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1.
Surgery ; 175(6): 1587-1594, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38570225

RESUMEN

BACKGROUND: The use of robot-assisted and laparoscopic pancreatoduodenectomy is increasing, yet large adjusted analyses that can be generalized internationally are lacking. This study aimed to compare outcomes after robot-assisted pancreatoduodenectomy and laparoscopic pancreatoduodenectomy in a pan-European cohort. METHODS: An international multicenter retrospective study including patients after robot-assisted pancreatoduodenectomy and laparoscopic pancreatoduodenectomy from 50 centers in 12 European countries (2009-2020). Propensity score matching was performed in a 1:1 ratio. The primary outcome was major morbidity (Clavien-Dindo ≥III). RESULTS: Among 2,082 patients undergoing minimally invasive pancreatoduodenectomy, 1,006 underwent robot-assisted pancreatoduodenectomy and 1,076 laparoscopic pancreatoduodenectomy. After matching 812 versus 812 patients, the rates of major morbidity (31.9% vs 29.6%; P = .347) and 30-day/in-hospital mortality (4.3% vs 4.6%; P = .904) did not differ significantly between robot-assisted pancreatoduodenectomy and laparoscopic pancreatoduodenectomy, respectively. Robot-assisted pancreatoduodenectomy was associated with a lower conversion rate (6.7% vs 18.0%; P < .001) and higher lymph node retrieval (16 vs 14; P = .003). Laparoscopic pancreatoduodenectomy was associated with shorter operation time (446 minutes versus 400 minutes; P < .001), and lower rates of postoperative pancreatic fistula grade B/C (19.0% vs 11.7%; P < .001), delayed gastric emptying grade B/C (21.4% vs 7.4%; P < .001), and a higher R0-resection rate (73.2% vs 84.4%; P < .001). CONCLUSION: This European multicenter study found no differences in overall major morbidity and 30-day/in-hospital mortality after robot-assisted pancreatoduodenectomy compared with laparoscopic pancreatoduodenectomy. Further, laparoscopic pancreatoduodenectomy was associated with a lower rate of postoperative pancreatic fistula, delayed gastric emptying, wound infection, shorter length of stay, and a higher R0 resection rate than robot-assisted pancreatoduodenectomy. In contrast, robot-assisted pancreatoduodenectomy was associated with a lower conversion rate and a higher number of retrieved lymph nodes as compared with laparoscopic pancreatoduodenectomy.


Asunto(s)
Laparoscopía , Pancreaticoduodenectomía , Complicaciones Posoperatorias , Puntaje de Propensión , Procedimientos Quirúrgicos Robotizados , Humanos , Pancreaticoduodenectomía/métodos , Pancreaticoduodenectomía/efectos adversos , Masculino , Femenino , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/métodos , Laparoscopía/métodos , Laparoscopía/efectos adversos , Estudios Retrospectivos , Persona de Mediana Edad , Europa (Continente)/epidemiología , Anciano , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Mortalidad Hospitalaria , Neoplasias Pancreáticas/cirugía , Neoplasias Pancreáticas/mortalidad , Resultado del Tratamiento
3.
Int J Surg ; 110(4): 2226-2233, 2024 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-38265434

RESUMEN

BACKGROUND: International multicenter audit-based studies focusing on the outcome of minimally invasive pancreatoduodenectomy (MIPD) are lacking. The European Registry for Minimally Invasive Pancreatic Surgery (E-MIPS) is the E-AHPBA endorsed registry aimed to monitor and safeguard the introduction of MIPD in Europe. MATERIALS AND METHODS: A planned analysis of outcomes among consecutive patients after MIPD from 45 centers in 14 European countries in the E-MIPS registry (2019-2021). The main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality. RESULTS: Overall, 1336 patients after MIPD were included [835 robot-assisted (R-MIPD) and 501 laparoscopic MIPD (L-MIPD)]. Overall, 20 centers performed R-MIPD, 15 centers L-MIPD, and 10 centers both. Between 2019 and 2021, the rate of centers performing L-MIPD decreased from 46.9 to 25%, whereas for R-MIPD this increased from 46.9 to 65.6%. Overall, the rate of major morbidity was 41.2%, 30-day/in-hospital mortality 4.5%, conversion rate 9.7%, postoperative pancreatic fistula grade B/C 22.7%, and postpancreatectomy hemorrhage grade B/C 10.8%. Median length of hospital stay was 12 days (IQR 8-21). A lower rate of major morbidity, postoperative pancreatic fistula grade B/C, postpancreatectomy hemorrhage grade B/C, delayed gastric emptying grade B/C, percutaneous drainage, and readmission was found after L-MIPD. The number of centers meeting the Miami Guidelines volume cut-off of ≥20 MIPDs annually increased from 9 (28.1%) in 2019 to 12 (37.5%) in 2021 ( P =0.424). Rates of conversion (7.4 vs. 14.8% P <0.001) and reoperation (8.9 vs. 15.1% P <0.001) were lower in centers, which fulfilled the Miami volume cut-off. CONCLUSION: During the first 3 years of the pan-European E-MIPS registry, morbidity and mortality rates after MIPD were acceptable. A shift is ongoing from L-MIPD to R-MIPD. Variations in outcomes between the two minimally invasive approaches and the impact of the volume cut-off should be further evaluated over a longer time period.


