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OBJECTIVE: We aimed to establish global benchmark outcomes indicators for L-RPS/H67. BACKGROUND: Minimally invasive liver resections has seen an increase in uptake in recent years. Over time, challenging procedures as laparoscopic right posterior sectionectomies (L-RPS)/H67 are also increasingly adopted. METHODS: This is a post hoc analysis of a multicenter database of 854 patients undergoing minimally invasive RPS (MI-RPS) in 57 international centers in 4 continents between 2015 and 2021. There were 651 pure L-RPS and 160 robotic RPS (R-RPS). Sixteen outcome indicators of low-risk L-RPS cases were selected to establish benchmark cutoffs. The 75th percentile of individual center medians for a given outcome indicator was set as the benchmark cutoff. RESULTS: There were 573 L-RPS/H67 performed in 43 expert centers, of which 254 L-RPS/H67 (44.3%) cases qualified as low risk benchmark cases. The benchmark outcomes established for operation time, open conversion rate, blood loss ≥500 mL, blood transfusion rate, postoperative morbidity, major morbidity, 90-day mortality and textbook outcome after L-RPS were 350.8 minutes, 12.5%, 53.8%, 22.9%, 23.8%, 2.8%, 0% and 4% respectively. CONCLUSIONS: The present study established the first global benchmark values for L-RPS/H6/7. The benchmark provided an up-to-date reference of best achievable outcomes for surgical auditing and benchmarking.
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BACKGROUND: Robotic distal pancreatectomy has increasingly been accepted as it has overcome some of the limitations of open distal pancreatectomy, whilst the outcomes following robotic radical antegrade modular pancreatosplenectomy (RAMPS) in patients with pancreatic ductal adenocarcinoma (PDAC) are still uncertain. This study aimed to evaluate the short and long-term outcomes of robotic RAMPS and open RAMPS for PDAC. METHODS: The patients who underwent robotic RAMPS and open RAMPS for PDAC at our clinical centre between January 2017 and December 2021 were reviewed. After a propensity score matching (PSM) at a 1:1 ratio, the perioperative and pathological outcomes in the both groups were reviewed. Univariable and multivariable Cox regression analyses were used to identify independent prognosis factors for overall survival (OS) and recurrence-free survival (RFS) of these patients. RESULTS: 318 cases were recorded in robotic and open groups. The robotic group showed advantages in operative time [205.00 (166.00, 240.00) min vs 235 (184.75, 270.00) min, P = 0.002], estimated blood loss [100 (50, 100) ml vs 300 (100, 400) ml, P < 0.001], delayed gastric emptying [0 vs 5.03%, P = 0.007] and postoperative hospital stay [7.00 (5.00, 10.00) days vs 11.00 (8.00, 14.00) days, P < 0.001]. There were no significant differences in rate of severe postoperative complications between the robotic group and the open group. Multivariable analysis showed that carbohydrate antigen 19-9, estimated blood loss, N stage, tumour differentiation, chemotherapy and vascular invasion were independent risk factors for OS and RFS of these patients. CONCLUSIONS: Robotic RAMPS was safe and had some advantages over open RAMPS for PDAC. There were no significantly differences in oncological outcomes and long-term survival rates between the robotic and open groups. Robotic RAMPS expanded the indications for minimally invasive surgeries for PDAC to a certain extent.
