Phase II clinical trial to study the safety and efficacy of combined S-1 + oxaliplatin therapy as neoadjuvant chemotherapy for locally advanced gastric cancer in older patients.

BACKGROUND: Gastrectomy with D2 dissection and adjuvant chemotherapy is the standard treatment for locally advanced gastric cancer (LAGC) in Asia. However, administering chemotherapy with sufficient intensity after gastrectomy is challenging. Several trials demonstrated the efficacy of neoadjuvant chemotherapy (NAC). However, limited studies explored the feasibility of NAC-SOX for older patients with LAGC. This phase II study (KSCC1801) evaluated the safety and efficacy of NAC-SOX in patients with LAGC aged ≥ 70 years. METHODS: Patients received three cycles of SOX130 (oxaliplatin 130 mg/m2 on day 1, oral S-1 40-60 mg twice daily for two weeks every three weeks) as NAC, followed by gastrectomy with lymph node dissection. The primary endpoint was the dose intensity (DI). The secondary endpoints were safety, R0 resection rate, pathological response rate (pRR), overall survival, and relapse-free survival. RESULTS: The median age of 26 enrolled patients was 74.5 years. The median DI in NAC-SOX130 was 97.2% for S-1 and 98.3% for oxaliplatin. Three cycles of NAC were administered in 25 patients (96.2%), of whom 24 (92.3%) underwent gastrectomy with lymphadenectomy. The R0 resection rate was 92.3% and the pRR (≥ grade 1b) was 62.5%. The major adverse events (≥ grade 3) were neutropenia (20.0%), thrombocytopenia (11.5%), anorexia (11.5%), nausea (7.7%), and hyponatremia (7.7%). Postoperative complications of abdominal infection, elevated blood amylase, and bacteremia occurred in one patient each. Severe diarrhea and dehydration caused one treatment-related death. CONCLUSIONS: NAC-SOX130 is a feasible therapy for older patients, although systemic management and careful monitoring of adverse events are necessary.

Quantitative Comparison of Surgical Device Usage in Laparoscopic Gastrectomy Between Surgeons' Skill Levels: an Automated Analysis Using a Neural Network.

BACKGROUND: Whether surgical device usage in laparoscopic gastrectomy differs with respect to operator's skill levels is unknown. Further, device usage analysis using artificial intelligence has not been reported to date. Herein, we compared the patterns of surgical device usage during laparoscopic gastrectomy for gastric cancer among surgeons at different skill levels. The data of device usage was acquired from laparoscopic video recordings using an automated surgical-instrument detection system. METHODS: In total, 100 video recordings of infrapyloric lymphadenectomy and 33 of D2 suprapancreatic lymphadenectomy during laparoscopic gastrectomy for gastric cancer were analyzed in this retrospective study. The system's accuracy was evaluated by comparing the automatic and the manual usage time. Surgical device usage patterns were compared between qualified and nonqualified surgeons of The Japan Society for Endoscopic Surgery Endoscopic Surgical Skill Qualification System. RESULTS: For every device, the automatic detection time and manual detection time were consistent with each other. In infrapyloric lymphadenectomy, the usage time proportions of dissector forceps and clip applier were higher among nonqualified operators than among qualified operators (dissector, 5.1% vs. 2.3%, P < 0.001; clip applier, 1.6% vs. 1.3%, P < 0.01). In suprapancreatic lymphadenectomy, the usage time proportions of energy devices, clip applier, and grasper forceps were significantly different (energy devices, 59.6% vs. 50.6%, P < 0.001; clip applier, 1.4% vs. 0.9%, P < 0.001; only grasper forceps; 18.3% vs. 27.9%, P = 0.022). CONCLUSIONS: Quantitative analysis of laparoscopic device usage using the automated surgical device detection system showed that the patterns of device usage during laparoscopic gastrectomy differed depending on surgeons' skill levels. These differences could suggest how the qualified and nonqualified surgeons performed the procedures.

