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BACKGROUND: Guidelines are inconclusive on whether contrast-enhanced MRI using gadoxetic acid and diffusion-weighted imaging should be added routinely to CT in the investigation of patients with colorectal liver metastases who are scheduled for curative liver resection or thermal ablation, or both. Although contrast-enhanced MRI is reportedly superior than contrast-enhanced CT in the detection and characterisation of colorectal liver metastases, its effect on clinical patient management is unknown. We aimed to assess the clinical effect of an additional liver contrast-enhanced MRI on local treatment plan in patients with colorectal liver metastases amenable to local treatment, based on contrast-enhanced CT. METHODS: We did an international, multicentre, prospective, incremental diagnostic accuracy trial in 14 liver surgery centres in the Netherlands, Belgium, Norway, and Italy. Participants were aged 18 years or older with histological proof of colorectal cancer, a WHO performance status score of 0-4, and primary or recurrent colorectal liver metastases, who were scheduled for local therapy based on contrast-enhanced CT. All patients had contrast-enhanced CT and liver contrast-enhanced MRI including diffusion-weighted imaging and gadoxetic acid as a contrast agent before undergoing local therapy. The primary outcome was change in the local clinical treatment plan (decided by the individual clinics) on the basis of liver contrast-enhanced MRI findings, analysed in the intention-to-image population. The minimal clinically important difference in the proportion of patients who would have change in their local treatment plan due to an additional liver contrast-enhanced MRI was 10%. This study is closed and registered in the Netherlands Trial Register, NL8039. FINDINGS: Between Dec 17, 2019, and July 31, 2021, 325 patients with colorectal liver metastases were assessed for eligibility. 298 patients were enrolled and included in the intention-to-treat population, including 177 males (59%) and 121 females (41%) with planned local therapy based on contrast-enhanced CT. A change in the local treatment plan based on liver contrast-enhanced MRI findings was observed in 92 (31%; 95% CI 26-36) of 298 patients. Changes were made for 40 patients (13%) requiring more extensive local therapy, 11 patients (4%) requiring less extensive local therapy, and 34 patients (11%) in whom the indication for curative-intent local therapy was revoked, including 26 patients (9%) with too extensive disease and eight patients (3%) with benign lesions on liver contrast-enhanced MRI (confirmed by a median follow-up of 21·0 months [IQR 17·5-24·0]). INTERPRETATION: Liver contrast-enhanced MRI should be considered in all patients scheduled for local treatment for colorectal liver metastases on the basis of contrast-enhanced CT imaging. FUNDING: The Dutch Cancer Society and Bayer AG - Pharmaceuticals.
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Neoplasias Colorrectales , Neoplasias Hepáticas , Masculino , Femenino , Humanos , Medios de Contraste , Estudios Prospectivos , Tomografía Computarizada por Rayos X/métodos , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/terapia , Neoplasias Hepáticas/patología , Imagen por Resonancia Magnética/métodos , Neoplasias Colorrectales/diagnóstico por imagen , Neoplasias Colorrectales/terapia , Neoplasias Colorrectales/patologíaRESUMEN
OBJECTIVE: Assess outcomes of patients with right-sided colon cancer with metastases in the D3 volume after personalized surgery. BACKGROUND: Patients with central lymph node metastasis (D3-PNG) are considered to have a systemic disease with a poor prognosis. A 3-dimensional definition of the dissection volume allows the removal of all central nodes. MATERIALS AND METHODS: D3-PNG includes consecutive patients from an ongoing clinical trial. Patients were stratified into residual disease negative (D3-RDN) and residual disease positive (D3-RDP) groups. D3-RDN was further stratified into 4 periods to identify a learning curve. A personalized D3 volume (defined through arterial origins and venous confluences) was removed " en bloc" through medial-to-lateral dissection, and the D3 volume of the specimen was analyzed separately. RESULTS: D3-PNG contained 42 (26 females, 63.1 SD 9.9 y) patients, D3-RDN:29 (17 females, 63.4 SD 10.1 y), and D3-RDP:13 (9 females, 62.2 SD 9.7 y). The mean overall survival (OS) days were D3-PNG:1230, D3-RDN:1610, and D3-RDP:460. The mean disease-free survival (DFS) was D3-PNG:1023, D3-RDN:1461, and D3-RDP:74 days. The probability of OS/DFS were D3-PNG:52.1%/50.2%, D3-RDN:72.9%/73.1%, D3-RDP: 7.7%/0%. There is a significant change in OS/DFS in the D3-RDN from 2011-2013 to 2020-2022 (both P =0.046) and from 2014-2016 to 2020-2022 ( P =0.028 and P =0.005, respectively). CONCLUSION: Our results indicate that surgery can achieve survival in most patients with central lymph node metastases by removing a personalized and anatomically defined D3 volume. The extent of mesenterectomy and the quality of surgery are paramount since a learning curve has demonstrated significantly improved survival over time despite the low number of patients. These results imply a place for the centralization of this patient group where feasible.