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Carcinoma Ductal Pancreático , Laparoscopia , Neoplasias Pancreáticas , Procedimentos Cirúrgicos Robóticos , Humanos , Pontuação de Propensão , Estudos Retrospectivos , Estudos de Coortes , Esplenectomia , Neoplasias Pancreáticas/patologia , Pancreatectomia , Carcinoma Ductal Pancreático/cirurgiaRESUMO
Objective: To study the immunoadjuvant effects of chitosan oligosaccharide (COS), including the immune activation and the triggering of lysosomal escape, and to explore whether COS can be used as an adjuvant for attenuated live bacteria vector vaccines. Methods: 1) Mouse macrophages RAW264.7 cells were cultured with COS at 0 mg/mL (the control group) and 0.1-4 mg/mL for 24 h and the effect on cell viability was measured by CCK8 assay. Mouse macrophages RAW264.7 were treated with COS at 0 (the control group), 1, 2, and 4 mg/mL for 24 h. Then, the mRNA expression levels of the cytokines, including IFN-γ, IL-10, TGF-ß, and TLR4, were determined by RT-qPCR assay. 2) RAW264.7 cells were treated with 1 mL of PBS containing different components, including calcein at 50 µg/mL, COS at 2 mg/mL, and bafilomycin A1, an inhibitor, at 1 µmol/mL, for culturing. The cells were divided into the Calcein group, Calcein+COS group, and Calcein+COS+Bafilomycin A1 group accordingly. Laser scanning confocal microscopy was used to observe the phagocytosis and the intracellular fluorescence distribution of calcein, a fluorescent dye, in RAW264.7 cells in the presence or absence of COS intervention to determine whether COS was able to trigger lysosomal escape. 3) LM∆E6E7 and LI∆E6E7, the attenuated Listeria vector candidate therapeutic vaccines for cervical cancer, were encapsulated with COS at the mass concentrations of 0.5 mg/mL, 1 mg/mL, 2 mg/mL , 4 mg/mL, and 8 mg/mL. Then, the changes in zeta potential were measured to select the concentration of COS that successfully encapsulated the bacteria. Phagocytosis of the vaccine strains by RAW264.7 cells was measured before and after LM∆E6E7 and LI∆E6E7 were coated with COS at 2 mg/mL. Results: 1) CCK8 assays showed that, compared with the findings for the control group, the intervention of RAW264.7 cells with COS at different concentrations for 24 h was not toxic to the cells and promoted cell proliferation, with the difference being statistically significant (P<0.05). According to the RT-qPCR results, compared with those of the control group, the COS intervention up-regulated the mRNA levels of TLR4 and IFN-γ in RAW264.7 cells, while it inhibited the mRNA expression levels of TGF-ß and IL-10, with the most prominent effect being observed in the 4 mg/mL COS group (P<0.05). 2) Laser scanning confocal microscopy revealed that the amount of fluorescent dye released from lysosomes into the cells was greater in the Calcein+COS group than that in the Calcein group. In other words, a greater amount of fluorescent dye was released from lysosomes into the cells under COS intervention. Furthermore, this process could be blocked by bafilomycin A1. 3) The zeta potential results showed that COS could successfully encapsulate the surface of bacteria when its mass concentration reached 2 mg/mL. Before and after the vaccine strain was encapsulated by COS, the phagocytosis of LM∆E6E7 by RAW264.7 cells was 5.70% and 22.00%, respectively, showing statistically significant differences (P<0.05); the phagocytosis of LI∆E6E7 by RAW264.7 cells was 1.55% and 6.12%, respectively, showing statistically significant differences (P<0.05). Conclusion: COS has the effect of activating the immune response of macrophages and triggering lysosomal escape. The candidates strains of coated live attenuated bacterial vector vaccines can promote the phagocytosis of bacteria by macrophages. Further research is warranted to develop COS into an adjuvant for bacterial vector vaccine.
