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Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: The FAIRY Randomized Clinical Trial.
Kim, YW, Bae, JM, Park, YK, Yang, HK, Yu, W, Yook, JH, Noh, SH, Han, M, Ryu, KW, Sohn, TS, et al
JAMA. 2017;(20):2097-2104
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Abstract
IMPORTANCE Acute isovolemic anemia occurs when blood loss is replaced with fluid. It is often observed after surgery and negatively influences short-term and long-term outcomes. OBJECTIVE To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy. DESIGN, SETTING, AND PARTICIPANTS The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 2015, in 7 centers across the Republic of Korea. Patients with a serum hemoglobin level of 7 g/dL to less than 10 g/dL at 5 to 7 days following radical gastrectomy were included. INTERVENTIONS Patients were randomized to receive a 1-time or 2-time injection of 500 mg or 1000 mg of ferric carboxymaltose according to body weight (ferric carboxymaltose group, 228 patients) or normal saline (placebo group, 226 patients). MAIN OUTCOMES AND MEASURES The primary end point was the number of hemoglobin responders, defined as a hemoglobin increase of 2 g/dL or more from baseline, a hemoglobin level of 11 g/dL or more, or both at week 12. Secondary end points included changes in hemoglobin, ferritin, and transferrin saturation levels over time, percentage of patients requiring alternative anemia management (oral iron, transfusion, or both), and quality of life at weeks 3 and 12. RESULTS Among 454 patients who were randomized (mean age, 61.1 years; women, 54.8%; mean baseline hemoglobin level, 9.1 g/dL), 96.3% completed the trial. At week 12, the number of hemoglobin responders was significantly greater for ferric carboxymaltose vs placebo (92.2% [200 patients] for the ferric carboxymaltose group vs 54.0% [115 patients] for the placebo group; absolute difference, 38.2% [95% CI, 33.6%-42.8%]; P = .001). Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level (week 12: 233.3 ng/mL for the ferric carboxymaltose group vs 53.4 ng/mL for the placebo group; absolute difference, 179.9 ng/mL [95% CI, 150.2-209.5]; P = .001) and transferrin saturation level (week 12: 35.0% for the ferric carboxymaltose group vs 19.3% for the placebo group; absolute difference, 15.7% [95% CI, 13.1%-18.3%]; P = .001); but there were no significant differences in quality of life. Patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group (1.4% for the ferric carboxymaltose group vs 6.9% for the placebo group; absolute difference, 5.5% [95% CI, 3.3%-7.6%]; P = .006). The total rate of adverse events was higher in the ferric carboxymaltose group (15 patients [6.8%], including injection site reactions [5 patients] and urticaria [5 patients]) than the placebo group (1 patient [0.4%]), but no severe adverse events were reported in either group. CONCLUSION AND RELEVANCE Among adults with isovolemic anemia following radical gastrectomy, the use of ferric carboxymaltose compared with placebo was more likely to result in improved hemoglobin response at 12 weeks. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01725789.
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Laparoscopy-assisted pylorus-preserving gastrectomy is better than laparoscopy-assisted distal gastrectomy for middle-third early gastric cancer.
Suh, YS, Han, DS, Kong, SH, Kwon, S, Shin, CI, Kim, WH, Kim, HH, Lee, HJ, Yang, HK
Annals of surgery. 2014;(3):485-93
Abstract
OBJECTIVE The purpose of this study is to compare the surgical, oncologic safety and the nutritional, functional benefit of laparoscopy-assisted pylorus-preserving gastrectomy (LAPPG) with laparoscopy-assisted distal gastrectomy (LADG) for middle-third early gastric cancers (EGC). BACKGROUND Of those patients with middle-third EGC, it is still difficult to determine which procedure is better between LADG and LAPPG despite alleged advantages of LAPPG. METHODS For middle-third EGC, a retrospective analysis was performed comparing those who underwent LADG and those who underwent LAPPG. To evaluate surgical and oncologic safety, clinicopathologic differences including the postoperative morbidity, the pattern of lymph node metastasis and recurrence were analyzed. Postoperative protein, albumin, quantification of abdominal fat area using abdomen computed tomography, and the incidence of postoperative gallstone were compared for the evaluation of functional advantages. RESULTS The overall postoperative morbidity rate was similar between LADG (n = 176) and LAPPG (n = 116). Delayed gastric emptying was less frequent in LADG than in LAPPG (1.7% vs 7.8%); however, the rates of all the other complications were significantly higher in LADG than in LAPPG (17.0% vs 7.8%). The number of examined lymph nodes and metastatic lymph nodes at each lymph node station was not significantly different and 3-year recurrence-free survival rates were also similar between LADG and LAPPG (98.8% vs 98.2%). Decreases in serum protein and albumin in postoperative 1 to 6 months and abdominal fat area in postoperative 1 year were significantly greater in LADG than in LAPPG. The 3-year cumulative incidence of gallstone was significantly higher in LADG than in LAPPG (6.5% vs 0.0%). CONCLUSIONS For middle-third EGC, LAPPG can be considered as a better treatment option than LADG in terms of nutritional advantage and lower incidence of gallstone.
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The effects of patient participation-based dietary intervention on nutritional and functional status for patients with gastrectomy: a randomized controlled trial.
Kim, H, Suh, EE, Lee, HJ, Yang, HK
Cancer nursing. 2014;(2):E10-20
Abstract
BACKGROUND Patients undergoing gastrectomy because of stomach cancer often face weight loss in the perioperational period, which can lead to malnutrition and negative treatment outcomes. OBJECTIVE The purpose of this study was to develop a patient participation-based dietary intervention (PPDI) and evaluate its effects on patient outcomes. INTERVENTIONS/METHODS This was a prospective, randomized controlled trial in which the patients were recruited in a cancer center in South Korea. The participants (N = 56), who underwent gastrectomy with stomach cancer stage I to III, were randomly assigned into either the experimental or the control group. The PPDI, which was given on the day before the hospital discharge, comprised 2 face-to-face and 2 telephone interventions. The outcome variables included body weight, body mass index, muscle mass, the Patient-Generated Subjective Global Assessment, Dietary Symptom Scale, Functional Assessment Cancer Therapy-General, Karnofsky Performance Status, Adherence to Dietary Guidelines Scale, Scale of Dietary Knowledge, Patient Satisfaction Scale, and a 3-day food diary. RESULTS Participants in the PPDI intervention demonstrated significant (P < .05) reductions in adverse dietary symptoms and significant improvements (P < .05) in functional status, performance status, dietary intake, adherence to dietary guidelines, dietary knowledge, and satisfaction with the intervention as compared with the control group over time. CONCLUSION The PPDI was an effective dietary intervention for patients undergoing a gastrectomy for gastric cancer and deserves additional study in other populations of patients. IMPLICATIONS FOR PRACTICE Incorporating patients' perspectives into a dietary intervention after gastrectomy for gastric cancer may contribute to improved patient outcomes and quality care.