Precision Hepatic Arterial Irinotecan Therapy in the Treatment of Unresectable Intrahepatic Cholangiocellular Carcinoma: Optimal Tolerance and Prolonged Overall Survival

Background

Unresectable intrahepatic cholangiocellular carcinoma (ICC) carries a poor prognosis, and there are few chemotherapeutic treatments to prolong survival. The purpose of this study was to assess the efficacy of drug-eluting bead (DEB) therapy by transarterial infusion for unresectable ICC.

Methods

A prospective multicenter study of ICC patients who received hepatic arterial DEB therapy.

Results

Twenty-four patients with unresectable ICC were treated with DEB. Ten patients (41.6%) had recurrent ICC after prior radiofrequency ablation (n = 3) or hepatectomy (n = 7). Twenty patients (80%) had received prior chemotherapy, mostly of gemcitabine (n = 8) or Eloxatin (n = 6). The percent of overall liver involvement was < 25% (n = 8), 26% to 50% (n = 11), and > 50% (n = 4). Ten patients (40%) had sites of extrahepatic disease located at lymph nodes (n = 5), bone (n = 2), peritoneum (n = 1), lung (n = 1), and mouth (n = 1). A total of 42 DEB treatments were administered. Eight were administered in combination with systemic chemotherapy of FOLFOX (n = 4) or Gemzar (n = 4). Twelve patients (48%) received a second treatment, and 4 patients (16%) received a third treatment. The median length of stay was 23 h (23–72 h). Eleven adverse reactions (26.2%) were reported. Of these, 7 (63.6%) were minor (less than grade 3). One patient died from hepatorenal syndrome. The disease of one patient was downstaged to resection. After a median follow-up of 13.6 months, the median overall survival of a multitherapeutic regimen with DEB therapy was significantly greater than chemotherapy alone (17.5 vs. 7.4 months; P = 0.02).

Conclusions

Bead therapy is safe and effective in patients with unresectable ICC. There is a marked survival benefit when DEB therapy is used as adjunctive therapy.     

“GIOSAT”: a tool to assess CanMEDS competencies during simulated crises

Purpose

Our objective was to develop and evaluate a Generic Integrated Objective Structured Assessment Tool (GIOSAT) to integrate Medical Expert and intrinsic (non-medical expert) CanMEDS competencies with non-technical skills for crisis simulation.

Methods

An assessment tool was designed and piloted using two pediatric anesthesia scenarios (laryngospasm and hyperkalemia). Following revision of the tool, we used previously recorded videos of anesthesia residents (n = 50) who managed one of two intraoperative advanced cardiac life support (ACLS) scenarios (ventricular tachycardia or ventricular fibrillation). Four independent trained raters, blinded to the residents’ level of training, analyzed the video recordings using the GIOSAT scale. Inter-rater reliability was calculated using intraclass correlations (ICCs) for single raters (single measure) and the average of the four raters (average measure), and construct validity was investigated by correlating GIOSAT scores with postgraduate year of residency (PGY).

Results

Total GIOSAT scores for the ACLS scenarios had single measure ICCs of 0.62 and average measure ICCs of 0.85. Inter-rater reliability was substantial for both Medical Expert and intrinsic competencies (single measure ICCs 0.69 and 0.62, respectively; average measure ICCs 0.90 and 0.82, respectively). We found significant correlations between PGY level and total GIOSAT score (r = 0.36; P = 0.011) and between PGY level and Medical Expert competencies (r = 0.42; P = 0.003); however, correlations were not found between PGY level and intrinsic CanMEDS competencies (r = 0.24; P = 0.09).

Conclusion

Inter-rater reliability of the total GIOSAT scores using four trained raters was substantial. Significant correlation between PGY and (i) total GIOSAT score and (ii) Medical Expert competencies supports construct validity. Evidence of validity was not obtained for intrinsic CanMEDS competencies.     

Noninvasive diagnosis of compensated cirrhosis using an analysis of the time–intensity curve portal vein slope gradient on contrast-enhanced ultrasonography

Purpose

We measured the slope gradients (SGs) of the vascular time–intensity curves (TICs) of the intrahepatic vessels on contrast-enhanced ultrasonography (CEUS). The aim of this study was to assess the diagnostic accuracy of the SG of each hepatic vessel, particularly the portal vein (PV), for detecting cirrhosis and to compare this method with conventional modalities.

