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Background: Open partial pancreatoduodenectomy (OPD) represents the current gold standard of surgical treatment of a wide range of diseases of the pancreatic head but is associated with morbidity in around 40% of cases. Robotic partial pancreatoduodenectomy (RPD) is being used increasingly, yet, no randomised controlled trials (RCTs) of RPD versus OPD have been published, leaving a low level of evidence to support this practice. Methods: This investigator-initiated, exploratory RCT with two parallel study arms was conducted at a high-volume pancreatic centre in line with IDEAL recommendations (stage 2b). Patients scheduled for elective partial pancreatoduodenectomy (PD) for any indication were randomised (1:1) to RPD or OPD with a centralised web-based tool. The primary endpoint was postoperative cumulative morbidity within 90 days, assessed via the Comprehensive Complication Index (CCI). Biometricians were blinded to the intervention, but patients and surgeons were not. The trial was registered prospectively (DRKS00020407). Findings: Between June 3, 2020 and February 14, 2022, 81 patients were randomly assigned to RPD (n = 41) or OPD (n = 40), of whom 62 patients (RPD: n = 29, OPD: n = 33) were analysed in the modified intention to treat analysis. Four patients in the OPD group were randomised, but did not undergo surgery in our department and one patient was excluded in the RPD group due to other reason. Nine patients in the RPD group and 3 patients in the OPD were excluded from the primary analysis because they did not undergo PD, but rather underwent other types of surgery. The CCI after 90 days was comparable between groups (RPD: 34.02 ± 23.48 versus OPD: 36.45 ± 27.65, difference in means [95% CI]: -2.42 [-15.55; 10.71], p = 0.713). The RPD group had a higher incidence of grade B/C pancreas-specific complications compared to the OPD group (17 (58.6%) versus 11 (33.3%); difference in rates [95% CI]: 25.3% [1.2%; 49.4%], p = 0.046). The only complication that occurred significantly more often in the RPD than in the OPD group was clinically relevant delayed gastric emptying. Procedure-related and overall hospital costs were significantly higher and duration of surgery was longer in the RPD group. Blood loss did not differ significantly between groups. The intraoperative conversion rate of RPD was 23%. Overall 90-day mortality was 4.8% without significant differences between RPD and OPD. Interpretation: In the setting of a very high-volume centre, both RPD and OPD can be considered safe techniques. Further confirmatory multicentre RCTs are warranted to uncover potential advantages of RPD in terms of perioperative and long-term outcomes. Funding: Federal Ministry of Education and Research (BMBF: 01KG2010).
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OBJECTIVE: The goal of the current study was to investigate the perioperative outcomes of robotic pancreaticoduodenectomy (RPD) and open pancreaticoduodenectomy (OPD) in a high-volume center. BACKGROUND: Despite RPDs prospective advantages over OPD, current evidence comparing the 2 has been limited and has prompted further investigation. The aim of this study was to compare both approaches while including the learning curve phase for RPD. METHODS: A 1:1 propensity score-matched analysis of a prospective database of RPD with OPD (2017-2022) at a high-volume center was performed. The main outcomes were overall- and pancreas-specific complications. RESULTS: Of 375 patients who underwent PD (OPD n=276; RPD n=99), 180 were included in propensity score-matched analysis (90 per group). RPD was associated with less blood loss [500 (300-800) vs 750 (400-1000) mL; P =0.006] and more patients without a complication (50% vs 19%; P <0.001). Operative time was longer [453 (408-529) vs 306 (247-362) min; P <0.001]; in patients with ductal adenocarcinoma, fewer lymph nodes were harvested [24 (18-27) vs 33 (27-39); P <0.001] with RPD versus OPD. There were no significant differences for major complications (38% vs 47%; P =0.291), reoperation rate (14% vs 10%; P =0.495), postoperative pancreatic fistula (21% vs 23%; P =0.858), and patients with the textbook outcome (62% vs 55%; P =0.452). CONCLUSIONS: Including the learning phase, RPD can be safely implemented in high-volume settings and shows potential for improved perioperative outcomes versus OPD. Pancreas-specific morbidity was unaffected by the robotic approach. Randomized trials with specifically trained pancreatic surgeons and expanded indications for the robotic approach are needed.
