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1.
Updates Surg ; 2024 Jul 21.
Artículo en Inglés | MEDLINE | ID: mdl-39033485

RESUMEN

During the COVID-19 pandemic, pancreatic surgery for pancreatic neuroendocrine tumors (PNETs) with surgical indications was postponed or canceled. Patients with PNET patients who underwent pancreatic surgery during the COVID-19 restriction period (3 years) were compared with a similar cohort of patients who underwent surgery in the previous 3 years. Data on patients' characteristics, waiting time, and surgical and pathology outcomes were evaluated. During the study period, 370 patients received surgery for PNETs, 205 (55%) during the first period, and 165 (45%) during the pandemic. A lengthening of the waiting list (182 [IQR 100-357] vs. 60 [40-88] days, p < 0.001) and increased use of anti-tumor medical treatments (any therapy, peptide receptor radionuclide therapy, and somatostatin analogs; all p < 0.001) was found. During the pandemic, surgery occurred after a median of 381 days [IQR 200-610] from diagnosis (vs. 103 [IQR 52-192] of the pre-COVID-19 period, p < 0.001). No statistically significant differences in tumor size and grading distribution were found between the two periods (both p > 0.05), yet only a modest increase of the median Ki67 values in cases operated during the pandemic (4% vs. 3%, p = 0.03). Lastly, these latter patients experienced less major postoperative complications (13% vs. 24%, p = 0.007). During COVID-19, the surgical waiting list of PNET patients was drastically extended, and bridge therapies were preferred. This did not result in more advanced cases at final pathology. PRRT and SSA are valid alternative therapies for PNETs when surgery is not feasible.

2.
Surgery ; 176(1): 189-195, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38729888

RESUMEN

BACKGROUND: Postoperative fluid collections at the resection margin of the pancreatic stump are frequent after distal pancreatectomy, yet their clinical impact is unclear. The aim of this study was to assess the 30-day prevalence of postoperative fluid collections after distal pancreatectomy and the factors associated with a clinically relevant condition. METHODS: Patients enrolled in a randomized controlled trial of parenchymal transection with either reinforced, triple-row staple, or ultrasonic dissector underwent routine magnetic resonance 30 days postoperatively. Postoperative fluid collection was defined as a cyst-like lesion of at least 1 cm at the pancreatic resection margin. Postoperative fluid collections requiring any therapy were defined as clinically relevant. RESULTS: A total of 133 patients were analyzed; 69 were in the triple-row staple transection arm, and 64 were in the ultrasonic dissector transection arm. The overall 30-day prevalence of postoperative fluid collections was 68% (n = 90), without any significant difference between the two trial arms. Postoperative serum hyperamylasemia was more frequent in patients with postoperative fluid collections than those without (31% vs 7%, P = .001). Among the postoperative fluid collection population, an early postoperative pancreatic fistula (odds ratio 14.9, P = .002), post pancreatectomy acute pancreatitis (odds ratio 12.7, P = .036), and postoperative fluid collection size larger than 50 mm (odds ratio 6.6, P = .046) were independently associated with a clinically relevant postoperative fluid collection. CONCLUSION: Postoperative fluid collections at the resection margin are common after distal pancreatectomy and can be predicted by early assessment of postoperative serum hyperamylasemia. A preceding pancreatectomy acute pancreatitis and/or postoperative pancreatic fistula and large collections (>50 mm) were associated with a clinically relevant postoperative fluid collection, representing targets for closer follow-up or earlier therapeutic interventions.


Asunto(s)
Pancreatectomía , Complicaciones Posoperatorias , Humanos , Pancreatectomía/efectos adversos , Pancreatectomía/métodos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Estudios de Seguimiento , Prevalencia , Neoplasias Pancreáticas/cirugía , Imagen por Resonancia Magnética , Fístula Pancreática/epidemiología , Fístula Pancreática/etiología , Fístula Pancreática/prevención & control , Adulto
3.
Ann Surg ; 277(5): e1099-e1105, 2023 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-35797608