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Neoplasias del Colon , Laparoscopía , Femenino , Humanos , Escisión del Ganglio Linfático/métodos , Neoplasias del Colon/patología , Laparoscopía/métodos , Ganglios Linfáticos/patología , Metástasis Linfática/patologíaRESUMEN
OBJECTIVES: The aim of this international multicentric study is to characterize postoperative hyperamylasemia (POH) after distal pancreatectomy (DP), with particular focus on its relationship with postoperative pancreatic fistula (POPF) occurrence and severity. BACKGROUND: The clinical relevance of POH after DP and its relationship with the occurrence and severity of POPF have not been explored yet. METHODS: All patients undergoing DP for any indication between 2015 and 2021 at three European referral Centers for pancreatic surgery were retrospectively analyzed. Drain fluid amylase (DFA), C-reactive protein (C-RP), and serum amylase were examined from postoperative-day (POD) 1 to 3. Biochemical leak (BL), POPF, POH, and post-pancreatectomy hemorrhage (PPH) were defined and graded according to ISGPS definitions. RESULTS: In total 1192 patients were included. Overall rates of POH and POPF were 18% (n= 210) and 29% (n= 344), respectively. The presence of DFA ≥2000 U/L on POD 1 (OR=2.11, 95% CI 1.68-2.86), C-RP ≥200 mg/L on POD 3 (OR=2.19, 95% CI 1.68-2.86), and POH (OR=1.58, 95% CI 1.14-2.19) were all independent early predictors of POPF (all P< 0.01). The presence of POH almost doubled the rate of POPF (43% vs. 26%, P<0.001), and higher POPF severity presented also higher POH rates (no POPF= 12%; BL= 19%; B POPF= 24%; C POPF= 52%). Among patients developing POPF, patients with POH had higher rates of PPH (22% vs 9%, P= 0.001), sepsis (24% vs 13%; P=0.011), re-operation (21% vs 8%; P< 0.01), and mortality (3% vs 0.3%; P= 0.025). CONCLUSIONS: The occurrence of POH is an early predictor of POPF and its severity after DP. The diagnosis of POH might define patients at higher risk for a complicated course, targeting them for prevention / mitigation strategies against pancreas specific complications.
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OBJECTIVE: To develop and update evidence-based and consensus-based guidelines on laparoscopic and robotic pancreatic surgery. SUMMARY BACKGROUND DATA: Minimally invasive pancreatic surgery (MIPS), including laparoscopic and robotic surgery, is complex and technically demanding. Minimizing the risk for patients requires stringent, evidence-based guidelines. Since the International Miami Guidelines on MIPS in 2019, new developments and key publications have been reported, necessitating an update. METHODS: Evidence-based guidelines on 22 topics in 8 domains were proposed: terminology, indications, patients, procedures, surgical techniques and instrumentation, assessment tools, implementation and training, and artificial intelligence. The Brescia Internationally Validated European Guidelines on Minimally Invasive Pancreatic Surgery (EGUMIPS, September 2022) used the Scottish Intercollegiate Guidelines Network (SIGN) methodology to assess the evidence and develop guideline recommendations, the Delphi method to establish consensus on the recommendations among the Expert Committee, and the AGREE II-GRS tool for guideline quality assessment and external validation by a Validation Committee. RESULTS: Overall, 27 European experts, 6 international experts, 22 international Validation Committee members, 11 Jury Committee members, 18 Research Committee members, and 121 registered attendees of the 2-day meeting were involved in the development and validation of the guidelines. In total, 98 recommendations were developed, including 33 on laparoscopic, 34 on robotic, and 31 on general MIPS, covering 22 topics in 8 domains. Out of 98 recommendations, 97 reached at least 80% consensus among the experts and congress attendees, and all recommendations were externally validated by the Validation Committee. CONCLUSIONS: The EGUMIPS evidence-based guidelines on laparoscopic and robotic MIPS can be applied in current clinical practice to provide guidance to patients, surgeons, policy-makers, and medical societies.
