Comparative effectiveness of laparoscopic versus open colectomy in colon cancer patients: a study protocol for emulating a target trial using cancer registry data.
Gespeichert in:
| Titel: | Comparative effectiveness of laparoscopic versus open colectomy in colon cancer patients: a study protocol for emulating a target trial using cancer registry data. |
|---|---|
| Autoren: | Abera SF; Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, 17489, Greifswald, Germany. semaw.abera@uni-greifswald.de., Robers G; Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, 17489, Greifswald, Germany.; Cancer Registry Mecklenburg-Western Pomerania, 17475, Greifswald, Germany., Kästner A; Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, 17489, Greifswald, Germany., Stentzel U; Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, 17489, Greifswald, Germany., Weitmann K; Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, 17489, Greifswald, Germany.; Cancer Registry Mecklenburg-Western Pomerania, 17475, Greifswald, Germany., Hoffmann W; Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, 17489, Greifswald, Germany.; Cancer Registry Mecklenburg-Western Pomerania, 17475, Greifswald, Germany. |
| Quelle: | Journal of cancer research and clinical oncology [J Cancer Res Clin Oncol] 2025 Jan 11; Vol. 151 (1), pp. 34. Date of Electronic Publication: 2025 Jan 11. |
| Publikationsart: | Clinical Trial Protocol; Journal Article |
| Sprache: | English |
| Info zur Zeitschrift: | Publisher: Springer-Verlag Country of Publication: Germany NLM ID: 7902060 Publication Model: Electronic Cited Medium: Internet ISSN: 1432-1335 (Electronic) Linking ISSN: 01715216 NLM ISO Abbreviation: J Cancer Res Clin Oncol Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Berlin ; New York : Springer-Verlag. |
| MeSH-Schlagworte: | Colectomy*/methods , Colonic Neoplasms*/surgery , Colonic Neoplasms*/pathology , Colonic Neoplasms*/mortality , Laparoscopy*/methods, Adult ; Female ; Humans ; Male ; Registries ; Survival Rate ; Clinical Trials, Phase III as Topic ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic |
| Abstract: | Introduction: The objective of this study is to compare the 5 year overall survival of patients with stage I-III colon cancer treated by laparoscopic colectomy versus open colectomy. Methods: Using Mecklenburg-Western Pomerania Cancer Registry data from 2008 to 2018, we will emulate a phase III, multicenter, open-label, two-parallel-arm hypothetical target trial in adult patients with stage I-III colon cancer who received laparoscopic or open colectomy as an elective treatment. An inverse-probability weighted Royston‒Parmar parametric survival model (RPpsm) will be used to estimate the hazard ratio of laparoscopic versus open surgery after confounding factors are balanced between the two treatment arms. Further to the hazard ratio, we will also compute differences in the absolute risk (at 1, 3, and 5 years) and restricted mean survival time (up to 1, 3, and 5 years). A weighted Kaplan‒Meier curve will be used to compare five-year overall survival in both treatment arms. Various comparator and sensitivity analyses will be performed to check the robustness of the results that will be estimated by the RPpsm main model. Treatment period- and stage-specific results will also be provided. Discussion: This study aims to causally model the effect of laparoscopic versus open colectomy on 5 year overall survival using a target trial emulation approach. As the cancer registry data do not cover BMI, comorbidity, and previous abdominal surgery for non-malignant indications, the potential for residual confounding arising from these factors is a limitation of this study. This will be approached in a quantitative bias analysis using the E-method. The results will substantiate existing evidence on the comparative effectiveness of laparoscopic versus open colectomy in patients with stage I-III colon cancer and may guide clinical decisions as to whether a laparoscopic approach is as safe as an open approach in terms of improving 5-year overall survival in these patient groups. (© 2025. The Author(s).) |
