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A nonrandomized cohort and a randomized study of local control of large hepatocarcinoma by targeting intratumoral lactic acidosis.
Chao, M, Wu, H, Jin, K, Li, B, Wu, J, Zhang, G, Yang, G, Hu, X
eLife. 2016
Abstract
BACKGROUND Previous works suggested that neutralizing intratumoral lactic acidosis combined with glucose deprivation may deliver an effective approach to control tumor. We did a pilot clinical investigation, including a nonrandomized (57 patients with large HCC) and a randomized controlled (20 patients with large HCC) study. METHODS The patients were treated with transarterial chemoembolization (TACE) with or without bicarbonate local infusion into tumor. RESULTS In the nonrandomized controlled study, geometric mean of viable tumor residues (VTR) in TACE with bicarbonate was 6.4-fold lower than that in TACE without bicarbonate (7.1% [95% CI: 4.6%–10.9%] vs 45.6% [28.9%–72.0%]; p<0.0001). This difference was recapitulated by a subsequent randomized controlled study. TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized). The survival data suggested that bicarbonate may bring survival benefit. CONCLUSIONS Bicarbonate markedly enhances the anticancer activity of TACE. FUNDING Funded by National Natural Science Foundation of China. CLINICAL TRIAL NUMBER ChiCTR-IOR-14005319.
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Immunonutrition suppresses acute inflammatory responses through modulation of resolvin E1 in patients undergoing major hepatobiliary resection.
Uno, H, Furukawa, K, Suzuki, D, Shimizu, H, Ohtsuka, M, Kato, A, Yoshitomi, H, Miyazaki, M
Surgery. 2016;(1):228-236
Abstract
BACKGROUND Although several studies have reported the effects of immunonutrition on clinical outcomes, detailed mechanisms of immunonutrition after an operation are still unclear. It was recently reported that resolvin E1, a novel lipid mediator generated from eicosapentaenoic acid (EPA), activates factors that reduce inflammation. This randomized clinical trial was designed to investigate not only the effect of immunonutrition on postoperative complications but also the participation of resolvin E1 on anti-inflammatory effects of immunonutrition in patients undergoing major hepatobiliary resection. METHODS Forty patients who underwent major hepatobiliary resection were divided into 2 groups. Twenty patients received oral supplementation enriched with EPA, arginine, and nucleotides before the operation (group IN). Twenty patients (control group) received no artificial nutrition before the operation (group C). RESULTS The rate of infectious complications and severity of complications in group IN was significantly lower than in group C (P < .05). Immediately after the operation, plasma resolvin E1 levels were significantly higher in group IN than in group C (P < .05), and plasma interleukin-6 levels were significantly lower in group IN than in group C (P < .05). Preoperative serum EPA levels correlated with plasma resolvin E1 levels immediately after the operation. Plasma resolvin E1 levels correlated with plasma interleukin-6 levels immediately after the operation. CONCLUSION Preoperative immunonutrition reduced inflammatory responses and protected against the aggravation of postoperative complications in patients undergoing major hepatobiliary resection. Resolvin E1 may play a key role in the resolution of acute inflammation when immunonutrition is supplemented with EPA. (ClinicalTrials.gov Identifier: NCT01256047.).
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Effects of Thyroid Hormone Withdrawal and Recombinant Human Thyrotropin on Glomerular Filtration Rate During Radioiodine Therapy for Well-Differentiated Thyroid Cancer.
Coura-Filho, GB, Willegaignon, J, Buchpiguel, CA, Sapienza, MT
Thyroid : official journal of the American Thyroid Association. 2015;(12):1291-6
Abstract
BACKGROUND Renal function is related to thyroid hormonal status, and glomerular filtration rate (GFR) seems to be impaired in patients with hypothyroidism. The aim of this work was to evaluate quantitatively the effect of hypothyroidism on GFR using a (51)Cr-EDTA radioisotope assay. METHODS Twenty-eight patients without known renal disease or dysfunction who had been referred for radioiodine therapy (RIT) after total thyroidectomy were enrolled in this study and divided into two groups. Group A underwent thyroid hormone withdrawal (THW) resulting in hypothyroidism, while group B underwent recombinant human thyrotropin (rhTSH) stimulation and hence remained euthyroid. GFR was assessed by (51)Cr-EDTA before and after THW or rhTSH. RESULTS No clinical differences were observed between the two groups. The mean ± SD GFRs were 94 ± 19 mL/min/1.73 m(2) before THW and 76 ± 16 mL/min/1.73 m(2) after THW for group A (p = 0.009), and 91 ± 18 mL/min/1.73 m(2) before rhTSH and 93 ± 15 mL/min/1.73 m(2) after rhTSH for group B (p = 0.613). The percent decrease in GFR during hypothyroidism is approximately 18-22%. CONCLUSION GFR decreases in patients with normal kidney function during THW for RIT, and rhTSH preserves GFR in these patients. This GFR impairment following thyroidectomy is related to hypothyroidism due to a significant reduction in thyroid hormone levels and is not due to a rise in the TSH level.