Methods

Fifty-one preoperative patients underwent CEUS, and the TICs were plotted. The SGs of the hepatic artery, PV and hepatic vein were obtained from the linear functions between the slope of the arrival time of the contrast agent and the peak enhancement time of each vessel. The transit times and levels of biochemical markers were also measured. The patients were divided into three groups according to the Metavir score: F0/1 group (n = 14), F2/3 group (n = 21) and F4 group (n = 16).

Results

The PVSG significantly decreased in the F4 group (F0/1: 29.1 ± 2.27, F2/3: 23.1 ± 1.86, F4: 14.7 ± 2.13). The PVSG demonstrated high accuracy for diagnosing cirrhosis and was correlated with the levels of ICG-R15 and hyaluronic acid (Spearman rank correlation; ρ = ?0.5691, p < 0.001 and ρ = ?0.4652, p = 0.0006).

Conclusions

The PVSG has the potential to be a diagnostic marker for identifying patients with well-compensated cirrhosis.     

动脉期强化肝脏炎性假瘤超声造影特征

目的探讨CEUS表现为动脉期强化的肝脏炎性假瘤(IPT)的增强模式。方法回顾性分析31例经病理证实的肝脏IPT患者的临床与超声资料。应用低机械指数实时CEUS技术,造影剂用量为2.4ml;分析各病灶在动脉期、门静脉期以及延迟期的增强特点,并进行比较。结果肿瘤平均最大径(3.53±1.21)cm(1.0~7.7cm)。CEUS表现为整体增强18个、环状增强6个、蜂窝状增强7个。27个病灶在门静脉期及延迟期均呈低回声,4个病灶的增强部分与肝实质同步消褪。病灶平均开始增强时间平均(17.10±3.86)s,达峰时间(22.33±4.82)s,呈等回声时间(28.83±6.42)s,呈低回声时间(51.33±45.29)s。结论肝脏IPT可呈现多种CEUS增强模式,取决于病灶内病理学改变。     

乳腺黏液癌常规超声和超声造影表现

目的观察乳腺黏液癌的常规超声和超声造影(CEUS)表现。方法回顾性分析16例经手术病理确诊的乳腺黏液癌患者(17个病灶),术前均接受常规超声及CEUS检查;以常规超声观察并记录病灶位置、大小、形态、内部回声、钙化、后方回声及血流特点等,CEUS观察病灶增强程度及增强方式等。结果 17个病灶中,常规超声显示16个(16/17, 94.12%)呈低回声、1个为等回声;15个(15/17, 88.24%)形态不规则或呈分叶状,14个(14/17, 82.35%)边界不清或有毛刺;10个(10/17, 58.82%)内部回声不均匀;3个(3/17, 17.65%)内部可见局灶性液化区,9个(9/17, 52.94%)可见砂砾样钙化;11个(11/17, 64.71%)内部可探及血流信号,其中8个可探及动脉频谱。CEUS表现为低增强15个、高增强2个;不均匀增强16个、均匀增强1个;16个病灶内见持续性无增强区;13个结节被膜呈稍高增强、4个无被膜高增强。结论乳腺黏液癌超声表现有一定特征性,对诊断该病具有一定临床价值。     

嗜酸性肝脓肿的影像表现:与病理对照

目的 探讨嗜酸性肝脓肿的影像和病理表现.方法 回顾性分析8例经病理证实的嗜酸性肝脓肿的资料,分析其影像表现.结果 8例行CT增强扫描,表现为3种强化方式:动脉期病变边缘轻度强化,静脉期及延迟期呈分隔状强化3例;动脉期病变边缘轻度强化,静脉期及延迟期呈蜂窝状强化4例;动脉期病变表现为连续的环状强化,静脉期及延迟期呈低密度1例.MR检查2例,平扫病灶均呈T1WI等、T2WI高信号,DWI表现为高信号;MR增强扫描动脉期病变呈蜂窝状强化,静脉期及平衡期持续强化.结论 了解嗜酸性肝脓肿的影像表现对于提高该病的诊断准确率具有重要意义.     

Endoscopic and Pathologic Findings Associated with Clinical Outcomes of Melanoma in the Upper Gastrointestinal Tract

Background

Melanoma that involves the upper gastrointestinal (GI) tract is rare and studies relating to endoscopic and pathologic findings with clinical outcomes are lacking. We reviewed the gross and microscopic patterns of the upper GI tract in primary and metastatic melanoma, and examined their association with clinical outcomes.