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Adjuvantes Imunológicos , Vacinas Bacterianas , Quitosana , Oligossacarídeos , Animais , Camundongos , Células RAW 264.7 , Oligossacarídeos/farmacologia , Adjuvantes Imunológicos/farmacologia , Vacinas Bacterianas/imunologia , Macrófagos/metabolismo , Macrófagos/imunologia , Macrófagos/efeitos dos fármacos , Vacinas Atenuadas/imunologia , Citocinas/metabolismo , Sobrevivência Celular/efeitos dos fármacosRESUMO
BACKGROUND: The flexibility of the robotic system in resection and reconstruction provides potential benefits in pancreaticoduodenectomy. Increasingly, robotic pancreaticoduodenectomy (RPD) has been reported with favourable outcomes, but high-level evidence is still scarce. We aimed to compare the short-term postoperative outcomes of RPD with those of open pancreaticoduodenectomy (OPD), and hypothesised that postoperative length of hospital stay would be shorter after RPD than after OPD. METHODS: This multicentre, open-label randomised controlled trial was conducted at three high-volume hospitals in China. Patients were considered for participation in this trial if they were aged 18-75 years, had a resectable benign, premalignant, or malignant tumour in the pancreatic head or periampullary region; and were suitable for both RPD and OPD. Patients with distant metastases were excluded. Block randomisation was done with random block sizes of four, stratified by centre. Allocation was concealed via individual, sequentially numbered, opaque sealed envelopes. Eligible patients were randomly assigned to the RPD group or the OPD group in a 1:1 ratio by a masked research assistant. Surgeons and patients were not masked to trial group, but data collectors, postoperative outcome assessors, and data analysts were. All patients underwent RPD or OPD according to previously reported techniques. Participating surgeons had surpassed the learning curves of at least 40 RPD and 60 OPD procedures. The primary outcome was postoperative length of hospital stay, which was analysed in the modified intention-to-treat (mITT) population. This trial is registered with the Chinese Clinical Trial Registry (ChiCTR2200056809) and is complete. FINDINGS: Between March 5 and Dec 20, 2022, 292 patients were screened for eligibility, of whom 164 were enrolled and randomly assigned to the RPD group (n=82) or the OPD group (n=82). 161 patients who underwent surgical resection were included in the mITT analysis (81 in the RPD group and 80 in the OPD group). 94 (58%) participants were male and 67 (42%) were female. Postoperative length of hospital stay was significantly shorter in the RPD group than in the OPD group (median 11·0 days [IQR 9·0 to 19·5] vs 13·5 days [11·5 to 18·0]; median difference -2·0 [95% CI -4·0 to 0·0]; p=0·029). During a follow-up period of 90 days, six (7%) of 81 patients in the RPD group and five (6%) of 80 patients in the OPD group required readmission. Reasons for readmission were intra-abdominal haemorrhage (one in each group), vomiting (two in the RPD group and one in the OPD group), electrolyte disturbance (one in each group), and fever (two in each group). There were two (1%) in-hospital deaths within 90 days of surgery, one in each group. The postoperative 90-day mortality rate (difference -0·02% [-5·6 to 5·5]; p=1·00) and the incidence of severe complications (ie, Clavien-Dindo grade ≥3; difference -1·5% [-14·5 to 11·4]; p=0·82) were similar between the two groups. INTERPRETATION: For surgeons who had passed the learning curve, RPD was safe and feasible with the advantage of shorter postoperative length of hospital stay than OPD. Future research should focus on the medium-term and long-term outcomes between RPD and OPD. FUNDING: None.
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Neoplasias Pancreáticas , Procedimentos Cirúrgicos Robóticos , Feminino , Humanos , Masculino , Tempo de Internação , Neoplasias Pancreáticas/patologia , Pancreaticoduodenectomia/efeitos adversos , Pancreaticoduodenectomia/métodos , Complicações Pós-Operatórias/epidemiologia , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/métodos , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , IdosoRESUMO
Background: With the rapid development of robotic surgery, especially for the abdominal surgery, robotic pancreatic surgery (RPS) has been applied increasingly around the world. However, evidence-based guidelines regarding its application, safety, and efficacy are still lacking. To harvest robust evidence and comprehensive clinical practice, this study aims to develop international guidelines on the use of RPS. Methods: World Health Organization (WHO) Handbook for Guideline Development, GRADE Grid method, Delphi vote, and the AGREE-II instrument were used to establish the Guideline Steering Group, Guideline Development Group, and Guideline Secretary Group, formulate 19 clinical questions, develop the recommendations, and draft the guidelines. Three online meetings were held on 04/12/2020, 30/11/2021, and 25/01/2022 to vote on the recommendations and get advice and suggestions from all involved experts. All the experts focusing on minimally invasive surgery from America, Europe and Oceania made great contributions to this consensus guideline. Results: After a systematic literature review 176 studies were included, 19 questions were addressed and 14 recommendations were developed through the expert assessment and comprehensive judgment of the quality and credibility of the evidence. Conclusions: The international RPS guidelines can guide current practice for surgeons, patients, medical societies, hospital administrators, and related social communities. Further randomized trials are required to determine the added value of RPS as compared to open and laparoscopic surgery.