Laparoscopic creation of a retrosternal route for gastric conduit reconstruction.

BACKGROUND: Retrosternal reconstruction is associated with a lower risk of mediastinitis, gastro-tracheal fistula, and hiatal hernia. Historically, traumatic manual creation of the retrosternal tunnel has been performed using one's fist. We report a novel and atraumatic laparoscopic procedure to create the retrosternal route. METHODS: We have laparoscopically created the retrosternal route in 25 thoracoscopic, mediastinoscopic, or robot-assisted minimally invasive esophagectomies since August 2019. Specifically, a peritoneal incision is started at the dorsal side of the xiphoid process. Through a 12-mm port inserted slightly to the right of and superior to the umbilical camera port, we dissect loose connective tissues from the caudal to the cranial side using behind the sternum and inside the internal thoracic vessels as landmarks. The time required to create the route was calculated. Then, the cumulative sum (CUSUM) method and the simple moving average of five cases were used to evaluate the learning curve of this novel procedure. Operative outcomes were analyzed according to the learning curve results and also compared with 25 cases of postmediastinal reconstruction counterparts. RESULTS: Twenty-five patients were divided into the early group (six patients) and late group (19 patients) based on the peak of the CUSUM chart. The time required for route creation was 28.5 min (median) in the early and 15 min in the late group, indicating a significant difference (P = 0.038). The overall incidence of pleural injury was 20% (5 of 25 patients), with no significant difference between the groups. There was no significant difference in the incidence of perioperative complications. Also, there were no significant differences in perioperative complications or gastric conduit functions 1 year after surgery between the retrosternal and the postmediastinal reconstruction. CONCLUSION: Laparoscopic creation of a retrosternal route for gastric conduit reconstruction is safe and feasible and has a short learning curve.

Approaches for Controlling Antibody-Mediated Allograft Rejection Through Targeting B Cells.

Both acute and chronic antibody-mediated allograft rejection (AMR), which are directly mediated by B cells, remain difficult to treat. Long-lived plasma cells (LLPCs) in bone marrow (BM) play a crucial role in the production of the antibodies that induce AMR. However, LLPCs survive through a T cell-independent mechanism and resist conventional immunosuppressive therapy. Desensitization therapy is therefore performed, although it is accompanied by severe side effects and the pathological condition may be at an irreversible stage when these antibodies, which induce AMR development, are detected in the serum. In other words, AMR control requires the development of a diagnostic method that predicts its onset before LLPC differentiation and enables therapeutic intervention and the establishment of humoral immune monitoring methods providing more detailed information, including individual differences in the susceptibility to immunosuppressive agents and the pathological conditions. In this study, we reviewed recent studies related to the direct or indirect involvement of immunocompetent cells in the differentiation of naïve-B cells into LLPCs, the limitations of conventional methods, and the possible development of novel control methods in the context of AMR. This information will significantly contribute to the development of clinical applications for AMR and improve the prognosis of patients who undergo organ transplantation.

Preoperative endoscopic tattooing using India ink to determine the resection margins during totally laparoscopic distal gastrectomy for gastric cancer.

PURPOSE: This study was conducted to determine whether establishing the proximal resection line using India ink tattooing can ensure safe resection margins during totally laparoscopic distal gastrectomy. METHODS: This retrospective study included 81 patients who underwent totally laparoscopic distal gastrectomy for gastric cancer on the lower two-thirds of the stomach. The proximal resection margins were analyzed with respect to the macroscopic type and clinical T stage, and the intraoperative appearance of the stain on the serosa was classified by reviewing surgical videos. RESULTS: R0 resection was performed in all patients. The rates of the intended margins were 89.2% in patients without a frozen section diagnosis and 84.2% in patients with differentiated type lesions who underwent a frozen section diagnosis; however, most patients with undifferentiated advanced lesions failed to achieve the intended resection margins. Intraoperative appearance revealed that 85.2% of patients had localized type stains, whereas 11.1% had widespread-type stains. CONCLUSIONS: Our procedure to determine the proximal resection line in totally laparoscopic distal gastrectomy is oncologically safe. However, careful observation of the resected specimen and a frozen section analysis should be performed for undifferentiated advanced lesions.