| Competing Interests: | Declarations. Conflict of interest: The authors declare no competing interests. Ethical approval: We will consult the Ethics Committee of the University Medical Center Greifswald for ethics clearance. Consent to participate: Since the protocol plans to use anonymized secondary data exclusively, informed consent of the participants is not required. Consent for publication: Not applicable. |
| References: | Antoine A, Perol D, Robain M, Delaloge S, Lasset C, Drouet Y (2023) Target trial emulation to assess real-world efficacy in the Epidemiological Strategy and Medical Economics metastatic breast cancer cohort. J Natl Cancer Inst 115(8):971–980. (PMID: 3722089310407701) Arndt V, Holleczek B, Kajuter H, Luttmann S, Nennecke A, Zeissig SR, Kraywinkel K, Katalinic A (2020) Data from Population-based Cancer Registration for Secondary Data Analysis: Methodological challenges and perspectives. Gesundheitswesen 82(S 01):S62–S71. (PMID: 31663107) Austin PC, Stuart EA (2015) Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med 34(28):3661–3679. (PMID: 262389584626409) Bagshaw PF, Allardyce RA, Frampton CM, Frizelle FA, Hewett PJ, McMurrick PJ, Rieger NA, Smith JS, Solomon MJ, Stevenson AR et al (2012) Long-term outcomes of the Australasian randomized clinical trial comparing laparoscopic and conventional open surgical treatments for colon cancer: the Australasian laparoscopic Colon Cancer Study trial. Ann Surg 256(6):915–919. (PMID: 23154392) Benz S, Barlag H, Gerken M, Furst A, Klinkhammer-Schalke M (2017) Laparoscopic surgery in patients with colon cancer: a population-based analysis. Surg Endosc 31(6):2586–2595. (PMID: 27704244) Bilimoria KY, Bentrem DJ, Nelson H, Stryker SJ, Stewart AK, Soper NJ, Russell TR, Ko CY (2008) Use and outcomes of laparoscopic-assisted colectomy for cancer in the United States. Arch Surg 143(9):832–839. (PMID: 18794419) Bonjer HJ, Hop WC, Nelson H, Sargent DJ, Lacy AM, Castells A, Guillou PJ, Thorpe H, Brown J, Delgado S et al (2007) Laparoscopically assisted vs open colectomy for colon cancer: a meta-analysis. Arch Surg 142(3):298–303. (PMID: 17372057) Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pahlman L, Cuesta MA, Msika S et al (2009) Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol 10(1):44–52. (PMID: 19071061) Bykov K, Patorno E, D’Andrea E, He M, Lee H, Graff JS, Franklin JM (2022) Prevalence of Avoidable and Bias-Inflicting Methodological pitfalls in Real-World studies of Medication Safety and Effectiveness. Clin Pharmacol Ther 111(1):209–217. (PMID: 34260087) Choi HK, Law WL, Poon JT (2010) The optimal number of lymph nodes examined in stage II colorectal cancer and its impact of on outcomes. BMC Cancer 10:267. (PMID: 205293522895612) Deijen CL, Vasmel JE, de Lange-de Klerk ESM, Cuesta MA, Coene PLO, Lange JF, Meijerink W, Jakimowicz JJ, Jeekel J, Kazemier G et al (2017) Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer. Surg Endosc 31(6):2607–2615. (PMID: 27734203) Di B, Li Y, Wei K, Xiao X, Shi J, Zhang Y, Yang X, Gao P, Zhang K, Yuan Y et al (2013) Laparoscopic versus open surgery for colon cancer: a meta-analysis of 5-year follow-up outcomes. Surg Oncol 22(3):e39–43. (PMID: 23643698) Emilsson L, Garcia-Albeniz X, Logan RW, Caniglia EC, Kalager M, Hernan MA (2018) Examining Bias in studies of Statin Treatment and Survival in patients with Cancer. JAMA Oncol 4(1):63–70. (PMID: 28822996) Federal Ministry of Health of Germany (2013) Act on the development of early cancer detection and quality assurance through clinical cancer registries (Cancer Early Detection and Registry Act - KFRG). FLG 116:617–623. Federal Statistical Office of Germany (2024) Medical facilities, hospital beds and movement of patient [ https://www.destatis.de/EN/Themes/Society-Environment/Health/Hospitals/Tables/gd-hospitals-laender.html ]. Fleshman J, Sargent DJ, Green E, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr, Peters W, Nelson H et al (2007) Laparoscopic colectomy for cancer is not inferior to open surgery based on 5-year data from the COST Study Group trial. Ann Surg 246(4):655–662. (PMID: 17893502) German Cancer Society (2024). OncoMap [https://www.oncomap.de/centers?selectedOrgans=[Darm]&selectedCountries=[Deutschland]&selectedStates=[Mecklenburg-Vorpommern]&showMap=1]. German Guideline Program in Oncology (2019) S3-Guideline Colorectal Cancer, long version 2.1,2019 [ http://www.leitlinienprogrammonkologie.de/leitlinien/kolorektales-karzinom/ ]. German Institute for Medical Documentation and Information (2023) ICD-10-GM Version Systematic Index International Statistical Classification of Diseases and Related Health Problems, 10th Revision-German Modification. [ https://www.dimdi.de/static/de/klassifikationen/ops/kode-suche/opshtml2023/ ]. Hernan MA, Robins JM (2016) Using Big Data to emulate a target Trial when a Randomized Trial is not available. Am J Epidemiol 183(8):758–764. (PMID: 269940634832051) Hernan MA, Robins JM (2017) Per-protocol analyses of pragmatic trials. N Engl J Med 377(14):1391–1398. (PMID: 28976864) Hernan MA, Sauer BC, Hernandez-Diaz S, Platt R, Shrier I (2016) Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses. J Clin Epidemiol 79:70–75. (PMID: 272370615124536) Horie T, Shida D, Ahiko Y, Takamizawa Y, Inoue M, Tanabe T, Nakamura Y, Imaizumi J, Tsukamoto S, Kanemitsu Y (2021) Laparoscopic versus Open Colectomy for Elderly patients with Colon cancer: a propensity score analysis with the Controlling Nutritional Status (CONUT) score. Nutr Cancer 73(2):246–251. (PMID: 32252556) Hou J, Zhao R, Cai T, Beaulieu-Jones B, Seyok T, Dahal K, Yuan Q, Xiong X, Bonzel CL, Fox C et al (2022) Temporal trends in clinical evidence of 5-Year Survival within Electronic Health Records among patients with early-stage Colon cancer managed with laparoscopy-assisted colectomy vs Open Colectomy. JAMA Netw Open 5(6):e2218371. (PMID: 357373849227003) Interactive report of the Mecklenburg-Western Pomerania Cancer Registry [database on the Internet][ https://kr-mv-interaktiv.med.uni-greifswald.de/interaktiverBericht/. ] Accessed 22 Oct 2024. Jayne DG, Thorpe HC, Copeland J, Quirke P, Brown JM, Guillou PJ (2010) Five-year follow-up of the Medical Research Council CLASICC trial of laparoscopically assisted versus open surgery for colorectal cancer. Br J Surg 97(11):1638–1645. (PMID: 20629110) Kitano S, Inomata M, Mizusawa J, Katayama H, Watanabe M, Yamamoto S, Ito M, Saito S, Fujii S, Konishi F et al (2017) Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol 2(4):261–268. (PMID: 28404155) Kutcher SA, Brophy JM, Banack HR, Kaufman JS, Samuel M (2021) Emulating a Randomised Controlled Trial with Observational Data: an introduction to the Target Trial Framework. Can J Cardiol 37(9):1365–1377. (PMID: 34090982) Lacy AM, Delgado S, Castells A, Prins HA, Arroyo V, Ibarzabal A, Pique JM (2008) The long-term results of a randomized clinical trial of laparoscopy-assisted versus open surgery for colon cancer. Ann Surg 248(1):1–7. (PMID: 18580199) Lacy AM, Garcia-Valdecasas JC, Delgado S, Castells A, Taura P, Pique JM, Visa J (2002) Laparoscopy-assisted colectomy versus open colectomy for treatment of non-metastatic colon cancer: a randomised trial. Lancet 359(9325):2224–2229. (PMID: 12103285) Lederer DJ, Bell SC, Branson RD, Chalmers JD, Marshall R, Maslove DM, Ost DE, Punjabi NM, Schatz M, Smyth AR et al (2019) Control of confounding and reporting of results in causal inference studies. Guidance for authors from editors of respiratory, sleep, and critical care journals. Ann Am Thorac Soc 16(1):22–28. (PMID: 30230362) Martinuka O, Cube MV, Hazard D, Marateb HR, Mansourian M, Sami R, Hajian MR, Ebrahimi S, Wolkewitz M (2023) Target Trial Emulation using hospital-based Observational Data: demonstration and application in COVID-19. Life 13(3):1. Mazaki J, Katsumata K, Tago T, Kasahara K, Wada T, Kuwabara H, Enomoto M, Ishizaki T, Nagakawa Y, Tsuchida A (2021) Long-term outcomes of laparoscopic Versus Open surgery for Colon cancer in Noncancer-Specific Hospital: propensity score analysis. J Laparoendosc Adv Surg Tech A 31(4):433–442. (PMID: 32865445) Mbona SV, Ndlovu P, Mwambi H, Ramroop S (2023) Multiple imputation using chained equations for missing data in survival models: applied to multidrug-resistant tuberculosis and HIV data. J Public Health Afr 14(8):2388. (PMID: 