Asunto(s)
Laparoscopía , Pancreaticoduodenectomía , Sistema de Registros , Humanos , Pancreaticoduodenectomía/métodos , Pancreaticoduodenectomía/efectos adversos , Pancreaticoduodenectomía/mortalidad , Sistema de Registros/estadística & datos numéricos , Masculino , Europa (Continente) , Femenino , Anciano , Persona de Mediana Edad , Estudios Retrospectivos , Laparoscopía/efectos adversos , Laparoscopía/mortalidad , Laparoscopía/métodos , Laparoscopía/estadística & datos numéricos , Complicaciones Posoperatorias/epidemiología , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/mortalidad , Procedimientos Quirúrgicos Robotizados/métodos , Procedimientos Quirúrgicos Robotizados/estadística & datos numéricos , Mortalidad Hospitalaria , Resultado del Tratamiento , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Procedimientos Quirúrgicos Mínimamente Invasivos/efectos adversos
4.
Ann Surg ; 279(1): 45-57, 2024 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-37450702

RESUMEN

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.


Asunto(s)
Laparoscopía , Cirujanos , Humanos , Inteligencia Artificial , Páncreas/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Laparoscopía/métodos
5.
Ann Surg ; 2023 Nov 03.
Artículo en Inglés | MEDLINE | ID: mdl-37922237

RESUMEN

OBJECTIVE: To gain insight in global practice of RAMIG and evaluated perioperative outcomes using an international registry. BACKGROUND: The techniques and perioperative outcomes of robot-assisted minimally invasive gastrectomy (RAMIG) for gastric cancer vary substantially in literature. METHODS: Prospectively registered RAMIG-cases for gastric cancer (≥10 per center) were extracted from 25 centers in Europe, Asia and South-America. Techniques for the resection, reconstruction, anastomosis and lymphadenectomy were analyzed, and related to perioperative surgical and oncological outcomes. Complications were uniformly defined by the Gastrectomy Complications Consensus Group. RESULTS: Between 2020-2023, 759 patients underwent total (n=272), distal (n=465) or proximal (n=22) gastrectomy (RAMIG). After total gastrectomy with Roux-en-Y-reconstruction, anastomotic leakage rates were 8% with hand-sewn (n=9/111) and 6% with linear stapled anastomoses (n=6/100). After distal gastrectomy with Roux-en-Y (67%) or Billroth-II-reconstruction (31%), anastomotic leakage rates were 3% with linear stapled (n=11/433) and 0% with hand-sewn anastomoses (n=0/26). Extent of lymphadenectomy consisted of D1+ (28%), D2 (59%) or D2+ (12%). Median nodal harvest yielded 31 nodes [IQR 21-47] after total and 34 nodes [IQR 24-47] after distal gastrectomy. R0-resection rates were 93% after total and 96% distal gastrectomy. Hospital stay was 9 days after total and distal gastrectomy, and was 3 days shorter without perianastomotic drains versus routine drain placement. Postoperative 30-day mortality was 1%. CONCLUSIONS: This large multicenter study provided a worldwide overview of current RAMIG-techniques with their respective perioperative outcomes. These outcomes demonstrated high surgical quality, set a quality standard for RAMIG and can be considered an international reference for surgical standardization.

6.
Ann Surg ; 278(6): e1232-e1241, 2023 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-37288547

RESUMEN

OBJECTIVE: To assess the feasibility, proficiency, and mastery learning curves for robotic pancreatoduodenectomy (RPD) in "second-generation" RPD centers following a multicenter training program adhering to the IDEAL framework. BACKGROUND: The long learning curves for RPD reported from "pioneering" expert centers may discourage centers interested in starting an RPD program. However, the feasibility, proficiency, and mastery learning curves may be shorter in "second-generation" centers that participated in dedicated RPD training programs, although data are lacking. We report on the learning curves for RPD in "second-generation" centers trained in a dedicated nationwide program. METHODS: Post hoc analysis of all consecutive patients undergoing RPD in 7 centers that participated in the LAELAPS-3 training program, each with a minimum annual volume of 50 pancreatoduodenectomies, using the mandatory Dutch Pancreatic Cancer Audit (March 2016-December 2021). Cumulative sum analysis determined cutoffs for the 3 learning curves: operative time for the feasibility (1) risk-adjusted major complication (Clavien-Dindo grade ≥III) for the proficiency, (2) and textbook outcome for the mastery, (3) learning curve. Outcomes before and after the cutoffs were compared for the proficiency and mastery learning curves. A survey was used to assess changes in practice and the most valued "lessons learned." RESULTS: Overall, 635 RPD were performed by 17 trained surgeons, with a conversion rate of 6.6% (n=42). The median annual volume of RPD per center was 22.5±6.8. From 2016 to 2021, the nationwide annual use of RPD increased from 0% to 23% whereas the use of laparoscopic pancreatoduodenectomy decreased from 15% to 0%. The rate of major complications was 36.9% (n=234), surgical site infection 6.3% (n=40), postoperative pancreatic fistula (grade B/C) 26.9% (n=171), and 30-day/in-hospital mortality 3.5% (n=22). Cutoffs for the feasibility, proficiency, and mastery learning curves were reached at 15, 62, and 84 RPD. Major morbidity and 30-day/in-hospital mortality did not differ significantly before and after the cutoffs for the proficiency and mastery learning curves. Previous experience in laparoscopic pancreatoduodenectomy shortened the feasibility (-12 RPDs, -44%), proficiency (-32 RPDs, -34%), and mastery phase learning curve (-34 RPDs, -23%), but did not improve clinical outcome. CONCLUSIONS: The feasibility, proficiency, and mastery learning curves for RPD at 15, 62, and 84 procedures in "second-generation" centers after a multicenter training program were considerably shorter than previously reported from "pioneering" expert centers. The learning curve cutoffs and prior laparoscopic experience did not impact major morbidity and mortality. These findings demonstrate the safety and value of a nationwide training program for RPD in centers with sufficient volume.