Methods

Twenty-nine cases of primary esophageal (n = 19) and metastatic gastric and/or duodenal melanoma (n = 10) that were detected during upper GI endoscopy between 1995 and 2011 were retrospectively analyzed.

Results

Three types of gross patterns were recognized—nodular pattern in 7 cases, mass-forming pattern in 18 cases, and flat pigmented pattern in 4 cases. In primary esophageal melanoma, 13 patients (68.4 %) underwent surgery and 9 received palliative therapy. Of all cases, 22 patients (75.9 %) died of disease progression; the median overall survival period was 12 months (interquartile range [IQR] 4.5–24.5 months), and from recognition of upper GI tract melanoma the median overall survival period was 9 months (IQR 3.5–17.0 months). In primary esophageal cases, skin melanoma stage better discriminated the patients with good prognosis than the esophageal cancer stage. The flat pigmented gross pattern proved to be a good prognostic factor in primary and metastatic GI tract melanomas (p = 0.016 and p = 0.046, respectively).

Conclusions

Melanoma of the GI tract is a highly aggressive disease with a poor prognosis, both in primary and metastatic cases. However, in primary esophageal melanoma, careful inspection of the mucosa during endoscopic examination followed by surgical resection may result in extended survival.     

Evaluation of the Nodal Status in the 7th Edition of the UICC-TNM Classification for Esophageal Squamous Cell Carcinoma: Proposed Modifications for Improved Survival Stratification

Background

The 7th edition of the Union for International Cancer Control-TNM (UICC-TNM) classification for esophageal carcinoma made considerable modifications to the definition of N-staging by the number of involved lymph nodes and the regional node boundary. There were few validations of the regional boundary. We evaluated the nodal status of this classification for esophageal squamous cell carcinoma (ESCC).

Methods

There were 665 patients reviewed who had ESCC and underwent esophagectomy between 1997 and 2012. We evaluated the impact of the location of lymph node metastasis on overall survival.

Results

There were 414 patients (61.7 %) who had lymph node metastases. The overall 5-year survival rate was 54.7 %. There were no significant differences in survival among N2, N3, and M1 patients. Cox regression analysis revealed that common hepatic or splenic node involvements (P = 0.001), pT stage (P = 0.0002), and pN stage (P < 0.0001) were independent predictors of survival, but supraclavicular node involvement (P = 0.29) was not. We propose a modified nodal status that designates supraclavicular node as regional: m-N0 (5-year survival = 79 %; n = 251); m-N1 (5-year = 56 %; n = 212); m-N2 (5-year = 30 %; n = 114); m-N3 (5-year = 18 %; n = 52); m-M1 (5-year = 6.2 %; n = 36). This modified nodal staging predicts survival better than the current staging system.

Conclusions

The modification of supraclavicular lymph node from nonregional to regional in the 7th UICC classification of ESCC may allow for better stratification of overall survival.     

肝脏罕见、疑难病例超声造影表现

目的探讨肝脏罕见、疑难病变的CEUS表现。方法回顾性分析6例经手术后病理证实的肝脏罕见、疑难病变的CEUS增强特点。结果 2例肝脏未分化肉瘤,动脉期实性成分呈高增强,门静脉及延迟期呈低增强;1例肝内胆管囊腺瘤,动脉期囊壁呈高增强,门静脉期及延迟期呈等增强;1例肝内胆管囊状扩张症和1例慢性肝脓肿,囊壁及分隔处三期均呈等增强;1例肝脏炎性肌纤维母细胞瘤动脉期呈稍高增强,门静脉期呈等增强,延迟期呈低增强。结论肝脏未分化肉瘤及炎性肌纤维母细胞瘤的CEUS增强模式与肝脏恶性肿瘤相似;通过CEUS观察动脉期病灶囊壁及分隔处是否高增强,有助于鉴别肝内胆管囊腺瘤和其他二维图像相似的肝脏分房囊性病变。     

Natural History of Asymptomatic Papillary Thyroid Microcarcinoma: Time-Dependent Changes in Calcification and Vascularity During Active Surveillance

Background

Prospective trials of non-surgical observation have shown progression rates of only 5–10 % in patients with asymptomatic papillary microcarcinoma (PMC). This study investigated time-dependent changes in calcification patterns and tumor vascularity on ultrasonography (US) to clarify the natural course of PMC.

