Publications by authors named "S M Lagarde"

203 Publications

Impact of menopausal status on kidney adaptation after unilateral nephrectomy for kidney donation in women.

J Nephrol 2021 Jun 1. Epub 2021 Jun 1.

Explorations Fonctionnelles Physiologiques, Hôpital Rangueil, CHU de Toulouse, Toulouse, France.

Introduction: Although living kidney donation is not a high-risk surgery, there is still a need to identify situations at risk of kidney disease after uninephrectomy. Estrogens exhibit a protective role against various nephropathies. The aim of this study was to assess renal adaptation following nephrectomy according to menopausal status in women.

Methods: A prospective bicentric study including living women donors measured glomerular filtration rate (GFR) (inulin or Cr-EDTA clearances) and kidney volume (using CT-scan and 3-dimensional reconstruction), before and after 1-year post-uninephrectomy. Renal adaptation was compared according to menopausal status.

Results: Sixteen non-menopausal women and 18 menopausal women were included. One year following uninephrectomy, the mean decrease in GFR (global population) was - 32 ± 12 ml/min/1.73 m, and the mean increase in remnant kidney volume was + 32 ± 13 cm/1.73 m. No significant difference was observed between the two groups for both the decrease in GFR (-32.9 ± 13.3 in non-menopausal vs - 31.5 ± 9.9 in menopausal, ml/min/1.73 m, p = 0.84), and the increase in kidney volume (+ 36.1 ± 13.4 in non-menopausal vs + 28.1 ± 12.5 in menopausal, cm/1.73 m, p = 0.09).

Discussion: Menopausal status did not influence kidney adaptation following uninephrectomy, and in this respect is not a potential limiting factor for living kidney donation.
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http://dx.doi.org/10.1007/s40620-021-01067-1DOI Listing
June 2021

Updated protocol of the SANO trial: a stepped-wedge cluster randomised trial comparing surgery with active surveillance after neoadjuvant chemoradiotherapy for oesophageal cancer.

Trials 2021 May 17;22(1):345. Epub 2021 May 17.

Department of Surgery, Erasmus MC Cancer Institute, Erasmus University Medical Centre, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands.

Background: The Surgery As Needed for Oesophageal cancer (SANO) trial compares active surveillance with standard oesophagectomy for patients with a clinically complete response (cCR) to neoadjuvant chemoradiotherapy. The last patient with a clinically complete response is expected to be included in May 2021. The purpose of this update is to present all amendments to the SANO trial protocol as approved by the Institutional Research Board (IRB) before accrual is completed.

Design: The SANO trial protocol has been published ( https://doi.org/10.1186/s12885-018-4034-1 ). In this ongoing, phase-III, non-inferiority, stepped-wedge, cluster randomised controlled trial, patients with cCR (i.e. after neoadjuvant chemoradiotherapy no evidence of residual disease in two consecutive clinical response evaluations [CREs]) undergo either active surveillance or standard oesophagectomy. In the active surveillance arm, CREs are repeated every 3 months in the first year, every 4 months in the second year, every 6 months in the third year, and yearly in the fourth and fifth year. In this arm, oesophagectomy is offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant metastases. The primary endpoint is overall survival.

Update: Amendments to the study design involve the first cluster in the stepped-wedge design being partially randomised as well and continued accrual of patients at baseline until the predetermined number of patients with cCR is reached. Eligibility criteria have been amended, stating that patients who underwent endoscopic treatment prior to neoadjuvant chemoradiotherapy cannot be included and that patients who have highly suspected residual tumour without histological proof can be included. Amendments to the study procedures include that patients proceed to the second CRE if at the first CRE the outcome of the pathological assessment is uncertain and that patients with a non-passable stenosis at endoscopy are not considered cCR. The sample size was recalculated following new insights on response rates (34% instead of 50%) and survival (expected 2-year overall survival of 75% calculated from the moment of reaching cCR instead of 3-year overall survival of 67% calculated from diagnosis). This reduced the number of required patients with cCR from 264 to 224, but increased the required inclusions from 480 to approximately 740 patients at baseline.

