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, 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, S van Brunschot, H C van Santvoort, M G H Besselink, O J Bakker, P Fockens, H G Gooszen, M A Boermeester, M J Bruno, C H C Dejong, R Timmer, B J M Witteman, M A Boermeester, T L Bollen, M Bruno, V C Cappendijk, C H C Dejong, C van Eijck, P Fockens, H van Goor, H G Gooszen, J W Haveman, H S Hofker, J S Laméris, K P van Lienden, V B Nieuwenhuijs, J W Poley, A F M Schaapherder, R Timmer, J G P Tijssen, J F Lange, H J Bonjer, J Stoker, A A M Masclee, K M A J Tytgat, P Fockens, T Seerden, C Rosman, E J Schoon, M J Bruno, G W Erkelens, B Witteman, M A C Meijssen, K Bosscha, A F M Schaapherder, H Hadithi, R J J de Ridder, J W A Straathof, E C Consten, E R Manusama, N G Venneman, J M Jansen, H van Goor, J J G Scheepers, B W M Spanier, R Timmer, H S Hofker, F P Vleggaar, C J Mulder, J van Grinsven, H van der Eng, Sandra van Brunschot, 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, S van Brunschot, H C van Santvoort, M G H Besselink, O J Bakker, P Fockens, H G Gooszen, M A Boermeester, M J Bruno, C H C Dejong, R Timmer, B J M Witteman, M A Boermeester, T L Bollen, M Bruno, V C Cappendijk, C H C Dejong, C van Eijck, P Fockens, H van Goor, H G Gooszen, J W Haveman, H S Hofker, J S Laméris, K P van Lienden, V B Nieuwenhuijs, J W Poley, A F M Schaapherder, R Timmer, J G P Tijssen, J F Lange, H J Bonjer, J Stoker, A A M Masclee, K M A J Tytgat, P Fockens, T Seerden, C Rosman, E J Schoon, M J Bruno, G W Erkelens, B Witteman, M A C Meijssen, K Bosscha, A F M Schaapherder, H Hadithi, R J J de Ridder, J W A Straathof, E C Consten, E R Manusama, N G Venneman, J M Jansen, H van Goor, J J G Scheepers, B W M Spanier, R Timmer, H S Hofker, F P Vleggaar, C J Mulder, J van Grinsven, H van der Eng

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.

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.