Methods

We examined calcification patterns and tumor vascularity for 480 lesions in 384 patients. Calcification patterns were classified as: (A) none; (B) micro; (C) macro; or (D) rim. Tumor vascularity was classified as rich or poor via color Doppler US.

Results

After a mean of 6.8 years of observation, 29 lesions (6.0 %) had increased in size. Mean age for initial calcification pattern was 52.1 years for A (n = 135), 54.2 years for B (n = 235), 56.3 years for C (n = 96), and 60.1 years for D (n = 14), and the incidence rates of tumor enlargement were 9.6, 5.5, 3.2, and 0 %, respectively. The cumulative rate of upgrade in calcification pattern was 51.8 % at 10 years. Lesions with initially rich vascularity (n = 70) had significantly higher rate of tumor enlargement than those with poor vascularity (n = 410); however, the majority of tumor (61.4 %) with initially rich vascularity had decreased their blood supply during the follow-up. Multivariate analysis showed that strong calcification (C or D) and poor vascularity at last examination correlated significantly with non-progressive disease.

Conclusions

PMCs in older patients showed significantly stronger calcification patterns and poorer vascularity. Both consolidation of calcification and loss of vascularity occurred in a time-dependent manner during observation and were significant indicators for non-progressive disease.

     

Utility and accuracy of endobronchial ultrasound as a diagnostic and staging tool for the evaluation of mediastinal adenopathy

Background

Endobronchial ultrasound (EBUS) is an emerging technology for mediastinal evaluation which is less invasive than cervical mediastinoscopy, the traditional gold standard. The purpose of our study is to evaluate the utility and accuracy of EBUS as a diagnostic and staging tool at our regional teaching institution.

Methods

We retrospectively reviewed the institutional thoracic surgery database for all patients undergoing EBUS between August, 2008 and March, 2011.

Results

190 patients underwent EBUS. 87 (46 %) patients underwent EBUS for diagnosis only; 73 (38 %) for staging only; and 30 (16 %) for both diagnosis and staging. Diagnoses obtained by diagnostic EBUS included non-small cell lung cancer—n = 36 (31 %); other cancer—n = 22 (19 %); sarcoid/granulomatous—n = 8 (7 %); benign lymphoid tissue—n = 50 (43 %); and was nondiagnostic in one case (1 %). For staging EBUS 53 (51 %) patients had benign lymph node tissue. 103 patients had a benign result at the time of EBUS. Fifty-six (54 %) of these patients underwent subsequent mediastinal lymph node dissection or mediastinoscopy for tissue confirmation with the remainder undergoing follow up surveillance chest CT scans. Two patients had a false negative EBUS. Both false negative studies sampled levels 4L, 4R, and 7. The overall false negative rate was 2 % for all benign results, and 4 % for those benign results confirmed with lymph node dissection or mediastinoscopy. The sensitivity and specificity of diagnostic EBUS was 97 and 100 %. The sensitivity and specificity for staging EBUS was 98 and 100 %. In those patients (n = 103) undergoing a staging EBUS, a mean of 2.6 nodal stations were sampled, with 59 % (n = 61) of these patients having three lymph node stations sampled and 33 % (n = 30) had two lymph node stations sampled.

Conclusion

We found that EBUS is a highly accurate and minimally invasive manner in which to both diagnose mediastinal masses and stage the mediastinum.     

Comparison of arterial lactate levels during sevoflurane versus spinal anesthesia in elderly females undergoing total knee arthroplasty

Prolonged tourniquet inflation during total knee arthroplasty (TKR) could lead to ischemic muscle injury. The aim of this study was to investigate the effects of spinal and sevoflurane anesthesia on arterial lactate levels, acid–base status, and on hemodynamic variables in elderly women undergoing TKR. Forty women more than 65 years of age scheduled for elective TKR were enrolled in this study. Patients were allocated to receiving either sevoflurane anesthesia (sevoflurane group, n = 20) or spinal anesthesia (spinal group, n = 20) according to the patient’s decision. Arterial lactate levels were significantly higher in the sevoflurane group than in the spinal group at 5 and 65 min after tourniquet deflation (P < 0.001 and P = 0.033, respectively), but there were no intergroup differences in the increment of arterial glucose levels at any time point. Mean arterial pressure and heart rate were significantly higher at 5 min before tourniquet inflation (P < 0.001, P = 0.029, respectively) and lower at 65 min after tourniquet deflation (P = 0.009, P = 0.033, respectively) in the spinal group than in the sevoflurane group. Our results suggest that spinal anesthesia is associated with lower production of ischemic metabolites than sevoflurane anesthesia after pneumatic tourniquet deflation in elderly women undergoing TKR.     

