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1. Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled trial

Author

Grinsven, J. (Janneke) van, Dijk, S.M. (Sven) van, Dijkgraaf, M.G.W. (Marcel), Boermeester, M.A. (Marja), Bollen, T.L. (Thomas), Bruno, M.J. (Marco), Brunschot, S. (Sandra) van, Dejong, C.H. (Cees), Eijck, C.H.J. (Casper) van, Lienden, K.P. (Krijn) van, Boerma, D. (Djamila), Duijvendijk, P. (Peter) van, Hadithi, M. (Muhammed), Haveman, J.-W. (Jan-Willem), van der Hulst, R. W., Jansen, J.M., Lips, D.J., Manusama, E.R., Molenaar, I.Q. (I. Quintus), Peet, D.L. (Donald) van der, Poen, A.C. (Alexander), Quispel, R. (Rutger), Schaapherder, A.F.M. (Alexander), Schoon, E.J. (Erik), Schwartz, M.P. (Matthijs), Seerden, T.C., Spanier, BWM, Straathof, J.W., Venneman, N.G. (Niels), van de Vrie, W, Witteman, B.J.M. (Ben), Goor, H. (Harry) van, Fockens, P. (Paul), Santvoort, H.C. (Hjalmar) van, Besselink, M.G. (Marc), Grinsven, J. (Janneke) van, Dijk, S.M. (Sven) van, Dijkgraaf, M.G.W. (Marcel), Boermeester, M.A. (Marja), Bollen, T.L. (Thomas), Bruno, M.J. (Marco), Brunschot, S. (Sandra) van, Dejong, C.H. (Cees), Eijck, C.H.J. (Casper) van, Lienden, K.P. (Krijn) van, Boerma, D. (Djamila), Duijvendijk, P. (Peter) van, Hadithi, M. (Muhammed), Haveman, J.-W. (Jan-Willem), van der Hulst, R. W., Jansen, J.M., Lips, D.J., Manusama, E.R., Molenaar, I.Q. (I. Quintus), Peet, D.L. (Donald) van der, Poen, A.C. (Alexander), Quispel, R. (Rutger), Schaapherder, A.F.M. (Alexander), Schoon, E.J. (Erik), Schwartz, M.P. (Matthijs), Seerden, T.C., Spanier, BWM, Straathof, J.W., Venneman, N.G. (Niels), van de Vrie, W, Witteman, B.J.M. (Ben), Goor, H. (Harry) van, Fockens, P. (Paul), Santvoort, H.C. (Hjalmar) van, and Besselink, M.G. (Marc)

Abstract

Background Infected necrosis complicates 10% of all acute pancreatitis episodes and is associated with 15–20% mortality. The current standard treatment for infected necrotizing pancreatitis is the step-up approach (catheter drainage, followed, if necessary, by minimally invasive necrosectomy). Catheter drainage is preferably postponed until the stage of walled-off necrosis, which usually takes 4 weeks. This delay stems from the time when open necrosectomy was the standard. It is unclear whether such delay is needed for catheter drainage or whether earlier intervention could actually be beneficial in the current step-up approach. The POINTER trial investigates if immediate catheter drainage in patients with infected necrotizing pancreatitis is superior to the current practice of postponed intervention. Methods POINTER is a randomized controlled multicenter superiority trial. All patients with necrotizing pancreatitis are screened for eligibility. In total, 104 adult patients with (suspected) infected necrotizing pancreatitis will be randomized to immediate (within 24 h) catheter drainage or current standard care involving postponed catheter drainage. Necrosectomy, if necessary, is preferably postponed until the stage of walled-off necrosis, in both treatment arms. The primary outcome is the Comprehensive Complication Index (CCI), which covers all complications between randomization and 6-month follow up. Secondary outcomes include mortality, complications, number of (repeat) interventions, hospital and intensive care unit (ICU) lengths of stay, quality-adjusted life years (QALYs) and direct and indirect costs. Standard follow-up is at 3 and 6 months after randomization. Discussion The POINTER trial investigates if immediate catheter drainage in infected necrotizing pancreatitis reduces the composite endpoint of complications, as compared with the current standard treatment strategy involving delay of intervention until the stage of walled-off necrosis.

Published
2019
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2. Evaluation of PET and laparoscopy in STagIng advanced gastric cancer : A multicenter prospective study (PLASTIC-study)

Author

Brenkman, H. J.F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D.P., Nieuwenhuijzen, G. A.P., van Lanschot, J. J.B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H.M.B., Hulsewe, K. W.E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C.T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J.T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W.M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W.J., Siersema, P. D., Ruurda, J. P., on behalf of the PLASTIC Study Group, Brenkman, H. J.F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D.P., Nieuwenhuijzen, G. A.P., van Lanschot, J. J.B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H.M.B., Hulsewe, K. W.E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C.T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J.T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W.M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W.J., Siersema, P. D., Ruurda, J. P., and on behalf of the PLASTIC Study Group

Published
2018

3. Evaluation of PET and laparoscopy in STagIng advanced gastric cancer : A multicenter prospective study (PLASTIC-study)

Author

Brenkman, H. J.F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D.P., Nieuwenhuijzen, G. A.P., van Lanschot, J. J.B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H.M.B., Hulsewe, K. W.E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C.T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J.T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W.M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W.J., Siersema, P. D., Ruurda, J. P., on behalf of the PLASTIC Study Group, Brenkman, H. J.F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D.P., Nieuwenhuijzen, G. A.P., van Lanschot, J. J.B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H.M.B., Hulsewe, K. W.E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C.T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J.T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W.M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W.J., Siersema, P. D., Ruurda, J. P., and on behalf of the PLASTIC Study Group

Published
2018

4. Evaluation of PET and laparoscopy in STagIng advanced gastric cancer : A multicenter prospective study (PLASTIC-study)

Author

Brenkman, H. J.F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D.P., Nieuwenhuijzen, G. A.P., van Lanschot, J. J.B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H.M.B., Hulsewe, K. W.E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C.T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J.T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W.M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W.J., Siersema, P. D., Ruurda, J. P., on behalf of the PLASTIC Study Group, Brenkman, H. J.F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D.P., Nieuwenhuijzen, G. A.P., van Lanschot, J. J.B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H.M.B., Hulsewe, K. W.E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C.T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J.T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W.M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W.J., Siersema, P. D., Ruurda, J. P., and on behalf of the PLASTIC Study Group

Published
2018

5. Evaluation of PET and laparoscopy in STagIng advanced gastric cancer: A multicenter prospective study (PLASTIC-study)

Author

MS CGO, Cancer, Divisie Beeld & Oncologie, MS Radiologie, MS Medische Oncologie, Verplegingswetenschap, Other research (not in main researchprogram), JC onderzoeksprogramma Methodologie, HEE, Child Health, Brenkman, H. J.F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D.P., Nieuwenhuijzen, G. A.P., van Lanschot, J. J.B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H.M.B., Hulsewe, K. W.E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C.T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J.T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W.M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W.J., Siersema, P. D., Ruurda, J. P., on behalf of the PLASTIC Study Group, MS CGO, Cancer, Divisie Beeld & Oncologie, MS Radiologie, MS Medische Oncologie, Verplegingswetenschap, Other research (not in main researchprogram), JC onderzoeksprogramma Methodologie, HEE, Child Health, Brenkman, H. J.F., Gertsen, E. C., Vegt, E., van Hillegersberg, R., van Berge Henegouwen, M. I., Gisbertz, S. S., Luyer, M. D.P., Nieuwenhuijzen, G. A.P., van Lanschot, J. J.B., Lagarde, S. M., de Steur, W. O., Hartgrink, H. H., Stoot, J. H.M.B., Hulsewe, K. W.E., Spillenaar Bilgen, E. J., van Det, M. J., Kouwenhoven, E. A., van der Peet, D. L., Daams, F., van Sandick, J. W., van Grieken, N. C.T., Heisterkamp, J., van Etten, B., Haveman, J. W., Pierie, J. P., Jonker, F., Thijssen, A. Y., Belt, E. J.T., van Duijvendijk, P., Wassenaar, E., van Laarhoven, H. W.M., Wessels, F. J., Haj Mohammad, N., van Stel, H. F., Frederix, G. W.J., Siersema, P. D., Ruurda, J. P., and on behalf of the PLASTIC Study Group

Published
2018

6. Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial)

Author

Brunschot, S. (Sandra) van, Grinsven, J. (Janneke) van, Voermans, R.P. (Rogier), Bakker, O.J. (Olaf ), Besselink, M.G. (Marc), Boermeester, M.A. (Marja), Bollen, T.L. (Thomas), Bosscha, K. (Koop), Bouwense, S.A.W. (Stefan), Bruno, M.J. (Marco), Cappendijk, V.C., Consten, E.C. (Esther), Dejong, C.H. (Cees), Dijkgraaf, M.G.W. (Marcel), Eijck, C.H.J. (Casper) van, Erkelens, D.W. (Dirk Willem), Goor, H. (Harry) van, Hadithi, M. (Muhammed), Haveman, J.-W. (Jan-Willem), Hofker, S.H. (Sijbrand), Jansen, J.J.M. (Jeroen), Laméris, J.S. (Johan ), Lienden, K.P. (Krijn) van, Manusama, E.R. (Eric), Meijssen, M.A.C. (Maarten), Mulder, C.J.J. (Chris), Nieuwenhuis, V.B. (Vincent), Poley, J.-W. (Jan-Werner), Ridder, R. (Rogier) de, Rosman, C. (Camiel), Schaapherder, A.F.M. (Alexander), Scheepers, J.J. (Joris), Schoon, E.J. (Erik), Seerden, T.C.J. (Tom), Spanier, B.W.M. (Marcel), Straathof, J.W.A., Timmer, R. (Robin), Venneman, N.G. (Niels), Vleggaar, F.P. (Frank), Witteman, B.J.M. (Ben), Gooszen, H.G. (Hein), Santvoort, H.C. (Hjalmar) van, Fockens, P. (Paul), Brunschot, S. (Sandra) van, Grinsven, J. (Janneke) van, Voermans, R.P. (Rogier), Bakker, O.J. (Olaf ), Besselink, M.G. (Marc), Boermeester, M.A. (Marja), Bollen, T.L. (Thomas), Bosscha, K. (Koop), Bouwense, S.A.W. (Stefan), Bruno, M.J. (Marco), Cappendijk, V.C., Consten, E.C. (Esther), Dejong, C.H. (Cees), Dijkgraaf, M.G.W. (Marcel), Eijck, C.H.J. (Casper) van, Erkelens, D.W. (Dirk Willem), Goor, H. (Harry) van, Hadithi, M. (Muhammed), Haveman, J.-W. (Jan-Willem), Hofker, S.H. (Sijbrand), Jansen, J.J.M. (Jeroen), Laméris, J.S. (Johan ), Lienden, K.P. (Krijn) van, Manusama, E.R. (Eric), Meijssen, M.A.C. (Maarten), Mulder, C.J.J. (Chris), Nieuwenhuis, V.B. (Vincent), Poley, J.-W. (Jan-Werner), Ridder, R. (Rogier) de, Rosman, C. (Camiel), Schaapherder, A.F.M. (Alexander), Scheepers, J.J. (Joris), Schoon, E.J. (Erik), Seerden, T.C.J. (Tom), Spanier, B.W.M. (Marcel), Straathof, J.W.A., Timmer, R. (Robin), Venneman, N.G. (Niels), Vleggaar, F.P. (Frank), Witteman, B.J.M. (Ben), Gooszen, H.G. (Hein), Santvoort, H.C. (Hjalmar) van, and Fockens, P. (Paul)

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.

Published
2013
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7. Analysis of gene expression using gene sets discriminates cancer patients with and without late radiation toxicity

Author

Svensson, J. Peter, Stalpers, L.J., Esveldt-van Lange, R.E., Franken, N., Haveman, J., Klein, B., Turesson, Ingela, Vrieling, I., Giphart-Gassler, M., Svensson, J. Peter, Stalpers, L.J., Esveldt-van Lange, R.E., Franken, N., Haveman, J., Klein, B., Turesson, Ingela, Vrieling, I., and Giphart-Gassler, M.

Abstract

Background Radiation is an effective anti-cancer therapy but leads to severe late radiation toxicity in 5%-10% of patients. Assuming that genetic susceptibility impacts this risk, we hypothesized that the cellular response of normal tissue to X-rays could discriminate patients with and without late radiation toxicity. Methods and Findings Prostate carcinoma patients without evidence of cancer 2 y after curative radiotherapy were recruited in the study. Blood samples of 21 patients with severe late complications from radiation and 17 patients without symptoms were collected. Stimulated peripheral lymphocytes were mock-irradiated or irradiated with 2-Gy X-rays. The 24-h radiation response was analyzed by gene expression profiling and used for classification. Classification was performed either on the expression of separate genes or, to augment the classification power, on gene sets consisting of genes grouped together based on function or cellular colocalization. X- ray irradiation altered the expression of radio-responsive genes in both groups. This response was variable across individuals, and the expression of the most significant radio-responsive genes was unlinked to radiation toxicity. The classifier based on the radiation response of separate genes correctly classified 63% of the patients. The classifier based on affected gene sets improved correct classification to 86%, although on the individual level only 21/38 (55%) patients were classified with high certainty. The majority of the discriminative genes and gene sets belonged to the ubiquitin, apoptosis, and stress signaling networks. The apoptotic response appeared more pronounced in patients that did not develop toxicity. In an independent set of 12 patients, the toxicity status of eight was predicted correctly by the gene set classifier. Conclusions Gene expression profiling succeeded to some extent in discriminating groups of patients with and without severe late radiotherapy toxicity. Moreover, the discr

Published
2006
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