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Sökning: WFRF:(Palsdottir Kolbrun)

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1.
  • Falconer, Henrik, et al. (författare)
  • Robot-assisted approach to cervical cancer (RACC) : An international multi-center, open-label randomized controlled trial
  • 2019
  • Ingår i: International Journal of Gynecological Cancer. - : Wiley-Blackwell. - 1048-891X .- 1525-1438. ; 29:6, s. 1072-1076
  • Tidskriftsartikel (refereegranskat)abstract
    • Background Radical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally invasive surgery is inferior to laparotomy with regards to disease-free and overall survival. Primary Objective To investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy. Study Hypothesis Robot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes. Trial Design Prospective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden. Major Inclusion/Exclusion Criteria Women over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years. Primary Endpoint Recurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer. Sample Size The clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (α) of 5% and a power (1-β) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients. Estimated Dates for Completing Accrual and Presenting Results Trial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter. Trial Registration The trial is registered at ClinicalTrials.gov (NCT03719547).
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  • Pálsdóttir, Kolbrún (författare)
  • The role of new ultrasound modalities to refine the diagnostic workup on women with cervical carcinoma
  • 2019
  • Doktorsavhandling (övrigt vetenskapligt)abstract
    • Background: Cervical cancer is the fourth most common female cancer in the world and has traditionally been clinically staged not including imaging. Despite that, clinicians depend on diagnostic imaging in the management of patients to triage them to treatment. Ultrasonography (US) is the most widely used diagnostic imaging technique by gynecologists worldwide and is equally accurate as Magnetic resonance imaging (MRI) for local assessment of cervical cancer in the pelvis in low volume disease, whereas both methods lack accuracy for detection of lymph node metastasis. New ultrasound modalities such as three-dimensional ultrasonography (3D US), contrast-enhanced ultrasonography (CEUS) and strain elastography (SE) have shown promising results in the assessment of tumours, but the clinical value in cervical cancer patients is uncertain. The aims of this thesis were to explore the clinical value of 3D US, CEUS and SE and to assess the inter-rater agreement of conventional US and MRI in the assessment of patients with cervical cancer. Methods: Study I was a multicenter study including 104 women with surgically resectable cervical cancer from 5 European institutions. Studies II-IV were based on a single center cohort of 93 women with all stages of cervical cancer, from Karolinska University Hospital. In study I subjective evaluation was compared to objective measurements of 2D and 3D US parameters for prediction of deep stromal and parametrial invasion as well as lymph node metastases. In study II semi-quantitative parameters and filling pattern of CEUS were compared in 49 patients with cervical cancer and 21 healthy controls. The features of SE in 30 patients with all stages of cervical cancer were explored in study III. In study IV the inter-rater agreement of raters with varying experience on US and MRI were compared in off-line settings for the assessment of cervical tumours in a cohort of 60 patients with all stages of cervical cancer. Results: Subjective assessment with 2D US had high accuracy to detect deep stromal and parametrial invasion (sensitivity 91% and 100%; specificity 97% and 95% respectively) but not to predict lymph node metastases. Tumour size measured by 2D and volume measured by 3D US were accurate to predict deep stromal invasion (AUC 0.83 and 0.85) but outperformed by subjective assessment. 3D vascular indices (VI, VFI, FI) had no value to predict deep stromal invasion or lymph node metastases. A focal CEUS pattern had a higher specificity 91% versus 73% (p=0.62) and a similar sensitivity 80% versus 85% (p=1.00) compared to subjective assessment using conventional US for tumour detection. The semi-quantitative CEUS parameter area under the time intensity curve had high accuracy to separate tumour lesions from healthy stroma (AUC 0.923, p<0.001). Size measures of early stage tumours were accurate with SE (mean difference -0.11 mm, p=0.66) with no bias found. An elasticity score of 4-5 was found in 45% (9/20) with early stage and 80% (8/10) with advanced disease where SE was even useful in 7/10 (70%) of cases to delineate tumour borders. The inter-rater agreement for tumour visualization, 1/3 deep stromal and parametrial invasion was moderate for US raters (0.4-0.6) and moderate-good (0.4-0.8) for MRI raters irrespective of experience. Conclusion: Subjective 2D US assessment is accurate for detecting deep stromal and parametrial invasion where it outperforms objective measurements with 2D and 3D vascular indices. A focal contrast pattern with CEUS has high specificity and high accuracy for tumour detection. SE is accurate to measure tumour size and may improve delineation of advanced tumours. In off-line settings, inter-rater agreement is moderate for US raters and moderate-good for MRI raters irrespective of experience.
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