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Laparoscopía , Cirujanos , Humanos , Inteligencia Artificial , Páncreas/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Laparoscopía/métodosRESUMEN
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: Laparoscopic liver surgery is increasingly used for more challenging procedures. The aim of this study was to assess the feasibility and oncological safety of laparoscopic right hepatectomy for colorectal liver metastases after portal vein embolization. METHODS: This was an international retrospective multicentre study of patients with colorectal liver metastases who underwent open or laparoscopic right and extended right hepatectomy after portal vein embolization between 2004 and 2020. The perioperative and oncological outcomes for patients who underwent laparoscopic and open approaches were compared using propensity score matching. RESULTS: Of 338 patients, 84 patients underwent a laparoscopic procedure and 254 patients underwent an open procedure. Patients in the laparoscopic group less often underwent extended right hepatectomy (18% versus 34.6% (P = 0.004)), procedures in the setting of a two-stage hepatectomy (42% versus 65% (P < 0.001)), and major concurrent procedures (4% versus 16.1% (P = 0.003)). After propensity score matching, 78 patients remained in each group. The laparoscopic approach was associated with longer operating and Pringle times (330 versus 258.5 min (P < 0.001) and 65 versus 30 min (P = 0.001) respectively) and a shorter length of stay (7 versus 8 days (P = 0.011)). The R0 resection rate was not different (71% for the laparoscopic approach versus 60% for the open approach (P = 0.230)). The median disease-free survival was 12 (95% c.i. 10 to 20) months for the laparoscopic approach versus 20 (95% c.i. 13 to 31) months for the open approach (P = 0.145). The median overall survival was 28 (95% c.i. 22 to 48) months for the laparoscopic approach versus 42 (95% c.i. 35 to 52) months for the open approach (P = 0.614). CONCLUSION: The advantages of a laparoscopic over an open approach for (extended) right hepatectomy for colorectal liver metastases after portal vein embolization are limited.
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Neoplasias Colorrectales , Embolización Terapéutica , Hepatectomía , Laparoscopía , Neoplasias Hepáticas , Vena Porta , Humanos , Hepatectomía/métodos , Neoplasias Hepáticas/secundario , Neoplasias Hepáticas/cirugía , Neoplasias Colorrectales/patología , Laparoscopía/métodos , Masculino , Femenino , Vena Porta/cirugía , Embolización Terapéutica/métodos , Estudios Retrospectivos , Persona de Mediana Edad , Anciano , Puntaje de Propensión , Resultado del Tratamiento , Estudios de Factibilidad , Tiempo de InternaciónRESUMEN
INTRODUCTION: Laparoscopic liver surgery has advanced significantly, offering benefits, such as reduced intraoperative complications and quicker recovery. However, complex laparoscopic hepatectomy (CLH) is technically demanding, requiring skilled surgeons. This study aims to share technical aspects, insightful tips, and outcomes of CLH at our center, focusing on the safety and learning curve. METHODS: We reviewed all patients undergoing liver resection at our center from July 2017 to December 2023, focusing on those who underwent CLH. Of 135 laparoscopic liver resections, 63 (46.7%) were CLH. The learning curve of CLH was also assessed through linear and piecewise regression analyses considering the operation time and intraoperative blood loss. RESULTS: Postoperative complications occurred only in 4.8% of patients, with a 90-day mortality rate of 3.2%. The mean operation time and blood loss significantly decreased after the first 20 operations, marking the learning curve's optimal cut-off. Significant improvements in R0 resection (p = 0.024) and 90-day mortality (p = 0.035) were noted beyond the learning curve threshold. CONCLUSION: CLH is a safe and effective approach, with a relatively short learning curve of 20 operations. Future large-scale studies should further investigate the impact of surgical experience on CLH outcomes to establish guidelines for training programs.
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Pérdida de Sangre Quirúrgica , Hepatectomía , Laparoscopía , Curva de Aprendizaje , Tempo Operativo , Complicaciones Posoperatorias , Humanos , Hepatectomía/educación , Hepatectomía/métodos , Laparoscopía/educación , Laparoscopía/métodos , Femenino , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Pérdida de Sangre Quirúrgica/estadística & datos numéricos , Anciano , Estudios Retrospectivos , Adulto , Neoplasias Hepáticas/cirugía , Neoplasias Hepáticas/mortalidad , Competencia ClínicaRESUMEN
BACKGROUND: The relation between operative time and postoperative complications in liver surgery is unclear. The aim of this study is to assess the impact of operative time on the development of postoperative complications in patients who underwent minimally invasive or open liver resections of various anatomical extent and technical difficulty levels. METHODS: In this retrospective cohort study, patients that underwent a right hemihepatectomy (RH), technically major resection (anatomically minor resection in segment 1, 4a, 7 or 8; TMR) or left lateral sectionectomy (LLS) between 2000 and 2022 were extracted from a multicenter database comprising the prospectively maintained databases of 31 centers in 13 countries. Minimally invasive procedures performed during the learning curve were omitted. Logistic regression models, performed separately for 9 different groups based on stratification by procedure type and allocated surgical approach, were used to assess the association between the fourth quartile of operative time (25% of patients with the longest operative time) and postoperative complications. RESULTS: Overall, 5424 patients were included: 1351 underwent RH (865 open, 373 laparoscopic and 113 robotic), 2821 TMR (1398 open, 1225 laparoscopic and 198 robotic), and 1252 LLS (241 open, 822 laparoscopic and 189 robotic). After adjusting for potential confounders (age, BMI, gender, ASA grade, previous abdominal surgery, disease type and extent, blood loss, Pringle, intraoperative transfusions and incidents), the fourth quartile of operative time, compared to the first three quartiles, was associated with an increased risk of postoperative complications after open, laparoscopic and robotic TMR (aOR 1.35, p = 0.031; aOR 1.74, p = 0.001 and aOR 3.11, p = 0.014, respectively), laparoscopic and robotic RH (aOR 1.98, p = 0.018 and aOR 3.28, p = 0.055, respectively) and solely laparoscopic LLS (aOR 1.69, p = 0.019). CONCLUSIONS: A prolonged operative time is associated with an increased risk of postoperative complications, although it remains to be defined if this is a causal relationship.