Aortic involvement in relapsing polychondritis

Objective

To assess prevalence of aortic involvement in relapsing polychondritis (RP) patients; to evaluate clinical features and long-term outcome of RP patients exhibiting aortitis, aortic ectasia and/or aneurysm.

Contrast enhanced ultrasound (CEUS) reliably detects critical perfusion changes in compartmental muscle: a model in healthy volunteers

Purpose

The purpose of this study was to assess the utility of contrast enhanced ultrasound (CEUS) in the differentiation between physiological and simulated pathophysiological lower limb muscle perfusion pressures in healthy volunteers.

Methods

The lower limb muscle perfusion pressures in eight healthy volunteers were assessed in the supine position (as a control) and then subsequently in an elevated position with a thigh tourniquet applied to induce venous stasis. An intravenous bolus injection of 2.5 ml contrast agent was given to create a perfusion signal, which was measured with a multiple-frequency probe. Semiquantitative analysis was performed using specific software to create a perfusion curve which allowed measurement of six parameters: the time to arrival (TTA) starting from bolus application (s); peak of signal intensity (%); time to peak (TTP) maximum (seconds); regional blood volume (RBV), regional blood flow (RBF), and mean transit time (MTT) in seconds. Statistical analysis was performed using the Mann–Whitney U test as a non-parametric test (IBM SPSS statistics, version 21, USA).

Results

The group of simulated hypoperfusion showed significant higher values for TTA (39.8 ± 5.1 s) (p = 0.028), TTP (43.8 ± 13.6 s) (p = 0.003), RBV (8,424 ± 5,405) (p = 0.028), and MTT (262 ± 90.6 s) (p = 0.005). In contrast, the parameter of regional blood flow (32.1 ± 10.9) was significantly lower (p = 0.038). The peak signal intensity (25.8 ± 8.2 %) was lower, but this was not significant (p = 0.083).

Conclusions

CEUS provides a reliable non-invasive imaging modality for the assessment of lower limb muscle perfusion pressures. This may be of clinical use in the assessment of a developing compartment syndrome. Further clinical studies are required to further define its accuracy and reproducibility.     

Postoperative Complications Influence Prognosis and Recurrence Patterns in Periampullary Cancer

Background

The present study was performed to elucidate the influence of postoperative complications on the prognosis and recurrence patterns of periampullary cancer after pancreaticoduodenectomy (PD).

Methods

Clinical data were reviewed from 200 consecutive patients who had periampullary cancer and underwent PD between October 2003 and July 2010, and survival outcomes and recurrence patterns were analyzed. Postoperative complications were classified according to a modification of Clavien’s classification.

Results

Overall, 86 major complications of grade II or higher occurred in 71 patients. The patients were classified into two groups according to the presence of postoperative complications of grade II or higher: group Cx?, absence of complications (n = 129); and group Cx+, presence of complications (n = 71). There were no differences in gender, mean age, tumor node metastasis stage, biliary drainage, type of resection, and radicality between the two groups (P > 0.05). The 3-year overall and disease-free survival rates of the group Cx+ patients (31.0 and 22.3 %, respectively) were significantly lower than those of the group Cx? patients (49.0 and 40.0 %; P = 0.003 and 0.002, respectively). The multivariate analysis showed that postoperative complications (P = 0.001; RR = 1.887; 95 % confidence interval [CI] 1.278–2.785), a T stage of T3 or T4 (P = 0.001; RR = 2.503; 95 % CI 1.441–4.346), positive node metastasis (P = 0.001; RR = 2.093; 95 % CI, 1.378–3.179), R1 or R2 resection (P = 0.023; RR = 1.863; 95 % CI 1.090–3.187), and angiolymphatic invasion (P = 0.013; RR = 1.676; 95 % CI 1.117–2.513) were independent prognostic factors for disease-free survival. Regarding recurrence patterns, group Cx+ patients exhibited more distant recurrences than did group Cx? patients (P = 0.025).

