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Randomized Controlled Trial
. 2013 Nov 25:13:161.
doi: 10.1186/1471-230X-13-161.

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]

Sandra van Brunschot  1 , Janneke van Grinsven, Rogier P Voermans, Olaf J Bakker, Marc G H Besselink, Marja A Boermeester, Thomas L Bollen, Koop Bosscha, Stefan A Bouwense, Marco J Bruno, Vincent C Cappendijk, Esther C Consten, Cornelis H Dejong, Marcel G W Dijkgraaf, Casper H van Eijck, G Willemien Erkelens, Harry van Goor, Mohammed Hadithi, Jan-Willem Haveman, Sijbrand H Hofker, Jeroen J M Jansen, Johan S Laméris, Krijn P van Lienden, Eric R Manusama, Maarten A Meijssen, Chris J Mulder, Vincent B Nieuwenhuis, Jan-Werner Poley, Rogier J de Ridder, Camiel Rosman, Alexander F Schaapherder, Joris J Scheepers, Erik J Schoon, Tom Seerden, B W Marcel Spanier, Jan Willem A Straathof, Robin Timmer, Niels G Venneman, Frank P Vleggaar, Ben J Witteman, Hein G Gooszen, Hjalmar C van Santvoort, Paul Fockens; Dutch Pancreatitis Study Group
Collaborators, Affiliations
Randomized Controlled Trial

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]

Sandra van Brunschot et al. BMC Gastroenterol. .

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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Figures

Figure 1
Figure 1
Endoscopic step-up approach. Endoscopic step-up approach consisting of endoscopic transluminal drainage (ETD) and endoscopic transluminal necrosectomy (ETN). A large peripancreatic collection containing fluid and necrosis is shown. (A) ETD: the collection is punctured through the gastric wall, followed by balloon dilatation of the tract. Two double-pigtail stents and a nasocystic catheter for continuous postoperative irrigation are placed. (B) ETN: the cystostomy tract is dilated, the collection is entered with a endoscope, and necrosectomy is performed. (Reprinted from van Brunschot et al. [11]; copyright 2013, with permission from Elsevier).
Figure 2
Figure 2
Surgical step-up approach. Surgical step-up approach consisting of percutaneous catheter drainage (PCD) and video-assisted retroperitoneal débridement (VARD). (A) Cross-sectional image and torso depicting a peripancreatic collection. The preferred route is through the left retroperitoneal space between the kidney, spleen and descending colon. A percutaneous catheter drain is inserted in the collection to mitigate sepsis and postpone or even obviate necrosectomy. The area of detail is shown in (B). (C) A 5 cm subcostal incision is made and the percutaneous drain is followed into the collection. The first necrosis is removed under direct vision with a long grasping forceps, followed by further debridement under videoscopic assistance (D). (Reprinted from van Brunschot et al. [11]; copyright 2013, with permission from Elsevier).
Figure 3
Figure 3
Flowchart TENSION trial according to CONSORT [12].
Figure 4
Figure 4
Flowchart treatment protocol TENSION trial.
See this image and copyright information in PMC

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