RESUMEN

OBJECTIVE: To develop 2 distinct preoperative and intraoperative risk scores to predict postoperative pancreatic fistula (POPF) after distal pancreatectomy (DP) to improve preventive and mitigation strategies, respectively. BACKGROUND: POPF remains the most common complication after DP. Despite several known risk factors, an adequate risk model has not been developed yet. METHODS: Two prediction risk scores were designed using data of patients undergoing DP in 2 Italian centers (2014-2016) utilizing multivariable logistic regression. The preoperative score (calculated before surgery) aims to facilitate preventive strategies and the intraoperative score (calculated at the end of surgery) aims to facilitate mitigation strategies. Internal validation was achieved using bootstrapping. These data were pooled with data from 5 centers from the United States and the Netherlands (2007-2016) to assess discrimination and calibration in an internal-external validation procedure. RESULTS: Overall, 1336 patients after DP were included, of whom 291 (22%) developed POPF. The preoperative distal fistula risk score (preoperative D-FRS) included 2 variables: pancreatic neck thickness [odds ratio: 1.14; 95% confidence interval (CI): 1.11-1.17 per mm increase] and pancreatic duct diameter (OR: 1.46; 95% CI: 1.32-1.65 per mm increase). The model performed well with an area under the receiver operating characteristic curve of 0.83 (95% CI: 0.78-0.88) and 0.73 (95% CI: 0.70-0.76) upon internal-external validation. Three risk groups were identified: low risk (<10%), intermediate risk (10%-25%), and high risk (>25%) for POPF with 238 (18%), 684 (51%), and 414 (31%) patients, respectively. The intraoperative risk score (intraoperative D-FRS) added body mass index, pancreatic texture, and operative time as variables with an area under the receiver operating characteristic curve of 0.80 (95% CI: 0.74-0.85). CONCLUSIONS: The preoperative and the intraoperative D-FRS are the first validated risk scores for POPF after DP and are readily available at: http://www.pancreascalculator.com . The 3 distinct risk groups allow for personalized treatment and benchmarking.


Asunto(s)
Pancreatectomía , Pancreaticoduodenectomía , Humanos , Pancreatectomía/efectos adversos , Pancreatectomía/métodos , Pancreaticoduodenectomía/métodos , Medición de Riesgo/métodos , Factores de Riesgo , Fístula Pancreática/epidemiología , Fístula Pancreática/etiología , Fístula Pancreática/prevención & control , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos
4.
Pancreatology ; 22(7): 1035-1040, 2022 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-36220757

RESUMEN

OBJECTIVES: This study aims to assess the prevalence of preoperative fatigue, depression and anxiety among patients undergoing pancreatic surgery for pancreatic cancer (PC), and possible relationship with postoperative outcomes. METHODS: Prospective data from 162 consecutive patients undergoing pancreatectomy for PC at a third-level referral centers for pancreatic surgery were collected. All patients preoperatively completed four questionnaires assessing depression (PHQ-9), anxiety (STAI-Y2), chronic illness fatigue (FACIT-F) and cancer therapy fatigue (FACT-G). RESULTS: Forty patients (25%) where in the first quartile for chronic illness (FACIT-F ≤34) and/or cancer therapy (FACT-G ≤78) fatigue, 26 patients (16%) met the criteria for major depression (PHQ-9 ≥10) and 34 patients (21%) had anxiety symptoms (STAI-Y2 ≥40). Cancer therapy fatigue was significantly associated with higher rates of morbidity (70% vs 49%), major morbidity (Clavien-Dindo ≥3) (28% vs 11%), post-pancreatectomy hemorrhage (18% vs 4%), pulmonary complications (20% vs 9%) and mortality (8% vs null) (all P ≤ 0.01). Major depression was associated with higher rates of post-pancreatectomy hemorrhage and readmission (23% vs 5%). Multivariable logistic regression analysis of preoperative factors confirmed diabetes (OR 2.71, 95%CI 1.01-7.20; P = 0.04), ASA score ≥3 (OR 4.12, 95%CI 1.52-11.21; P < 0.01) and cancer therapy fatigue (OR 2.95, 95%CI 1.01-8.74; P = 0.04) to be independent predictors of major morbidity. CONCLUSIONS: Higher levels of fatigue (in particular cancer therapy fatigue) strongly correlates with worse postoperative outcomes.


Asunto(s)
Pancreatectomía , Neoplasias Pancreáticas , Humanos , Pancreatectomía/efectos adversos , Estudios Prospectivos , Pronóstico , Depresión/epidemiología , Depresión/etiología , Ansiedad/epidemiología , Ansiedad/etiología , Neoplasias Pancreáticas/complicaciones , Neoplasias Pancreáticas/cirugía , Fatiga/epidemiología , Fatiga/etiología , Hemorragia , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/cirugía , Neoplasias Pancreáticas
5.
Br J Surg ; 109(8): 733-738, 2022 07 15.
Artículo en Inglés | MEDLINE | ID: mdl-35595258