Survival Benefit of Neoadjuvant Chemotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction.

Background/Aim: Adenocarcinoma of the esophagogastric junction (AEG) is refractory even when curative resection is followed by adjuvant chemotherapy. This study evaluated the efficacy of neoadjuvant chemotherapy (NAC) using an oral fluoropyrimidine-platinum regimen for AEG. Patients and Methods: Out of 35 patients with locally advanced AEG who underwent curative resection, 21 who underwent surgery first and 14 who received NAC were retrospectively compared in terms of survival. Results: The NAC regimens comprised of S-1 or capecitabine plus oxaliplatin or cisplatin; trastuzumab was added to six borderline resectable cases. The downstaging rate was 50% and the pathological response rate including complete response (29%) was 50%. The three-year relapse-free survival in the NAC group was significantly superior than the surgery-first group (78% vs. 22%, p=0.011). The NAC group had a significantly longer median survival time than the surgery-first group (NR vs. 29 months, p=0.032). Conclusion: NAC using an oral fluoropyrimidine-platinum regimen may provide survival benefit in AEG.

Three-dimensional visualization system is one of the factors that improve short-term outcomes after minimally invasive esophagectomy.

PURPOSE: Minimally invasive esophagectomy (MIE) has been increasingly used, but many reports have stated that recurrent laryngeal nerve (RLN) palsy after MIE is a major complication associated with postoperative pneumonia. Prevention of RLN palsy clearly has been a challenging task. The study aim was to determine if a three-dimensional (3-D) stereoscopic vision system can reduce the RLN palsy rate after MIE. METHODS: This was a retrospective study of MIE (McKeown esophagectomy) using a 3-D or 2-D stereoscopic vision system to treat 358 patients in the prone position between April 2010 and March 2019. The patients who underwent 3-D MIE (3-D group) or 2-D MIE (2-D group) were matched by using propensity score matching. After matching, the perioperative outcomes were compared between the groups. RESULTS: After propensity score matching, 154 patients were analyzed (77 patients, 3-D group; 77 patients, 2-D group). There were no significant differences in the patients' baseline characteristics in the matched cohort. There were no significant differences in the rates of pneumonia (Clavien-Dindo (C-D) grade ≥ II, 3-D vs. 2-D, 11 (14%) vs. 12 (16%)), anastomotic leakage (C-D grade ≥ II, 10 (13%) vs. 18 (23%)) and mortality. The rates of left RLN palsy (C-D grade ≥ IIIa, 1 (1.3%) vs. 7 (9.1%), P = 0.029), right RLN palsy (C-D grade ≥ I, 2 (3%) vs. 8 (10%), P = 0.049), comprehensive complication index (CCI®) (8.5 vs. 14.3, P = 0.011), and postoperative hospital stay period (median: 25 vs. 30 days, P = 0.034) were significantly lower in the 3-D group than in the 2-D group, respectively. CONCLUSIONS: In MIE, the 3-D viewing system was one of the factors that reduced postoperative morbidities such as the rates of each RLN palsy and CCI®, leading to shorter postoperative hospital stay.

Characteristics of Immunoglobulin M Type Antibodies of Different Origins from the Immunologic and Clinical Viewpoints and Their Application in Controlling Antibody-Mediated Allograft Rejection.