Asunto(s)
Laparoscopía , Procedimientos Quirúrgicos Robotizados , Robótica , Humanos , Pancreaticoduodenectomía/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Curva de Aprendizaje , Estudios de Factibilidad , Laparoscopía/métodos , Estudios Retrospectivos , Complicaciones Posoperatorias/epidemiología
7.
HPB (Oxford) ; 25(4): 400-408, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-37028826

RESUMEN

BACKGROUND: The European registry for minimally invasive pancreatic surgery (E-MIPS) collects data on laparoscopic and robotic MIPS in low- and high-volume centers across Europe. METHODS: Analysis of the first year (2019) of the E-MIPS registry, including minimally invasive distal pancreatectomy (MIDP) and minimally invasive pancreatoduodenectomy (MIPD). Primary outcome was 90-day mortality. RESULTS: Overall, 959 patients from 54 centers in 15 countries were included, 558 patients underwent MIDP and 401 patients MIPD. Median volume of MIDP was 10 (7-20) and 9 (2-20) for MIPD. Median use of MIDP was 56.0% (IQR 39.0-77.3%) and median use of MIPD 27.7% (IQR 9.7-45.3%). MIDP was mostly performed laparoscopic (401/558, 71.9%) and MIPD mostly robotic (234/401, 58.3%). MIPD was performed in 50/54 (89.3%) centers, of which 15/50 (30.0%) performed ≥20 MIPD annually. This was 30/54 (55.6%) centers and 13/30 (43%) centers for MIPD respectively. Conversion rate was 10.9% for MIDP and 8.4% for MIPD. Overall 90 day mortality was 1.1% (n = 6) for MIDP and 3.7% (n = 15) for MIPD. CONCLUSION: Within the E-MIPS registry, MIDP is performed in about half of all patients, mostly using laparoscopy. MIPD is performed in about a quarter of patients, slightly more often using the robotic approach. A minority of centers met the Miami guideline volume criteria for MIPD.


Asunto(s)
Laparoscopía , Neoplasias Pancreáticas , Procedimientos Quirúrgicos Robotizados , Humanos , Neoplasias Pancreáticas/cirugía , Procedimientos Quirúrgicos Robotizados/efectos adversos , Páncreas/cirugía , Pancreatectomía/efectos adversos , Pancreaticoduodenectomía/efectos adversos , Procedimientos Quirúrgicos Mínimamente Invasivos , Laparoscopía/efectos adversos , Sistema de Registros , Complicaciones Posoperatorias/etiología , Resultado del Tratamiento
8.
Surgery ; 173(6): 1438-1446, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36973127

RESUMEN

BACKGROUND: Difficulty scoring systems are important for the safe, stepwise implementation of new procedures. We designed a retrospective observational study for building a difficulty score for robotic pancreatoduodenectomy. METHODS: The difficulty score (PD-ROBOSCORE) aims at predicting severe postoperative complications after robotic pancreatoduodenectomy. The PD-ROBOSCORE was developed in a training cohort of 198 robotic pancreatoduodenectomies and was validated in an international multicenter cohort of 686 robotic pancreatoduodenectomies. Finally, all centers tested the model during the early learning curve (n = 300). Growing difficulty levels (low, intermediate, high) were defined using cut-off values set at the 33rd and 66th percentile (NCT04662346). RESULTS: Factors included in the final multivariate model were a body mass index of ≥25 kg/m2 for males and ≥30 kg/m2 for females (odds ratio:2.39; P < .0001), borderline resectable tumor (odd ratio:1.98; P < .0001), uncinate process tumor (odds ratio:1.69; P < .0001), pancreatic duct size <4 mm (odds ratio:1.59; P < .0001), American Society of Anesthesiologists class ≥3 (odds ratio:1.59; P < .0001), and hepatic artery originating from the superior mesenteric artery (odds ratio:1.43; P < .0001). In the training cohort, the absolute score value (odds ratio = 1.13; P = .0089) and difficulty groups (odds ratio = 2.35; P = .041) predicted severe postoperative complications. In the multicenter validation cohort, the absolute score value predicted severe postoperative complications (odds ratio = 1.16, P < .001), whereas the difficulty groups did not (odds ratio = 1.94, P = .082). In the learning curve cohort, both absolute score value (odds ratio:1.078, P = .04) and difficulty groups (odds ratio: 2.25, P = .017) predicted severe postoperative complications. Across all cohorts, a PD-ROBOSCORE of ≥12.51 doubled the risk of severe postoperative complications. The PD-ROBOSCORE score also predicted operative time, estimated blood loss, and vein resection. The PD-ROBOSCORE predicted postoperative pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage, and postoperative mortality in the learning curve cohort. CONCLUSION: The PD-ROBOSCORE predicts severe postoperative complications after robotic pancreatoduodenectomy. The score is readily available via www.pancreascalculator.com.