RESUMEN

BACKGROUND: The safety of observing small non-functioning pancreatic neuroendocrine tumours (NF-Pan-NETs) remains under debate. METHODS: This was a multicentre retrospective study of patients with small incidental NF-Pan-NETs. Survival of patients who underwent upfront surgery versus active surveillance was compared. The risk of death was matched with that in the healthy population. The excess hazard rate and probability of a normal lifespan (NLP) were calculated. Propensity score matching (PSM) with a 1 : 1 ratio was used to minimize the risk of selection bias. RESULTS: Some 222 patients (43.7 per cent) underwent upfront surgery and 285 (56.3 per cent) were observed. The excess hazard rate for the entire cohort was quantifiable as 0.04 (95 per cent c.i. 0 to 0.08) deaths per 1000 persons per year, and the NLP was 99.7 per cent. Patients in the active surveillance group were older (median age 65 versus 58 years; P < 0.001), and more often had co-morbidity (45.3 versus 24.8 per cent; P = 0.001), and smaller tumours (median 12 versus 13 mm; P < 0.001), less frequently located in the pancreatic body-tail (59.5 versus 69.6 per cent; P = 0.008, 59.3 versus 73.9 per cent; P = 0.001). Median follow-up was longer for patients who underwent upfront surgery (5.6 versus 2.7 years; P < 0.001). After PSM, 118 patients per group were included. The excess hazard rates were 0.2 and 0.9 deaths per 1000 persons per year (P = 0.020) for patients in the active surveillance and upfront surgery groups respectively. Corresponding NLPs were 99.9 and 99.5 per cent respectively (P = 0.011). CONCLUSION: Active surveillance of small incidental NF-Pan-NETs is a reasonable alternative to resection.


Asunto(s)
Tumores Neuroendocrinos , Neoplasias Pancreáticas , Anciano , Humanos , Tumores Neuroendocrinos/patología , Tumores Neuroendocrinos/cirugía , Páncreas/patología , Estudios Retrospectivos , Espera Vigilante
6.
Updates Surg ; 74(4): 1247-1252, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35298787

RESUMEN

The spread of COVID-19 has overwhelmed medical facilities across the globe, with patients filling beds in both regular wards and in intensive care units. The repurposing of hospital facilities has resulted in a dramatic decrease in the capacity of hospitals-in terms of available beds, surgical facilities, and medical and nursing staff- to care for oncology patients. The Italian National Board of Bioethics provided precise and homogeneous guidelines for the allocation of the scarce resources available. In our experience, strictly following these general guidelines and not considering the clinical vocation of each single health care center did not allow us to resume usual activities but generated further confusion in resource allocation. To face the scarcity of available resources and guarantee our patients fair access to the health care system we created a surgical triage with four fundamental steps. We took into consideration " well defined and widely accepted clinical prognostic factors " as stated by the Italian Society of Anesthesia and Resuscitation. We were able to draw up a list of patients giving priority to those who theoretically should have a greater chance of overcoming their critical situation. The age criterion has also been used in the overall evaluation of different cure options in each case, but it has never been considered on its own or outside the other clinical parameters. Although not considered acceptable by many we had to forcefully adopt the criterion of comparison between patients to give priority to those most in need of immediate care.


Asunto(s)
Bioética , COVID-19 , Humanos , Unidades de Cuidados Intensivos , Pandemias , Triaje/métodos
7.
Surg Endosc ; 36(9): 7025-7037, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35102430

RESUMEN

BACKGROUND: This study aimed to discuss and report the trend, outcomes, and learning curve effect after minimally invasive distal pancreatectomy (MIDP) at two high-volume centres. METHODS: Patients undergoing MIDP between January 1999 and December 2018 were retrospectively identified from prospectively maintained electronic databases. The entire cohort was divided into two groups constituting the "early" and "recent" phases. The learning curve effect was analyzed for laparoscopic (LDP) and robotic distal pancreatectomy (RDP). The follow-up was at least 2 years. RESULTS: The study population included 401 consecutive patients (LDP n = 300, RDP n = 101). Twelve surgeons performed MIDP during the study period. Although patients were more carefully selected in the early phase, in terms of median age (49 vs. 55 years, p = 0.026), ASA class higher than 2 (3% vs. 9%, p = 0.018), previous abdominal surgery (10% vs. 34%, p < 0.001), and pancreatic adenocarcinoma (PDAC) (7% vs. 15%, p = 0.017), the recent phase had similar perioperative outcomes. The increase of experience in LDP was inversely associated with the operative time (240 vs 210 min, p < 0.001), morbidity rate (56.5% vs. 40.1%, p = 0.005), intra-abdominal collection (28.3% vs. 17.3%, p = 0.023), and length of stay (8 vs. 7 days, p = 0.009). Median survival in the PDAC subgroup was 53 months. CONCLUSION: In the setting of high-volume centres, the surgical training of MIDP is associated with acceptable rates of morbidity. The learning curve can be largely achieved by several team members, improving outcomes over time. Whenever possible resection of PDAC guarantees adequate oncological results and survival.