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INTRODUCTION: The use of laparoscopic and robotic liver surgery is increasing. However, it presents challenges such as limited field of view and organ deformations. Surgeons rely on laparoscopic ultrasound (LUS) for guidance, but mentally correlating ultrasound images with pre-operative volumes can be difficult. In this direction, surgical navigation systems are being developed to assist with intra-operative understanding. One approach is performing intra-operative ultrasound 3D reconstructions. The accuracy of these reconstructions depends on tracking the LUS probe. MATERIAL AND METHODS: This study evaluates the accuracy of LUS probe tracking and ultrasound 3D reconstruction using a hybrid tracking approach. The LUS probe is tracked from laparoscope images, while an optical tracker tracks the laparoscope. The accuracy of hybrid tracking is compared to full optical tracking using a dual-modality tool. Ultrasound 3D reconstruction accuracy is assessed on an abdominal phantom with CT transformed into the optical tracker's coordinate system. RESULTS: Hybrid tracking achieves a tracking error < 2 mm within 10 cm between the laparoscope and the LUS probe. The ultrasound reconstruction accuracy is approximately 2 mm. CONCLUSION: Hybrid tracking shows promising results that can meet the required navigation accuracy for laparoscopic liver surgery.
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Imagenología Tridimensional , Laparoscopía , Hígado , Fantasmas de Imagen , Ultrasonografía , Laparoscopía/métodos , Humanos , Imagenología Tridimensional/métodos , Ultrasonografía/métodos , Hígado/diagnóstico por imagen , Hígado/cirugía , Cirugía Asistida por Computador/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Procedimientos Quirúrgicos Robotizados/instrumentación , Sistemas de Navegación Quirúrgica , LaparoscopiosRESUMEN
BACKGROUND: Distal pancreatectomy (DP) is performed for lesions in the body and tail of the pancreas. The morbidity profile is considerable, mainly due to clinically relevant postoperative pancreatic fistula (CR-POPF). This study aims to investigate potential differences in CR-POPF related to transection site. METHODS: An observational cohort study from a prospectively maintained database was performed. Subtotal distal pancreatectomy (SDP) was defined as transection over the superior mesenteric vein, and DP was defined as transection lateral to this point. Propensity score matching (PSM) in 1:1 fashion was applied based on demographical and perioperative variables. RESULTS: Six hundred and six patients were included in the analysis (1997-2020). Four hundred twenty (69.3%) underwent DP, while 186 (30.7%) underwent SDP. The rate of CR-POPF was 19.3% after DP and 20.4% after SDP (p = 0.74). SDP was associated with older age (63.1 vs 60.1 years, p = 0.016), higher occurrence of ductal adenocarcinoma (37.1 vs 17.6%, p = 0.001) and more frequent use of neoadjuvant chemotherapy (3.8 vs 0.7%, p = 0.012). After PSM, 155 patients were left in each group. The difference in CR-POPF between DP and SDP remained statistically non-significant (20.6 vs 18.7%, p = 0.67). CONCLUSION: This study found no difference in CR-POPF related to transection site during distal pancreatectomy.
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Pancreatectomía , Fístula Pancreática , Puntaje de Propensión , Humanos , Fístula Pancreática/etiología , Fístula Pancreática/epidemiología , Pancreatectomía/efectos adversos , Masculino , Femenino , Persona de Mediana Edad , Incidencia , Anciano , Factores de Riesgo , Neoplasias Pancreáticas/cirugía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Bases de Datos Factuales , Estudios RetrospectivosRESUMEN
BACKGROUND: Evidence on the value of minimally invasive pancreatic surgery (MIPS) has been increasing but it is unclear how this has influenced the view of pancreatic surgeons on MIPS. METHODS: An anonymous survey was sent to members of eight international Hepato-Pancreato-Biliary Associations. Outcomes were compared with the 2016 international survey. RESULTS: Overall, 315 surgeons from 47 countries participated. The median volume of pancreatic resections per center was 70 (IQR 40-120). Most surgeons considered minimally invasive distal pancreatectomy (MIDP) superior to open (ODP) (94.6%) and open pancreatoduodenectomy (OPD) superior to minimally invasive (MIPD) (67.9%). Since 2016, there has been an increase in the number of surgeons performing both MIDP (79%-85.7%, p = 0.024) and MIPD (29%-45.7%, p < 0.001), and an increase in the use of the robot-assisted approach for both MIDP (16%-45.6%, p < 0.001) and MIPD (23%-47.9%, p < 0.001). The use of laparoscopy remained stable for MIDP (91% vs. 88.1%, p = 0.245) and decreased for MIPD (51%-36.8%, p = 0.024). CONCLUSION: This survey showed considerable changes of MIPS since 2016 with most surgeons considering MIDP superior to ODP and an increased use of robot-assisted MIPS. Surgeons prefer OPD and therefore the value of MIPD remains to be determined in randomized trials.