Asunto(s)
Procedimientos Quirúrgicos Robotizados , Robótica , Masculino , Femenino , Humanos , Pancreaticoduodenectomía/efectos adversos , Pancreaticoduodenectomía/métodos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Páncreas/cirugía , Fístula Pancreática/etiología , Estudios Retrospectivos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/patología
9.
Ann Surg ; 278(2): 253-259, 2023 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-35861061

RESUMEN

BACKGROUND AND OBJECTIVE: Robotic distal pancreatectomy (DP) is an emerging attractive approach, but its role compared with laparoscopic or open surgery remains unclear. Benchmark values are novel and objective tools for such comparisons. The aim of this study was to identify benchmark cutoffs for many outcome parameters for DP with or without splenectomy beyond the learning curve. METHODS: This study analyzed outcomes from international expert centers from patients undergoing robotic DP for malignant or benign lesions. After excluding the first 10 cases in each center to reduce the effect of the learning curve, consecutive patients were included from the start of robotic DP up to June 2020. Benchmark patients had no significant comorbidities. Benchmark cutoff values were derived from the 75th or the 25th percentile of the median values of all benchmark centers. Benchmark values were compared with a laparoscopic control group from 4 high-volume centers and published open DP landmark series. RESULTS: Sixteen centers contributed 755 cases, whereof 345 benchmark patients (46%) were included the analysis. Benchmark cutoffs included: operation time ≤300 minutes, conversion rate ≤3%, clinically relevant postoperative pancreatic fistula ≤32%, 3 months major complication rate ≤26.7%, and lymph node retrieval ≥9. The comprehensive complication index at 3 months was ≤8.7 without deterioration thereafter. Compared with robotic DP, laparoscopy had significantly higher conversion rates (5×) and overall complications, while open DP was associated with more blood loss and longer hospital stay. CONCLUSION: This first benchmark study demonstrates that robotic DP provides superior postoperative outcomes compared with laparoscopic and open DP. Robotic DP may be expected to become the approach of choice in minimally invasive DP.


Asunto(s)
Laparoscopía , Neoplasias Pancreáticas , Procedimientos Quirúrgicos Robotizados , Humanos , Pancreatectomía/efectos adversos , Neoplasias Pancreáticas/cirugía , Benchmarking , Nivel de Atención , Complicaciones Posoperatorias/etiología , Laparoscopía/efectos adversos , Tiempo de Internación , Resultado del Tratamiento , Estudios Retrospectivos
10.
Ann Surg ; 276(6): e886-e895, 2022 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-33534227

RESUMEN

OBJECTIVE: To assess feasibility and safety of a multicenter training program in robotic pancreatoduodenectomy (RPD) adhering to the IDEAL framework for implementation of surgical innovation. BACKGROUND: Good results for RPD have been reported from single center studies. However, data on feasibility and safety of implementation through a multicenter training program in RPD are lacking. METHODS: A multicenter training program in RPD was designed together with the University of Pittsburgh Medical Center, including an online video bank, robot simulation exercises, biotissue drills, and on-site proctoring. Benchmark patients were based on the criteria of Clavien. Outcomes were collected prospectively (March 2016-October 2019). Cumulative sum analysis of operative time was performed to distinguish the first and second phase of the learning curve. Outcomes were compared between both phases of the learning curve. Trends in nationwide use of robotic and laparoscopic PD were assessed in the Dutch Pancreatic Cancer Audit. RESULTS: Overall, 275 RPD procedures were performed in seven centers by 15 trained surgeons. The recent benchmark criteria for low-risk PD were met by 125 (45.5%) patients. The conversion rate was 6.5% (n = 18) and median blood loss 250ml [interquartile range (IQR) 150-500]. The rate of Clavien-Dindo grade ≥III complications was 44.4% (n = 122), postoperative pancreatic fistula (grade B/C) rate 23.6% (n = 65), 90-day complication-related mortality 2.5% (n = 7) and 90-day cancer-related mortality 2.2.% (n = 6). Median postoperative hospital stay was 12 days (IQR 8-20). In the subgroup of patients with pancreatic cancer (n = 80), the major complication rate was 31.3% and POPF rate was 10%. Cumulative sum analysis for operative time found a learning curve inflection point at 22 RPDs (IQR 10-35) with similar rates of Clavien-Dindo grade ≥III complications in the first and second phase (43.4% vs 43.8%, P = 0.956, respectively). During the study period the nationwide use of laparoscopic PD reduced from 15% to 1%, whereas the use of RPD increased from 0% to 25%. CONCLUSIONS: This multicenter RPD training program in centers with sufficient surgical volume was found to be feasible without a negative impact of the learning curve on clinical outcomes.