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Exploring the relationship between patients' information preference style and knowledge acquisition process in a computerized patient decision aid randomized controlled trial.
Sawka, AM, Straus, S, Rodin, G, Tsang, RW, Brierley, JD, Rotstein, L, Segal, P, Gafni, A, Ezzat, S, Goldstein, DP
BMC medical informatics and decision making. 2015;:48
Abstract
BACKGROUND We have shown in a randomized controlled trial that a computerized patient decision aid (P-DA) improves medical knowledge and reduces decisional conflict, in early stage papillary thyroid cancer patients considering adjuvant radioactive iodine treatment. Our objectives were to examine the relationship between participants' baseline information preference style and the following: 1) quantity of detailed information obtained within the P-DA, and 2) medical knowledge. METHODS We randomized participants to exposure to a one-time viewing of a computerized P-DA (with usual care) or usual care alone. In pre-planned secondary analyses, we examined the relationship between information preference style (Miller Behavioural Style Scale, including respective monitoring [information seeking preference] and blunting [information avoidance preference] subscale scores) and the following: 1) the quantity of detailed information obtained from the P-DA (number of supplemental information clicks), and 2) medical knowledge. Spearman correlation values were calculated to quantify relationships, in the entire study population and respective study arms. RESULTS In the 37 P-DA users, high monitoring information preference was moderately positively correlated with higher frequency of detailed information acquisition in the P-DA (r = 0.414, p = 0.011). The monitoring subscale score weakly correlated with increased medical knowledge in the entire study population (r = 0.268, p = 0.021, N = 74), but not in the respective study arms. There were no significant associations with the blunting subscale score. CONCLUSIONS Individual variability in information preferences may affect the process of information acquisition from computerized P-DA's. More research is needed to understand how individual information preferences may impact medical knowledge acquisition and decision-making.
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Lateral neck sentinel lymph node biopsy in papillary thyroid carcinoma, is it really necessary? A randomized, controlled study.
Lee, SK, Lee, JH, Bae, SY, Kim, J, Kim, M, Lee, HC, Jung, YY, Kil, WH, Kim, SW, Lee, JE, et al
Surgery. 2015;(3):518-25
Abstract
BACKGROUND Although occult metastasis to lymph node in the lateral neck compartment is common in papillary thyroid carcinoma (PTC), the clinical impact of these metastasis is unknown. We hypothesized that sentinel lymph node biopsy (SLNB) of the lateral neck compartment with radioisotopes may detect occult metastasis, which could prevent recurrence. METHODS This randomized, controlled study was conducted from June 2009 to January 2011 and included 283 patients with PTC who were receiving treatment at the Samsung Medical Center. RESULTS Of the 283 patients enrolled in the study, 141 were randomized to a lateral SLNB (LSLNB) group and 142 patients were to the control group. Lateral sentinel lymph nodes (LSLNs) were identified in 80 of the 127 patients (63.0%) for whom stimulated thyroglobulin (sTg) levels were available. Among the 80 patients with LSLNs, 24 (30.0%) had metastases and underwent an ipsilateral modified radical neck dissection. Among the 191 patients for whom repeated sTg test results were available, the first median level of sTg in the LSLNB study group was less compared with the control group (P = .012, adjusted for duration). However, the second sTg level (after the first radioactive iodine ablation) was not different between the 2 groups. Moreover, the sTg levels were not significantly different between the LSLN-positive (n = 23) and other patients (n = 168) after the first and second ablations. During patient follow-up (median, 39 months; range, 7-55), 3 cases of recurrence were observed in the control group and 1 case in the study group (a LSLN had not been detected in this case). CONCLUSION Although LSLNB was able to remove occult metastasis in PTC, this procedure had no effect on either sTg levels or on recurrence rates at a mean follow-up of 39 months. Additional long-term studies are needed to explore fully the clinical usefulness of LSLNB in the prevention of PTC recurrence.