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Laparoscopia , Neoplasias Pancreáticas , Procedimentos Cirúrgicos Robóticos , Humanos , Pancreaticoduodenectomia/efeitos adversos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Pontuação de Propensão , Pâncreas/cirurgia , Complicações Pós-Operatórias/etiologia , Curva de Aprendizado , Estudos Retrospectivos , Neoplasias Pancreáticas/cirurgia , Neoplasias Pancreáticas/complicações , Laparoscopia/efeitos adversosRESUMO
With increasing trends for the adoption of robotic surgery, many centers are considering changing their practices from open or laparoscopic to robot-assisted surgery for rectal cancer. We compared the outcomes of robot-assisted rectal resection with those of open and laparoscopic surgery. We searched Medline, Web of Science, and CENTRAL databases until October 2022. All randomized controlled trials (RCTs) and prospective studies comparing robotic surgery with open or laparoscopic rectal resection were included. Fifteen RCTs and 11 prospective studies involving 6922 patients were included. The meta-analysis revealed that robotic surgery has lower blood loss, less surgical site infection, shorter hospital stays, and higher negative resection margins than open resection. Robotic surgery also has lower conversion rates, lower blood loss, lower rates of reoperation, and higher negative circumferential margins than laparoscopic surgery. Robotic surgery had longer operation times and higher costs than open and laparoscopic surgery. There were no differences in other complications, mortality, and survival between robotic surgery and the open or laparoscopic approach. However, heterogeneity between studies was moderate to high in some analyses. The robotic approach can be the method of choice for centers planning to change from open to minimally invasive rectal surgery. The higher costs of robotic surgery should be considered as a substitute for laparoscopic surgery (PROSPERO: CRD42022381468).
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OBJECTIVE: The objective of this study was to identify the indications for and report the outcomes of completion pancreatectomy (CPLP) in the postoperative course after pancreatoduodenectomy (PD). BACKGROUND: CPLP may be considered or even inevitable for damage control after PD. METHODS: A prospectively maintained database of all patients undergoing PD between 2001 and 2019 was searched for patients who underwent CPLP in the postoperative course after PD. Baseline characteristics, perioperative details, and outcomes of CPLP patients were analyzed and specific indications for CPLP were identified. RESULTS: A total of 3953 consecutive patients underwent PD during the observation period. CPLP was performed in 120 patients (3%) after a median of 10 days following PD. The main indications for CPLP included postpancreatectomy acute necrotizing pancreatitis [n=47 (39%)] and postoperative pancreatic fistula complicated by hemorrhage [n=41 (34%)] or associated with uncontrollable leakage of the pancreatoenteric anastomosis [n=23 (19%)]. The overall 90-day mortality rate of all 3953 patients was 3.5% and 37% for patients undergoing CPLP. CONCLUSIONS: Our finding that only very few patients (3%) need CPLP suggests that conservative, interventional, and organ-preserving surgical measures are the mainstay of complication management after PD. Postpancreatectomy acute necrotizing pancreatitis, uncontrollable postoperative pancreatic fistula, and fistula-associated hemorrhage are highly dangerous and represent the main indications for CPLP after PD.
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Pancreatectomia , Pancreatite Necrosante Aguda , Humanos , Pancreatectomia/efeitos adversos , Pancreaticoduodenectomia/efeitos adversos , Fístula Pancreática/epidemiologia , Fístula Pancreática/etiologia , Pancreatite Necrosante Aguda/cirurgia , Pâncreas/cirurgia , Complicações Pós-Operatórias/etiologia , Estudos RetrospectivosRESUMO
OBJECTIVE: To evaluate the outcomes of pancreatic cancer [pancreatic ductal adenocarcinoma (PDAC)] surgery with concomitant portal vein resection (PVR), focusing on the PVR type according to the International Study Group of Pancreatic Surgery (ISGPS). BACKGROUND: Surgery offers the only chance for cure in PDAC. PVR is often performed for borderline or locally advanced tumors. METHODS: Consecutive patients with PDAC operated between January 2006 and January 2018 were included. Clinicopathologic characteristics and outcomes were analyzed and tested for survival prediction. RESULTS: Of 2265 PDAC resections, 1571 (69.4%) were standard resections and 694 (30.6%) were resections with PVR, including 149 (21.5%) tangential resections with venorrhaphy (ISGPS type 1), 21 (3.0%) resections with patch reconstruction (type 2), 491 (70.7%) end-to-end anastomoses (type 3), and 33 (4.8%) resections with graft interposition (type 4). The 90-day mortality rate was 2.6% after standard resection and 6.3% after resection with PVR ( P <0.0001). Postoperative portal vein thrombosis and pancreas-specific surgical complications most frequently occurred after PVR with graft interposition (21.2% and 48.5%, respectively). In multivariable analysis, age 70 years and above, ASA stages 3/4, increased preoperative serum carbohydrate antigen 19-9, neoadjuvant treatment, total pancreatectomy, PVR, higher UICC stage, and R+ resections were significant negative prognostic factors for overall survival. Radical R0 (>1 mm) resection resulted in 23.3 months of median survival. CONCLUSIONS: This is the largest single-center, comparative cohort study of PVR in PDAC surgery, showing that postoperative morbidity correlates with the reconstruction type. When radical resection is achieved, thrombosis risk is outweighed by beneficial overall survival times of nearly 2 years.
