Randomized controlled trial of the LigaSure vessel sealing system versus conventional open gastrectomy for gastric cancer

Purpose

LigaSure, a bipolar electronic vessel sealing system, has become popular in abdominal surgery but few clinical studies have been conducted to evaluate its effectiveness in radical gastrectomy for gastric cancer.

Methods

In this multicenter, prospective, randomized controlled trial, patients with curative gastric cancer were randomly assigned to undergo gastrectomy either with LigaSure or a conventional technique.

Results

Of the 160 patients enrolled, 80 were randomized to the LigaSure group and 78 to the conventional group. Patient characteristics were well balanced in the two groups. There were no significant differences between the LigaSure and conventional groups in blood loss (288 vs. 260 ml, respectively; P = 0.748) or operative time (223 and 225 min, respectively; P = 0.368); nor in the incidence of surgical complications or duration of postoperative hospital stay. In a subgroup analysis of patients who underwent gastrectomy that preserved the distal part of the greater omentum, the use of LigaSure significantly reduced blood loss (179 vs. 245 ml; P = 0.033), and the duration of the operation (195 vs. 221 min; P = 0.039).

Conclusions

LigaSure did not contribute to reducing intraoperative blood loss, operative time, or other adverse surgical outcomes. The usefulness of the device may be limited to a specific part of the surgical procedure in open gastrectomy.     

The impact of nerve‐sparing robot‐assisted radical prostatectomy on lower urinary tract function: Prospective assessment of patient‐reported outcomes and frequency volume charts

Aims

To elucidate the effects of a nerve‐sparing (NS) procedure on lower urinary tract symptoms (LUTS) and urinary function after robot‐assisted radical prostatectomy (RARP), the associations between the NS procedure and LUTS and urinary function were investigated.

Methods

The participants in this study were 200 consecutive patients who underwent RARP. These patients were categorized into unilateral and bilateral NS groups and the non‐NS group. The International Prostate Symptom Score (IPSS), quality of life (QOL) index, frequency‐volume chart, uroflowmetry, 1‐h pad test, and the 5‐item International Index of Erectile Function (IIEF‐5) questionnaire were evaluated before and after RARP.

Results

The total IPSS score was significantly lower in the unilateral (P = 0.03) and bilateral NS groups (P = 0.03) than in the non‐NS group after RARP. Diurnal maximum voided volume (MVV) values were significantly greater in the bilateral NS group than in the non‐NS group after RARP (P = 0.002). Nocturnal frequency was significantly decreased in the unilateral NS group than in the non‐NS group after RARP (3 months P = 0.01, 12 months P = 0.01). Erectile function was significantly better in both the unilateral NS group (P < 0.0001) and the bilateral NS group (P = 0.02) than in the non‐NS group 12 months after RARP.

Conclusions

The NS procedure in RARP has the possibility to improve not only erectile function, but also LUTS, owing to both the increase of MVV and the decrease of nocturia. Therefore, the NS procedure is also recommended from the viewpoint of early improvement of LUTS and lower urinary tract dysfunction after RARP.     

Predictive Ability of the Five-time Chair Stand Test for Postoperative Pneumonia after Minimally Invasive Esophagectomy for Esophageal Cancer

Annals of Surgical Oncology - The revised sarcopenia guidelines proposed handgrip strength (HGS) and five-time chair stand test (5-CST) as the primary parameters of muscle function. HGS and 5-CST...     

Cell therapy for aseptic necrosis of femoral head

As the clinical application of mesenchymal stem cell (MSC), we have engaged in the development of cell transplantation therapy for aseptic necrosis of femoral head. Based on the results obtained by in vitro and in vivo preclinical experiments, we established the protocol for the clinical trial combining MSC with vascularized bone grafts. The protocol was approved by IRB on November 25, 2007, and the first case was operated on February 22, 2008. Since then 10 cases have been successfully treated and were followed at least 24 months with satisfactory results.     

Ciltacabtagene autoleucel in patients with relapsed/refractory multiple myeloma: CARTITUDE‐1 (phase 2) Japanese cohort

Chimeric antigen receptor (CAR) T cells targeting B‐cell maturation antigen have shown positive responses in patients with multiple myeloma (MM). The phase 2 portion of the CARTITUDE‐1 study of ciltacabtagene autoleucel (cilta‐cel) included a cohort of Japanese patients with relapsed/refractory MM. Following a conditioning regimen of cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²), patients received a single cilta‐cel infusion at a target dose of 0.75 × 10⁶ (range, 0.5–1.0 × 10⁶CAR‐positive viable T cells/kg). The primary endpoint was overall response rate (ORR; defined as partial response or better) by International Myeloma Working Group criteria. A key secondary endpoint was the rate of very good partial response (VGPR) or better (defined as VGPR, complete response, stringent complete response). This first analysis was performed at 6 months after the last patient received cilta‐cel. Thirteen patients underwent apheresis, nine of whom received cilta‐cel infusion. Eight patients who received cilta‐cel at the target dose responded, yielding an ORR of 100%. Seven of eight (87.5%) patients achieved a VGPR or better. One additional patient who received a below‐target dose of cilta‐cel also achieved a best response of VGPR. MRD negativity (10⁻⁵ threshold) was achieved in all six evaluable patients. Eight of nine (88.9%) patients who received cilta‐cel infusion experienced a grade 3 or 4 adverse event, and eight (88.9%) patients experienced cytokine release syndrome (all grade 1 or 2). No CAR‐T cell neurotoxicity was reported. A positive benefit/risk profile for cilta‐cel was established for heavily pretreated Japanese patients with relapsed or refractory MM.     

A Novel Model of Perifascial Areolar Tissue Transplant in Rats

Background  Perifascial areolar tissue (PAT) transplant is a method of transplanting loose connective tissue harvested in a sheet form from above the fascia to the wound bed and is effective for wounds with exposed ischemic tissue. However, the engraftment mechanism is unknown, and no animal models of PAT transplant for wound healing exist. Methods  In this study, we harvested connective tissue from the backs of Wistar rats in a sheet form to simulate a human PAT transplant. The PAT was affixed to exposed bone of the head. Results  In the PAT(+) group, the wound areas gradually decreased due to epithelialization and contraction. The wound area of the PAT(+) group was significantly smaller than that of the PAT(−) group. Conclusions  This clinically relevant rat model is useful for elucidating the mechanism of the PAT transplant and establishing a reliable surgical method.