Zuyderland Medisch Centrum

'Breast Implant Illness' (BII) refers to non-specific constitutional, rheumatic, mental and cognitive symptoms experienced by women with silicone breast implants (SBIs). This potential late effect of SBIs challenges the safety of SBI-use in oncologic breast reconstruction (BR). Previous studies on BII mainly focused on women with cosmetic SBIs. It remains unclear whether symptoms reported in this population differ from those reported by breast cancer (BC) survivors with SBI-based BR. We conducted a cross-sectional survey in a Dutch cohort including 578 breast augmentation recipients and 2,884 BC survivors, of whom 1,039 had an SBI-based BR. Eighteen BII-related symptoms were assessed. Multivariable logistic regression was used to compare breast augmentation recipients with BC survivors with and without SBIs. Median follow-up time was 8.0 (IQR, 3.9) years. Overall, breast augmentation recipients had a higher risk of myalgia (Odds ratio (OR) 2.10, 95%CI [1.25-3.54]) and food intolerance (OR 1.77, 95%CI [1.01-3.09]) than BC survivors with SBIs, whereas the latter group did not report more BII-associated symptoms than BC survivors without SBIs. In a sensitivity analysis excluding BC patients treated with (neo)adjuvant systemic therapy, breast augmentation recipients reported more BII-related symptoms-headache, myalgia, hair loss, muscle weakness, sleep impairment, and morning stiffness (ORs 1.69-3.35; all p < 0.05) compared to BC survivors with SBIs. Breast augmentation recipients report more BII-related symptoms than BC survivors with or without SBIs. These findings do not support the hypothesis that BII is a distinct disease entity mediated by a generic SBI-related pathogenesis that exists across different populations.Trial registration: This study was preregistered at ClinicalTrials.gov on June 2 nd 2022 (NCT05400954).

Extremely preterm birth (24–28 weeks of gestation) carries high perinatal risk. While intrapartum cardiotocography (CTG) is routinely used at term, its interpretation in extremely preterm birth remains unclear. This study aims to explore the relationship between intrapartum CTG characteristics and perinatal outcomes in extremely preterm birth. An exploratory retrospective cohort study, part of the NIEM-O study, was conducted at the Obstetrics Department of a tertiary referral hospital. Intrapartum CTG recordings of 73 women with a spontaneous onset of birth between 24 and 28 weeks of gestation were included. Signal loss (n = 73) and CTG characteristics during the last hour of the first stage of labor (n = 55), and during second stage of labor (n = 24) were assessed using computerized analysis. CTG characteristics (baseline fetal heart rate, heart rate variability, accelerations, decelerations, uterine contractions, and combinations of these characteristics) were compared between fetuses with neonatal outcome of low 5-minute Apgar score (< 7) and a group with 5-minute Apgar score > 7. CTG tracings in preterm fetuses frequently displayed recognizable features, including baseline variability (median 18 bpm) and both accelerative (median five/hour) and decelerative (median 11/hour) responses. Preterm fetuses with a low 5-minute Apgar score (n = 20) exhibited significantly more variable decelerations (median 14/hour vs. six/hour) and uterine contractions (19/hour vs. 13/hour), compared to those without this outcome. CTG characteristics commonly described as indicators of hypoxia in term fetuses were not consistently observed in the studied preterm population. Although CTG features were often identifiable in preterm fetuses, their presentation differed from those commonly described at term, particularly in those with low 5-minute Apgar score. These findings highlight the need for gestational age-specific CTG reference ranges. Adapting CTG interpretation to reflect the unique physiology of this group is essential for improving timely clinical decision-making and reducing perinatal morbidity and mortality. Registered on 22 November 2023 in Clinicaltrails.gov (Number: NCT06151613) via https://clinicaltrials.gov/study/NCT06151613 and on 18 October 2022 to the Central Committee on Research Involving Human Subjects (NL82869.015.22).