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Anti-caries effect of CPP-ACP in irradiated nasopharyngeal carcinoma patients.
Sim, CP, Wee, J, Xu, Y, Cheung, YB, Soong, YL, Manton, DJ
Clinical oral investigations. 2015;(5):1005-11
Abstract
OBJECTIVE The aim of this study was to determine the effect of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) on caries progression in irradiated nasopharyngeal carcinoma (NPC) patients. METHODS Twenty-one males and three females (median age, 50 years) were randomized into two groups before radiotherapy. Subjects had at least eight teeth after oral health clearance. The test group used 0.4 % stannous fluoride gel and a crème containing 10 % CPP-ACP daily; the control group used a similar crème without CPP-ACP and otherwise identical care. Subjects applied the crème three times daily and fluoride gel once daily. Caries status, saliva and plaque parameters were measured pre-radiotherapy, at 2 weeks and 3 months post-radiotherapy. RESULTS Baseline International Caries Detection and Assessment System (ICDAS) scores were 0-1126 surfaces (93.9 %), 1-28 surfaces (2.3 %), 2-40 surfaces (3.3 %) and 3-6 surfaces (0.5 %) for the control and 0-1186 surfaces (95.6 %), 1-31 surfaces (2.5 %), 2-15 surfaces (1.2 %) and 3-8 surfaces (0.7 %) for the test group. Twenty-two subjects returned at 3 months post-radiotherapy with reduced plaque pH, salivary flow, pH and buffering capacity. Nine test and 8 control subjects developed 32 and 59 new caries lesions, respectively. Test subjects showed lower caries progression than the controls: all surfaces (OR 0.51, 95 % CI 0.17∼1.59), occlusal (OR 0.20, 95 % CI 0.03∼1.29) and smooth surfaces (OR 0.61, 95 % CI 0.16∼2.38). The difference was not statistically significant. CONCLUSION Application of CPP-ACP did not significantly reduce caries progression in NPC patients in the first 3 months after radiotherapy as compared to controls. CLINICAL RELEVANCE Adjunct use of CPP-ACP with stannous fluoride gel in irradiated NPC patients gave comparable results compared to stannous fluoride gel alone in reducing caries progression.
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Fast track for elderly patients: is it feasible for colorectal surgery?
Compagna, R, Aprea, G, De Rosa, D, Gentile, M, Cestaro, G, Vigliotti, G, Bianco, T, Massa, G, Amato, M, Massa, S, et al
International journal of surgery (London, England). 2014;:S20-S22
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Abstract
BACKGROUND Fast-track program has been applied in several surgical fields. However, currently many surgical patients are elderly over 70 years of age, and discussion about the application of such protocols for elderly patients is inadequate. MATERIALS AND METHODS The present study was designed to consider the safety and feasibility of application of a fast-track program after colorectal surgery in elderly patients. A total of 76 elderly patients with colorectal cancer who underwent laparoscopic colorectal resection were randomly assigned to receive either the fast-track care program (n = 40) or the conventional perioperative care protocol (control group, n = 36). The fast track protocol included no preoperative mechanical bowel irrigation, immediate oral alimentation and earlier postoperative ambulation exercise. The length of postoperative hospital stay, the length of time to regain bowel function and the rate of postoperative complications were compared between the two groups. RESULTS The length of time to regain bowel function, including the passage of flatus [32 (24-40) h vs 42 (32-52) h], and to start a liquid diet (13 [10-16] h v/s 43 [36-50] h) were significantly shorter in patients receiving the fast track care protocol compared with those receiving the conventional care protocol. A shorter duration of postoperative hospital stay was recorded in patients receiving the fast-track program than in those receiving conventional care [6 (5-7) days v/s 9.5 (7-12) days]. A reduced percentage of patients who developed general complications was also observed in the fast-track group (5.0% v/s 18%). CONCLUSION Fast-track after laparoscopic colorectal surgery can be safely applied in carefully selected elderly patients older than age 70 years. The fast-track recovery program resulted in a more rapid postoperative recovery, earlier discharge from hospital and fewer general complications compared with a conventional postoperative protocol.
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Early oral feeding vs. traditional feeding in patients undergoing elective open bowel surgery-a randomized controlled trial.