References

    1. Rodriguez JR, Razo AO, Targarona J, Thayer SP, Rattner DW, Warshaw AL, Fernandez-del Castillo C. Debridement and closed packing for sterile or infected necrotizing pancreatitis: insights into indications and outcomes in 167 patients. Ann Surg. 2008;247(2):294–299. doi: 10.1097/SLA.0b013e31815b6976.
    1. van Santvoort HC, Besselink MG, Bakker OJ, Hofker HS, Boermeester MA, Dejong CH, van Goor H, Schaapherder AF, van Eijck CH, Bollen TL, van Ramshorst B, Nieuwenhuijs VB, Timmer R, Lameris JS, Kruyt PM, Manusama ER, van der Harst E, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, van Leeuwen MS, Buskens E, Gooszen HG. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med. 2010;362(16):1491–1502. doi: 10.1056/NEJMoa0908821.
    1. Besselink MG, van Santvoort HC, Buskens E, Boermeester MA, van Goor H, Timmerman HM, Nieuwenhuijs VB, Bollen TL, van Ramshorst B, Witteman BJ, Rosman C, Ploeg RJ, Brink MA, Schaapherder AF, Dejong CH, Wahab PJ, van Laarhoven CJ, van der Harst E, van Eijck CH, Cuesta MA, Akkermans LM, Gooszen HG. Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;371(9613):651–659. doi: 10.1016/S0140-6736(08)60207-X.
    1. Raraty MG, Halloran CM, Dodd S, Ghaneh P, Connor S, Evans J, Sutton R, Neoptolemos JP. Minimal access retroperitoneal pancreatic necrosectomy: improvement in morbidity and mortality with a less invasive approach. Ann Surg. 2010;251(5):787–793. doi: 10.1097/SLA.0b013e3181d96c53.
    1. van Santvoort HC, Bakker OJ, Bollen TL, Besselink MG, Ahmed Ali U, Schrijver AM, Boermeester MA, van Goor H, Dejong CH, van Eijck CH, van Ramshorst B, Schaapherder AF, van der Harst E, Hofker S, Nieuwenhuijs VB, Brink MA, Kruyt PM, Manusama ER, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, Cuesta MA, Wahab PJ, Gooszen HG. A conservative and minimally invasive approach to necrotizing pancreatitis improves outcome. Gastroenterology. 2011;141(4):1254–1263. doi: 10.1053/j.gastro.2011.06.073.
    1. Working Group IAP/APA/APG. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013;13(4 Suppl 2):e1–e15.
    1. Haghshenasskashani A, Laurence JM, Kwan V, Johnston E, Hollands MJ, Richardson AJ, Pleass HC, Lam VW. Endoscopic necrosectomy of pancreatic necrosis: a systematic review. Surg Endosc. 2011;25(12):3724–3730. doi: 10.1007/s00464-011-1795-x.
    1. Bakker OJ, van Santvoort HC, van Brunschot S, Geskus RB, Besselink MG, Bollen TL, van Eijck CH, Fockens P, Hazebroek EJ, Nijmeijer RM, Poley JW, van Ramshorst B, Vleggaar FP, Boermeester MA, Gooszen HG, Weusten BL, Timmer R. Endoscopic transgastric vs surgical necrosectomy for infected necrotizing pancreatitis: a randomized trial. JAMA. 2012;307(10):1053–1061. doi: 10.1001/jama.2012.276.
    1. Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care -associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008;36(5):309–332. doi: 10.1016/j.ajic.2008.03.002.
    1. Besselink MG, van Santvoort HC, Nieuwenhuijs VB, Boermeester MA, Bollen TL, Buskens E, Dejong CH, van Eijck CH, van Goor H, Hofker SS, Lameris JS, van Leeuwen MS, Ploeg RJ, van Ramshorst B, Schaapherder AF, Cuesta MA, Consten EC, Gouma DJ, van der Harst E, Hesselink EJ, Houdijk LP, Karsten TM, van Laarhoven CJ, Pierie JP, Rosman C, Bilgen EJ, Timmer R, van der Tweel I, de Wit RJ, Witteman BJ. et al.Minimally invasive ‘step-up approach’ versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868] BMC surgery. 2006;6:6. doi: 10.1186/1471-2482-6-6.
    1. van Brunschot S, Bakker OJ, Besselink MG, Bollen TL, Fockens P, Gooszen HG, van Santvoort HC. Dutch Pancreatitis Study G. Treatment of necrotizing pancreatitis. Clin Gastroenterol Hepatol. 2012;10(11):1190–1201. doi: 10.1016/j.cgh.2012.05.005.
    1. Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. doi: 10.1136/bmj.c332.
    1. van Santvoort HC, Besselink MG, Horvath KD, Sinanan MN, Bollen TL, van Ramshorst B, Gooszen HG. Videoscopic assisted retroperitoneal debridement in infected necrotizing pancreatitis. HPB (Oxford) 2007;9(2):156–159. doi: 10.1080/13651820701225688.
    1. Horvath KD, Kao LS, Wherry KL, Pellegrini CA, Sinanan MN. A technique for laparoscopic-assisted percutaneous drainage of infected pancreatic necrosis and pancreatic abscess. Surg Endosc. 2001;15(10):1221–1225. doi: 10.1007/s004640080166.
    1. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473–483. doi: 10.1097/00005650-199206000-00002.
    1. Brooks R. EuroQol: the current state of play. Health Pol. 1996;37(1):53–72. doi: 10.1016/0168-8510(96)00822-6.
    1. van Roijen L, Essink-Bot ML, Koopmanschap MA, Bonsel G, Rutten FF. Labor and health status in economic evaluation of health care. The health and labor questionnaire. Int J Technol Assess Health Care. 1996;12(3):405–415. doi: 10.1017/S0266462300009764.
    1. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Charnley RM, Lochan R, Gray H, O’Sullivan CB, Scott J, Oppong KE. Endoscopic necrosectomy as primary therapy in the management of infected pancreatic necrosis. Endoscopy. 2006;38(9):925–928. doi: 10.1055/s-2006-944731.
    1. Escourrou J, Shehab H, Buscail L, Bournet B, Andrau P, Moreau J, Fourtanier G. Peroral transgastric/transduodenal necrosectomy: success in the treatment of infected pancreatic necrosis. Ann Surg. 2008;248(6):1074–1080. doi: 10.1097/SLA.0b013e31818b728b.
    1. Schrover IM, Weusten BL, Besselink MG, Bollen TL, van Ramshorst B, Timmer R. EUS-guided endoscopic transgastric necrosectomy in patients with infected necrosis in acute pancreatitis. Pancreatology. 2008;8(3):271–276. doi: 10.1159/000134275.
    1. Seewald S, Groth S, Omar S, Imazu H, Seitz U, de Weerth A, Soetikno R, Zhong Y, Sriram PV, Ponnudurai R, Sikka S, Thonke F, Soehendra N. Aggressive endoscopic therapy for pancreatic necrosis and pancreatic abscess: a new safe and effective treatment algorithm (videos) Gastrointest Endosc. 2005;62(1):92–100. doi: 10.1016/S0016-5107(05)00541-9.
    1. Seifert H, Biermer M, Schmitt W, Jurgensen C, Will U, Gerlach R, Kreitmair C, Meining A, Wehrmann T, Rosch T. Transluminal endoscopic necrosectomy after acute pancreatitis: a multicentre study with long-term follow-up (the GEPARD Study) Gut. 2009;58(9):1260–1266. doi: 10.1136/gut.2008.163733.
    1. Voermans RP, Veldkamp MC, Rauws EA, Bruno MJ, Fockens P. Endoscopic transmural debridement of symptomatic organized pancreatic necrosis (with videos) Gastrointest Endosc. 2007;66(5):909–916. doi: 10.1016/j.gie.2007.05.043.
    1. UK guidelines for the management of acute pancreatitis. Gut. 2005;54(Suppl 3):iii1–iii9.
    1. Buchler MW, Gloor B, Muller CA, Friess H, Seiler CA, Uhl W. Acute necrotizing pancreatitis: treatment strategy according to the status of infection. Ann Surg. 2000;232(5):619–626. doi: 10.1097/00000658-200011000-00001.
    1. Forsmark CE, Baillie J. AGA Institute technical review on acute pancreatitis. Gastroenterology. 2007;132(5):2022–2044. doi: 10.1053/j.gastro.2007.03.065.
    1. Nathens AB, Curtis JR, Beale RJ, Cook DJ, Moreno RP, Romand JA, Skerrett SJ, Stapleton RD, Ware LB, Waldmann CS. Management of the critically ill patient with severe acute pancreatitis. Crit Care Med. 2004;32(12):2524–2536. doi: 10.1097/01.CCM.0000148222.09869.92.
    1. AGA Institute medical position statement on acute pancreatitis. Gastroenterology. 2007;132(5):2019–2021. doi: 10.1053/j.gastro.2007.03.066.
    1. Banks PA, Freeman ML. Practice guidelines in acute pancreatitis. Am J Gastroenterol. 2006;101(10):2379–2400. doi: 10.1111/j.1572-0241.2006.00856.x.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever