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1. Neoadjuvant FOLFOXIRI prior to chemoradiotherapy for high-risk ('ugly') locally advanced rectal cancer: study protocol of a single-arm, multicentre, open-label, phase II trial (MEND-IT)

Author

van den Berg, K., Schaap, D. P., Voogt, E. L. K., Buffart, T. E., Verheul, H. M. W., de Groot, J. W. B., Verhoef, C., Melenhorst, J., Roodhart, J. M. L., de Wilt, J. H. W., van Westreenen, H. L., Aalbers, A. G. J., van 't Veer, M., Marijnen, C. A. M., Vincent, J., Simkens, L. H. J., Peters, N. A. J. B., Berbée, M., Werter, I. M., Snaebjornsson, P., Peulen, H. M. U., van Lijnschoten, I. G., Roef, M. J., Nieuwenhuijzen, G. A. P., Bloemen, J. G., Willems, J. M. W. E., Creemers, G. J. M., Nederend, J., Rutten, H. J. T., Burger, J. W. A., Surgery, MUMC+: MA Heelkunde (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Radiotherapie, MUMC+: MA Radiotherapie OC (9), RS: GROW - R2 - Basic and Translational Cancer Biology, Internal medicine, Radiation Oncology, Eindhoven MedTech Innovation Center, Cardiovascular Biomechanics, and Rehabilitation Medicine

Subjects
Neoadjuvant treatment, Cancer Research, Organoplatinum Compounds, Leucovorin, SDG 3 – Goede gezondheid en welzijn, Fluorouracil/therapeutic use, Neoadjuvant chemotherapy, Chemoradiotherapy/methods, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], All institutes and research themes of the Radboud University Medical Center, Clinical Trials, Phase II as Topic, SDG 3 - Good Health and Well-being, Neoplasms, Antineoplastic Combined Chemotherapy Protocols, Genetics, Humans, Multicenter Studies as Topic, Clinical Trials, Locally advanced rectal cancer, Neoplasm Staging, Neoplasms, Second Primary/pathology, Pathological complete response, Rectal Neoplasms, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Neoadjuvant Therapy/methods, Phase II as Topic, Neoplasms, Second Primary, Chemoradiotherapy, Complete response, Clinical complete response, Neoadjuvant Therapy, Second Primary/pathology, Treatment Outcome, Oncology, Induction chemotherapy, Quality of Life, Camptothecin/analogs & derivatives, Camptothecin, Fluorouracil, Rectal Neoplasms/pathology
Abstract

Background The presence of mesorectal fascia (MRF) invasion, grade 4 extramural venous invasion (EMVI), tumour deposits (TD) or extensive or bilateral extramesorectal (lateral) lymph nodes (LLN) on MRI has been suggested to identify patients with indisputable, extensive locally advanced rectal cancer (LARC), at high risk of treatment failure. The aim of this study is to evaluate whether or not intensified chemotherapy prior to neoadjuvant chemoradiotherapy improves the complete response (CR) rate in these patients. Methods This multicentre, single-arm, open-label, phase II trial will include 128 patients with non-metastatic high-risk LARC (hr-LARC), fit for triplet chemotherapy. To ensure a study population with indisputable, unfavourable prognostic characteristics, hr-LARC is defined as LARC with on baseline MRI at least one of the following characteristics; MRF invasion, EMVI grade 4, enlarged bilateral or extensive LLN at high risk of an incomplete resection, or TD. Exclusion criteria are the presence of a homozygous DPD deficiency, distant metastases, any chemotherapy within the past 6 months, previous radiotherapy within the pelvic area precluding standard chemoradiotherapy, and any contraindication for the planned treatment. All patients will be planned for six two-weekly cycles of FOLFOXIRI (5-fluorouracil, leucovorin, oxaliplatin and irinotecan) prior to chemoradiotherapy (25 × 2 Gy or 28 × 1.8 Gy with concomitant capecitabine). A resection will be performed following radiological confirmation of resectable disease after the completion of chemoradiotherapy. A watch and wait strategy is allowed in case of a clinical complete response. The primary endpoint is the CR rate, described as a pathological CR or a sustained clinical CR one year after chemoradiotherapy. The main secondary objectives are long-term oncological outcomes, radiological and pathological response, the number of resections with clear margins, treatment-related toxicity, perioperative complications, health-related costs, and quality of life. Discussion This trial protocol describes the MEND-IT study. The MEND-IT study aims to evaluate the CR rate after intensified chemotherapy prior to concomitant chemoradiotherapy in a homogeneous group of patients with locally advanced rectal cancer and indisputably unfavourable characteristics, defined as hr-LARC, in order to improve their prognosis. Trial registration Clinicaltrials.gov: NCT04838496, registered on 02–04-2021 Netherlands Trial Register: NL9790. Protocol version Version 3 dd 11–4-2022.

Published
2022

2. Perioperative management and anaesthetic considerations in pelvic exenterations using Delphi methodology: results from the PelvEx Collaborative

Author

PelvEx Collaborative, [missing], Chok, A Y, Oliver, A, Rasheed, S, Tan, E J, Kelly, M E, Aalbers, A G J, Abdul Aziz, N, Abecasis, N, Abraham-Nordling, M, Akiyoshi, T, Alberda, W, Albert, M, Andric, M, Angenete, E, Antoniou, A, Auer, R, Austin, K K, Aziz, O, Baker, R P, Bali, M, Baseckas, G, Bebington, B, Bedford, M, Bednarski, B K, Beets, G L, Berg, P L, Beynon, J, Biondo, S, Boyle, K, Bordeianou, L, Bremers, A B, Brunner, M, Buchwald, P, Bui, A, Burgess, A, Burger, J W A, Burling, D, Burns, E, Campain, N, Carvalhal, S, Castro, L, Caycedo-Marulanda, A, Chan, K K L, Chang, G J, Chew, M H, Chong, P, Christensen, H K, Clouston, H, Codd, M, Collins, D, Colquhoun, A J, Corr, A, Coscia, M, Coyne, P E, Creavin, B, Croner, R S, Damjanovic, L, Daniels, I R, Davies, M, Davies, R J, Delaney, C P, de Wilt, J H W, Denost, Q, Deutsch, C, Dietz, D, Domingo, S, Dozois, E J, Duff, M, Eglinton, T, Enrique-Navascues, J M, Espin-Basany, E, Evans, M D, Fearnhead, N S, Flatmark, K, Fleming, F, Frizelle, F A, Gallego, M A, Garcia-Granero, E, Garcia-Sabrido, J L, Gentilini, L, George, M L, George, V, Ghouti, L, Giner, F, Ginther, N, Glynn, R, Golda, T, Griffiths, B, Harris, D A, Hagemans, J A W, Hanchanale, V, Harji, D P, Helewa, R M, Hellawell, G, Heriot, A G, Hochman, D, Hohenberger, W, Holm, T, Holmström, A, Hompes, R, Jenkins, J T, Kaffenberger, S, Kandaswamy, G V, Kapur, S, Kanemitsu, Y, Kelley, S R, Keller, D S, Khan, M S, Kim, H, Kim, H J, Koh, C E, Kok, N F M, Kokelaar, R, Kontovounisios, C, Kristensen, H Ø, Kroon, H M, Kusters, M, Lago, V, Larsen, S G, Larson, D W, Law, W L, Laurberg, S, Lee, P J, Limbert, M, Lydrup, M L, Lyons, A, Lynch, A C, Mantyh, C, Mathis, K L, Margues, C F S, Martling, A, Meijerink, W J H J, Merkel, S, Mehta, A M, McArthur, D R, McDermott, F D, McGrath, J S, Malde, S, Mirnezami, A, Monson, J R T, Morton, J R, Mullaney, T G, Negoi, I, Neto, J W M, Nguyen, B, Nielsen, M B, Nieuwenhuijzen, G A P, Nilsson, P J, O’Dwyer, S T, Palmer, G, Pappou, E, Park, J, Patsouras, D, Pellino, G, Peterson, A C, Poggioli, G, Proud, D, Quinn, M, Quyn, A, Radwan, R W, Rasmussen, P C, Rausa, E, Regenbogen, S E, Renehan, A, Rocha, R, Rochester, M, Rohila, J, Rothbarth, J, Rottoli, M, Roxburgh, C, Rutten, H J T, Ryan, É J, Safar, B, Sagar, P M, Sahai, A, Saklani, A, Sammour, T, Sayyed, R, Schizas, A M P, Schwarzkopf, E, Scripcariu, V, Selvasekar, C, Shaikh, I, Shida, D, Simpson, A, Smart, N J, Smart, P, Smith, J J, Solbakken, A M, Solomon, M J, Sørensen, M M, Steele, S R, Steffens, D, Stitzenberg, K, Stocchi, L, Stylianides, N A, Swartling, T, Sumrien, H, Sutton, P A, Swartking, T, Taylor, C, Teras, J, Thurairaja, R, Toh, E L, Tsarkov, P, Tsukada, Y, Tsukamoto, S, Tuech, J J, Turner, W H, Tuynman, J B, van Ramshorst, Gabriëlle, Zoggel, D van, Vasquez-Jimenez, W, Verhoef, C, Vizzielli, G, Voogt, E L K, Uehara, K, Wakeman, C, Warrier, S, Wasmuth, H H, Weber, K, Weiser, M R, Wheeler, J M D, Wild, J, Wilson, M, Wolthuis, A, Yano, H, Yip, B, Yip, J, Yoo, R N, Winter, D C, Tekkis, P P, Surgery, Chok, A Y, Oliver, A, Rasheed, S, Tan, E J, Kelly, M E, Aalbers, A G J, Abdul Aziz, N, Abecasis, N, Abraham-Nordling, M, Akiyoshi, T, Alberda, W, Albert, M, Andric, M, Angenete, E, Antoniou, A, Auer, R, Austin, K K, Aziz, O, Baker, R P, Bali, M, Baseckas, G, Bebington, B, Bedford, M, Bednarski, B K, Beets, G L, Berg, P L, Beynon, J, Biondo, S, Boyle, K, Bordeianou, L, Bremers, A B, Brunner, M, Buchwald, P, Bui, A, Burgess, A, Burger, J W A, Burling, D, Burns, E, Campain, N, Carvalhal, S, Castro, L, Caycedo-Marulanda, A, Chan, K K L, Chang, G J, Chew, M H, Chong, P, Christensen, H K, Clouston, H, Codd, M, Collins, D, Colquhoun, A J, Corr, A, Coscia, M, Coyne, P E, Creavin, B, Croner, R S, Damjanovic, L, Daniels, I R, Davies, M, Davies, R J, Delaney, C P, de Wilt, J H W, Denost, Q, Deutsch, C, Dietz, D, Domingo, S, Dozois, E J, Duff, M, Eglinton, T, Enrique-Navascues, J M, Espin-Basany, E, Evans, M D, Fearnhead, N S, Flatmark, K, Fleming, F, Frizelle, F A, Gallego, M A, Garcia-Granero, E, Garcia-Sabrido, J L, Gentilini, L, George, M L, George, V, Ghouti, L, Giner, F, Ginther, N, Glynn, R, Golda, T, Griffiths, B, Harris, D A, Hagemans, J A W, Hanchanale, V, Harji, D P, Helewa, R M, Hellawell, G, Heriot, A G, Hochman, D, Hohenberger, W, Holm, T, Holmström, A, Hompes, R, Jenkins, J T, Kaffenberger, S, Kandaswamy, G V, Kapur, S, Kanemitsu, Y, Kelley, S R, Keller, D S, Khan, M S, Kim, H, Kim, H J, Koh, C E, Kok, N F M, Kokelaar, R, Kontovounisios, C, Kristensen, H Ø, Kroon, H M, Kusters, M, Lago, V, Larsen, S G, Larson, D W, Law, W L, Laurberg, S, Lee, P J, Limbert, M, Lydrup, M L, Lyons, A, Lynch, A C, Mantyh, C, Mathis, K L, Margues, C F S, Martling, A, Meijerink, W J H J, Merkel, S, Mehta, A M, McArthur, D R, McDermott, F D, McGrath, J S, Malde, S, Mirnezami, A, Monson, J R T, Morton, J R, Mullaney, T G, Negoi, I, Neto, J W M, Nguyen, B, Nielsen, M B, Nieuwenhuijzen, G A P, Nilsson, P J, O’Dwyer, S T, Palmer, G, Pappou, E, Park, J, Patsouras, D, Pellino, G, Peterson, A C, Poggioli, G, Proud, D, Quinn, M, Quyn, A, Radwan, R W, Rasmussen, P C, Rausa, E, Regenbogen, S E, Renehan, A, Rocha, R, Rochester, M, Rohila, J, Rothbarth, J, Rottoli, M, Roxburgh, C, Rutten, H J T, Ryan, É J, Safar, B, Sagar, P M, Sahai, A, Saklani, A, Sammour, T, Sayyed, R, Schizas, A M P, Schwarzkopf, E, Scripcariu, V, Selvasekar, C, Shaikh, I, Shida, D, Simpson, A, Smart, N J, Smart, P, Smith, J J, Solbakken, A M, Solomon, M J, Sørensen, M M, Steele, S R, Steffens, D, Stitzenberg, K, Stocchi, L, Stylianides, N A, Swartling, T, Sumrien, H, Sutton, P A, Swartking, T, Taylor, C, Teras, J, Thurairaja, R, Toh, E L, Tsarkov, P, Tsukada, Y, Tsukamoto, S, Tuech, J J, Turner, W H, Tuynman, J B, Ramshorst, G H van, Zoggel, D van, Vasquez-Jimenez, W, Verhoef, C, Vizzielli, G, Voogt, E L K, Uehara, K, Wakeman, C, Warrier, S, Wasmuth, H H, Weber, K, Weiser, M R, Wheeler, J M D, Wild, J, Wilson, M, Wolthuis, A, Yano, H, Yip, B, Yip, J, Yoo, R N, Winter, D C, Tekkis, P P, Mcarthur, D R, Mcdermott, F D, Mcgrath, J S, Psychiatrie & Neuropsychologie, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Faculteit FHML Centraal, Health Services Research, RS: CAPHRI - R1 - Ageing and Long-Term Care, RS: FdR IC Goederenrecht, School Office GROW, and Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
BLOOD-TRANSFUSION, CARDIAC RISK, AcademicSubjects/MED00910, medicine.medical_treatment, Delphi method, Computer-assisted web interviewing, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 0302 clinical medicine, 030202 anesthesiology, Multidisciplinary approach, Medicine and Health Sciences, Medicine, humans, RISK, COMPLICATIONS, Perioperative management - anaesthetic - pelvic exenterations - rectal cancer - Delphi - PelvEx Collaborative, Manchester Cancer Research Centre, General Medicine, SYSTEMIC INFLAMMATORY RESPONSE, 030220 oncology & carcinogenesis, Original Article, Medical emergency, EPIDURAL-ANESTHESIA, AcademicSubjects/MED00010, Life Sciences & Biomedicine, Consensus, ENHANCED RECOVERY, Best practice, education, MEDLINE, patient care team/organization & administration, 03 medical and health sciences, anesthetics, Humans, MAJOR ABDOMINAL-SURGERY, METAANALYSIS, RECTAL-CANCER, Anesthetics, Patient Care Team, Science & Technology, Pelvic exenteration, business.industry, ResearchInstitutes_Networks_Beacons/mcrc, MORTALITY, LONG-TERM SURVIVAL, Perioperative, COMPARTMENT SYNDROME, medicine.disease, pelvic exenteration, Pelvic Exenteration, Subject-matter expert, consensus, Surgery, business
Abstract

Background The multidisciplinary perioperative and anaesthetic management of patients undergoing pelvic exenteration is essential for good surgical outcomes. No clear guidelines have been established, and there is wide variation in clinical practice internationally. This consensus statement consolidates clinical experience and best practice collectively, and systematically addresses key domains in the perioperative and anaesthetic management. Methods The modified Delphi methodology was used to achieve consensus from the PelvEx Collaborative. The process included one round of online questionnaire involving controlled feedback and structured participant response, two rounds of editing, and one round of web-based voting. It was held from December 2019 to February 2020. Consensus was defined as more than 80 per cent agreement, whereas less than 80 per cent agreement indicated low consensus. Results The final consensus document contained 47 voted statements, across six key domains of perioperative and anaesthetic management in pelvic exenteration, comprising preoperative assessment and preparation, anaesthetic considerations, perioperative management, anticipating possible massive haemorrhage, stress response and postoperative critical care, and pain management. Consensus recommendations were developed, based on consensus agreement achieved on 34 statements. Conclusion The perioperative and anaesthetic management of patients undergoing pelvic exenteration is best accomplished by a dedicated multidisciplinary team with relevant domain expertise in the setting of a specialized tertiary unit. This consensus statement has addressed key domains within the framework of current perioperative and anaesthetic management among patients undergoing pelvic exenteration, with an international perspective, to guide clinical practice, and has outlined areas for future clinical research., The PelvEx Collaborative consensus statement systematically addresses the perioperative and anaesthetic management of patients undergoing pelvic exenteration (PE). Using the modified Delphi methodology, recommendations across six key clinical domains comprising preoperative assessment and preparation, anaesthetic considerations, perioperative management, anticipating possible massive haemorrhage, stress response and postoperative critical care, and pain management were developed. pelvic exenteratio and recommendation

Published
2021

3. Changing outcomes following pelvic exenteration for locally advanced and recurrent rectal cancer

Author

Kelly, M. E., Aalbers, A. G. J., Aziz, N. Abdul, Abraham-Nordling, M., Alberda, W., Antoniou, A., Austin, K. K., Baker, R., Bali, M., Baseckas, G., Bednarski, B. K., Beets, G. L., Berg, P. L., Beynon, J., Biondo, S., Bordeianou, L., Brunner, M., Buchwald, P., Burger, J. W. A., Burling, D., Campain, N., Chan, K. K. L., Chang, G., Chew, M. H., Chong, P. C., Christensen, H. K., Codd, M., Colquhoun, A. J., Corr, A., Coscia, M., Coyne, P. E., Creavin, B., Damjanovic, L., Daniels, I. R., Davies, M., Davies, R. J., de Wilt, J. H. W., Denost, Q., Deutsch, C., Dietz, D., Dozois, E. J., Duff, M., Eglinton, T., Evans, M., Evans, M. D., Fearnhead, N. S., Frizelle, F. A., Garcia-Granero, E., Garcia-Sabrido, J. L., Gentilini, L., George, M. L., Glynn, R., Golda, T., Griffiths, B., Hagemans, J. A. W., Harji, D. P., Harris, D. A., Heriot, A. A. G., Hohenberger, W., Holm, T., Jenkins, J. T., Kanemitsu, Y., Kapur, S., Keller, D. S., Kelley, S. R., Kim, H., Koh, C. E., Kok, N. F. M., Kokelaar, R., Kontovounisios, C., Kusters, M., Larson, D. W., Laurberg, S., Law, W. L., Lee, P., Lydrup, M. L., Lynch, A. C., Martling, A., Mathis, K. L., Meijerink, W. J. H. J., Mentha, A. M., Merkel, S., McDermott, F. D., McGrath, J. S., Mihailo, A., Mirnezami, A., Morton, J. R., Mullaney, T. G., Nielsen, M. B., Nieuwenhuijzen, G. A. P., Nilsson, P. J., O'Connell, P. R., Palmer, G., Patsouras, D., Pellino, G., Poggioli, G., Quinn, M., Quyn, A., Radwan, R. W., Rasheed, S., Rasmussen, P. C., Rocha, R., Rothbarth, J., Roxburgh, C., Rutten, H. J. T., Ryan, E., Sagar, P. M., Sammour, T., Schizas, A. M. P., Schwarzkopf, E., Scripcariu, V, Shaikh, I, Shida, D., Simpson, A., Smart, N. J., Smith, J., Solomon, M. J., Sorensen, M. M., Steele, S. R., Steffens, D., Stocchi, L., Stylianides, N. A., Taylor, C., Tekkis, P. P., Tsukamoto, S., Turner, W. H., Tuynman, J. B., van Ramshorst, Gabriëlle, van Zoggel, D., Vasquez-Jimenez, W., Verhoef, C., Verstegen, M., Wakeman, C., Warrier, S., Wasmuth, H. H., Weiser, M. R., Wheeler, J. M. D., Wild, J., Winter, D. C., Yip, J., Kelly, M. E., Aalbers, A. G. J., Aziz, N. Abdul, Abraham‐Nordling, M., Alberda, W., Antoniou, A., Austin, K. K., Baker, R., Bali, M., Baseckas, G., Bednarski, B. K., Beets, G. L., Berg, P. L., Beynon, J., Biondo, S., Bordeianou, L., Brunner, M., Buchwald, P., Burger, J. W. A., Burling, D., Campain, N., Chan, K. K. L., Chang, G., Chew, M. H., Chong, P. C., Christensen, H. K., Codd, M., Colquhoun, A. J., Corr, A., Coscia, M., Coyne, P. E., Creavin, B., Damjanovic, L., Daniels, I. R., Davies, M., Davies, R. J., Wilt, J. H. W., Denost, Q., Deutsch, C., Dietz, D., Dozois, E. J., Duff, M., Eglinton, T., Evans, M., Evans, M.D., Fearnhead, N. S., Frizelle, F. A., Garcia‐Granero, E., Garcia‐Sabrido, J. L., Gentilini, L., George, M. L., Glynn, R., Golda, T., Griffiths, B., Hagemans, J. A.W., Harji, D. P., Harris, D. A., Heriot, A. A. G., Hohenberger, W., Holm, T., Jenkins, J. T., Kanemitsu, Y., Kapur, S., Keller, D. S., Kelley, S. R., Kim, H., Koh, C. E., Kok, N. F. M., Kokelaar, R., Kontovounisios, C., Kusters, M., Larson, D. W., Laurberg, S., Law, W. L., Lee, P., Lydrup, M. L., Lynch, A. C., Martling, A., Mathis, K. L., Meijerink, W. J. H. J., Mentha, A. M., Merkel, S., McDermott, F. D., McGrath, J. S., Mihailo, A., Mirnezami, A., Morton, J. R., Mullaney, T. G., Nielsen, M. B., Nieuwenhuijzen, G. A. P., Nilsson, P. J., O'Connell, P. R., Palmer, G., Patsouras, D., Pellino, G., Poggioli, G., Quinn, M., Quyn, A., Radwan, R. W., Rasheed, S., Rasmussen, P. C., Rocha, R., Rothbarth, J., Roxburgh, C., Rutten, H. J. T., Ryan, É., Sagar, P. M., Sammour, T., Schizas, A. M. P., Schwarzkopf, E., Scripcariu, V., Shaikh, I., Shida, D., Simpson, A., Smart, N. J., Smith, J., Solomon, M. J., Sørensen, M.M., Steele, S. R., Steffens, D., Stocchi, L., Stylianides, N. A., Taylor, C., Tekkis, P. P., Tsukamoto, S., Turner, W. H., Tuynman, J. B., Ramshorst, G. H., Zoggel, D., Vasquez‐Jimenez, W., Verhoef, C., Verstegen, M., Wakeman, C., Warrier, S., Wasmuth, H. H., Weiser, M. R., Wheeler, J. M. D., Wild, J., Winter, D. C., Yip, J., Kelly, Me, Aalbers, Agj, Aziz, Na, Abraham-Nordling, M, Alberda, W, Antoniou, A, Austin, Kk, Baker, R, Bali, M, Baseckas, G, Bednarski, Bk, Beets, Gl, Berg, Pl, Beynon, J, Biondo, S, Bordeianou, L, Brunner, M, Buchwald, P, Burger, Jwa, Burling, D, Campain, N, Chan, Kkl, Chang, G, Chew, Mh, Chong, Pc, Christensen, Hk, Codd, M, Colquhoun, Aj, Corr, A, Coscia, M, Coyne, Pe, Creavin, B, Damjanovic, L, Daniels, Ir, Davies, M, Davies, Rj, de Wilt, Jhw, Denost, Q, Deutsch, C, Dietz, D, Dozois, Ej, Duff, M, Eglinton, T, Evans, M, Evans, Md, Fearnhead, N, Frizelle, Fa, Garcia-Granero, E, Garcia-Sabrido, Jl, Gentilini, L, George, Ml, Glynn, R, Golda, T, Griffiths, B, Hagemans, Jaw, Harji, Dp, Harris, Da, Heriot, Aag, Hohenberger, W, Holm, T, Jenkins, Jt, Kanemitsu, Y, Kapur, S, Keller, D, Kelley, Sr, Kim, H, Koh, Ce, Kok, Nfm, Kokelaar, R, Kontovounisios, C, Kusters, M, Larson, Dw, Laurberg, S, Law, Wl, Lee, P, Lydrup, Ml, Lynch, Ac, Martling, A, Mathis, Kl, Meijerink, Wjhj, Mentha, Am, Merkel, S, Mcdermott, Fd, Mcgrath, J, Mihailo, A, Mirnezami, A, Morton, Jr, Mullaney, Tg, Nielsen, Mb, Nieuwenhuijzen, Gap, Nilsson, Pj, O'Connell, Pr, Palmer, G, Patsouras, D, Pellino, G, Poggioli, G, Quinn, M, Quyn, A, Radwan, Rw, Rasheed, S, Rasmussen, Pc, Rocha, R, Rothbarth, J, Roxburgh, C, Rutten, Hjt, Ryan, E, Sagar, Pm, Sammour, T, Schizas, Amp, Schwarzkopf, E, Scripcariu, V, Shaikh, I, Shida, D, Simpson, A, Smart, Nj, Smith, J, Solomon, Mj, Sorensen, Mm, Steele, Sr, Steffens, D, Stocchi, L, Stylianides, Na, Taylor, C, Tekkis, Pp, Tsukamoto, S, Turner, Wh, Tuynman, Jb, van Ramshorst, Gh, van Zoggel, D, Vasquez-Jimenez, W, Verhoef, C, Verstegen, M, Wakeman, C, Warrier, S, Wasmuth, Hh, Weiser, Mr, Wheeler, Jmd, Wild, J, Winter, Dc, and Yip, J