Asunto(s)
Adenocarcinoma , Laparoscopía , Neoplasias Pancreáticas , Procedimientos Quirúrgicos Robotizados , Adenocarcinoma/cirugía , Humanos , Laparoscopía/métodos , Tiempo de Internación , Pancreatectomía/métodos , Neoplasias Pancreáticas/cirugía , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/métodos , Resultado del Tratamiento
8.
Updates Surg ; 74(5): 1705-1713, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-35050488

RESUMEN

Recent advances in the field of tissue regeneration are offering promising therapeutic options for the treatment of short bowel syndrome. This study aimed to evaluate the glucose absorptive capacity of a neoformed intestine obtained from a biological scaffold in a rodent model and the steadiness of the engrafted segment area. Twenty-four male Sprague-Dawley rats were used for this study. Under anesthesia, a patch of biological material (2.2 × 1.5 cm) was engrafted in the anti-mesenteric border of the small bowels of 12 rats. Twelve rats were sham-operated. Animals were studied at 4, 8, and 10 months postengraftment. Functional and histological analyses were performed. The functional analysis was performed using an 18F-FDG analog as a probe and the results were acquired with an optical imager. The intensity of the fluorescent signal emitted by the neointestine was comparable with that emitted by the native intestine in all animals and was visible after injection in the preserved mesentery. The mean intestinal volume at time of engraftment and after 10 months was 4.08 cm3 (95% CI [3.58-4.58]) and 3.26 cm3 (CI 95% [3.23-3.29]), respectively, with a mean shrinkage of 17.3% (range 10.6-23.8%), without any evidence of stenosis. Morphological analysis revealed the progression of the biological material toward a neoformed intestine similar to the native intestine, especially at 8 and 10 months. In a rodent model, we demonstrated that a neointestine, obtained from a biological scaffold showed glucose absorption and a durable increase in diameter.


Asunto(s)
Glucosa , Síndrome del Intestino Corto , Animales , Fluorodesoxiglucosa F18 , Intestinos , Masculino , Ratas , Ratas Sprague-Dawley
9.
Updates Surg ; 74(3): 953-961, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-34689316

RESUMEN

INTRODUCTION: The COVID-19 pandemic has severely limited the access to cancer surgery, but it is not known to what extent referral centers for pancreatic diseases were affected by its outbreak. The aim of this study is to describe the effect of COVID-19 pandemic on a third-level referral center for pancreatic surgery in Italy. METHODS: The 2020 activity of The Pancreas Institute of the University of Verona was reviewed, comparing different phases of the COVID-19 pandemic outbreaks using the pre-COVID era as a control. Endpoints were the overall caseload of pancreatic resections, surgical waiting list, administration of preoperative therapy, major morbidity and mortality, residents' training; number of inpatients beds, outpatient visits/procedures/diagnostics. RESULTS: In 2020, there was an overall significant reduction of pancreatic resections performed (394 vs. 506 in 2019), particularly during the first (March-May) and second (October-December) COVID-19 outbreaks, with an all-time-low of 16 resections/months in April (compared to 43 average resection/month in 2019). The rates of major morbidity (Clavien-Dindo ≥ 3) and mortality were similar to 2019 (16 vs 12%, p = 0.11 and 3 vs 2%, p = 0.29, respectively). During the first and second outbreaks resident's training, inpatient beds, outpatient visits, diagnostics, and procedures were severely impaired, while the waiting list for up-front cancer resections and the use of preoperative chemotherapy concomitantly raised. CONCLUSION: The COVID-19 pandemic has severely disrupted the activity of a third-level referral center for pancreatic surgery, affecting the access to cancer surgical procedures and raising concerns regarding the solidity of the current centralization model.


Asunto(s)
COVID-19 , Neoplasias , Humanos , Neoplasias/epidemiología , Pancreatectomía/métodos , Pandemias , Derivación y Consulta
10.
Ann Surg ; 276(6): 1029-1038, 2022 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-33630454

RESUMEN

OBJECTIVE: The aim of the present study was to critically reappraise the experience at our high-volume institution to obtain new insights for future directions. SUMMARY BACKGROUND DATA: The indications, surgical techniques, and perioperative management of pancreatoduodenectomy (PD) have profoundly evolved over the last 20 years. METHODS: All consecutive PDs performed during the last 20 years at the Verona Pancreas Institute were divided into four 5-year timeframes and retrospectively analyzed in terms of indications, intraoperative features, and surgical outcomes. Significant milestones were provided to understand practice changes using a before-after analysis method. RESULTS: The study population consisted of 3000 patients. The median age, ASA ≥ 3 and number of nonbenchmark cases significantly increased over time ( P < 0.005). Pancreatic cancer was the leading indication, representing 60% of patients/year in the last timeframe, 40% of whom received neoadjuvant treatment. Conversely, after the development of International Guidelines, the proportion of resected cystic neoplasms progressively and thoroughly decreased. Given the increased complexity of surgery for pancreatic cancer, the evolution of technologies, surgical techniques, and postoperative management allowed the maintenance of favorable surgical outcomes over time, with a stable 20.0% of patients with a Clavien-Dindo grade ≥ 3, an 11.7% failure to rescue and a 2.3% in-hospital mortality rate. The incidence of postoperative pancreatic fistula, hemorrhage, and delayed gastric emptying was 22.4%, 13.4%, and 12.4%, respectively. CONCLUSIONS: PD significantly evolved in Verona over the past 2 decades. Surgeries of greater complexity are currently performed on increasingly frailer patients, mostly for pancreatic cancer and often after neoadjuvant chemotherapy. However, the progression of all fields of pancreatic surgery, including the expanding use of postoperative pancreatic fistula mitigation strategies, has allowed satisfactory outcomes to be maintained.