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Carcinoma Ductal Pancreático , Neoplasias Pancreáticas , Trombose Venosa , Humanos , Idoso , Estudos de Coortes , Veia Porta/cirurgia , Veia Porta/patologia , Pancreatectomia/métodos , Pâncreas/cirurgia , Pancreaticoduodenectomia/métodos , Trombose Venosa/patologia , Estudos Retrospectivos , Neoplasias PancreáticasRESUMO
OBJECTIVE: To assesses the prevalence and severity of CAS in patients undergoing PD/total pancreatectomy and its association with major postoperative complications after PD. SUMMARY OF BACKGROUND DATA: CAS may increase the risk of ischemic complications after PD. However, the prevalence of CAS and its relevance to major morbidity remain unknown. METHODS: All patients with a preoperative computed tomography with arterial phase undergoing partial PD or TP between 2014 and 2017 were identified from a prospective database. CAS was assessed based on computed tomography and graded according to its severity: no stenosis (<30%), grade A (30%-<50%), grade B (50%-≤80%), and grade C (>80%). Postoperative complications were assessed and uni- and multivariable risk analyses were performed. RESULTS: Of 989 patients, 273 (27.5%) had CAS: 177 (17.9%) with grade A, 83 (8.4%) with grade B, and 13 (1.3%) with grade C. Postoperative morbidity and 90-day mortality occurred in 278 (28.1%) patients and 41 (4.1%) patients, respectively. CAS was associated with clinically relevant pancreatic fistula ( P =0.019), liver perfusion failure ( P =0.003), gastric ischemia ( P =0.001), clinically relevant biliary leakage ( P =0.006), and intensive care unit ( P =0.016) and hospital stay ( P =0.001). Multivariable analyses confirmed grade B and C CAS as independent risk factors for liver perfusion failure; in addition, grade C CAS was an independent risk factor for clinically relevant pancreatic fistula and gastric complications. CONCLUSIONS: CAS is common in patients undergoing PD. Higher grade of CAS is associated with an increased risk for clinically relevant complications, including liver perfusion failure and postoperative pancreatic fistula. Precise radiological assessment may help to identify CAS. Future studies should investigate measures to mitigate CAS-associated risks.
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Fístula Pancreática , Pancreaticoduodenectomia , Humanos , Pancreaticoduodenectomia/efeitos adversos , Pancreaticoduodenectomia/métodos , Fístula Pancreática/epidemiologia , Fístula Pancreática/etiologia , Pancreatectomia/efeitos adversos , Pancreatectomia/métodos , Fatores de Risco , Complicações Pós-Operatórias/etiologia , Morbidade , Estudos RetrospectivosRESUMO
BACKGROUND: Obesity is a major health burden worldwide and is associated with nonalcoholic fatty liver disease, which can lead to cirrhosis. Bariatric surgery is increasingly being used to treat obesity, and the number of patients with obesity and cirrhosis undergoing bariatric surgery is also rising. However, the safety and feasibility of bariatric surgery in patients with obesity and cirrhosis are controversial. OBJECTIVES: In this meta-analysis, we compared postoperative complications, mortality, and weight loss between patients with and without cirrhosis undergoing bariatric surgery. SETTING: An electronic search of Medline, Web of Science, and Cochrane Central Register of Controlled Trials (CENTRAL). METHODS: Patient morbidity and mortality odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs) were assessed. Intraoperative and overall complications, length of hospital stay, in-hospital mortality, long-term mortality, and total weight loss were recorded. RESULTS: The literature search yielded 2977 articles. Eight studies were included in the analysis. Meta-analysis showed that the overall complications (OR: 2.1; 95% CI: 1.47-3.00; P < .0001), postoperative bleeding (OR: 2.22; 95% CI: 1.95-2.54; P < .00001), length of hospital stay (MD: .68; 95% CI: .14-1.19; P = .01), and in-hospital/90-day mortality (OR: 3.59; 95% CI: 2.84-4.54; P < .00001) were significantly higher in patients with compensated cirrhosis than in patients without cirrhosis. Intraoperative complications, operation time, major complications, and long-term mortality were similar between the groups. Total weight loss was also not significantly different between the groups. CONCLUSION: Bariatric surgery can be considered only in highly selected patients with obesity and compensated cirrhosis.