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Laparoscopía , Neoplasias Pancreáticas , Procedimientos Quirúrgicos Robotizados , Robótica , Humanos , Neoplasias Pancreáticas/cirugía , Estudios de Seguimiento , Procedimientos Quirúrgicos Robotizados/efectos adversos , Resultado del Tratamiento , Pancreatectomía/efectos adversos , Pancreaticoduodenectomía/efectos adversos , Laparoscopía/efectos adversos , Procedimientos Quirúrgicos Mínimamente Invasivos , Complicaciones Posoperatorias/cirugía , Estudios RetrospectivosRESUMEN
BACKGROUND: Solid benign liver lesions (BLL) are increasingly discovered, but clear indications for surgical treatment are often lacking. Concomitantly, laparoscopic liver surgery is increasingly performed. The aim of this study was to assess if the availability of laparoscopic surgery has had an impact on the characteristics and perioperative outcomes of patients with BLL. METHODS: This is a retrospective international multicenter cohort study, including patients undergoing a laparoscopic or open liver resection for BLL from 19 centers in eight countries. Patients were divided according to the time period in which they underwent surgery (2008-2013, 2014-2016, and 2017-2019). Unadjusted and risk-adjusted (using logistic regression) time-trend analyses were performed. The primary outcome was textbook outcome (TOLS), defined as the absence of intraoperative incidents ≥ grade 2, bile leak ≥ grade B, severe complications, readmission and 90-day or in-hospital mortality, with the absence of a prolonged length of stay added to define TOLS+. RESULTS: In the complete dataset comprised of patients that underwent liver surgery for all indications, the proportion of patients undergoing liver surgery for benign disease remained stable (12.6% in the first time period, 11.9% in the second time period and 12.1% in the last time period, p = 0.454). Overall, 845 patients undergoing a liver resection for BLL in the first (n = 374), second (n = 258) or third time period (n = 213) were included. The rates of ASA-scores≥3 (9.9%-16%,p < 0.001), laparoscopic surgery (57.8%-77%,p < 0.001), and Pringle maneuver use (33.2%-47.2%,p = 0.001) increased, whereas the length of stay decreased (5 to 4 days,p < 0.001). There were no significant changes in the TOLS rate (86.6%-81.3%,p = 0.151), while the TOLS + rate increased from 41.7% to 58.7% (p < 0.001). The latter result was confirmed in the risk-adjusted analyses (aOR 1.849,p = 0.004). CONCLUSION: The surgical treatment of BLL has evolved with an increased implementation of the laparoscopic approach and a decreased length of stay. This evolution was paralleled by stable TOLS rates above 80% and an increase in the TOLS + rate.
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Enfermedades del Sistema Digestivo , Laparoscopía , Neoplasias Hepáticas , Humanos , Estudios Retrospectivos , Estudios de Cohortes , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Tiempo de Internación , Laparoscopía/efectos adversos , Hepatectomía/efectos adversos , Enfermedades del Sistema Digestivo/cirugía , Neoplasias Hepáticas/cirugía , Resultado del TratamientoRESUMEN
INTRODUCTION: The accurate assessment and grading of adverse events (AE) is essential to ensure comparisons between surgical procedures and outcomes. The current lack of a standardized severity grading system may limit our understanding of the true morbidity attributed to AEs in surgery. The aim of this study is to review the prevalence in which intraoperative adverse event (iAE) severity grading systems are used in the literature, evaluate the strengths and limitations of these systems, and appraise their applicability in clinical studies. METHODS: A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. PubMed, Web of Science, and Scopus were queried to yield all clinical studies reporting the proposal and/or the validation of iAE severity grading systems. Google Scholar, Web of Science, and Scopus were searched separately to identify the articles citing the systems to grade iAEs identified in the first search. RESULTS: Our search yielded 2957 studies, with 7 studies considered for the qualitative synthesis. Five studies considered only surgical/interventional iAEs, while 2 considered both surgical/interventional and anesthesiologic iAEs. Two included studies validated the iAE severity grading system prospectively. A total of 357 citations were retrieved, with an overall self/nonself-citation ratio of 0.17 (53/304). The majority of citing articles were clinical studies (44.1%). The average number of citations per year was 6.7 citations for each classification/severity system, with only 2.05 citations/year for clinical studies. Of the 158 clinical studies citing the severity grading systems, only 90 (56.9%) used them to grade the iAEs. The appraisal of applicability (mean%/median%) was below the 70% threshold in 3 domains: stakeholder involvement (46/47), clarity of presentation (65/67), and applicability (57/56). CONCLUSION: Seven severity grading systems for iAEs have been published in the last decade. Despite the importance of collecting and grading the iAEs, these systems are poorly adopted, with only a few studies per year using them. A uniform globally implemented severity grading system is needed to produce comparable data across studies and develop strategies to decrease iAEs, further improving patient safety.
