IGT Baeten

The influence of learning curve of robot‐assisted laparoscopy on oncological outcomes in early‐stage cervical cancer: an observational cohort study

ObjectiveTo investigate the learning curve of robot‐assisted laparoscopy in early‐stage cervical cancer and quantify impact on oncological outcomes.DesignObservational cohort study.SettingTertiary referral centre with one surgical team.PopulationAll women with early‐stage cervical cancer treated consecutively with robot‐assisted laparoscopy between 2007 and 2017.MethodsWith multivariate risk‐adjusted cumulative sum analysis (RA‐CUSUM), we assessed the learning curve of robot‐assisted laparoscopy of a single surgical team based on cervical cancer recurrence. Subsequently, a survival analysis was conducted comparing oncological outcomes of women treated during different phases of the learning curve.Main outcome measuresSurgical proficiency based on recurrence, survival rates in the different learning phases.ResultsOne hundred and sixty‐five women with cervical cancer underwent robot‐assisted laparoscopy, with a median follow up of 57 months (range 3–132 months). The RA‐CUSUM analysis demonstrated two phases of the learning curve: a learning phase of 61 procedures (group 1) and an experienced phase representing the 104 procedures thereafter (group 2). The 5‐year disease‐free survival was 80.2% in group 1 and 91.1% in group 2 (P = 0.040). Both the 5‐year disease‐specific survival and overall survival significantly increased after the learning phase.ConclusionThe learning phase of robot‐assisted laparoscopy in early‐stage cervical cancer in this institutional cohort is at least 61 procedures, with higher survival rates in the women treated thereafter. The learning curve of robot‐assisted laparoscopy affects oncological outcomes and warrants more attention in the design of future studies.Tweetable abstractThe learning curve of robot‐assisted laparoscopy in early‐stage cervical cancer affects oncological outcomes and warrants more attention.

Indocyanine green versus technetium‐99m with blue dye for sentinel lymph node detection in early‐stage cervical cancer: A systematic review and meta‐analysis

AbstractBackgroundThe fluorescent dye indocyanine green (ICG) has emerged as a promising tracer for intraoperative detection of sentinel lymph nodes (SLNs) in early‐stage cervical cancer. Although researchers suggest the SLN detection of ICG is equal to the more conventional combined approach of a radiotracer and blue dye, no consensus has been reached.AimsWe aimed to assess the differences in overall and bilateral SLN detection rates with ICG versus the combined approach, the radiotracer technetium‐99m (99mTc) with blue dye.Methods and ResultsWe searched MEDLINE, Embase, and the Cochrane Library from inception to January 1, 2020 and included studies reporting on a comparison of SLN detection with ICG versus 99mTc with blue dye in early‐stage cervical cancer. The overall and bilateral detection rates were pooled with random‐effects meta‐analyses.From 118 studies retrieved seven studies (one cross‐sectional; six retrospective cohorts) were included, encompassing 589 patients. No significant differences were found in the pooled overall SLN detection rate of ICG versus 99mTc with blue dye. Meta‐analyses of all studies showed ICG to result in a higher bilateral SLN detection rate than 99mTc with blue dye; 90.3% (95%CI, 79.8‐100.0%) with ICG versus 73.5% (95%CI, 66.4‐80.6%) with 99mTc with blue dye. This resulted in a significant and clinically relevant risk difference of 16.6% (95%CI, 5.3‐28.0%). With sensitivity analysis, the risk difference of the bilateral detection rate maintained in favor of ICG but was no longer significant (13.2%, 95%CI −0.8‐27.3%).ConclusionICG appears to provide higher bilateral SLN detection rates compared to 99mTc with blue dye in patients with early‐stage cervical cancer. However, in adherence with the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) guidelines, the quality of evidence is too low to provide strong recommendations and directly omit the combined approach of 99mTc with blue dye.

Fluorescent Indocyanine Green versus Technetium-99m and Blue Dye for Bilateral SENTinel Lymph Node Detection in Stage I–IIA Cervical Cancer (FluoreSENT): protocol for a non-inferiority study

Introduction Nowadays, two predominant methods for detecting sentinel lymph nodes (SLNs) in cervical cancer are in use. The most conventional method is a combination of a radiotracer, technetium-99m ( 99m Tc) and blue dye. More recently, another method for SLN mapping using indocyanine green (ICG) is becoming widely accepted. ICG is a fluorescent dye, visualised intraoperatively with near-infrared (NIR) fluorescence imaging, providing real-time visual navigation. The presumed advantages of ICG over 99m Tc, that is, being cheaper, non-radioactive and logistically more attractive, are only valuable if its detection rate proves to be at least non-inferior. Before omitting the well-functioning and evidence-based combined approach of 99m Tc and blue dye, we aim to provide prospective evidence on the non-inferiority of ICG with NIR fluorescence imaging. Methods and analysis We initiated a prospective non-inferiority study with a paired comparison of both SLN methods in a single sample of 101 patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA–IB2 or IIA1 cervical cancer receiving primary surgical treatment. All patients undergo SLN mapping with ICG and NIR fluorescence imaging in adjunct to mapping with 99m Tc (including single photon emission computed tomography with X-ray computed tomography (SPECT/CT)) and blue dye. Surgeons start SLN detection with ICG while being blinded for the preoperative outcome of SPECT/CT to avoid biased detection with ICG. Primary endpoint of this study is bilateral SLN detection rate of both methods (ie, detection of at least one SLN in each hemipelvis). Since we compare strategies for SLN mapping that are already applied in current daily practice for different types of cancer, no additional risks or burdens are expected from these study procedures. Ethics and dissemination The current study is approved by the Medical Ethics Research Committee Utrecht (reference number 21–014). Findings arising from this study will be disseminated in peer-reviewed journals, academic conferences and through patient organisations. Trial registration number NL9011 and EudraCT 2020-005134-15.