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Cirurgia Bariátrica , Hepatopatia Gordurosa não Alcoólica , Cirurgia Bariátrica/efeitos adversos , Humanos , Cirrose Hepática/complicações , Cirrose Hepática/cirurgia , Hepatopatia Gordurosa não Alcoólica/complicações , Obesidade/complicações , Obesidade/cirurgia , Redução de PesoRESUMO
Importance: Comparability of morbidity and mortality rates after total pancreatectomy (TP) reported by different surgical centers is limited. Procedure-specific differences, such as the extent of resection, including additional vascular or multivisceral resections, are rarely acknowledged when postoperative outcomes are reported. Objectives: To evaluate postoperative outcomes after TP and categorize different types of TP based on the extent, complexity, and technical aspects of each procedure. Design, Setting, and Participants: This single-center study included a retrospective cohort of 1451 patients who had undergone TP between October 1, 2001, and December 31, 2020. Each patient was assigned to 1 of the following 4 categories that reflect increasing levels of procedure-related difficulty: standard TP (type 1), TP with venous resection (type 2), TP with multivisceral resection (type 3), and TP with arterial resection (type 4). Postoperative outcomes among the groups were compared. Main Outcomes and Measures: Categorization of different types of TP based on the procedure-related difficulty and differing postoperative outcomes. Results: Of the 1451 patients who had undergone TP and were included in the analysis, 840 were men (57.9%); median age was 64.9 (IQR, 56.7-71.7) years. A total of 676 patients (46.6%) were assigned to type 1, 296 patients (20.4%) to type 2, 314 patients (21.6%) to type 3, and 165 patients (11.4%) to type 4 TP. A gradual increase in surgical morbidity was noted by TP type (type 1: 255 [37.7%], type 2: 137 [46.3%], type 3: 178 [56.7%], and type 4: 98 [59.4%]; P < .001), as was noted for median length of hospital stay (type 1: 14 [IQR, 10-19] days, type 2: 16 [IQR, 12-23] days, type 3: 17 [IQR, 13-29] days, and type 4: 18 [IQR, 13-30] days; P < .001), and 90-day mortality (type 1: 23 [3.4%], type 2: 17 [5.7%], type 3: 29 [9.2%], and type 4: 20 [12.1%]; P < .001). In the multivariable analysis, type 3 (TP with multivisceral resection) and type 4 (TP with arterial resection) were independently associated with an increased 90-day mortality rate. Conclusions and Relevance: The findings of this study suggest there are significant differences in postoperative outcomes when the extent, complexity, and technical aspects of the procedure are considered. Classifying TP into 4 different categories may allow for better postoperative risk stratification as well as more accurate comparisons in future studies.
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Avaliação de Processos e Resultados em Cuidados de Saúde , Pancreatectomia/métodos , Neoplasias Pancreáticas/cirurgia , Complicações Pós-Operatórias , Idoso , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Medição de RiscoRESUMO
BACKGROUND: Activation of the oncogene yes-associated protein (YAP) is frequently detected in intrahepatic cholangiocarcinoma (iCCA); however, the expression pattern and the functional impact of its paralogue WW domain-containing transcription regulator 1 (WWTR1; synonym: TAZ) are not well described in different CCA subtypes. METHODS: Immunohistochemical analysis of YAP and TAZ in iCCA and extrahepatic CCA (eCCA) cohorts was performed. YAP/TAZ shuttling and their functional impact on CCA cell lines were investigated. Target genes expression after combined YAP/TAZ inhibition was analyzed. RESULTS: Immunohistochemical analysis of iCCA and eCCA revealed YAP or TAZ positivity in up to 49.2%; however, oncogene co-expression was less frequent (up to 23%). In contrast, both proteins were jointly detectable in most CCA cell lines and showed nuclear/cytoplasmic shuttling in a cell density-dependent manner. Next to the pro-proliferative function of YAP/TAZ, both transcriptional co-activators cooperated in the regulation of a gene signature that indicated the presence of chromosomal instability (CIN). A correlation between YAP and the CIN marker phospho-H2A histone family member X (pH2AX) was particularly observed in tissues from iCCA and distal CCA (dCCA). The presence of the CIN genes in about 25% of iCCA was statistically associated with worse prognosis. CONCLUSIONS: YAP and TAZ activation is not uncoupled from cell density in CCA cells and both factors cooperatively contribute to proliferation and expression of CIN-associated genes. The corresponding group of CCA patients is characterized by CIN and may benefit from YAP/TAZ-directed therapies.