Asunto(s)
Laparoscopía , Neoplasias Pancreáticas , Procedimientos Quirúrgicos Robotizados , Robótica , Humanos , Pancreaticoduodenectomía/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Fístula Pancreática/etiología , Laparoscopía/métodos , Neoplasias Pancreáticas/cirugía , Neoplasias Pancreáticas/complicaciones , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Neoplasias Pancreáticas
11.
Trials ; 22(1): 608, 2021 Sep 09.
Artículo en Inglés | MEDLINE | ID: mdl-34503548

RESUMEN

BACKGROUND: Recently, the first randomized trials comparing minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) for non-malignant and malignant disease showed a 2-day reduction in time to functional recovery after MIDP. However, for pancreatic ductal adenocarcinoma (PDAC), concerns have been raised regarding the oncologic safety (i.e., radical resection, lymph node retrieval, and survival) of MIDP, as compared to ODP. Therefore, a randomized controlled trial comparing MIDP and ODP in PDAC regarding oncological safety is warranted. We hypothesize that the microscopically radical resection (R0) rate is non-inferior for MIDP, as compared to ODP. METHODS/DESIGN: DIPLOMA is an international randomized controlled, patient- and pathologist-blinded, non-inferiority trial performed in 38 pancreatic centers in Europe and the USA. A total of 258 patients with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC of the pancreatic body or tail will be randomly allocated to MIDP (laparoscopic or robot-assisted) or ODP in a 1:1 ratio. The primary outcome is the microscopically radical resection margin (R0, distance tumor to pancreatic transection and posterior margin ≥ 1 mm), which is assessed using a standardized histopathology assessment protocol. The sample size is calculated with the following assumptions: 5% one-sided significance level (α), 80% power (1-ß), expected R0 rate in the open group of 58%, expected R0 resection rate in the minimally invasive group of 67%, and a non-inferiority margin of 7%. Secondary outcomes include time to functional recovery, operative outcomes (e.g., blood loss, operative time, and conversion to open surgery), other histopathology findings (e.g., lymph node retrieval, perineural- and lymphovascular invasion), postoperative outcomes (e.g., clinically relevant complications, hospital stay, and administration of adjuvant treatment), time and site of disease recurrence, survival, quality of life, and costs. Follow-up will be performed at the outpatient clinic after 6, 12, 18, 24, and 36 months postoperatively. DISCUSSION: The DIPLOMA trial is designed to investigate the non-inferiority of MIDP versus ODP regarding the microscopically radical resection rate of PDAC in an international setting. TRIAL REGISTRATION: ISRCTN registry ISRCTN44897265 . Prospectively registered on 16 April 2018.


Asunto(s)
Carcinoma Ductal Pancreático , Laparoscopía , Neoplasias Pancreáticas , Carcinoma Ductal Pancreático/cirugía , Humanos , Pancreatectomía/efectos adversos , Neoplasias Pancreáticas/cirugía , Complicaciones Posoperatorias , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos , Resultado del Tratamiento
12.
Ann Surg ; 273(2): 334-340, 2021 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-30829699

RESUMEN

OBJECTIVE: The aim of the study was to validate and optimize the alternative Fistula Risk Score (a-FRS) for patients undergoing minimally invasive pancreatoduodenectomy (MIPD) in a large pan-European cohort. BACKGROUND: MIPD may be associated with an increased risk of postoperative pancreatic fistula (POPF). The a-FRS could allow for risk-adjusted comparisons in research and improve preventive strategies for high-risk patients. The a-FRS, however, has not yet been validated specifically for laparoscopic, robot-assisted, and hybrid MIPD. METHODS: A validation study was performed in a pan-European cohort of 952 consecutive patients undergoing MIPD (543 laparoscopic, 258 robot-assisted, 151 hybrid) in 26 centers from 7 countries between 2007 and 2017. The primary outcome was POPF (International Study Group on Pancreatic Surgery grade B/C). Model performance was assessed using the area under the receiver operating curve (AUC; discrimination) and calibration plots. Validation included univariable screening for clinical variables that could improve performance. RESULTS: Overall, 202 of 952 patients (21%) developed POPF after MIPD. Before adjustment, the original a-FRS performed moderately (AUC 0.68) and calibration was inadequate with systematic underestimation of the POPF risk. Single-row pancreatojejunostomy (odds ratio 4.6, 95 confidence interval [CI] 2.8-7.6) and male sex (odds ratio 1.9, 95 CI 1.4-2.7) were identified as important risk factors for POPF in MIPD. The updated a-FRS, consisting of body mass index, pancreatic texture, duct size, and male sex, showed good discrimination (AUC 0.75, 95 CI 0.71-0.79) and adequate calibration. Performance was adequate for laparoscopic, robot-assisted, and hybrid MIPD and open pancreatoduodenectomy. CONCLUSIONS: The updated a-FRS (www.pancreascalculator.com) now includes male sex as a risk factor and is validated for both MIPD and open pancreatoduodenectomy. The increased risk of POPF in laparoscopic MIPD was associated with single-row pancreatojejunostomy, which should therefore be discouraged.


