Surgical site infection after pancreaticoduodenectomy is often caused by pathogens resistant to standard prophylactic antibiotics, suggesting that broad‐spectrum antibiotics may be more effective ...prophylactic agents. This article describes the rationale and methodology underlying a multicenter randomized trial evaluating piperacillin–tazobactam compared with cefoxitin for surgical site infection prevention following pancreaticoduodenectomy. As the first US randomized surgical trial to utilize a clinical registry for data collection, this study serves as proof of concept for registry‐based clinical trials.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
To determine if the degree of blood loss during resection of hepatocellular carcinoma (HCC) is predictive of recurrence and long-term survival.
Several studies have addressed the impact of blood ...transfusion on survival and recurrence after liver resection for HCC. However, the independent effect of intraoperative estimated blood loss (EBL) on oncologic outcome is unclear.
From our prospective database, we identified 192 patients who had a partial hepatectomy for HCC from 1985 to 2002. Clinicopathologic predictors of EBL were identified using logistic regression. Overall survival (OS), disease-specific survival (DSS), and recurrence free survival (RFS) were assessed using the Kaplan-Meier and Cox regression methods.
The median patient age was 64 (range, 19-86) and 66% were men. All patients had histologically proven HCC. The median follow-up time was 34 months (range, 1-297). Factors associated with increased EBL on multivariate analysis were male gender, vascular invasion, extent of hepatectomy, and operative time (P < 0.01). EBL and vascular invasion were independent predictors of OS and DSS. Only EBL was significantly associated with RFS on multivariate analysis (P = 0.02). Additionally, we found a significant inverse correlation between increasing levels of EBL and length of DSS (P = 0.01).
The magnitude of EBL during HCC resection is related to biologic characteristics of the tumor as well as the extent of surgery. Increased intraoperative blood loss during HCC resection is an independent prognostic factor for tumor recurrence and death.
To develop 2 instruments that predict the probability of perioperative red blood cell transfusion in patients undergoing elective liver resection for primary and secondary tumors.
Hepatic resection ...is the most effective treatment for several benign and malign conditions, but may be accompanied by substantial blood loss and the need for perioperative transfusions. While blood conservation strategies such as autologous blood donation, acute normovolemic hemodilution, or cell saver systems are available, they are economically efficient only if directed toward patients with a high risk of transfusion.
Using preoperative data from 1204 consecutive patients who underwent liver resection between 1995 and 2000 at Memorial Sloan- Kettering Cancer Center, we modeled the probability of perioperative red blood cell transfusion. We used the resulting model, validated on an independent dataset (n = 555 patients), to develop 2 prediction instruments, a nomogram and a transfusion score, which can be easily implemented into clinical practice.
The planned number of liver segments resected, concomitant extrahepatic organ resection, a diagnosis of primary liver malignancy, as well as preoperative hemoglobin and platelets levels predicted the probability of perioperative red blood cell transfusion. The predictions of the model appeared accurate and with good discriminatory abilities, generating an area under the receiver operating characteristic curve of 0.71.
Preoperative factors can be combined into risk profiles to predict the likelihood of transfusion during or after elective liver resection. These predictions, easy to calculate in the frame of a nomogram or of a transfusion score, can be used to identify patients who are at high risk for red cell transfusions and therefore most likely to benefit from blood conservation techniques.
To define a group of patients with pancreatic cysts who do not require resection.
The increased use of cross-sectional imaging has resulted in an increased identification of small, asymptomatic ...pancreatic cysts. Data have not been available to determine which lesions should be resected.
All patients evaluated at our institution between January 1995 and January 2005 for the ICD-9 diagnosis of pancreatic cyst were reviewed. Analysis was performed to identify associations between patient and cyst characteristics, and selection of operative or nonoperative management.
Pancreatic cysts were evaluated in 539 patients. Initial management was operative in 170 patients (32%), and nonoperative (radiographic follow-up) in 369 patients (68%). Factors associated with initial operative management included presence of a solid component (45% vs. 6%, P < 0.001), larger size of the lesion (mean 4.8 cm vs. 2.4 cm, P = 0.001), and presence of symptoms (44% vs. 16%, P = 0.001). Malignancy was present in 18% (32 of 170) of patients initially resected. Mucinous tumors (n = 18) were the most common malignant histologic subtype. None of the invasive cancers arising from mucinous cysts was <3 cm. Median radiographic follow-up in patients initially managed nonoperatively was 24 months (range, 1-172 months). In 29 patients (8%), changes developed within the cyst that resulted in resection; malignancy was present in 11 of 39 (38%), representing 3% (11 of 369) of all patients being followed radiographically.
Selected patients with cystic lesions <3 cm in diameter and without a solid component may be followed radiographically with a malignancy risk (3% this study) that approximates the risk of mortality from resection. Malignancy within mucinous tumors is associated with size, and small mucinous tumors are very unlikely to be malignant.