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Proteínas Adaptadoras de Transdução de Sinal/metabolismo , Neoplasias dos Ductos Biliares/genética , Colangiocarcinoma/genética , Instabilidade Cromossômica/genética , Peptídeos e Proteínas de Sinalização Intracelular/metabolismo , Fatores de Transcrição/metabolismo , Proteínas Adaptadoras de Transdução de Sinal/antagonistas & inibidores , Ductos Biliares Extra-Hepáticos , Ductos Biliares Intra-Hepáticos , Contagem de Células , Linhagem Celular Tumoral , Colangiocarcinoma/metabolismo , Colangiocarcinoma/patologia , Histonas/metabolismo , Humanos , Imuno-Histoquímica , Peptídeos e Proteínas de Sinalização Intracelular/antagonistas & inibidores , Prognóstico , Análise Serial de Tecidos , Fatores de Transcrição/antagonistas & inibidores , Proteínas com Motivo de Ligação a PDZ com Coativador Transcricional , Proteínas de Sinalização YAPRESUMO
Up to 50% of patients with colorectal cancer (CRC) have either synchronous or metachronous hepatic metastases in the course of their disease. Patients with metastatic CRC (mCRC) whose tumors express wild-type KRAS benefit from treatment with monoclonal antibodies (such as cetuximab or panitumumab) that target the epidermal growth factor receptor (EGFR). However, the therapeutic response to these antibodies is variable, and further predictive models are required. The present study examined whether expression of different EGFRs or their ligands in tumors was associated with the response to cetuximab treatment. Tumor tissues, collected during liver resection in 28 patients with mCRC, were analyzed. The protein expression levels of EGFR/ErbB1, ErbB2, ErbB3 and the EGFR ligands heregulin and amphiregulin were determined using Luminex 200® and enzyme-linked immunosorbent assays. Computed tomography or magnetic resonance imaging was performed 4 weeks before and 6-8 weeks after treatment with cetuximab. Response to treatment was assessed using the response evaluation criteria for solid tumors (RECIST). The association between the protein expression levels of different EGFRs and their ligands with RECIST criteria was then analyzed to determine whether these protein levels could predict the treatment response to cetuximab. A total of 12 patients exhibited a partial response, 9 exhibited stable disease and 7 exhibited progressive disease after cetuximab therapy according to RECIST. The expression levels of EGFRs (EGFR/ErbB1, ErbB2 and ErbB3) and their ligands (heregulin and amphiregulin) were not significantly associated with the response to cetuximab therapy. Therefore, the present study indicated that EGFR or EGFR ligand expression did not predict treatment response in patients with CRC with liver metastases following cetuximab therapy.
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Inhibition of the programmed cell death protein-1/ligand-1 (PD-1/PD-L1) axis has opened a new era in the treatment of solid cancers. However, there is no data on the expression and relevance of PD-L1 in Western gallbladder cancer (GBC). We assessed PD-L1 immunohistochemically in 131 GBC patients as Tumor Proportion Score (TPS), Immune Cell Score (IC) and Combined Positivity Score (CPS). Tumor cells expressed PD-L1 in a subset of 14.7% GBC patients at a TPS cut-off of 1%. Higher PD-L1 levels above 10% and 25% TPS were reached in 4.7% and 3.1% of GBC cases, respectively. At a 10% cut-off, TPS was associated with distinct histomorphological subtypes and correlated with poor tumor differentiation. Survival analysis revealed a TPS above 10% to be a highly significant and independent negative prognosticator in GBC. PD-L1 expression was associated with increased CD4+, CD8+ and PD-1+ immune cell densities. In 14.8% of the cases, scattered immune cells expressed T-cell immunoreceptor with Ig and ITIM domains (TIGIT), which was correlated to tumoral expression of its ligand CD155. We here show that a high PD-L1 expression confers a negative prognostic value in Western-world GBC and highlight the TIGIT/CD155 immune checkpoint as a potential new target for GBC immunotherapy.