Conclusions

Postoperative complications affect prognosis and recurrence patterns in patients with periampullary cancer after PD.     

Surgical Outcomes of the Mass-Forming plus Periductal Infiltrating Types of Intrahepatic Cholangiocarcinoma: A Comparative Study with the Typical Mass-Forming Type of Intrahepatic Cholangiocarcinoma

Background The purpose of this study was to clarify the clinicopathologic characteristics and surgical outcomes of patients with the mass-forming (MF) plus periductal infiltrating (PI) type of intrahepatic cholangiocellular carcinoma (ICC). Methods Between January 1, 1998, and December 31, 2004, a total of 94 patients with ICC underwent macroscopic curative resection, and the macroscopic type of the tumors was assessed prospectively. Among the 74 patients with the MF type (n = 46) and the MF plus PI type (n = 28) of ICC, multivariate analysis was conducted to identify the potential prognostic factors. The clinicopathologic data of the two groups were compared. Results The results revealed two independent prognostic factors: presence/absence of intrahepatic metastasis and the macroscopic type of the tumor. ICCs categorized macroscopically as the MF plus PI type were significantly associated with jaundice (p < 0.001), bile duct invasion (p < 0.001), portal vein invasion (p = 0.025), lymph node involvement (p = 0.017), and positive surgical margin (p = 0.038). Conclusion Identification of the macroscopic type of the tumor is useful for predicting survival after hepatectomy in patients with ICC. The MF plus PI type of ICC appears to have a more unfavorable prognosis, even after radical surgery, than the MF type of ICC.     

Simplified comorbidity score for elderly patients undergoing thoracoscopic surgery for lung cancer

Purpose

We investigated the efficiency of the Simplified Comorbidity Score (SCS) for predicting postoperative complications and prognosis in elderly patients undergoing video-assisted thoracoscopic surgery (VATS) for lung cancer.

Methods

We reviewed 216 patients aged 75 years or older, who underwent pulmonary resection by VATS for lung cancer between January, 2005 and December, 2012. The SCS assigns different scores to patients’ comorbidities; namely, smoking (n = 7); diabetes mellitus (n = 5); renal insufficiency (n = 4); and respiratory, neoplastic, and cardiovascular comorbidities or alcoholism (n = 1 each). Patients were divided into a high SCS group (SCS ≥ 9; n = 154) and a low SCS group (<9; n = 62), for a comparative analysis of differences in perioperative factors and prognoses.

Results

Limited resection was more frequent in the high SCS group (58 %) than in the low SCS group (40 %; P = 0.02). Postoperative complications were more frequent in the high SCS group (45 %) than in the low SCS group (15 %; P < 0.01). A logistic regression analysis revealed that a high SCS was significantly predictive of postoperative complications (odds ratio 2.7; P = 0.02). The 5-year overall survival rate was 79 % for the low SCS group and 52 % for the high SCS group (P < 0.01).

Conclusions

The SCS can predict the likelihood of postoperative complications and prognosis of elderly patients with VATS-treated lung cancers.

     

Oncological Feasibility of Laparoscopic Distal Pancreatectomy for Adenocarcinoma: A Single-Institution Comparative Study

Background

Laparoscopic distal pancreatectomy (LDP) is performed increasingly for pancreatic pathology in the body and tail of the pancreas. However, only few reports have compared its oncological efficacy with open distal pancreatectomy (ODP). We compared these two techniques in patients with pancreatic ductal adenocarcinoma.

Methods

From a prospectively maintained database, all patients who underwent either LDP or ODP for adenocarcinoma in the body and tail of the pancreas between January 2008 and December 2011 were compared. Data were analysed using SPSS^® v19 utilising standard tests. A p value <0.05 was considered significant.