Subjects
Male, Blood transfusion, Colorectal cancer, medicine.medical_treatment, Surgical Flaps, COLORECTAL-CANCER, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], Postoperative Complications, Retrospective Studie, Medicine and Health Sciences, Mortality rate, General Medicine, Middle Aged, Treatment Outcome, medicine.anatomical_structure, HOSPITAL VOLUME, SURVIVAL, Original Article, Female, Life Sciences & Biomedicine, Human, medicine.medical_specialty, lcsh:Surgery, Rectum, Subgroup analysis, SDG 3 - Good Health and Well-being, medicine, Humans, Blood Transfusion, Retrospective Studies, Aged, Science & Technology, Pelvic exenteration, Rectal Neoplasms, business.industry, MORTALITY, PelvEx Collaborative, Retrospective cohort study, Original Articles, lcsh:RD1-811, Length of Stay, medicine.disease, SURGEON VOLUME, Pelvic Exenteration, Surgery, Surgical Flap, Postoperative Complication, Neoplasm Recurrence, Local, business, Complication
Abstract

Contains fulltext : 215764.pdf (Publisher’s version ) (Open Access) Background: Pelvic exenteration for locally advanced rectal cancer (LARC) and locally recurrent rectal cancer (LRRC) is technically challenging but increasingly performed in specialist centres. The aim of this study was to compare outcomes of exenteration over time. Methods: This was a multicentre retrospective study of patients who underwent exenteration for LARC and LRRC between 2004 and 2015. Surgical outcomes, including rate of bone resection, flap reconstruction, margin status and transfusion rates, were examined. Outcomes between higher- and lower-volume centres were also evaluated. Results: Some 2472 patients underwent pelvic exenteration for LARC and LRRC across 26 institutions. For LARC, rates of bone resection or flap reconstruction increased from 2004 to 2015, from 3.5 to 12.8 per cent, and from 12.0 to 29.4 per cent respectively. Fewer units of intraoperative blood were transfused over this interval (median 4 to 2 units; P = 0.040). Subgroup analysis showed that bone resection and flap reconstruction rates increased in lower- and higher-volume centres. R0 resection rates significantly increased in low-volume centres but not in high-volume centres over time (low-volume: from 62.5 to 80.0 per cent, P = 0.001; high-volume: from 83.5 to 88.4 per cent, P = 0.660). For LRRC, no significant trends over time were observed for bone resection or flap reconstruction rates. The median number of units of intraoperative blood transfused decreased from 5 to 2.5 units (P < 0.001). R0 resection rates did not increase in either low-volume (from 51.7 to 60.4 per cent; P = 0.610) or higher-volume (from 48.6 to 65.5 per cent; P = 0.100) centres. No significant differences in length of hospital stay, 30-day complication, reintervention or mortality rates were observed over time. Conclusion: Radical resection, bone resection and flap reconstruction rates were performed more frequently over time, while transfusion requirements decreased.