Asunto(s)
Laparoscopía/efectos adversos , Enfermedades Pancreáticas/cirugía , Fístula Pancreática/epidemiología , Pancreaticoduodenectomía/efectos adversos , Complicaciones Posoperatorias/epidemiología , Procedimientos Quirúrgicos Robotizados/efectos adversos , Anciano , Estudios de Cohortes , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedades Pancreáticas/complicaciones , Enfermedades Pancreáticas/patología , Factores de Riesgo , Sensibilidad y Especificidad
13.
Ann Surg ; 271(2): 356-363, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-29864089

RESUMEN

OBJECTIVE: To assess short-term outcomes after minimally invasive (laparoscopic, robot-assisted, and hybrid) pancreatoduodenectomy (MIPD) versus open pancreatoduodenectomy (OPD) among European centers. BACKGROUND: Current evidence on MIPD is based on national registries or single expert centers. International, matched studies comparing outcomes for MIPD and OPD are lacking. METHODS: Retrospective propensity score matched study comparing MIPD in 14 centers (7 countries) performing ≥10 MIPDs annually (2012-2017) versus OPD in 53 German/Dutch surgical registry centers performing ≥10 OPDs annually (2014-2017). Primary outcome was 30-day major morbidity (Clavien-Dindo ≥3). RESULTS: Of 4220 patients, 729/730 MIPDs (412 laparoscopic, 184 robot-assisted, and 130 hybrid) were matched to 729 OPDs. Median annual case-volume was 19 MIPDs (interquartile range, IQR 13-22), including the first MIPDs performed in 10/14 centers, and 31 OPDs (IQR 21-38). Major morbidity (28% vs 30%, P = 0.526), mortality (4.0% vs 3.3%, P = 0.576), percutaneous drainage (12% vs 12%, P = 0.809), reoperation (11% vs 13%, P = 0.329), and hospital stay (mean 17 vs 17 days, P > 0.99) were comparable between MIPD and OPD. Grade-B/C postoperative pancreatic fistula (POPF) (23% vs 13%, P < 0.001) occurred more frequently after MIPD. Single-row pancreatojejunostomy was associated with POPF in MIPD (odds ratio, OR 2.95, P < 0.001), but not in OPD. Laparoscopic, robot-assisted, and hybrid MIPD had comparable major morbidity (27% vs 27% vs 35%), POPF (24% vs 19% vs 25%), and mortality (2.9% vs 5.2% vs 5.4%), with a fewer conversions in robot-assisted- versus laparoscopic MIPD (5% vs 26%, P < 0.001). CONCLUSIONS: In the early experience of 14 European centers performing ≥10 MIPDs annually, no differences were found in major morbidity, mortality, and hospital stay between MIPD and OPD. The high rates of POPF and conversion, and the lack of superior outcomes (ie, hospital stay, morbidity) could indicate that more experience and higher annual MIPD volumes are needed.


Asunto(s)
Procedimientos Quirúrgicos Mínimamente Invasivos , Enfermedades Pancreáticas/cirugía , Pancreaticoduodenectomía/métodos , Anciano , Europa (Continente) , Femenino , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos/mortalidad , Evaluación de Procesos y Resultados en Atención de Salud , Enfermedades Pancreáticas/mortalidad , Pancreaticoduodenectomía/mortalidad , Puntaje de Propensión , Estudios Retrospectivos
14.
Ann Pathol ; 39(4): 292-296, 2019 Aug.
Artículo en Francés | MEDLINE | ID: mdl-30711334

RESUMEN

Microcystic variant of serous cystadenoma of the pancreas is a rare neoplasm; essentially located in the body or tail of the pancreas and associated with the von Hippel-Lindau. Often, patients are asymptomatic and the neoplasm is incidentally discovered. Usually radiographic manifestations are characteristic. Histopathological examination revealed uniform clear cuboidal cells; they can be confused with other clear cell neoplasms like renal cell carcinomas, well-differentiated neuroendocrine tumors and solid pseudopapillary tumors of the pancreas. Immunohistochemistry can be help to establish the diagnosis and to remove differential diagnosis. Serous cystadenoma is a benign neoplasm whose prognosis is excellent. We herein report two cases of microcystic serous cystadenomas of the pancreas diagnosed in two asymptomatic women and review analysis in the literature to remind the main features of this lesion and the main differential diagnosis.


Asunto(s)
Cistadenoma Seroso/patología , Neoplasias Pancreáticas/patología , Anciano , Anciano de 80 o más Años , Femenino , Humanos
15.
J Laparoendosc Adv Surg Tech A ; 29(5): 589-594, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-30596541

RESUMEN

Background: Laparoscopic total gastrectomy with extended lymphadenectomy is a technically demanding surgical procedure with steep learning curve that has limited its widespread use. The aim of this study was to evaluate the feasibility of the robotic approach in total gastrectomy for cancer. We present our experience of 17 consecutive patients who underwent robotic total gastrectomy with intracorporal sutured Roux-en-Y esophagojejunostomy and jejuno jejunostomy between 2014 and 2017. Methods: Data were collected, and patients' demographics and outcomes were examined retrospectively. Results: Seventeen patients with a median age of 68 years (range 32-81) were identified (10 males, 7 females). Mean operative time was 198 minutes (range 108-277) including mean anastomosis time of 25 minutes (range 18-35). There was no conversion to open surgery or requirement for perioperative blood transfusion. Median length of hospital stay was 9 days (range 2-30). Two patients developed postoperative complications including one anastomotic leakage treated conservatively and one internal hernia requiring surgical revision. There was no 90-day mortality or readmission. Conclusion: Robot-assisted total gastrectomy is feasible and reproducible. It overcomes several laparoscopic technical difficulties especially regarding anastomosis. It has the potential to become an alternative to open gastrectomy for gastric cancer. Nevertheless, further follow-up and randomized clinical trials are needed to evaluate mid-term and long-term outcomes of this approach.