Asunto(s)
Neoplasias Pancreáticas , Pancreaticoduodenectomía , Humanos , Pancreaticoduodenectomía/efectos adversos , Fístula Pancreática/epidemiología , Fístula Pancreática/etiología , Fístula Pancreática/cirugía , Estudios Retrospectivos , Páncreas/cirugía , Complicaciones Posoperatorias/etiología , Neoplasias Pancreáticas
11.
Surg Endosc ; 36(6): 4033-4041, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-34518950

RESUMEN

BACKGROUND: The pancreatic transection method during distal pancreatectomy is thought to influence postoperative fistula rates. Yet, the optimal technique for minimizing fistula occurrence is still unclear. The present randomized controlled trial compared stapled versus ultrasonic transection in elective distal pancreatectomy. METHODS: Patients undergoing distal pancreatectomy from July 2018 to July 2020 at two high-volume institutions were considered for inclusion. Exclusion criteria were contiguous organ resection and a parenchymal thickness > 17 mm on intraoperative ultrasound. Eligible patients were randomized in a 1:1 ratio to stapled transection (Endo GIA Reinforced Reload with Tri-Staple Technology®) or ultrasonic transection (Harmonic Focus® + or Harmonic Ace® + shears). The primary endpoint was postoperative pancreatic fistula. Secondary endpoints included overall complications, abdominal collections, and length of hospital stay. RESULTS: Overall, 72 patients were randomized in the stapled transection arm and 73 patients in the ultrasonic transection arm. Postoperative pancreatic fistula occurred in 23 patients (16%), with a comparable incidence between groups (12% in stapled transection versus 19% in ultrasonic dissection arm, p = 0.191). Overall complications did not differ substantially (35% in stapled transection versus 44% in ultrasonic transection arm, p = 0.170). There was an increased incidence of abdominal collections in the ultrasonic dissection group (32% versus 14%, p = 0.009), yet the need for percutaneous drain did not differ between randomization arms (p = 0.169). The median length of stay was 8 days in both groups (p = 0.880). Intraoperative blood transfusion was the only factor independently associated with postoperative pancreatic fistula on logistic regression analysis (OR 4.8, 95% CI 1.2-20.0, p = 0.032). CONCLUSION: The present randomized controlled trial of stapled versus ultrasonic transection in elective distal pancreatectomy demonstrated no significant difference in postoperative pancreatic fistula rates and no substantial clinical impact on other secondary endpoints.


Asunto(s)
Pancreatectomía , Fístula Pancreática , Humanos , Páncreas/cirugía , Pancreatectomía/métodos , Fístula Pancreática/epidemiología , Fístula Pancreática/etiología , Fístula Pancreática/prevención & control , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Grapado Quirúrgico/métodos , Ultrasonido
12.
Langenbecks Arch Surg ; 407(1): 143-152, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-34432127

RESUMEN

BACKGROUND: We designed a retrospective computational study to evaluate the effects of hemodynamics on portal confluence remodeling in real models of patients with malignancies of the pancreatic head. METHODS: Patient-specific models were created according to computed tomography data. Fluid dynamics was simulated by using finite-element methods. Computational results were compared to morphological findings. RESULTS: Five patients underwent total pancreatectomy, one had duodenopancreatectomy. Vein resection was performed en-bloc with the specimen. Histopathological findings showed that in patients without a vein stenosis and a normal hemodynamics, the three-layered wall of the vein was preserved. In patients with a stenosis > 70% of vein diameter and modified hemodynamics, the three-layered structure of the resected vein was replaced by a dense inflammatory infiltrate in absence of tumor infiltration. CONCLUSIONS: The portal confluence involved by malignancies of the pancreatic head undergoes a remodeling that is not mainly due to a wall infiltration by the tumor but instead to a persistent pathological hemodynamics that disrupts the balance between eutrophic remodeling and degradative process of the vein wall that can lead to the complete upheaval of the three-layered vein wall. This finding can have useful surgical application in planning resection of the vein involved by tumor growth.