Results

Of 101 patients who underwent distal pancreatectomy, 22 had histologically confirmed adenocarcinoma (LDP n = 8, ODP n = 14). Both groups were well matched for age and the size of tumour (22 vs. 32 mm, p = 0.22). Intraoperative blood loss was 306 ml compared with 650 ml for ODP (p = 0.152). A longer operative time was noted for LDP (376 vs. 274 min, p < 0.05). Total length of stay was shorter for LDP compared with ODP (8 vs. 12 days, p = 0.05). The number of postoperative pancreatic fistulas were similar (LDP n = 2 vs. ODP n = 3, p = 0.5). Complete resection (R0) was achieved in 88 % of LDP (n = 7) compared with 86 % of ODP (n = 12). The median number of lymph nodes harvested was 16 for LDP versus 14 for ODP. Overall 3-year survival also was similar: LDP = 82 %, ODP = 74 % (p = 0.89).

Conclusions

From an oncological perspective, LDP is a viable procedure and its results are comparable to ODP for ductal adenocarcinomas arising in the body and tail of the pancreas.     

The effect of injection speed on the spinal block characteristics of hyperbaric bupivacaine 0.5% in the elderly

Purpose

The purpose of this prospective, randomized, double-blind study was to compare anesthetic characteristics after two speeds of intrathecal injection of hyperbaric bupivacaine in elderly patients.

Methods

Fifty-six patients, aged ≥65 years, undergoing transurethral surgery under spinal anesthesia were allocated randomly to two groups according to rate of intrathecal injection of 2 ml hyperbaric bupivacaine 0.5%: group Fast (maximum possible rate; mean 0.38 ml/s) n = 26; group Slow (over 40 s; 0.05 ml/s), n = 25. Spinal blocks were administered in the lateral position. Data collection at different times included sensory level, motor block, hemodynamic changes, and occurrence of neurological symptoms.

Results

There was no significant difference between the groups regarding maximum sensory anesthetic level achieved (group Fast: T7 (T4–T10), median (range); group Slow T8 (T6–T10), P = 0.184); times (min) to reach (a) T10 sensory level (group Fast 5.3 ± 4.2 (mean ± SD), group Slow 8.0 ± 6.5, P = 0.093); (b) maximum sensory level (group Fast 11.6 ± 4.7; group Slow 13.6 ± 6.1, P = 0.199); and (c) 2-segment regression of anesthesia (group Fast 92.2 ± 29.6; group Slow 104.7 ± 36.1, P = 0.182). Degree and duration of motor block were similar (P = 0.947 and P = 0.895, respectively). Hemodynamic changes, ephedrine and atropine requirement, incidence of postoperative neurological symptoms after 24 h and 1 week were similar (all P > 0.05).

Conclusions

An eightfold difference in speed of intrathecal injection of 0.5% hyperbaric bupivacaine did not affect the clinical characteristics of spinal anesthesia in elderly patients undergoing transurethral surgery.     

Sequential mTOR inhibitor treatment with temsirolimus in metastatic renal cell carcinoma following failure of VEGF receptor tyrosine kinase inhibitors

Purpose

Agents targeting the mammalian target of rapamycin (mTOR) pathway, e. g. everolimus, can provide clinical benefit in pretreated patients with metastatic renal cell carcinoma (mRCC), but data from randomized trials on the sequential use of temsirolimus are lacking. We retrospectively studied the efficacy and safety of temsirolimus therapy following failure of rTKI therapy.

Methods

Twenty-nine patients treated with temsirolimus (25 mg/week) following progression on rTKI therapy were studied at four institutions. All patients had failed at least one prior rTKI therapy (sunitinib, n = 6; sorafenib, n = 1; both, n = 22). Over 80% had two or more prior therapies. Data on efficacy (response assessment, progression-free survival [PFS], overall survival [OS]) and safety (NCI-CTC) were analyzed.

Results

Adverse events occurred in 90% of patients with the majority being grade 1 (n = 4, 14%) or grade 2 (n = 12, 41%). Most grade 3/4 toxicities (n = 10, 34%) were manageable and included anemia (n = 4, 14%), leukopenia/neutropenia (n = 2, 7%), hyperglycemia (n = 1, 3%), acidosis/alkalosis (n = 2, 7%), and infection (n = 1, 3%). One patient discontinued temsirolimus for grade 3 pneumonitis. Median (range) PFS and OS were 5.1 months (1–10.4) and 18.0 months (12.6–23.3), respectively. Best response included partial response (n = 1) and stable disease (n = 15) for a disease control rate of 55%, and disease progression of 45% (n = 13).

Conclusions

Temsirolimus after rTKI failure appears to provide promising safety and efficacy comparable to other treatment options in pretreated patients with mRCC.