Published
2019

4. Factors affecting outcomes following pelvic exenteration for locally recurrent rectal cancer

Author

Kelly M. E., Glynn R., Aalbers A. G. J., Abraham-Nordling M., Alberda W., Antoniou A., Austin K. K., Beets G. L., Beynon J., Bosman S. J., Brunner M., Buchler M. W., Burger J. W. A., Campain N., Christensen H. K., Codd M., Coscia M., Colquhoun A. J., Daniels I. R., Davies R. J., de Wilt J. H. W., Deutsch C., Dietz D., Eglinton T., Fearnhead N., Frizelle F. A., Garcia-Sabrido J. L., George M. L., Gentilini L., Harris D. A., Harji D., Heriot A. G., Hohenberger Brunner W., Jenkins J. T., Kanemitsu Y., Chan K. K. L., Kim H., Koh C. E., Kok N. F., Kontovounisios C., Kulu Y., Law W. L., Le G. N., Lee P., Lydrup M. L., Lynch A. C., Martling A., Meijerink J., Merkel S., McDermott F. D., McGrath J. S., Nielsen Christensen M. B., Nieuwenhuijzen G. A. P., Nordling M. A., Northover J. M. A., O'Connell P. R., Patsouras D., Poggioli G., Radwan R. W., Rasheed S., Rasmussen P. C., Rothbarth J., Rutten H. J. T., Sagar P. M., Schizas A. M. P., Shida D., Smart N. J., Solomon M. J., Stocchi L., Tekkis P. P., Tsukamoto S., Turner W. H., Tuynman J., Ulrich A., van Leeuwenhoek A., van Ramshorst G. H., Vasquez-Jimenez W., Verhoef C., Versteegen M., Wakeman C., Warrier S., Yip J., Winter D. C., Surgery, Kelly M.E., Glynn R., Aalbers A.G.J., Abraham-Nordling M., Alberda W., Antoniou A., Austin K.K., Beets G.L., Beynon J., Bosman S.J., Brunner M., Buchler M.W., Burger J.W.A., Campain N., Christensen H.K., Codd M., Coscia M., Colquhoun A.J., Daniels I.R., Davies R.J., de Wilt J.H.W., Deutsch C., Dietz D., Eglinton T., Fearnhead N., Frizelle F.A., Garcia-Sabrido J.L., George M.L., Gentilini L., Harris D.A., Harji D., Heriot A.G., Hohenberger Brunner W., Jenkins J.T., Kanemitsu Y., Chan K.K.L., Kim H., Koh C.E., Kok N.F., Kontovounisios C., Kulu Y., Law W.L., Le G.N., Lee P., Lydrup M.L., Lynch A.C., Martling A., Meijerink J., Merkel S., McDermott F.D., McGrath J.S., Nielsen Christensen M.B., Nieuwenhuijzen G.A.P., Nordling M.A., Northover J.M.A., O'Connell P.R., Patsouras D., Poggioli G., Radwan R.W., Rasheed S., Rasmussen P.C., Rothbarth J., Rutten H.J.T., Sagar P.M., Schizas A.M.P., Shida D., Smart N.J., Solomon M.J., Stocchi L., Tekkis P.P., Tsukamoto S., Turner W.H., Tuynman J., Ulrich A., van Leeuwenhoek A., van Ramshorst G.H., Vasquez-Jimenez W., Verhoef C., Versteegen M., Wakeman C., Warrier S., Yip J., Winter D.C., AGEM - Re-generation and cancer of the digestive system, and CCA - Cancer Treatment and quality of life

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, 030230 surgery, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 03 medical and health sciences, 0302 clinical medicine, SDG 3 - Good Health and Well-being, medicine, Clinical endpoint, Humans, Survival rate, Survival analysis, Neoadjuvant therapy, Aged, Rectal Neoplasm, Pelvic exenteration, Rectal Neoplasms, business.industry, Odds ratio, Middle Aged, Survival Analysis, Neoadjuvant Therapy, Pelvic Exenteration, Surgery, Radiation therapy, Treatment Outcome, 030220 oncology & carcinogenesis, Resection margin, Female, Survival Analysi, Neoplasm Recurrence, Local, business, Human
Abstract

Background Pelvic exenteration for locally recurrent rectal cancer (LRRC) is associated with variable outcomes, with the majority of data from single-centre series. This study analysed data from an international collaboration to determine robust parameters that could inform clinical decision-making. Methods Anonymized data on patients who had pelvic exenteration for LRRC between 2004 and 2014 were accrued from 27 specialist centres. The primary endpoint was survival. The impact of resection margin, bone resection, node status and use of neoadjuvant therapy (before exenteration) was assessed. Results Of 1184 patients, 614 (51·9 per cent) had neoadjuvant therapy. A clear resection margin (R0 resection) was achieved in 55·4 per cent of operations. Twenty-one patients (1·8 per cent) died within 30 days and 380 (32·1 per cent) experienced a major complication. Median overall survival was 36 months following R0 resection, 27 months after R1 resection and 16 months following R2 resection (P < 0·001). Patients who received neoadjuvant therapy had more postoperative complications (unadjusted odds ratio (OR) 1·53), readmissions (unadjusted OR 2·33) and radiological reinterventions (unadjusted OR 2·12). Three-year survival rates were 48·1 per cent, 33·9 per cent and 15 per cent respectively. Bone resection (when required) was associated with a longer median survival (36 versus 29 months; P < 0·001). Node-positive patients had a shorter median overall survival than those with node-negative disease (22 versus 29 months respectively). Multivariable analysis identified margin status and bone resection as significant determinants of long-term survival. Conclusion Negative margins and bone resection (where needed) were identified as the most important factors influencing overall survival. Neoadjuvant therapy before pelvic exenteration did not affect survival, but was associated with higher rates of readmission, complications and radiological reintervention.