Asunto(s)
Anastomosis en-Y de Roux/métodos , Gastrectomía/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Urología/educación , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Yeyunostomía/métodos , Yeyuno/cirugía , Laparoscopía/métodos , Tiempo de Internación , Escisión del Ganglio Linfático , Masculino , Persona de Mediana Edad , Tempo Operativo , Complicaciones Posoperatorias/cirugía , Reoperación , Estudios Retrospectivos , Neoplasias Gástricas/cirugía
16.
Arch Endocrinol Metab ; 62(2): 139-148, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29641730

RESUMEN

OBJECTIVE: Incidental thyroid cancers (ITCs) are often microcarcinomas; among them, the most frequent histotype is the papillary one. The purpose of this study was to evaluate the rate of papillary thyroid cancer (PTC) in patients thyroidectomized for benign multinodular goiter. SUBJECT AND METHODS: We retrospectively evaluated the histological incidence of PTC in 207 consecutive patients who, in a 1-year period, underwent thyroidectomy for benign multinodular goiter. All patients came from an iodine-deficient area (Orleans, France) with three nuclear power stations located in the neighboring areas of the county town. RESULTS: Overall, 25 thyroids (12.1%) harbored 37 PTC, of which 31 were microcarcinomas. In these 25 PTC patients, mean age was 55 ± 10 years (range 30-75), female:male ratio 20:5 (4:1). In 10 patients (40% of 25 and 4.8% of 207), PTCs were bilateral, and in 7 (2 with microPTCs) the thyroid capsule was infiltrated. These 7 patients underwent central and lateral cervical lymph node dissections, which revealed lymph node metastases in one and two cases, respectively. Radioiodine treatment was performed in 7 cases. Neither mortality nor transient and permanent nerve injuries were observed. Four (16%) transient hypocalcaemias occurred as early complications. At last follow-up visit (mean length of follow-up 17.2 ± 3.4 months), all patients were doing well and free of any clinical local recurrence or distant metastases. CONCLUSION: With a 12% risk that multinodular goiter harbors preoperatively unsuspected PTCs, which can have already infiltrated the capsule and that can be accompanied by PTC foci contralaterally, an adequate surgical approach has to be considered.


Asunto(s)
Carcinoma Papilar/epidemiología , Bocio Nodular/cirugía , Neoplasias de la Tiroides/epidemiología , Tiroidectomía/estadística & datos numéricos , Adulto , Anciano , Carcinoma Papilar/diagnóstico , Femenino , Francia/epidemiología , Humanos , Incidencia , Hallazgos Incidentales , Masculino , Persona de Mediana Edad , Periodo Preoperatorio , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Neoplasias de la Tiroides/diagnóstico
17.
Arch. endocrinol. metab. (Online) ; 62(2): 139-148, Mar.-Apr. 2018. tab, graf
Artículo en Inglés | LILACS | ID: biblio-887644

RESUMEN

ABSTRACT Objective Incidental thyroid cancers (ITCs) are often microcarcinomas; among them, the most frequent histotype is the papillary one. The purpose of this study was to evaluate the rate of papillary thyroid cancer (PTC) in patients thyroidectomized for benign multinodular goiter. Subject and methods We retrospectively evaluated the histological incidence of PTC in 207 consecutive patients who, in a 1-year period, underwent thyroidectomy for benign multinodular goiter. All patients came from an iodine-deficient area (Orleans, France) with three nuclear power stations located in the neighboring areas of the county town. Results Overall, 25 thyroids (12.1%) harbored 37 PTC, of which 31 were microcarcinomas. In these 25 PTC patients, mean age was 55 ± 10 years (range 30-75), female:male ratio 20:5 (4:1). In 10 patients (40% of 25 and 4.8% of 207), PTCs were bilateral, and in 7 (2 with microPTCs) the thyroid capsule was infiltrated. These 7 patients underwent central and lateral cervical lymph node dissections, which revealed lymph node metastases in one and two cases, respectively. Radioiodine treatment was performed in 7 cases. Neither mortality nor transient and permanent nerve injuries were observed. Four (16%) transient hypocalcaemias occurred as early complications. At last follow-up visit (mean length of follow-up 17.2 ± 3.4 months), all patients were doing well and free of any clinical local recurrence or distant metastases. Conclusion With a 12% risk that multinodular goiter harbors preoperatively unsuspected PTCs, which can have already infiltrated the capsule and that can be accompanied by PTC foci contralaterally, an adequate surgical approach has to be considered.