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We report a case of successful robot-assisted major liver resection in a patient with liver alveolar echinococcosis (AE). A 62-year-old male patient was incidentally diagnosed with a large infiltrative lesion in the right liver lobe suspicious for AE. A radical surgical resection as a right-sided hemihepatectomy was indicated. The operation was carried out via a robotic-assisted procedure using the DaVinci Xi Surgical System. The tumor measured 12.4 × 8.8 cm and was successfully resected through a suprapubic incision of 13 cm. The patient was free of pain after the second post-operative day. A fluid collection near the resection plate was easily drained without bile leakage. The patient had no surgical complications. Radical resection is inevitable for adequate curative therapy of AE and provides clear margins. Robotic surgery is a relatively new and safe option for curative resection of AE lesions, with remarkable advantages for patients and surgeons.
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Robotic surgical procedures have been implemented and have become an important development in pancreatic surgery with an increasing acceptance worldwide. Nearly all types of pancreatic surgery have now been performed robotically and especially standardized resections, such as distal pancreatectomy (RDP) and partial pancreatoduodenectomy (RPD) have gained importance despite a potentially long learning curve and high associated procedural costs. The present review article summarizes the available literature and evidence on the respective procedures focused on their use for indications of malignancy.
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Laparoscopia , Neoplasias Pancreáticas , Procedimentos Cirúrgicos Robóticos , Robótica , Humanos , Pancreatectomia , Neoplasias Pancreáticas/cirurgia , Pancreaticoduodenectomia , Resultado do TratamentoRESUMO
BACKGROUND: The feasibility and safety of minimally invasive enucleation (ME) for benign or borderline pancreatic tumors is still unclear. The aim of this study was to compare outcomes between ME and open enucleation (OE). METHODS: All patients undergoing pancreatic enucleation between October 2001 and January 2020 were analyzed from a prospective database. Consecutive patients undergoing ME were compared with patients undergoing OE in a matched-pair analysis (1:2). RESULTS: Of 358 patients, undergoing enucleation, 120 matched patients (ME n = 40, OE n = 80) were included. Patients undergoing ME had less blood loss (median 50 vs. 100 ml, P = 0.025) and had a higher proportion of patients discharged by 7 days, than patients undergoing OE (38% vs. 18%, P = 0.016). The rates of clinically relevant postoperative pancreatic fistula (POPF) and major complications (Clavien grade ≥ 3) were similar between both groups. Risk factor analysis for POPF B/C showed no significant parameters associated with POPF, including tumor size and proximity to the main pancreatic duct. CONCLUSION: Compared with conventional OE, ME reduces the amount of bleeding and allows earlier postoperative discharge, without increasing the incidence of major complications. Thus, minimally invasive enucleation should be considered for benign tumors of the pancreas when technically and oncologically feasible.
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Laparoscopia , Neoplasias Pancreáticas , Humanos , Laparoscopia/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos , Pancreatectomia/efeitos adversos , Fístula Pancreática/etiologia , Neoplasias Pancreáticas/cirurgia , Complicações Pós-Operatórias/etiologia , Estudos RetrospectivosRESUMO
INTRODUCTION: Peritoneal fenestration is an effective preventive method for reducing the rate of lymphatic complications in kidney transplantation (KTx). The size of the fenestration plays an important role in its effectiveness. A large peritoneal window is no longer indicated, due to herniation and difficulties in performing biopsies. Small preventive fenestration is effective but will be closed too early. The aim of this study is to evaluate whether metal clips around the edges of a small fenestration result in optimal effects with minimum fenestration size. METHODS AND ANALYSIS: This trial has been initiated in July 2019 and is expected to last for 2 and a half years. All patients older than 18 years, who receive kidneys from deceased donors, will be included. The kidney recipients will be randomly allocated to either a control arm (small fenestration alone) or an intervention arm (small fenestration with clipping). All fenestrations will be round, maximum 2 cm, and close to the kidney hilum. Clipping will be performed with eight metal clips around the peritoneal window (360°) in every 45° in an oblique position. The primary endpoint is the incidence of symptomatic post-KTx lymphatic complications, which require interventional treatment within 6 months after KTx. Secondary endpoints are intraoperative and postoperative outcomes, including blood loss, operation time, severity grade of lymphocele/lymphorrhea and relative symptoms. ETHICS AND DISSEMINATION: This protocol study received approval from the Ethics Committee of the University of Heidelberg (Registration Number S-318/2017). A Standard Protocol Items: Recommendations for Interventional Trials checklist is available for this protocol. The results will be disseminated through peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03682627).