Published
2018

5. Minimally invasive surgery techniques in pelvic exenteration: a systematic and meta-analysis review

Author

Srinivasaiah N., Shekleton F., Kelly M. E., Harji D., Malietzis G., Askari A., Aalbers A. G. J., Alberda W., Antoniou A., Austin K. K., Beets G. L., Berg P. L., Beynon J., Bosman S. J., Brunner M., Burger J. W. A., Campain N., Christensen H. K., Coscia M., Colquhoun A. J., Coyne P., Daniels I. R., Davies R. J., de Wilt J. H. W., Denost Q., Deutsch C., Dietz D., Duff M., Eglinton T., Fearnhead N., Frizelle F. A., Garcia-Sabrido J. L., George M. L., Gentilini L., Griffiths B., Harris D. A., Evans M., Heriot A. G., Hohenberger W., Hoe C. M., Holm T., Kanemitsu Y., Chan K. K. L., Kim H., Koh C. E., Kok N. F., Kontovounisios C., Law W. L., Laurberg S., Lee P., Lydrup M. L., Lynch A. C., Martling A., Meijerink J., Mentha A., Merkel S., McDermott F. D., McGrath J. S., Nielsen M. B., Nieuwenhuijzen G. A. P., Nilsson P. J., Abraham-Nordling M., O'Connell P. R., Patsouras D., Poggioli G., Radwan R. W., Rasheed S., Rasmussen P. C., Rothbarth J., Rutten H. J. T., Sagar P. M., Schizas A. M. P., Shida D., Smart N. J., Solomon M. J., Sorensen M. M., Stocchi L., Tekkis P. P., Tsukamoto S., Turner W. H., Tuynman J. B., van Ramshorst G. H., van Zoggel D., Vasquez-Jimenez W., Verhoef C., Verstegen M., Wakeman C., Warrier S., Yip J., Winter D. C., Jenkins J. T., Srinivasaiah N., Shekleton F., Kelly M.E., Harji D., Malietzis G., Askari A., Aalbers A.G.J., Alberda W., Antoniou A., Austin K.K., Beets G.L., Berg P.L., Beynon J., Bosman S.J., Brunner M., Burger J.W.A., Campain N., Christensen H.K., Coscia M., Colquhoun A.J., Coyne P., Daniels I.R., Davies R.J., de Wilt J.H.W., Denost Q., Deutsch C., Dietz D., Duff M., Eglinton T., Fearnhead N., Frizelle F.A., Garcia-Sabrido J.L., George M.L., Gentilini L., Griffiths B., Harris D.A., Evans M., Heriot A.G., Hohenberger W., Hoe C.M., Holm T., Kanemitsu Y., Chan K.K.L., Kim H., Koh C.E., Kok N.F., Kontovounisios C., Law W.L., Laurberg S., Lee P., Lydrup M.L., Lynch A.C., Martling A., Meijerink J., Mentha A., Merkel S., McDermott F.D., McGrath J.S., Nielsen M.B., Nieuwenhuijzen G.A.P., Nilsson P.J., Abraham-Nordling M., O'Connell P.R., Patsouras D., Poggioli G., Radwan R.W., Rasheed S., Rasmussen P.C., Rothbarth J., Rutten H.J.T., Sagar P.M., Schizas A.M.P., Shida D., Smart N.J., Solomon M.J., Sorensen M.M., Stocchi L., Tekkis P.P., Tsukamoto S., Turner W.H., Tuynman J.B., van Ramshorst G.H., van Zoggel D., Vasquez-Jimenez W., Verhoef C., Verstegen M., Wakeman C., Warrier S., Yip J., Winter D.C., and Jenkins J.T.

Subjects
Laparoscopic surgery, medicine.medical_specialty, medicine.medical_treatment, 03 medical and health sciences, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 0302 clinical medicine, Minimally invasive surgery, Surgical complication, medicine, Humans, Minimally Invasive Surgical Procedures, Pelvic Neoplasms, Robotic surgery, Neoplasm Staging, Surgical outcome, Pelvic exenteration, business.industry, Patient Selection, Mortality rate, Minimally Invasive Surgical Procedure, Surgery, Outcome and Process Assessment, Health Care, 030220 oncology & carcinogenesis, Relative risk, Meta-analysis, Cohort, 030211 gastroenterology & hepatology, business, Human
Abstract

BACKGROUND: Pelvic exenteration is potentially curative for locally advanced and recurrent pelvic cancers. Evolving technology has facilitated the use of minimally invasive surgical (MIS) techniques in selected cases. We aimed to compare outcomes between open and MIS pelvic exenteration.METHODS: A review of comparative studies was performed. Firstly, we evaluated the differences in surgical techniques with respect to operative time, blood loss, and margin status. Secondly, we assessed differences in 30-day morbidity and mortality rates, and length of hospital stay.RESULTS: Four studies that directly compared open and MIS exenteration were included. Analysis was performed on 170 patients; 78.1% (n = 133) had open pelvic exenteration, while 21.8% (n = 37) had a MIS exenteration. The median age for open exenteration was 57.7 years versus 63 years for MIS exenteration. Even though the operative time for MIS exenteration was 83 min longer (p CONCLUSION: MIS exenteration can be performed in highly selective cases, where there is favourable patient anatomy and tumour characteristics. When feasible, it is associated with reduced intra-operative blood loss, shorter length of hospital stay, and reduced morbidity.

Published
2018

7. Improved local control following preoperative radiotherapy and total mesorectal excision in patients with resectable rectal carcinoma: A randomised multicentre trial,Betere lokale controle na preoperatieve radiotherapie bij patiënten met een resectabel rectumcarcinoom en totale mesorectale excisie; een gerandomiseerd multicentraonderzoek

Author

Kapiteijn, E., Marijnen, C. A. M., Iris Nagtegaal, Putter, H., Steup, W. H., Wiggers, T., Rutten, H. J. T., Pahlman, L., Glimelius, B., Krieken, J. H. J. M., Leer, J. W. H., and Velde, C. J. H.

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