Pragatheeswarane, M, Muthukumarassamy, R, Kadambari, D, Kate, V
Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract. 2014;(5):1017-23
Abstract
OBJECTIVE This prospective randomized controlled trial was conducted to compare the safety, tolerability and outcome of early oral feeding vs. traditional feeding in patients undergoing elective open bowel surgery. METHODS A total of 120 consecutive patients who underwent elective open bowel surgeries were randomized into either early feeding (n = 60) or traditional feeding group (n = 60). Patients in the early feeding group were started on oral fluids on post-operative day 1, while those in the traditional feeding group were started orals after the resolution of ileus. Patient characteristics, surgical procedures, co-morbidity, first flatus, first defecation, time of starting solid diet, complications and length of hospitalization were assessed between the two groups. RESULTS The two groups were similar in demographic and baseline data. The number of days to first flatus (p < 0.0001), first defecation (p < 0.0001), length of post-operative stay (p = 0.011) and time of starting solid diet (p < 0.0001) were significantly earlier in the early feeding group. Anastomotic leak, wound infection, fever, vomiting, abdominal distention and other complications were similar. Multivariate analysis showed that patients in the early oral feeding group were discharged 3.4 days earlier (p = 0.037). CONCLUSION In patients undergoing elective open bowel surgeries, early post-operative feeding is safe, is well tolerated and reduces the length of hospitalization.
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Effect of β-glucan on drain fluid and amount of drainage following modified radical mastectomy.
Yenidogan, E, Akgul, GG, Gulcelik, MA, Dinc, S, Colakoglu, MK, Kayaoglu, HA
Advances in therapy. 2014;(1):130-9
Abstract
INTRODUCTION To reduce the seroma formation following mastectomy and axillary dissection, many different techniques and drugs have been investigated. The aim of this study is to evaluate the effects of oral β-glucan on drain fluid and efficacy of daily drainage and drain removal day in mastectomy patients. METHODS One hundred and thirty breast cancer patients of Ankara Oncology Training and Research Hospital were divided into 2 groups by consecutive randomization (n = 65 each). β-glucan 10 mg capsules were administered to Group 1 twice a day for 10 days. Group 2 took placebos in the same manner. Age, menarche age, menopause, parity, history of oral contraceptives, comorbidities, postoperative daily drainage volumes and drain removal days were recorded and compared. Seroma samples during the first and second day of drainage were taken for analysis of Interleukin-6 (IL-6) and Tumor Necrosis Factor (TNF-α). RESULTS There was no difference between groups in terms of age, menarche age, menopause period, parity, oral contraceptive use and comorbidities. Group 1 showed significantly lower daily drainage volumes between days 2 and 8. Mean drain removal day was 7.16 ± 1.72 in Group 1 and 8.59 ± 2.27 in Group 2. The difference was significant (p < 0.001). TNF-α and IL-6 levels on days 1 and 2 in Group 1 were significantly lower (p < 0.001). In addition, β-glucan significantly shortened the number of days required for the drain removal in patients who have comorbidities (p = 0.018). The earliest removal was in patients without comorbidity and who received β-glucan (p = 0.002). CONCLUSION β-glucan decreased drain discharges after mastectomy. The drains were removed earlier in β-glucan administered patients.
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Prospective study comparing two iodine concentrations for multidetector computed tomography of the pancreas.
Liu, Y, Xu, XQ, Lin, XZ, Song, Q, Chen, KM
La Radiologia medica. 2010;(6):898-905
Abstract
PURPOSE The authors sought to determine the influence of two different iodine concentrations of nonionic contrast media (cm) on contrast enhancement in pancreatic computed tomography angiography (CTA). MATERIALS AND METHODS Sixty patients with clinically suspected or known pancreatic disease underwent pancreatic CTA. The patients were randomly assigned to group A (n = 30) and group B (n = 30). The contrast agent was injected with iodine concentrations of 400 mg I/ml (Iomeron 400) in group A and 300 mg I/ml (Iopamidol 300) in group B with the same total iodine dose (36 g). Arterial and portal venous phase contrast enhancement of the vessels, organs and pancreatic masses was measured, and blinded qualitative image assessment was performed by two expert radiologists. RESULTS In the arterial and portal venous phase, the highly concentrated cm led to significantly greater enhancement in the abdominal main vessels, pancreas and pancreatic carcinoma than did the low concentrated cm. No statistically significant attenuation differences were measured between pancreatic carcinomas and the pancreatic parenchyma in the arterial and portal venous phase between group A and B. The overall trend for both readers was to assign higher scores to group A than group B. CONCLUSIONS The higher iodine concentration leads to greater contrast enhancement of abdominal vessels and organs in pancreatic CTA. Detection and demarcation of hypovascular pancreatic carcinoma was not found to be improved by the higher iodine concentration.