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Transplante de Rim , Linfocele , Humanos , Incidência , Transplante de Rim/efeitos adversos , Linfocele/etiologia , Linfocele/prevenção & controle , Peritônio/cirurgia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Obesity, defined by body mass index (BMI), measured at colorectal cancer (CRC) diagnosis has been associated with postoperative complications and survival outcomes. However, BMI does not allow for a differentiation between fat and muscle mass. Computed tomography (CT)-defined body composition more accurately reflects different types of tissue and their associations with health-related quality of life (HRQoL) during the first year of disease, but this has not been investigated yet. We studied the role of visceral and subcutaneous fat area (VFA and SFA) and skeletal muscle mass (SMM) on longitudinally assessed HRQoL in CRC patients. METHODS: A total of 138 newly diagnosed CRC patients underwent CT scans at diagnosis and completed questionnaires prior to and six and twelve months post-surgery. We investigated the associations of VFA, SFA, and SMM with HRQoL at multiple time points. RESULTS: A higher VFA was associated with increased pain six and twelve months post-surgery (ß = 0.06, p = 0.04 and ß = 0.07, p = 0.01) and with worse social functioning six months post-surgery (ß = -0.08, p = 0.01). Higher SMM was associated with increased pain twelve months post-surgery (ß = 1.03, p < 0.01). CONCLUSIONS: CT-quantified body composition is associated with HRQoL scales post-surgery. Intervention strategies targeting a reduction in VFA and maintaining SMM might improve HRQoL in CRC patients during the first year post-surgery.
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Composição Corporal , Manutenção do Peso Corporal , Neoplasias Colorretais/diagnóstico por imagem , Neoplasias Colorretais/metabolismo , Gordura Intra-Abdominal , Músculo Esquelético , Obesidade/diagnóstico por imagem , Obesidade/metabolismo , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/prevenção & controle , Qualidade de Vida , Gordura Subcutânea , Tomografia Computadorizada por Raios X/métodos , Índice de Massa Corporal , Feminino , Humanos , Estudos Longitudinais , MasculinoRESUMO
CONTEXT: Studies on the surgical outcome in living kidney donors mainly report perioperative complications with short follow-up. OBJECTIVE: The objectives of this study are to evaluate the long-term surgical outcome in living kidney donors and to identify donors with an increased risk for a complicated postoperative course. BASIC PROCEDURES: A prospectively collected database of 496 living kidney donors at the Department of General, Visceral, and Transplantation Surgery of the Ruprecht Karls University Heidelberg was retrospectively analyzed in a retrospective, observational single-center study. RESULTS: The median follow-up time was 37 months. The perioperative severe complication (Clavien-Dindo IIIb) rate was 2.8%, the early postoperative (PO) severe complication rate (1-3 months post operation) was 0.7%, and the late PO severe complication rate (> 3 months post operation) was 8.4%. In multivariate analyses, male sex was associated with higher overall perioperative complication rate (odds ratio [OR], 1.930; P = .005) as well as higher rate of late PO complications (OR, 2.243; P = .014). An increased body mass index was associated with a higher late and severe (Clavien-Dindo ≥ IIIb) PO complication rate (OR, 1.107; P = .009 and OR, 1.105; P = .008, respectively). CONCLUSIONS AND RELEVANCE: Long-term surgery-associated severe complications occur in 8.4% of kidney donors. Older age is associated with an increased operative time, greater intraoperative blood loss, and longer PO hospital stay. Male donors and donors with an increased body mass index have a higher risk for a complicated PO course after kidney donation. Within a shared decision-making process before living kidney donation, special awareness should be brought to these facts.
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Transplante de Rim/métodos , Doadores Vivos , Nefrectomia/efeitos adversos , Complicações Pós-Operatórias/etiologia , Coleta de Tecidos e Órgãos/efeitos adversos , Adulto , Idoso , Índice de Massa Corporal , Feminino , Humanos , Rim/cirurgia , Masculino , Pessoa de Meia-Idade , Razão de Chances , Duração da Cirurgia , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Resultado do TratamentoRESUMO
PURPOSES: Cancer-related distress is known to persist long after completion of treatment. Factors related to distress are largely unexplored in colorectal cancer (CRC) survivors. We examined changes over time and risk factors for distress in CRC patients over the first year after surgery. METHODS: We included 212 CRC patients with data at 6 and 12 months post-surgery from the ColoCare Study in Heidelberg, Germany. Sociodemographic and lifestyle factors, social support, and health-related quality of life (HrQOL) prior to surgery were evaluated as predictors of cancer-related distress. Distress was measured with the Cancer and Treatment Distress instrument (CTXD). Linear regression analyses examined associations between risk factors and distress. RESULTS: Distress subscale scores varied significantly over time: health burden subscale score increased (P < .001), while finances (P = .004), medical demands (P < .001), and identity (P < .001) subscale scores decreased over time. Uncertainty and family strain subscale scores did not change. Younger age, lower income, advanced tumor stage, poorer social support, and poorer baseline HrQOL predicted higher level distress at 6 and 12 months. CONCLUSION: Cancer-related distress continues unresolved after surgery. Although some risk factors are difficult to alter, those at highest risk can be identified earlier for possible preventive strategies. IMPLICATIONS FOR CANCER SURVIVORS: Screening for risk factors pre-surgery would allow for targeted interventions including strategies to improve resources for those with low support, thereby reducing long-term distress in CRC survivors.