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Bibliometría , Complicaciones Intraoperatorias , Humanos , Complicaciones Intraoperatorias/diagnóstico , Complicaciones Intraoperatorias/epidemiologíaRESUMEN
OBJECTIVE: To compare short-term clinical outcomes after Kimura and Warshaw MIDP. BACKGROUND: Spleen preservation during distal pancreatectomy can be achieved by either preservation (Kimura) or resection (Warshaw) of the splenic vessels. Multicenter studies reporting outcomes of Kimura and Warshaw spleen-preserving MIDP are scarce. METHODS: Multicenter retrospective study including consecutive MIDP procedures intended to be spleen-preserving from 29 high-volume centers (≥15 distal pancreatectomies annually) in 8 European countries. Primary outcomes were secondary splenectomy for ischemia and major (Clavien-Dindo grade ≥III) complications. Sensitivity analysis assessed the impact of excluding ("rescue") Warshaw procedures which were performed in centers that typically (>75%) performed Kimura MIDP. RESULTS: Overall, 1095 patients after MIDP were included with successful splenic preservation in 878 patients (80%), including 634 Kimura and 244 Warshaw procedures. Rates of clinically relevant splenic ischemia (0.6% vs 1.6%, P = 0.127) and major complications (11.5% vs 14.4%, P = 0.308) did not differ significantly between Kimura and Warshaw MIDP, respectively. Mortality rates were higher after Warshaw MIDP (0.0% vs 1.2%, P = 0.023), and decreased in the sensitivity analysis (0.0% vs 0.6%, P = 0.052). Kimura MIDP was associated with longer operative time (202 vs 184 minutes, P = 0.033) and less blood loss (100 vs 150 mL, P < 0.001) as compared to Warshaw MIDP. Unplanned splenectomy was associated with a higher conversion rate (20.7% vs 5.0%, P < 0.001). CONCLUSIONS: Kimura and Warshaw spleen-preserving MIDP provide equivalent short-term outcomes with low rates of secondary splenectomy and postoperative morbidity. Further analyses of long-term outcomes are needed.
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Laparoscopía , Neoplasias Pancreáticas , Humanos , Bazo , Pancreatectomía/métodos , Estudios Retrospectivos , Laparoscopía/métodos , Complicaciones Posoperatorias/etiología , Neoplasias Pancreáticas/cirugía , Resultado del TratamientoRESUMEN
OBJECTIVE: To reach global expert consensus on the definition of TOLS in minimally invasive and open liver resection among renowned international expert liver surgeons using a modified Delphi method. BACKGROUND: Textbook outcome is a novel composite measure combining the most desirable postoperative outcomes into one single measure and representing the ideal postoperative course. Despite a recently developed international definition of Textbook Outcome in Liver Surgery (TOLS), a standardized and expert consensus-based definition is lacking. METHODS: This international, consensus-based, qualitative study used a Delphi process to achieve consensus on the definition of TOLS. The survey comprised 6 surgical domains with a total of 26 questions on individual surgical outcome variables. The process included 4 rounds of online questionnaires. Consensus was achieved when a threshold of at least 80% agreement was reached. The results from the Delphi rounds were used to establish an international definition of TOLS. RESULTS: In total, 44 expert liver surgeons from 22 countries and all 3 major international hepato-pancreato-biliary associations completed round 1. Forty-two (96%), 41 (98%), and 41 (98%) of the experts participated in round 2, 3, and 4, respectively. The TOLS definition derived from the consensus process included the absence of intraoperative grade ≥2 incidents, postoperative bile leakage grade B/C, postoperative liver failure grade B/C, 90-day major postoperative complications, 90-day readmission due to surgery-related major complications, 90-day/in-hospital mortality, and the presence of R0 resection margin. CONCLUSIONS: This is the first study providing an international expert consensus-based definition of TOLS for minimally invasive and open liver resections by the use of a formal Delphi consensus approach. TOLS may be useful in assessing patient-level hospital performance and carrying out international comparisons between centers with different clinical practices to further improve patient outcomes.