Asunto(s)
Neoplasias Pancreáticas , Vena Porta , Hemodinámica , Humanos , Pancreatectomía , Neoplasias Pancreáticas/diagnóstico por imagen , Neoplasias Pancreáticas/cirugía , Pancreaticoduodenectomía , Proyectos Piloto , Vena Porta/diagnóstico por imagen , Vena Porta/cirugía , Estudios Retrospectivos
13.
BMC Cancer ; 21(1): 165, 2021 Feb 16.
Artículo en Inglés | MEDLINE | ID: mdl-33593311

RESUMEN

BACKGROUND: The current management guidelines recommend that patients with borderline resectable pancreatic adenocarcinoma (BRPC) should initially receive neoadjuvant chemotherapy. The addition of advanced radiation therapy modalities, including stereotactic body radiation therapy (SBRT) and intraoperative radiation therapy (IORT), could result in a more effective neoadjuvant strategy, with higher rates of margin-free resections and improved survival outcomes. METHODS/DESIGN: In this single-center, single-arm, intention-to-treat, phase II trial newly diagnosed BRPC will receive a "total neoadjuvant" therapy with FOLFIRINOX (5-fluorouracil, irinotecan and oxaliplatin) and hypofractionated SBRT (5 fractions, total dose of 30 Gy with simultaneous integrated boost of 50 Gy on tumor-vessel interface). Following surgical exploration or resection, IORT will be also delivered (10 Gy). The primary endpoint is 3-year survival. Secondary endpoints include completion of neoadjuvant treatment, resection rate, acute and late toxicities, and progression-free survival. In the subset of patients undergoing resection, per-protocol analysis of disease-free and disease-specific survival will be performed. The estimated sample size is 100 patients over a 36-month period. The trial is currently recruiting. TRIAL REGISTRATION: NCT04090463 at clinicaltrials.gov.


Asunto(s)
Adenocarcinoma/terapia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Quimioradioterapia/métodos , Terapia Neoadyuvante/métodos , Neoplasias Pancreáticas/terapia , Radiocirugia/métodos , Adenocarcinoma/patología , Adulto , Anciano , Ensayos Clínicos Fase II como Asunto , Terapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Cuidados Intraoperatorios , Masculino , Persona de Mediana Edad , Neoplasias Pancreáticas/patología , Pronóstico , Tasa de Supervivencia
14.
HPB (Oxford) ; 23(4): 520-527, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-32859493

RESUMEN

BACKGROUND: Academic hospitals must train future surgeons, but whether residents could negatively affect the outcomes of major procedures is a matter of concern. The aim of this study is to assess if pancreatic surgery is a safe teaching model. METHODS: Outcomes of 1230 major pancreatic resections performed at a high-volume pancreatic teaching hospital between 2015 and 2018 were compared according to the first surgeon type, attending vs resident. RESULTS: Residents performed a selection of 132 (16%) pancreaticoduodenectomies (PD) and 46 (11%) distal pancreatectomies (DP). For PD, pancreatic fistula (25% vs 0, p < 0.001), biliary fistula (7.1% vs 3.5%, p = 0.04) and operative time (400 vs 390 min, p < 0.001) were lower for residents but post-pancreatectomy hemorrhage was higher (20.5% vs 13% p = 0.024). For DP, pancreatic fistula rate was lower for residents (31.7% vs 17.5% p = 0.046). There was no difference in terms of lymph nodes retrieval both for PDs and DPs, while the R1 resections were more frequent among PDs performed by attending surgeons (31.5% vs 15.7%, p = 0.023). CONCLUSION: The active participation of residents does not negatively affect outcomes of major pancreatic resections in a high-volume center. By means of case selection and continuous tutoring, pancreatic surgery represents a safe and valid teaching model.


Asunto(s)
Hospitales de Alto Volumen , Neoplasias Pancreáticas , Humanos , Pancreatectomía/efectos adversos , Fístula Pancreática , Neoplasias Pancreáticas/cirugía , Pancreaticoduodenectomía/efectos adversos , Complicaciones Posoperatorias , Estudios Retrospectivos
15.
J Gastrointest Surg ; 25(6): 1461-1470, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-32495136

RESUMEN

BACKGROUND: The application of postoperative pancreatic fistula (POPF) risk stratification and mitigation strategies requires an update of the protocol for an early drain removal after pancreaticoduodenectomy (PD). The aim of the study is to highlight the unreliability of a single drain fluid amylase (DFA) cutoff-based protocol in the setting of a risk-based drain management. METHODS: The role of postoperative day one (POD1) DFA in predicting POPF was explored in the setting of both selective drain placement and early drain removal protocols. Receiver operating characteristics (ROC) curves were used to assess the POPF diagnostic performance in terms of negative predictive value (NPV) of several POD1 DFA cutoffs in different clinical scenarios according to POPF risk and mitigation strategies. RESULTS: The areas under the curve (AUCs) for POD1-DFA were 0.815 for intermediate risk and pancreaticojejunostomy (PJ) (best cutoff 1000 IU/L, NPV 92.9%), 0.712 for intermediate risk and PJ with external stent (best cutoff 1000 IU/L, NPV 88.8%), and 0.574 for high risk and external stent (best cutoff 250 IU/L, NPV 93.7%). Independent predictors of POPF were body mass index, pancreatic texture, and early drain removal, whereas POD1 DFA was not. CONCLUSION: In the era of risk stratification and mitigation strategies, selective early drain removal still is associated with a reduced rate of POPF. However, a single protocol based on POD1-DFA is not suitable for all clinical scenarios after PD.