Assuntos
Neoplasias Colorretais/psicologia , Qualidade de Vida/psicologia , Sobreviventes de Câncer , Neoplasias Colorretais/mortalidade , Neoplasias Colorretais/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Período Pós-Operatório , Estudos Prospectivos , Fatores de Risco , Inquéritos e Questionários , Fatores de TempoRESUMO
BACKGROUND: Pancreas graft quality directly affects morbidity and mortality rates after pancreas transplantation (PTx). The criteria for pancreas graft allocation are restricted, which has decreased the number of available organs. Suitable pancreatic allografts are selected based on donor demographics, medical history, and the transplant surgeon's assessment of organ quality during procurement. Quality is assessed based on macroscopic appearance, which is biased by individual experience and personal skills. Therefore, we aim to assess the histopathological quality of unallocated pancreas organs to determine how many unallocated organs are potentially of suitable quality for PTx. METHODS AND ANALYSIS: This is a multicenter cross-sectional explorative study. The demographic data and medical history of donor and cause of rejection of the allocation of graft will be recorded. Organs of included donors will be explanted and macroscopic features such as weight, color, size, and stiffness will be recorded by 2 independent transplant surgeons. A tissue sample of the organ will be fixed for further microscopic assessments. Histopathologic assessments will be performed as soon as a biopsy can be obtained. We will evaluate up to 100 pancreata in this study. RESULT: This study will evaluate the histopathological quality of unallocated pancreas organs from brain-dead donors to determine how many of these unallocated organs were potentially suitable for transplantation based on a histopathologic evaluation of organ quality. CONCLUSION: The comprehensive findings of this study could help to increase the pancreas graft pool, overcome organ shortage, reduce the waiting time, and also increase the number of PTx in the future. Registration number: ClinicalTrials.gov: NCT04127266.
Assuntos
Morte Encefálica/patologia , Pâncreas/patologia , Doadores de Tecidos/estatística & dados numéricos , Obtenção de Tecidos e Órgãos/métodos , Distribuição de Qui-Quadrado , Protocolos Clínicos , Estudos Transversais , Alemanha , Sobrevivência de Enxerto , Humanos , Transplante de Pâncreas/métodos , Doadores de Tecidos/provisão & distribuição , Obtenção de Tecidos e Órgãos/estatística & dados numéricos , Obtenção de Tecidos e Órgãos/tendênciasRESUMO
BACKGROUND: Multidisciplinary treatment of rectal cancer, including neoadjuvant treatment, total mesorectal excision, and adjuvant chemotherapy, have improved oncological outcome. Preoperative radiation therapy is advocated by national and international guidelines in all patients with AJCC stage II and III rectal cancer. Although this treatment reduces local recurrence rates with no effect on overall survival, there are possible short- and long-term side effects of radiation exposure, so patients should be carefully selected for neoadjuvant radiation therapy. METHODS: We analyzed whether ventral or dorsal tumor location affects local recurrence rates following radical rectal resection. Patients who underwent radical rectal resection for mid or low rectal cancer in our department between October 2001 and December 2013 were included. Prognostic indicators for local recurrence were analyzed using univariate and multivariate analyses. RESULTS: Overall, 480 patients met the inclusion criteria. Univariate analysis identified surgical procedure (hazard ratio [HR] 1.9, p = 0.006), ventral tumor location (HR 3.8, p < 0.001), and a pathologic circumferential resection margin (pCRM) (HR 9.3, p < 0.001) as prognostic factors of local recurrence. Multivariate analysis revealed tumor location (HR 3.5, p < 0.001) and pCRM (HR 6.0, p = 0.002) as independent factors for local recurrence. Neoadjuvant treatment of AJCC stage II and III tumors reduced the local recurrence rate at ventral but not at dorsal tumor locations (p < 0.001). CONCLUSIONS: Ventral versus dorsal tumor location is an independent prognostic factor for local recurrence. Tumor location may aid in patient selection for neoadjuvant treatment.