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Hígado , Complicaciones Posoperatorias , Humanos , Técnica Delphi , Consenso , Complicaciones Posoperatorias/epidemiología , Encuestas y Cuestionarios , Hígado/cirugíaRESUMEN
BACKGROUND: Robot-assisted distal pancreatectomy (RDP) is increasingly used as an alternative to laparoscopic distal pancreatectomy (LDP) in patients with resectable pancreatic cancer but comparative multicenter studies confirming the safety and efficacy of RDP are lacking. METHODS: An international, multicenter, retrospective, cohort study, including consecutive patients undergoing RDP and LDP for resectable pancreatic cancer in 33 experienced centers from 11 countries (2010-2019). The primary outcome was R0-resection. Secondary outcomes included lymph node yield, major complications, conversion rate, and overall survival. RESULTS: In total, 542 patients after minimally invasive distal pancreatectomy were included: 103 RDP (19%) and 439 LDP (81%). The R0-resection rate was comparable (75.7% RDP vs. 69.3% LDP, p = 0.404). RDP was associated with longer operative time (290 vs. 240 min, p < 0.001), more vascular resections (7.6% vs. 2.7%, p = 0.030), lower conversion rate (4.9% vs. 17.3%, p = 0.001), more major complications (26.2% vs. 16.3%, p = 0.019), improved lymph node yield (18 vs. 16, p = 0.021), and longer hospital stay (10 vs. 8 days, p = 0.001). The 90-day mortality (1.9% vs. 0.7%, p = 0.268) and overall survival (median 28 vs. 31 months, p = 0.599) did not differ significantly between RDP and LDP, respectively. CONCLUSIONS: In selected patients with resectable pancreatic cancer, RDP and LDP provide a comparable R0-resection rate and overall survival in experienced centers. Although the lymph node yield and conversion rate appeared favorable after RDP, LDP was associated with shorter operating time, less major complications, and shorter hospital stay. The specific benefits associated with each approach should be confirmed by multicenter, randomized trials.
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Laparoscopía , Neoplasias Pancreáticas , Procedimientos Quirúrgicos Robotizados , Robótica , Humanos , Estudios Retrospectivos , Estudios de Cohortes , Pancreatectomía , Resultado del Tratamiento , Neoplasias Pancreáticas/patología , Tempo Operativo , Tiempo de Internación , Neoplasias PancreáticasRESUMEN
BACKGROUND: The role of laparoscopy in the treatment of intrahepatic cholangiocarcinoma (ICC) remains unclear. This multicenter study examined the outcomes of laparoscopic liver resection for ICC. METHODS: Patients with ICC who had undergone laparoscopic or open liver resection between 2012 and 2019 at four European expert centers were included in the study. Laparoscopic and open approaches were compared in terms of surgical and oncological outcomes. Propensity score matching was used for minimizing treatment selection bias and adjusting for confounders (age, ASA grade, tumor size, location, number of tumors and underlying liver disease). RESULTS: Of 136 patients, 50 (36.7%) underwent laparoscopic resection, whereas 86 (63.3%) had open surgery. Median tumor size was larger (73.6 vs 55.1 mm, p = 0.01) and the incidence of bi-lobar tumors was higher (36.6 vs 6%, p < 0.01) in patients undergoing open surgery. After propensity score matching baseline characteristics were comparable although open surgery was associated with a larger fraction of major liver resections (74 vs 38%, p < 0.01), lymphadenectomy (60 vs 20%, p < 0.01) and longer operative time (294 vs 209 min, p < 0.01). Tumor characteristics were similar. Laparoscopic resection resulted in less complications (30 vs 52%, p = 0.025), fewer reoperations (4 vs 16%, p = 0.046) and shorter hospital stay (5 vs 8 days, p < 0.01). No differences were found in terms of recurrence, recurrence-free and overall survival. CONCLUSION: Laparoscopic resection seems to be associated with improved short-term and with similar long-term outcomes compared with open surgery in patients with ICC. However, possible selection criteria for laparoscopic surgery are yet to be defined.
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Neoplasias de los Conductos Biliares , Colangiocarcinoma , Laparoscopía , Neoplasias Hepáticas , Humanos , Resultado del Tratamiento , Puntaje de Propensión , Estudios Retrospectivos , Hepatectomía/métodos , Laparoscopía/métodos , Colangiocarcinoma/cirugía , Hígado , Conductos Biliares Intrahepáticos , Neoplasias de los Conductos Biliares/cirugía , Tiempo de InternaciónRESUMEN
BACKGROUND: Surgical process model (SPM) analysis is a great means to predict the surgical steps in a procedure as well as to predict the potential impact of new technologies. Especially in complicated and high-volume treatments, such as parenchyma sparing laparoscopic liver resection (LLR), profound process knowledge is essential for enabling improving surgical quality and efficiency. METHODS: Videos of thirteen parenchyma sparing LLR were analyzed to extract the duration and sequence of surgical steps according to the process model. The videos were categorized into three groups, based on the tumor locations. Next, a detailed discrete events simulation model (DESM) of LLR was built, based on the process model and the process data obtained from the endoscopic videos. Furthermore, the impact of using a navigation platform on the total duration of the LLR was studied with the simulation model by assessing three different scenarios: (i) no navigation platform, (ii) conservative positive effect, and (iii) optimistic positive effect. RESULTS: The possible variations of sequences of surgical steps in performing parenchyma sparing depending on the tumor locations were established. The statistically most probable chain of surgical steps was predicted, which could be used to improve parenchyma sparing surgeries. In all three categories (i-iii) the treatment phase covered the major part (~ 40%) of the total procedure duration (bottleneck). The simulation results predict that a navigation platform could decrease the total surgery duration by up to 30%. CONCLUSION: This study showed a DESM based on the analysis of steps during surgical procedures can be used to predict the impact of new technology. SPMs can be used to detect, e.g., the most probable workflow paths which enables predicting next surgical steps, improving surgical training systems, and analyzing surgical performance. Moreover, it provides insight into the points for improvement and bottlenecks in the surgical process.