Conclusion: Substantial amendments were made prior to closure of enrolment of the SANO trial. These amendments do not affect the outcomes of the trial compared to the original protocol. The first results are expected late 2023. If active surveillance plus surgery as needed after neoadjuvant chemoradiotherapy for oesophageal cancer leads to non-inferior overall survival compared to standard oesophagectomy, active surveillance can be implemented as a standard of care.
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http://dx.doi.org/10.1186/s13063-021-05274-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8127221PMC
May 2021

Patient-reported outcomes after oesophagectomy in the multicentre LASER study.

Br J Surg 2021 May 11. Epub 2021 May 11.

Oesophago-gastric Centre, Churchill Hospital, University of Oxford, Oxford, UK.

Background: Data on the long-term symptom burden in patients surviving oesophageal cancer surgery are scarce. The aim of this study was to identify the most prevalent symptoms and their interactions with health-related quality of life.

Methods: This was a cross-sectional cohort study of patients who underwent oesophageal cancer surgery in 20 European centres between 2010 and 2016. Patients had to be disease-free for at least 1 year. They were asked to complete a 28-symptom questionnaire at a single time point, at least 1 year after surgery. Principal component analysis was used to assess for clustering and association of symptoms. Risk factors associated with the development of severe symptoms were identified by multivariable logistic regression models.

Results: Of 1081 invited patients, 876 (81.0 per cent) responded. Symptoms in the preceding 6 months associated with previous surgery were experienced by 586 patients (66.9 per cent). The most common severe symptoms included reduced energy or activity tolerance (30.7 per cent), feeling of early fullness after eating (30.0 per cent), tiredness (28.7 per cent), and heartburn/acid or bile regurgitation (19.6 per cent). Clustering analysis showed that symptoms clustered into six domains: lethargy, musculoskeletal pain, dumping, lower gastrointestinal symptoms, regurgitation/reflux, and swallowing/conduit problems; the latter two were the most closely associated. Surgical approach, neoadjuvant therapy, patient age, and sex were factors associated with severe symptoms.

Conclusion: A long-term symptom burden is common after oesophageal cancer surgery.
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http://dx.doi.org/10.1093/bjs/znab124DOI Listing
May 2021

Pattern of recurrence in patients with a pathologically complete response after neoadjuvant chemoradiotherapy and surgery for oesophageal cancer.

BJS Open 2021 03;5(2)

Department of Surgery, Erasmus MC University Medical Centre, Rotterdam, the Netherlands.

Background: Neoadjuvant chemoradiotherapy (nCRT) and surgery is a widely used treatment for locally advanced resectable oesophageal cancer, with 20-50 per cent of patients having a pathological complete response (pCR). Disease, however, still recurs in 20-30 per cent of these patients. The aim of this study was to assess the pattern of recurrence in patients with a pCR after nCRT and surgery.

Methods: All patients with a pCR after nCRT and surgery included in the phase II and III CROSS (ChemoRadiotherapy for Oesophageal followed by Surgery Study) trials (April 2001 to December 2008) and after the CROSS trials (September 2009 to October 2017) were identified. The site of recurrence was compared with the applied radiation and surgical fields. Outcomes were median time to recurrence, and overall and progression-free survival.

Results: A total of 141 patients with a median follow-up of 100 (i.q.r. 64-134) months were included. Some 29 of 141 patients (20,6 per cent) developed recurrence. Of these, four had isolated locoregional recurrence, 15 had distant recurrence only, and ten had both locoregional and distant recurrence. Among the 14 patients with locoregional recurrences, five had recurrence within the radiation field, seven outside the radiation field, and two at the border. Median time to recurrence was 24 (10-62) months. The 5-year overall survival rate was 74 per cent and the recurrence-free survival rate was 70 per cent.

Conclusion: Despite good overall survival, recurrence still occurred in 21 per cent of patients. Most recurrences were distant, outside the radiation and surgical fields.
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http://dx.doi.org/10.1093/bjsopen/zrab022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8055760PMC
March 2021