Asunto(s)
Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Anciano , Tiroidectomía/estadística & datos numéricos , Neoplasias de la Tiroides/epidemiología , Carcinoma Papilar/epidemiología , Bocio Nodular/cirugía , Neoplasias de la Tiroides/diagnóstico , Carcinoma Papilar/diagnóstico , Incidencia , Estudios Retrospectivos , Factores de Riesgo , Medición de Riesgo , Hallazgos Incidentales , Periodo Preoperatorio , Francia/epidemiología
18.
World J Surg ; 41(2): 457-463, 2017 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-27734084

RESUMEN

INTRODUCTION: Parathyroid autotransplantation is an easy procedure with a low complication rate. We adopted the transplantation into the sternocleidomastoid muscle, which allows an easier and time-saving surgical procedure using the same surgical incision. METHODS: In this study, we retrospectively reviewed the records of 396 consecutive patients, who underwent total thyroidectomy for benign thyroid disease. In all cases in which a parathyroid was damaged or inadvertently removed, the gland was transplanted; before the autotransplantation, the parathyroid tissue was put in a cell culture nutrient solution for 5 min, afterward fragmented, and then was transplanted in the sternocleidomastoid muscle. To demonstrate a beneficial effect of the cell nutrient solution step, we compared data of transplanted patients with a control group of cases (n = 190) undergoing a standard immediate autotransplantation. RESULTS: We divided patients in two main groups: group A (n = 160) including subjects that underwent one or more parathyroid gland autotransplantation using the cell nutrient solution, and group B (n = 236) concerning those who were not transplanted. Among patients, 62 hypocalcemias occurred, 40 in the group A and 22 in the group B (P < 0.001): 91.9 % were transient and 8.1 % (5 patients) definitive, all pertaining to the group B. Among controls (group C), 42 hypocalcemias occurred (P = 0.616 vs. group A and P = 0.002 vs. group B) and 3/42 became definitive (P = 0.096 vs. group A and P = 0.121 vs. group B). All differences concerning pre- and postoperative calcium values were statistically significant (P < 0.001). CONCLUSIONS: We recommend the routine parathyroid autotransplantation, when a vascular damage is certain or suspected, in order to reduce the rate of permanent hypoparathyroidism, using a cell culture nutrient solution before gland transplantation.


Asunto(s)
Medios de Cultivo , Glándulas Paratiroides/trasplante , Tiroidectomía , Adulto , Femenino , Humanos , Hipocalcemia/etiología , Hipoparatiroidismo/prevención & control , Masculino , Persona de Mediana Edad , Músculos del Cuello , Complicaciones Posoperatorias/prevención & control , Estudios Retrospectivos , Trasplante Autólogo
19.
Int J Clin Exp Pathol ; 8(9): 11629-34, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26617901

RESUMEN

INTRODUCTION: Backgrounds of this study were to examine and analyse the relationship among the number of lymph nodes with metastases harvested in central and lateral compartments, the characteristics of tumours and patients, and the recurrences rate. METHODS: A retrospective review of 118 patients treated for a papillary thyroid cancer and underwent to neck dissection, including in all cases both central and lateral compartment, was realised. A quantitative analysis, on this homogeneous cohort of patients, was performed to hypothesize the minimum number of cervical lymph nodes to be necessarily excised in order to obtain an adequate management of these patients. RESULTS: The mean follow-up time was 75.9 months. Five-year overall survival was 96.6%. The correlation among the metastatic lymph node number of the ipsilateral central compartment, isolated or pooled with those of the ipsilateral lateral compartment, age of patient and tumour size revealed a statistical significance (P=0.01); both parameters, tumour size and age, may be considered as dependent predictor variables. CONCLUSION: We suppose, notwithstanding the limited number of patients, that the number of lymph nodes harvested to achieve an optimal cervical dissection may be superior to 8 and 11 in central and lateral compartments, and 6 and 10 in contralateral ones, respectively. Moreover we recommend the bilateral dissection of central nodes compartment in presence of tumour localised in the isthmus.


Asunto(s)
Carcinoma/patología , Neoplasias de la Tiroides/patología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma Papilar , Femenino , Estudios de Seguimiento , Francia , Humanos , Ganglios Linfáticos/patología , Metástasis Linfática , Masculino , Persona de Mediana Edad , Cuello/patología , Disección del Cuello , Estudios Retrospectivos , Cáncer Papilar Tiroideo , Adulto Joven
20.
Ann Ital Chir ; 86(4): 357-61, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26344003

RESUMEN

Gastrointestinal stromal tumours are rare mesenchymal neoplasms, accounting less than 3% of all the gastrointestinal tumours, that may arise in all portions of the gastrointestinal tract but more frequently they involve stomach and small bowel. Generally are asymptomatic or slight symptomatic, although they may also cause acute clinical conditions. Histologically are characterised by a meshwork of spindle-like cells mixed with fibro-hyaline stroma. The immunohistochemical assessment, marked for a strong immunopositivity for CD117 antibodies, allows the differential diagnosis with others muscular, nervous and fibroblastic tumours. Tumour size and mitotic rate are the most important prognostic indicators. Surgery represents the treatment for patients with primary non-metastatic disease, however a prolonged oncologic follow-up is always recommended. Minimally invasive technique is increasingly adopted and preferred for its low morbidity and shorter in-hospital stay, and more and more reports confirm its safety, efficacy and feasibility. We report a case series of three pauci-sympomatic patients, all hospitalised for severe anaemia related to a chronic gastrointestinal bleeding, successfully treated by laparoscopic approach for the removal of gastrointestinal stromal tumours, two located in the stomach and one in the jejunum.


Asunto(s)
Neoplasias Gastrointestinales/cirugía , Tumores del Estroma Gastrointestinal/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos , Enfermedad Aguda , Hemorragia Gastrointestinal/etiología , Hemorragia Gastrointestinal/cirugía , Humanos , Pronóstico
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