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Laparoscopía , Neoplasias Hepáticas , Humanos , Neoplasias Hepáticas/cirugía , Hepatectomía/métodos , Laparoscopía/métodos , Tiempo de InternaciónRESUMEN
BACKGROUND: Randomized controlled trials (RCT) comparing long-term outcome after laparoscopic (LF) and open fundoplication (OF) in children are lacking. Here we report recurrence rates and time to recurrence, frequency of re-interventions, use of antisecretory drugs, gastrointestinal symptoms, and patient/parental satisfaction a decade after children were randomized to LF or OF. METHODS: Cross-sectional long-term follow-up study of a two-center RCT that included patients during 2003-2009. Patients/parents were interviewed and medical charts reviewed for any events that might be related to the fundoplication. If suspicion of recurrence, further diagnostics were performed. Informed consent and ethical approval were obtained. CLINICALTRIALS: gov: NCT01551134. RESULTS: Eighty-eight children, 56 (64%) boys, were randomized (LF 44, OF 44) at median 4.4 [interquartile range (IQR) 2.0-8.9] years. 46 (52%) had neurological impairment. Three were lost to follow-up before first scheduled control. Recurrence was significantly more frequent after LF (24/43, 56%) than after OF (13/42, 31%, p = 0.004). Median time to recurrence was 1.0 [IQR 0.3-2.2] and 5.1 [IQR 1.5-9.3] years after LF and OF, respectively. Eight (19%) underwent redo fundoplication after LF and three (7%) after OF (p = 0.094). Seventy patients/parents were interviewed median 11.9 [IQR 9.9-12.8] years postoperatively. Among these, use of anti-secretory drugs was significantly decreased from preoperatively after both LF (94% vs. 35%, p < 0.001) and OF (97% vs. 19%, p < 0.001). Regurgitation/vomiting were observed in 6% after LF and 3% after OF (p = 0.609), and heartburn in 14% after LF and 17% after OF (p = 1.000). Overall opinion of the surgical scars was good in both groups (LF: 95%, OF: 86%, p = 0.610). Patient/parental satisfaction with outcome was high, independent of surgical approach (LF: 81%, OF: 88%, p = 0.500). CONCLUSIONS: The recurrence rate was higher and recurrence occurred earlier after LF than after OF. Patient/parental satisfaction with outcome after both LF and OF was equally high.
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Reflujo Gastroesofágico , Laparoscopía , Masculino , Humanos , Niño , Femenino , Fundoplicación/métodos , Reflujo Gastroesofágico/cirugía , Reflujo Gastroesofágico/diagnóstico , Resultado del Tratamiento , Pirosis/cirugía , Laparoscopía/efectos adversos , Laparoscopía/métodos , Vómitos , Estudios de Seguimiento , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Traditionally, patients with large liver tumors (≥ 50 mm) have been considered for anatomic major hepatectomy. Laparoscopic resection of large liver lesions is technically challenging and often performed by surgeons with extensive experience. The current study aimed to evaluate the surgical and oncologic safety of laparoscopic parenchyma-sparing liver resection in patients with large colorectal metastases. METHODS: Patients who primarily underwent laparoscopic parenchyma-sparing liver resection (less than 3 consecutive liver segments) for colorectal liver metastases between 1999 and 2019 at Oslo University Hospital were analyzed. In some recent cases, a computer-assisted surgical planning system was used to better visualize and understand the patients' liver anatomy, as well as a tool to further improve the resection strategy. The surgical and oncologic outcomes of patients with large (≥ 50 mm) and small (< 50 mm) tumors were compared. Multivariable Cox-regression analysis was performed to identify risk factors for survival. RESULTS: In total 587 patients met the inclusion criteria (large tumor group, n = 59; and small tumor group, n = 528). Median tumor size was 60 mm (range, 50-110) in the large tumor group and 21 mm (3-48) in the small tumor group (p < 0.001). Patient age and CEA level were higher in the large tumor group (8.4 µg/L vs. 4.6 µg/L, p < 0.001). Operation time and conversion rate were similar, while median blood loss was higher in the large tumor group (500 ml vs. 200 ml, p < 0.001). Patients in the large tumor group had shorter 5 year overall survival (34% vs 49%, p = 0.027). However, in the multivariable Cox-regression analysis tumor size did not impact survival, unlike parameters such as age, ASA score, CEA level, extrahepatic disease at liver surgery, and positive lymph nodes in the primary tumor. CONCLUSION: Laparoscopic parenchyma-sparing resections for large colorectal liver metastases provide satisfactory short and long-term outcomes.