Qualitative motion analysis revealed that the cervical spine moves according to a consistent pattern. Current data analysis methods are limited by the extensive time required to process the retrieved data. A previous study demonstrated the feasibility of using a deep-learning model to automate analysis methods. However, segmentation accuracy needed to be improved. This study aims to improve segmentation model performance to enable reliable motion analysis. Four nnU-Net configurations were tested: baseline (A), pre-trained (B), with histogram equalization (C), and pre-trained with histogram equalization (D). Segmentation performance was evaluated using Dice Similarity Coefficient (DSC), Intersection over Union (IoU) and 95th percentile Hausdorff Distance (HD95). Vertebral rotation was estimated using mean shapes. Reliability was assessed using the Intraclass Correlation Coefficient (ICC). Sensitivity analyses were conducted. Across all models, mean DSC ranged from 0.67 to 0.92, mean IoU from 0.55 to 0.85, and mean HD95 from 2.35 to 19.67 mm. After sensitivity analysis for low segmental range of motion (sROM) and low-quality recordings, the mean ICC ranged from 0.617 to 0.837 for model A, from 0.609 to 0.780 for model B, from 0.409 to 0.689 for model C, and from 0.480 to 0.835 for model D. This study shows that Models A and B can accurately analyze cervical motion patterns. High image contrast and an adequate sROM are essential for robust model performance. It also marks an important step toward automated qualitative motion analysis, increasing the accessibility of motion pattern evaluation.

ObjectiveTo compare the effects of percutaneous nephrostomy (PCN) and JJ ureteric stent (JJ) for urinary tract decompression in patients with obstructive urolithiasis on health‐related quality of life (HRQoL), pain scores, urinary symptoms, and patient satisfaction.Patients and MethodsIn 11 hospitals, 204 patients with obstructive urolithiasis were randomised to JJ or PCN placement. Patient‐reported outcome measures (PROMs) were assessed until stone passage, surgical removal, or at 3 months.ResultsBoth PCN and JJ effectively improved HRQoL index scores (PCN: pre‐decompression 0.70, 1 day post‐decompression 0.82, P = 0.003; JJ: pre 0.59, post 0.85, P < 0.001), pain scores (PCN: pre 4.9, post 1.3, P < 0.001; JJ: pre 5.5, post 1.3, P < 0.001), and achieved patient satisfaction (score at discharge PCN: 7.9; JJ: 8.2), with no significant differences between interventions in overall HRQoL (generalised estimating equation [GEE] P = 0.7) or mean daily pain scores (GEE P = 0.4). PCN led to more self‐care difficulties (patients reporting no problems: PCN 74%, JJ 91%, P = 0.023), while JJ recipients reported more urinary symptoms and higher peak pain intensity (pain score PCN: 2.3, JJ: 3.7, between groups P = 0.018). Despite symptoms, more JJ recipients preferred the same intervention in future (60%), than PCN recipients (31%) (P < 0.001). Survey‐based data collection may introduce response bias (response rate 59%).ConclusionIn patients with obstructive urolithiasis, urinary decompression with PCN and JJ improved HRQoL and pain comparably. JJ causes more urinary symptoms and peak pain but allows better self‐care. Baseline self‐care and urinary symptoms should guide shared decision‐making. Drainage duration should be minimised.

With the growing adoption and implementation of vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES), structured hands-on simulation practice is essential for the training of gynecologists and residents. This study compares the performance of validated surgical tasks using a conventional multiport laparoscopy box and a single-port vNOTES box. Additionally, participants' experiences and task load for each training modality were evaluated. This multi-center, prospective comparative study included three groups: medical students and inexperienced gynecological residents (n = 15), gynecological residents (n = 15), and gynecologists (n = 15). Participants performed four validated laparoscopic skill tests on both the conventional laparoscopy box and the vNOTES box. For each task and box, total task time, number of errors, and total scores were recorded. Questionnaires regarding baseline characteristics, preferred box for hand-eye coordination, depth perception, and instrument handling, as well as task load (NASA Task Load Index scores) for both boxes were evaluated. A total of 45 participants were included, 35 females (77.8%) and 10 males (22.2%), with a mean age of 34.2years (SD 11.1). Across all four tasks, the use of the vNOTES box was associated with less favorable scores in terms of task time, error rates, and total scores compared to the conventional laparoscopy box. In addition, the laparoscopy box was favored for depth perception (86.7%), hand-eye coordination (91.1%) and instrument usage (97.8%). The vNOTES box was associated with higher scores across all NASA Task Load Index domains, indicating it was more demandingoverall. This study demonstrates that performing standardized surgical tasks using the vNOTES technique is significantly more challenging than with conventional laparoscopy, resulting in higher task load and inferior performance across all experience levels. These findings underline the need for tailored training, as existing laparoscopic skills do not directly translate to vNOTES proficiency. Future research should develop and validate vNOTES simulation exercises.

