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In PDAC patients, ctDNA detection’s prognostic significance needs validation especially in resected patients. This study investigated ctDNA kinetics in portal and peripheral blood before and after resection, and whether tissue mobilization during surgery influences ctDNA detection. In this single-center prospective cohort, portal and peripheral blood were drawn during pancreaticoduodenectomy before and after tissue mobilization, during 12 postoperative months and were associated with overall survival (OS), recurrence-free survival (RFS) and CA19-9 (secondary endpoints). Tumor mutations were identified using next-generation-sequencing and ctDNA detected by digital droplet PCR. From 2018 to 2022, 34 patients were included. The 2-year RFS and OS were 47.6%(95%CI[29.5; 63.6]) and 65.7%(95%CI[46.5; 79.4]) respectively. Intraoperatively, ctDNA detection in portal or peripheral blood was associated with worse RFS (HR[95%CI]3.26[1.26; 8.45],p = 0.010) and OS (HR[95%CI]5.46[1.65;18.01],p = 0.002). Portal vein sampling did not improve ctDNA detection. CtDNA levels were increased by 2.5-fold (p = 0.031) in peripheral blood after tissue mobilization but not significantly linked to RFS or OS. Detecting ctDNA intraoperatively was correlated with poorer RFS (HR [95% CI] 3.26 [1.26;8.45], p = 0.010) and 0S (HR [95% CI] 5.46 [1.65;18.01], p = 0.002). Portal vein sampling did not improve ctDNA detection. Tissue mobilization increases ctDNA levels. Intraoperative detection of ctDNA is associated with a worse prognosis.

Background Pancreatic cancer, predominantly characterized by ductal adenocarcinoma (PDAC) accounts for 90% of cases and is the fourth leading cause of cancer-related deaths globally. Its incidence is notably increasing. This poor prognosis is primarily due to late-stage diagnosis (approximately 70% to 80% of patients are diagnosed at an advanced stage), aggressive tumor biology, and low sensitivity to chemotherapy. Consequently, it is crucial to identify and develop a simple, feasible and reproducible blood-based signature (i.e., combination of biomarkers) for early detection of PDAC. Methods The PANLIPSY study is a multi-center, non-interventional prospective clinical trial designed to achieve early detection of PDAC with high specificity and sensitivity, using a combinatorial approach in blood samples. These samples are collected from patients with resectable, borderline or locally advanced, and metastatic stage PDAC within the framework of the French Biological and Clinical Database for PDAC cohort (BACAP 2). All partners of the BACAP consortium are eligible to participate. The study will include 215 PDAC patients, plus 25 patients with benign pancreatic conditions from the PAncreatic Disease Cohort of TOuLouse (PACTOL) cohort, and 115 healthy controls, totaling 355 individuals. Circulating biomarkers will be collected in a total volume of 50 mL of blood, divided into one CellSave tube (10 mL), two CELL-FREE DNA BCT® preservative tubes (18 mL), and five EDTA tubes (22 mL in total). Samples preparation will adhere to the guidelines of the European Liquid Biopsy Society (ELBS). A unique feature of the study is the AI-based comparison of these complementary liquid biopsy biomarkers. Main end-points: i) to define a liquid biopsy signature that includes the most relevant circulating biomarkers, ii) to validate the multi-marker panel in an independent cohort of healthy controls and patients, with resectable PDAC, and iii) to establish a unique liquid biopsy biobank for PDAC study. Discussion The PANLIPSY study is a unique prospective non-interventional clinical trial that brings together liquid biopsy experts. The aim is to develop a biological signature for the early detection of PDAC based on AI-assisted detection of circulating biomarkers in blood samples (CTCs, ctDNA, EVs, circulating immune system, circulating cell-free nucleosomes, proteins, and microbiota). Trial registration ClinicalTrials.gov Identifier: NCT06128343 / NCT05824403. Registration dates: June 8,2023 and April 21, 2023.

Parkinson's disease (PD) is characterized by its impact on quality of life, constituting a substantial economic burden on society. Education programs implicating patients more in the management of their illness and complementing medical treatment may be a beneficial adjunct in PD. This study assessed the impact of an education program on quality of life and its cost-effectiveness in PD patients. This single-center, prospective, randomized study assessed an education program consisting of individual and group sessions over a 12-month period. A total of 120 PD patients were assigned to either the Treated by Behavioral Intervention group (TTBI) or the no TTBI group. The primary outcome criterion was quality of life assessed using PDQ39. The Unified Parkinson's Disease Rating Scale (UPDRS) and psychological status were collected. An economic evaluation was performed, including calculations of incremental cost-effectiveness ratios (ICERs). After 12 months of follow-up, changes recorded in the PDQ39 between the groups were not significantly different but better changes were observed in each dimension in the TTBI group compared to the no TTBI group. UPDRS I, II and total score were significantly improved in TTBI group compared to the no TTBI group. Mean annual costs did not differ significantly between the two groups. This study suggested that the education program positively impacts the perceived health of PD patients without increasing medical costs.