Background The indications for minimally invasive (MIS) pancreatectomy have slowly increased as experience, techniques, and technology have improved and evolved to manage malignant lesions in ...selected patients without compromising safety and oncologic principles. There are sparse data comparing laparoscopic, robotic, and open distal pancreatectomy (DP). Study Design All patients undergoing DP at Memorial Sloan Kettering Cancer Center between 2000 and 2013 were analyzed from a prospective database. Clinicopathologic and survival data were analyzed to compare perioperative and oncologic outcomes in patients who underwent DP via open, laparoscopic, and robotic approaches. Results Eight hundred five DP were performed during the study period, comprising 37 robotic distal pancreatectomies (RDP), 131 laparoscopic distal pancreatectomies (LDP), and 637 open distal pancreatectomies (ODP). The 3 groups were similar with respect to American Society of Anesthesiologists (ASA) score, sex ratio, body mass index, pancreatic fistula rate, and 90-day morbidity and mortality. Patients in the ODP group were generally older (p = 0.001), had significantly higher intraoperative blood loss (p < 0.001), and had a trend toward a longer hospital stay (p = 0.05). Of the significant preoperative variables, visceral fat was predictive of conversion on multivariate analysis (p = 0.003). Oncologic outcomes in the adenocarcinoma cases were similar for the 3 groups, with high rates of R0 resection (88% to 100%). The ODP group had a higher lymph node yield than the LDP and RDP groups (15.4, SD 8.7 vs 10.4 SD 8.0 vs 12SD 7.2, p = 0.04). Conclusions The RDP and LDP were comparable with respect to most perioperative outcomes, with no clear advantage of one approach over the other. Both of these MIS techniques may have advantages over ODP in well-selected patients. All approaches achieved a similarly high rate of R0 resection for patients with adenocarcinoma.
Pancreatic ductal adenocarcinoma (PDAC) is lethal in 88% of patients
, yet harbours mutation-derived T cell neoantigens that are suitable for vaccines
. Here in a phase I trial of adjuvant autogene ...cevumeran, an individualized neoantigen vaccine based on uridine mRNA-lipoplex nanoparticles, we synthesized mRNA neoantigen vaccines in real time from surgically resected PDAC tumours. After surgery, we sequentially administered atezolizumab (an anti-PD-L1 immunotherapy), autogene cevumeran (a maximum of 20 neoantigens per patient) and a modified version of a four-drug chemotherapy regimen (mFOLFIRINOX, comprising folinic acid, fluorouracil, irinotecan and oxaliplatin). The end points included vaccine-induced neoantigen-specific T cells by high-threshold assays, 18-month recurrence-free survival and oncologic feasibility. We treated 16 patients with atezolizumab and autogene cevumeran, then 15 patients with mFOLFIRINOX. Autogene cevumeran was administered within 3 days of benchmarked times, was tolerable and induced de novo high-magnitude neoantigen-specific T cells in 8 out of 16 patients, with half targeting more than one vaccine neoantigen. Using a new mathematical strategy to track T cell clones (CloneTrack) and functional assays, we found that vaccine-expanded T cells comprised up to 10% of all blood T cells, re-expanded with a vaccine booster and included long-lived polyfunctional neoantigen-specific effector CD8
T cells. At 18-month median follow-up, patients with vaccine-expanded T cells (responders) had a longer median recurrence-free survival (not reached) compared with patients without vaccine-expanded T cells (non-responders; 13.4 months, P = 0.003). Differences in the immune fitness of the patients did not confound this correlation, as responders and non-responders mounted equivalent immunity to a concurrent unrelated mRNA vaccine against SARS-CoV-2. Thus, adjuvant atezolizumab, autogene cevumeran and mFOLFIRINOX induces substantial T cell activity that may correlate with delayed PDAC recurrence.
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GEOZS, IJS, IMTLJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBMB, UL, UM, UPUK, ZAGLJ
To assess the value of preoperative imaging studies and the intraoperative assessment of perihepatic lymph nodes in patients undergoing partial hepatectomy for malignancy.
Perihepatic lymph node ...status is an important prognostic factor for patients undergoing hepatic resection for 1(o) and metastatic cancer. The value of preoperative imaging studies and intraoperative assessment of perihepatic nodes is unknown.
Perihepatic lymph nodes were sampled in 100 patients undergoing resection for 1(o) and metastatic hepatic malignancy. At the time of sampling, participating surgeons assigned a clinical suspicion score (scale, 1-5: 1 = clinically negative, 5 = clinically positive). Preoperative CT scans and PET scans were reviewed in a blinded fashion by 2 radiologists. Clinical assessment, CT, and PET scan results were analyzed in the context of the pathologic status of the lymph nodes.
A mean of 3.2 +/- 0.2 nodes were sampled per patient. Fifteen patients had metastatic disease in perihepatic lymph nodes; 13 had suggestive findings on preoperative CT or PET, and 2 were clinically positive at exploration. Clinical assessment had a high negative predictive value (NPV) = 99% but a low positive predictive value (PPV) = 39%. Similarly, CT scans had a high NPV = 95% and a low PPV = 30%. PET scans had a NPV = 88% and a PPV of 100%. Of the 48 patients with both negative preoperative CT and PET scans, only 1 (2.1%) had metastatic nodal disease, and this was suspected based on the clinical assessment. Of the patients with negative CT and PET scans and a negative clinical assessment (n = 39), none had involved perihepatic nodes.
In patients with 1(o) and metastatic liver cancer, the incidence of truly occult metastatic disease to perihepatic lymph nodes is low. Routine sampling of perihepatic lymph nodes will therefore have a low yield in patients without some evidence of disease on preoperative CT or PET scans or at the time of exploration.
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