protocol TENSION trial.
Mentions: If a patient with pancreatic and/or extrapancreatic necrosis shows clinical deterioration and has reached the stage to decide on invasive intervention for (suspected) infected necrosis, the Dutch nationwide expert panel is consulted. This panel, consisting of 17 experts (9 surgeons, 4 gastroenterologists and 4 radiologists) is available 24 hours a day, 7 days a week, to assess the indication for intervention, the feasibility of both treatment options and advises on timing of intervention. In general, intervention is delayed to a phase of the disease at which necrosis is walled-off, usually 3–4 weeks after onset. A similar expert panel has already proven to be of value during the previous Dutch PANTER and PENGUIN trials [2,10]. After consultation of the expert panel, patients eligible for inclusion are randomly assigned to group A (endoscopic step-up approach, see Figure 1) or B (surgical step-up approach, see Figure 2) as shown in the flowcharts (Figures 3 and 4). Randomisation is performed by the study coordinator using an internet-based randomisation program (Academic Medical Center) ensuring allocation concealment between groups. Randomisation is stratified according to hospital.

Bottom Line: This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Gastroenterology and Hepatology, University of Amsterdam, Amsterdam, The Netherlands. s.vanbrunschot@pancreatitis.nl.

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.

Show MeSH
Related in: MedlinePlus