Surgery remains the only curative treatment for pancreatic ductal adenocarcinoma (PDAC). Therefore, a predictive score for resectability on diagnosis is needed. A total of 814 patients were included between 2014 and 2017 from 15 centers included in the BACAP (the national Anatomo-Clinical Database on Pancreatic Adenocarcinoma) prospective cohort. Three groups were defined: resectable (Res), locally advanced (LA), and metastatic (Met). Variables were analyzed and a predictive score was devised. Of the 814 patients included, 703 could be evaluated: 164 Res, 266 LA, and 273 Met. The median ages of the patients were 69, 71, and 69, respectively. The median survival times were 21, 15, and nine months, respectively. Six criteria were significantly associated with a lower probability of resectability in multivariate analysis: venous/arterial thrombosis (p = 0.017), performance status 1 (p = 0.032) or ≥ 2 (p = 0.010), pain (p = 0.003), weight loss ≥ 8% (p = 0.019), topography of the tumor (body/tail) (p = 0.005), and maximal tumor size 20–33 mm (p < 0.013) or >33 mm (p < 0.001). The BACAP score was devised using these criteria with an accuracy of 81.17% and an area under the receive operating characteristic (ROC) curve of 0.82 (95% confidence interval (CI): 0.78; 0.86). The presence of pejorative criteria or a BACAP score < 50% indicates that further investigations and even neoadjuvant treatment might be warranted. Trial registration: NCT02818829.

IntroductionAbdominoperineal resections performed for anorectal tumours leave a large pelvic and perineal defect causing a high rate of morbidity of the perineal wound (40%–60%). Biological meshes offer possibilities for new standards of perineal wound reconstruction. Perineal fillings with biological mesh are expected to increase quality of life by reducing perineal morbidity.Methods and analysisThis is a multicentre, randomised and single-blinded study with a blinded endpoint evaluation, the experimental arm of which uses a biological mesh and the control arm of which is defined by the primary closure after abdominoperineal resection for cancer. Patients eligible for inclusion are patients with a proven history of rectal adenocarcinoma and anal canal epidermoid carcinoma for whom abdominoperineal resection was indicated after a multidisciplinary team discussion. All patients must have social security insurance or equivalent social protection. The main objective is to assess the incremental cost–utility ratio (ICUR) of two strategies of perineal closure after an abdominoperineal resection performed for anorectal cancer treatment: perineal filling with biological mesh versus primary perineal closure (70 patient in each arm). The secondary objectives focus on quality of life and morbidity data during a 1-year follow-up. Deterministic and probabilistic sensitivity analyses will be performed in order to estimate the uncertainty surrounding the ICUR. CIs will be constructed using the non-parametric bootstrap approach. A cost-effectiveness acceptability curve will be built so as to estimate the probability of efficiency of the biological meshes given a collective willingness-to-pay threshold.Ethics and disseminationThe study was approved by the Regional Ethical Review Board of ‘Nord Ouest 1’ (protocol reference number: 20.05.14.60714; national number: 2020-A01169-30).The results will be disseminated through conventional scientific channels.Trial registration numberClinicalTrials.gov Registry (NCT02841293).