Asunto(s)
Amilasas , Pancreaticoduodenectomía , Drenaje , Humanos , Fístula Pancreática/etiología , Fístula Pancreática/prevención & control , Fístula Pancreática/cirugía , Pancreaticoduodenectomía/efectos adversos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Factores de Riesgo
16.
Psychooncology ; 30(4): 455-462, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33247996

RESUMEN

OBJECTIVE: (1) To determine the prevalence and type of depressive symptoms at day-hospital clinical evaluation, before undergoing major surgery in patients diagnosed with pancreatic neoplasm. (2) To analyze the association between depression and sociodemographic, clinical, and psychosocial variables. (3) To understand how coping strategies, perceived social support, and self-efficacy might affect depressive symptoms in this cohort of patients. METHODS: Secondary data analysis collected during the baseline phase of a randomized controlled trial performed at the Pancreas Institute of the University Hospital of Verona, Italy, between June 2017 and June 2018. RESULTS: 18.5% of pancreatic patients had a PHQ-9 score ≥10 (cut-off). Depressed patients were basically more often female (p = 0.07), younger (p = 0.06), and married/with a partner (p = 0.02). Depression was associated to high trait anxiety (p < 0.01), the use of anxiolytics (p < 0.01), sleep-inducing drugs (p < 0.01), and painkillers (p < 0.01). Among psychosocial variables, depressed patients showed lower perceived self-efficacy (p < 0.01) and family and friends' social support (p < 0.01) and used significantly more often dysfunctional coping strategies (p < 0.01), compared to nondepressed. A logistic multivariate model using psychosocial variables as explanatory and depression as dependent was calculated and post hoc analyses were conducted to describe the contribution of each psychosocial variable on depression. CONCLUSIONS: Our study advocates the need for screening for distress and depression in cancer surgery units and recommends to strengthen patients' adaptive coping, social support, and sense of effectiveness in facing the challenges related to the medical condition and treatment process.


Asunto(s)
Neoplasias Pancreáticas , Funcionamiento Psicosocial , Adaptación Psicológica , Ansiedad/epidemiología , Femenino , Hospitales , Humanos , Neoplasias Pancreáticas/epidemiología , Neoplasias Pancreáticas/cirugía , Prevalencia , Apoyo Social
17.
Surgery ; 169(5): 1069-1075, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33257037

RESUMEN

BACKGROUND: Surgical site infections are an important burden of pancreatic surgery, prolonging hospitalization and delaying adjuvant treatment. The aim of this study was to compare negative pressure wound therapy with standard sterile dressing in terms of the prevention of non-organ-space surgical site infection (superficial and deep surgical site infection) in the high-risk setting. METHODS: The trial was conducted at the University of Verona Hospital Trust, Verona, Italy, from July 25, 2018, through October 10, 2019, among adults undergoing surgery for periampullary neoplasms. Only patients at high-risk for surgical site infection based on body mass index, diabetes, steroids, neoadjuvant therapy, American Society of Anesthesiologists score, Charlson comorbidity index, duration of surgery, and blood loss were included and randomized. RESULTS: A total of 351 patients were screened, 100 met the inclusion criteria and were 1:1 allocated in the 2 arms. The difference in terms of non-organ-space surgical site infection comparing negative pressure wound therapy with standard sterile dressing was not significant (10.9 vs 12.2%, risk ratio [RR] 1.144, confidence interval [CI] 95% 0.324-4.040, P = 1.000). Hematomas (4.3 vs 2%, RR 1.565, CI 95% 0.312-7.848, P = .609) and organ-space infections (46.7 vs 43.8%, RR 1.059, CI 95% 0.711-1.576, P = .836) were similar. Negative pressure wound therapy prevented the development of seromas (0 vs 12.2%, RR 0.483, CI 95% 0.390-0.599, P = .027). The aesthetic result assessed on postoperative day 7 was better in the negative pressure wound therapy group (visual analogue scale, 8 vs 7, P = .029; Stony Brook Scar Evaluation Scale, 3.2 vs 2.5, P = .009), but it was no more evident on postoperative day 30 after a total number of 23 dropouts. CONCLUSION: Compared with standard sterile dressing, negative pressure wound therapy is not associated with an improved rate of non-organ-space surgical site infection after surgery for periampullary neoplasms in patients at high risk for surgical site infection. Additional studies will help identify the population that could benefit most from this intervention.