BackgroundPancreatic cancer treatment significantly impacts patients’ quality of life, making both safety and patient preference key considerations. Central venous access devices (CVADs) are indispensable for chemotherapy administration in pancreatic cancer, yet device selection varies widely. This study explored which CVADs oncology specialists use in pancreatic cancer care, focusing on the basis for their recommendations.Materials and methodsA nationwide expert survey was distributed among Dutch medical oncologists and nurse specialists involved in pancreatic cancer care via the Dutch Pancreatic Cancer Group, the Dutch Association for Medical Oncology, the Dutch association for nurses, and the study committee’s network.ResultsNinety-one clinicians responded. Most (88%) had access to both port-a-caths (PORTs) and peripherally inserted central catheters (PICCs), while 12% could only offer one device. Decision-making autonomy varied: 53% reported full autonomy, while others followed hospital-wide preferences (39%) or guidelines (9%). Even within these subgroups, preferred CVAD varied greatly. Although 60% listed patient preference among the top five influential factors, only 28% incorporated patients in that decision. Logistical constraints were key barriers influencing device choice.ConclusionSubstantial variability exists in CVAD selection, availability, and clinician autonomy in pancreatic cancer care. While evidence supports PORTs as the safer option, PICCs remain widely used in daily practice. This discrepancy appears driven by disease-specific and logistical factors, including poor prognosis and uncertainty regarding treatment tolerance. Addressing real-world barriers through improved access to PORTs, clearer guideline recommendations, and enhanced patient counseling may help align clinical practice with evidence and ensure high-quality care for patients receiving chemotherapy.

Abstract Background: In early-stage breast cancer, surgical de-escalation from axillary lymph node dissection (ALND) to sentinel lymph node biopsy (SLNB) did not compromise oncologic safety. This has led to the realization that SLNB predominantly provides prognostic information and may itself not influence recurrence or survival. The BOOG 2013-08 trial was therefore designed to evaluate whether omission of SLNB in clinically T1-2N0 patients treated with breast-conserving surgery and whole-breast irradiation (summarized together as BCT) is safe with respect to regional recurrence rates (RR) and distant disease-free survival (DDFS). Methods: The BOOG 2013-08 (NCT02271828) is a multicenter, non-inferiority, randomized phase-3 trial including women with unilateral cT1-2N0 breast cancer treated with BCT. Clinically node-negative was based on negative findings on physical examination and preoperative axillary ultrasound (including negative cyto- or histopathology in case of a suspicious findings). The trial was conducted in the Netherlands between 2015 and 2022 across 25 centers. Patients were randomized (1:1) to SLNB or omission of SLNB. Randomization was stratified by clinical tumor size (&amp;lt;3 cm vs ≥3 cm), histological grade (grade I-II vs III), hormone receptor status (HR), HER2 status, age (≤50, 50 ≤ 75, &amp;gt;75 years), primary systemic therapy (PST) and participating center. The primary endpoint was 5-year RR; secondary endpoints as presented here were 3-year RR and DDFS. Cumulative probabilities of RR and DDFS were estimated using the Kaplan-Meier method. Non-inferiority was defined as an absolute difference in RR ≤5% in favor of the control group at 5 years. Analyses were performed per-protocol. Results: A total of 1,733 patients were enrolled across 25 centers. After excluding 159 patients (n=106 due to radiation therapy protocol violations), 1574 patients were included (SLNB: n=749; no-SLNB: n=825). At the time of analysis, 100% of patients had reached 3 years and 73% 5-year follow-up. Median follow-up was 5.0 years (range 0.78-6.86, IQR 1.94). Mean age was 61.5 years, 83% had cT1 tumors and 17% cT2 tumors. Tumor grade was I in 28.7%, II in 54.1% and III in 17.2%. Breast cancer subtype was HR+HER2- in 86.8%, triple negative in 5.8% and HER2+ in 7.4% of patients. In the SLNB arm, micro- and macrometastatic disease was detected in 6.0% and 7.7%, respectively. Preliminary data at a median 5-year follow-up showed that the estimated probability of RR was 0.5% in the SLNB arm (95% CI 0.0-1.1) and 1.2% in the no-SLNB arm (95% CI 0.4-2.0), corresponding to an absolute difference of 0.7% (95% CI -0.3 to 1.7). The confidence interval ranges from -0.3 to 0.7, indicating that the 5% non-inferiority margin is not exceeded. Five-year DDFS was 98.3% (95% CI 97.3-99.3) in the SLNB arm versus 96.1% (95% CI 94.5-97.7) in the no-SLNB arm (log-rank p=0.071).Chemo- or endocrine therapy was administered in 11.3% of patients as PST (12.3% SLNB arm vs. 10.3 no-SLNB arm, p=0.214). In total, 50.0% of patients received systemic therapy (51.2% SLNB vs. 49.0% no-SLNB, p 0.202). Of these 50.0%, 39.4% received chemotherapy with or without targeted therapy. Among ER-positive patients, adjuvant endocrine therapy was administered in 48.6% (SLNB) and 46.6% (no-SLNB), p=0.732, while chemotherapy was given in 9.8% and 8.2%, respectively (p=0.532). Conclusions: In cT1-2N0 breast cancer patients treated with BCT, omission of SLNB resulted in a non-inferior median 5-year RR and DDFS compared with SLNB. These premature findings support the omission of SLNB, at least in case of cT1N0, ER+, grade 1-2 breast cancer. This study further demonstrates that adjuvant hormonal therapy should not be a prerequisite for omission of the SLNB. Citation Format: R. J. Schipper, L. M. van Roozendaal, V. M. Wintraecken, J. M. Simons, M. Moossdorff, E. J. T. Luiten, F. van Duijnhoven, L. de Munck, L. F. C. Dols, R. Koelemij, R. van Eekeren, A. B. Francken, T. van Dalen, K. Keymeulen, J. Volders, J. A. van der Hage, H. Torrenga, P. A. Neijenhuis, P. Nijhuis, D. van Uden, E. Heuts, M. A. Bessems, C. D. Dirksen, M. H. Martens, M. F. Bouwmeester, K. Schenk, A. V. R. J. Bell, S. Maaskant-Braat, L. J. A. Strobbe, S. C. Linn, P. M. P. Poortmans, M. L. G. Vane, V. C. G. Tjan-Heijnen, K. K. B. T. van der Vijver, M. B. I. Lobbes, J. de Vries, L. Emelianova-Hiddink, J. Kandt, L. J. Boersma, J. H. W. de Wilt, S. M. J. van Kuijk, M. L. Smidt, BOOG 2013-08 Study Group. Omission of sentinel lymph node biopsy in clinically T1-2 node-negative breast cancer patients treated with breast-conserving therapy: results of the Dutch BOOG 2013-08 randomized controlled trial after a median follow-up of 5 years [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr GS2-11.