Patients with pancreatic cancer (PC) carry the highest risk of venous thromboembolism (VTE) amongst all cancer patients. Appropriate use of primary thromboprophylaxis might significantly and safely reduce its burden. We performed a systematic review of published studies and meeting abstracts using MEDLINE and EMBASE through July 2020 to evaluate the efficacy and safety of primary thromboprophylaxis in ambulatory PC patients receiving chemotherapy. The Mantel–Haenszel random effect model was used to estimate the pooled event-based risk ratio (RR) and the pooled absolute risk difference (RD) with a 95% confidence interval (CI). Five randomized controlled studies with 1003 PC patients were included in this meta-analysis. Compared to placebo, thromboprophylaxis significantly decreased the risk of VTE (pooled RR 0.31, 95% CI 0.19–0.51, p < 0.00001, I2 = 8%; absolute RD −0.08, 95% CI −0.12–−0.05, p < 0.00001, I2 = 0%), with an estimated number needed to treat of 11.9 patients to prevent one VTE event. Similar reductions of VTE were observed in studies with parenteral (RR 0.30, 95% CI 0.17–0.53) versus oral anticoagulants (RR 0.37, 95% CI 0.14–0.99) and in studies using prophylactic doses of anticoagulants (RR 0.34, 95% CI 0.17–0.70) versus supra-prophylactic doses of anticoagulants (RR 0.27, 95% CI 0.08–0.90). The pooled RR for major bleeding was 1.08 (95% CI 0.47–2.52, p = 0.85, I2 = 0%) and the absolute RD was 0.00 (95% CI −0.02–0.03, p = 0.85, I2 = 0%). Evidence supports a net clinical benefit of thromboprophylaxis in ambulatory PC patients receiving chemotherapy. Adequately powered randomized phase III studies assessing the most effective anticoagulant and the optimal dose, schedule and duration of thromboprophylaxis to be used are warranted.

Background: Data on the performance of the Khorana, PROTECHT, and ONKOTEV risk assessment models (RAMs) to predict venous thromboembolism (VTE) in patients with pancreatic cancer (PC) receiving outpatient chemotherapy remain limited. We performed a head-to-head comparison of these RAMs in patients with newly diagnosed PC enrolled in the nationwide, multicenter, and prospective BACAP cohort. Methods: The Khorana, PROTECHT, and ONKOTEV scores were calculated at enrollment prior to chemotherapy. Patients were stratified into intermediate- and high-VTE-risk groups according to each RAM. The primary study outcome was VTE at a 6-month follow-up. The accuracy and discriminatory performance of the scores were assessed by calculating time-dependent Brier scores and c-indexes. Sub-distribution hazard ratios (SHRs) between high- and intermediate-risk patients were estimated. Results: Of 762 PC patients, 73 developed VTE within 6 months. In the competing risk analysis, the cumulative incidence of VTE at 6 months was 16.4% (95% CI, 13.8–19.1). The time-dependent Brier score was 0.14 (95% CI, 0.12–0.15) for all scores, indicating well-calibrated predictions. The respective time-dependent c-index of the Khorana, the PROTECHT, and the ONKOTEV scores was 0.50 (95% CI, 0.46–0.55), 0.50 (95% CI, 0.49–0.51), and 0.53 (95% CI, 0.48–0.58), indicating poor discrimination. The SHRs between high- and intermediate-risk patients ranged from 1.05 (95% CI, 0.76–1.44) for the ONKOTEV score to 1.06 (95% CI, 0.77–1.45) for the Khorana score. Conclusion: In newly diagnosed PC patients receiving outpatient chemotherapy, the Khorana, PROTECHT, and ONKOTEV scores demonstrated a poor performance in predicting VTE at 6 months, highlighting the need for new tools to guide thromboprophylaxis decisions.

Background: Abdominoperineal resection (APR) and pelvic exenteration (PE) for the treatment of cancer require extensive pelvic resection with a high rate of postoperative complications. The objective of this work was to systematically review and meta-analyze the effects of vertical rectus abdominis myocutaneous flap (VRAMf) and mesh closure on perineal morbidity following APR and PE (mainly for anal and rectal cancers).Methods: We searched PubMed, Cochrane, and EMBASE for eligible studies as of the year 2000. After data extraction, a meta-analysis was performed to compare perineal wound morbidity. The studies were distributed as follows: Group A comparing primary closure (PC) and VRAMf, Group B comparing PC and mesh closure, and Group C comparing PC and VRAMf in PE.Results: Our systematic review yielded 18 eligible studies involving 2180 patients (1206 primary closures, 647 flap closures, 327 mesh closures). The meta-analysis of Groups A and B showed PC to be associated with an increase in the rate of total (Group A: OR 0.55, 95% CI 0.43-0.71; p < 0.01/Group B: OR 0.54, CI 0.17-1.68; p = 0.18) and major perineal wound complications (Group A: OR 0.49, 95% CI 0.35-0.68; p < 0.001/Group B: OR 0.38, 95% CI 0.12-1.17; p < 0.01). PC was associated with a decrease in total (OR 2.46, 95% CI 1.39-4.35; p < 0.01) and major (OR 1.67, 95% CI 0.90-3.08; p = 0.1) perineal complications in Group C.Conclusion: Our results confirm the contribution of the VRAMf in reducing major complications in APR. Similarly, biological prostheses offer an interesting alternative in pelvic reconstruction. For PE, an adapted reconstruction must be proposed with specialized expertise.