Asunto(s)
Terapia de Presión Negativa para Heridas/instrumentación , Pancreaticoduodenectomía/efectos adversos , Infección de la Herida Quirúrgica/prevención & control , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infección de la Herida Quirúrgica/etiología
19.
Front Psychol ; 11: 362, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32194490

RESUMEN

INTRODUCTION: The aim of the present paper is to establish feasibility and required power of a one-session psychological intervention devoted to increasing patient's self-efficacy and awareness in dealing with anxiety symptoms before major pancreatic cancer surgery. METHODS: Parallel assignment RCT. All consenting patients listed for pancreatic major surgery during day-hospital visits (T0) between June 2017-June 2018 were assigned randomly in blocks of ten to a psychological intervention vs usual care group to be held the day before surgery (T1). The psychological intervention provided the patient the opportunity to increase self-efficacy in dealing with anxiety by talking with a psychologist about personal concerns and learning mindfulness based techniques to cope with anxiety. RESULTS: 400 patients were randomized into the experimental vs. usual care group. 49 and 65, respectively, completed baseline and post-intervention measures. The dropout rate between day-hospital (T0) and pre-surgery intervention (T1) was high (74.5%) due to several management and organization pitfalls. The main outcome, perceived self-efficacy in managing anxiety, showed a significant increase in the intervention group compared to the control group (p < 0.001), and was related to a reduction in state anxiety (p < 0.001). The intervention group perceived also lower emotional pain (p = 0.03). A power analysis was performed to define the appropriate sample size in a definitive RCT. CONCLUSION: Beneath the complexity in retaining patients along their trajectory in pancreatic surgery department, when they had the opportunity to follow a brief psychological intervention, most of them adhered, showing a significant reduction in preoperative emotional distress and less emotional pain perception after surgery. Even if results need caution because of the high attrition rate, we can infer that our psychological intervention has the potential to be proposed in surgical setting, being short, easy to learn and applicable to a wide range of patients. CLINICAL TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov (identifier: NCT03408002). The full protocol is available from the last author.

20.
JAMA Surg ; 155(4): 313-321, 2020 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-32101272

RESUMEN

Importance: The operative scenarios with the highest postoperative pancreatic fistula (POPF) risk represent situations in which fistula prevention and mitigation strategies have the strongest potential to affect surgical outcomes after pancreaticoduodenectomy. Evidence from studies providing risk stratification is lacking. Objective: To investigate whether pancreaticojejunostomy (PJ) or pancreaticogastrostomy (PG), both with externalized transanastomotic stent, is the best reconstruction method for patients at high risk of POPF after pancreaticoduodenectomy. Design, Setting, and Participants: A single-center, phase 3, randomized clinical trial was conducted at the Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy, from July 12, 2017, through March 15, 2019, among adults undergoing elective pancreaticoduodenectomy and considered at high risk for pancreatic fistula after intraoperative assessment of the fistula risk score, some of whom were randomized to undergo PG or PJ. All analyses were performed on an intention-to-treat basis. Interventions: Intervention consisted of PJ or PG, both with externalized transanastomotic stent and octreotide omission. Main Outcomes and Measures: The primary end point was POPF. The secondary end points were Clavien-Dindo grade 3 or higher morbidity, postpancreatectomy hemorrhage, delayed gastric emptying, and average complication burden. Results: A total of 604 patients were screened for eligibility; 82 were at high risk for POPF (fistula risk score, 7-10), and 72 were randomized undergo PG (n = 36; 20 men and 16 women; median age, 65 years [interquartile range, 23-82]) or PJ (n = 36; 26 men and 10 women; median age, 63 years [interquartile range, 35-79]). There was no significant difference in the incidence of POPF between patients who underwent PG and patients who underwent PJ (18 [50.0%] vs 14 [38.9%]; P = .48), but for patients who developed a POPF, the mean (SD) average complication burden was lower for those who underwent PJ than for those who underwent PG (0.25 [0.13] vs 0.39 [0.17]; P = .04). The rates of postpancreatectomy hemorrhage (14 [38.9%] in the PG group vs 9 [25.0%] in the PJ group; P = .31) and delayed gastric emptying (16 [44.4%] in the PG group vs 18 [50.0%] in the PJ group; P = .81) were similar, but patients who underwent PG presented with a significantly higher incidence of Clavien-Dindo grade 3 or higher morbidity than those who underwent PJ (17 [47.2%] vs 8 [22.2%]; P = .047). Conclusions and Relevance: Among patients at the highest risk for POPF, those who underwent PG or PJ experienced similar rates of POPF. However, PG was associated with an increased incidence of Clavien-Dindo grade 3 or higher morbidity and with an increased average complication burden for the patients who developed a POPF. For patients at high risk for pancreatic fistula, PJ with the use of externalized stent and octreotide omission should be considered the most appropriate technical strategy. Trial Registration: ClinicalTrials.gov Identifier: NCT03212196.


Asunto(s)
Fármacos Gastrointestinales/uso terapéutico , Gastrostomía/métodos , Octreótido/uso terapéutico , Fístula Pancreática/prevención & control , Pancreaticoduodenectomía , Pancreatoyeyunostomía/métodos , Complicaciones Posoperatorias/prevención & control , Stents , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo
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