Current guidelines recommend adding local radical therapy (LRT) to systemic treatment in synchronous oligometastatic non-small-cell lung cancer (sOM-NSCLC), but survival data on immunotherapy-based regimens are limited. Metabolic tumor volume (MTV) and total lesion glycolysis (TLG) are prognostic in NSCLC, with higher values linked to worse outcomes. This study examines their association with survival in sOM-NSCLC patients treated with immunotherapy. We conducted a multicenter retrospective study including all consecutive patients with [18F]FDG-PET and brain imaging-staged sOM-NSCLC, between 2015 and 2022, who received first-line (chemo)-immunotherapy and had baseline PET-scan available for review. Subgroups were analyzed based on median MTV and TLG values (high vs. low: H-MTV vs. L-MTV, H-TLG vs. L-TLG). Study endpoints were progression-free survival (PFS) and overall survival (OS), according to MTV and TLG distribution (high vs. low), in the overall population (primary endpoint) and in relation to LRT and systemic treatment type (secondary endpoints). 105 patients were included, 50% were male and 73% had non-squamous histology, median age was 64.9 years. Median PFS was significantly longer for L-MTV vs. H-MTV (14.73 months (95%CI, 7.06-22.40) vs. 7.63 months (95%CI, 5.73-9.52), p = 0.028), but also LRT was associated with PFS (19.04 months (95%CI, 8.47-29.60) versus 7.46 months (95%CI, 5.25-9.67), p = 0.045), while neither MTV nor TLG had impact on OS. In multivariate analysis, only PD-L1 < 50% and soft tissue metastases remained significantly associated with shorter PFS. Baseline MTV is preliminarily associated with PFS in sOM-NSCLC patients treated with immunotherapy, but results are exploratory and need prospective validation in larger cohorts.