3775343510519120) Nelson H, Sargent DJ, Wieand HS, Fleshman J, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr et al (2004) A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 350(20):2050–2059. (PMID: 15141043) Ptok H, Gastinger I, Bruns C, Lippert H (2014) Treatment reality with respect to laparoscopic surgery of colonic cancer in Germany. Chirurg 85(7):583–592. (PMID: 24924639) Raghunathan TE, Lepkowski JM, Van Hoewyk J, Solenberger P (2001) A multivariate technique for Multiply Imputing missing values using a sequence of regression models. Surv Methodol 27(1):85–95. Robert Koch Institute (2024). Cancer in Germany 2019/2020 [ https://www.krebsdaten.de/Krebs/EN/Content/Publications/Cancer_in_Germany/cancer_in_germany_node.html ]. Schunemann HJ, Reinap M, Piggott T, Laidmae E, Kohler K, Pold M, Ens B, Irs A, Akl EA, Cuello CA et al (2022) The ecosystem of health decision making: from fragmentation to synergy. Lancet Public Health 7(4):e378–e390. (PMID: 35366410) Schunemann HJ, Brennan S, Davoli M, Mustafa RA, Akl EA, Meerpohl JJ, Flottorp S, Rojas MX, Guyatt G, Langendam M et al (2022) Strong and high-quality evidence synthesis needs Cochrane: a statement of support by the GRADE Guidance Group. J Clin Epidemiol 152:285–287. (PMID: 36223813) Smith MJ, Mansournia MA, Maringe C, Zivich PN, Cole SR, Leyrat C, Belot A, Rachet B, Luque-Fernandez MA (2022) Introduction to computational causal inference using reproducible Stata, R, and Python code: a tutorial. Stat Med 41(2):407–432. (PMID: 34713468) Statistical Office of Mecklenburg-Western Pomerania (2024). Statistical Yearbook Mecklenburg-Western Pomerania 2024 [ https://www.laiv-mv.de/static/LAIV/Statistik/Dateien/Publikationen/Statistisches%20Jahrbuch/Z011%202024%2000.pdf ]. Suissa S (2008) Immortal time bias in pharmaco-epidemiology. Am J Epidemiol 167(4):492–499. (PMID: 18056625) Textor J, Hardt J, Knuppel S (2011) DAGitty: a graphical tool for analyzing causal diagrams. Epidemiology 22(5):745. (PMID: 21811114) The Cancer Registry of Mecklenburg-Western Pomerania (2024) [ https://www.kkr-mv.de/einzugsgebiete-registerstellen/ ]. Theophilus M, Platell C, Spilsbury K (2014) Long-term survival following laparoscopic and open colectomy for colon cancer: a meta-analysis of randomized controlled trials. Colorectal Dis 16(3):O75–81. (PMID: 24206016) Tonnies T, Kahl S, Kuss O (2022) Collider Bias in Observational studies. Dtsch Arztebl Int 119(7):107–122. (PMID: 349399189131185) van Buuren S, Boshuizen HC, Knook DL (1999) Multiple imputation of missing blood pressure covariates in survival analysis. Stat Med 18(6):681–694. (PMID: 10204197) VanderWeele TJ, Ding P (2017) Sensitivity analysis in Observational Research: introducing the E-Value. Ann Intern Med 167(4):268–274. (PMID: 28693043) Volkel V, Draeger T, Gerken M, Klinkhammer-Schalke M, Furst A (2018) Long-term oncologic outcomes after laparoscopic vs. open colon cancer resection: a high-quality population-based analysis in a southern German district. Surg Endosc 32(10):4138–4147. (PMID: 296029996132887) Voron T, Karoui M, Lo Dico R, Malicot KL, Espin E, Cianchi F, Jurgen W, Buggenhout A, Bruzzi M, Denimal F et al (2021) Impact of laparoscopy on oncological outcomes after colectomy for stage III colon cancer: a post-hoc multivariate analysis from PETACC8 European randomized clinical trial. Dig Liver Dis 53(8):1034–1040. (PMID: 34112615) White IR, Royston P (2009) Imputing missing covariate values for the Cox model. Stat Med 28(15):1982–1998. (PMID: 194525692998703) Zhang Y, Thamer M, Kshirsagar O, Herna`n MA (2019) Comparative Effectiveness Research Based on Observational Data to Emulate a Target Trial [ http://cerbot.org/ ]. |
| Contributed Indexing: | Keywords: Bias Analysis; Colon cancer; DAGs; Germany; Laparoscopic colectomy; Overall survival; Target trial emulation |
| Entry Date(s): | Date Created: 20250111 Date Completed: 20250111 Latest Revision: 20250526 |
| Update Code: | 20250526 |
| PubMed Central ID: | PMC11724780 |
| DOI: | 10.1007/s00432-024-06057-x |
| PMID: | 39798018 |
| Datenbank: | MEDLINE |
Full Text 
Full Text Finder 
Nájsť tento článok vo Web of Science Schreiben Sie den ersten Kommentar!