Antibody-mediated allograft rejection (AMR) hinders patient prognosis after organ transplantation. Current studies concerning AMR have mainly focused on the diagnostic value of immunoglobulin G (IgG)-type donor-specific antihuman leukocyte antigen antibodies (DSAs), primarily because of their antigen specificity, whereas the clinical significance of immunoglobulin M (IgM)-type DSAs has not been thoroughly investigated in the context of organ transplantation because of their nonspecificity against antigens. Although consensus regarding the clinical significance and role of IgM antibodies is not clear, as discussed in this review, recent findings strongly suggest that they also have a huge potential in novel diagnostic as well as therapeutic application for the prevention of AMR. Most serum IgM antibodies are known to comprise natural antibodies with low affinity toward antigens, and this is derived from B-1 cells (innate B cells). However, some of the serum IgM-type antibodies reportedly also produced by B-2 cells (conventional B cells). The latter are known to have a high affinity for donor-specific antigens. In this review, we initially discuss how IgM-type antibodies of different origins participate in the pathology of various diseases, directly or through cell surface receptors, complement activation, or cytokine production. Then, we discuss the clinical applicability of B-1 and B-2 cell-derived IgM-type antibodies for controlling AMR with reference to the involvement of IgM antibodies in various pathological conditions.

Impact of Immunoglobulin M-Type Donor-Specific Human Leukocyte Antigen-Antibody Levels in Supernatants from Cultured Peripheral Blood Mononuclear Cells as Predictors of Antibody-Mediated Rejection.

BACKGROUND: Antibody-mediated rejection (AMR) is a crucial barrier in the long-term prognosis of transplant recipients. METHODS: Peripheral blood mononuclear cells (PBMCs) were collected from kidney allograft recipients (N = 41) and cultured in vitro for 1 week. Furthermore, the supernatants of the cultured PBMCs were analyzed by Luminex single-antigen beads. RESULTS: Analyses using Luminex single-antigen beads revealed the presence of immunoglobulin (Ig) G donor-specific anti-HLA antibodies (DSAs) was detected in the supernatants of cultured PBMCs collected more frequently than IgM in de novo DSA-sensitized patients with AMR, and IgM were detectable in patients with stable graft function mainly and several IgM DSAs were detectable in the supernatants of the cultured PBMCs before detecting the IgG levels in sera. We also found that the DSA-specific IgM-secreting memory B cells (mBCs) were more sensitive to the chronic use of immunosuppressive agents than to the IgG-secreting mBCs. CONCLUSIONS: In the transplant recipients, the assessment of supernatants of cultured PBMCs provide more details of immune reactions than the commonly used method that directly measures IgG DSA levels in patient sera and some IgM DSA detection may be a better predictor of IgG DSAs production, which may cause AMR and enable early intervention, in initial stages of AMR development.

Significance of prediction of the dorsal landmark using three-dimensional computed tomography during laparoscopic lymph node dissection along the proximal splenic artery in gastric cancer.

OBJECTIVES: Dissection of the No. 11p lymph nodes is technically challenging because of variations in anatomical landmarks. This study aimed to determine the accuracy and efficacy of predicting the dorsal landmark of No. 11p lymph node using three-dimensional computed tomography simulation. METHODS: Laparoscopic gastrectomy with No. 11p lymph node dissection with preoperative simulation using three-dimensional computed tomography was performed in 24 patients at our institution from October 2016 to May 2018. Initially, preoperative three-dimensional computed tomography findings with operative videos in these 24 patients were compared. The dorsal landmark was defined as an anatomical structure behind the splenic artery on preoperative three-dimensional computed tomography and operative videos. The dorsal landmark of No. 11p lymph node was divided into four types: (1) splenic vein type, (2) splenic vein and pancreas type, (3) pancreas type, and (4) unclear type. Then, to investigate the efficacy of three-dimensional computed tomography, we compared the clinical and pathological features and surgical outcomes of nine patients who underwent preoperative three-dimensional computed tomography simulation (three-dimensional computed tomography group) and 23 patients who did not undergo three-dimensional computed tomography simulation from August 2014 to September 2016 (non-three-dimensional computed tomography group). All procedures were performed by one surgeon certified by the Endoscopic Surgical Skill Qualification System in Japan. RESULTS: The concordance rate between three-dimensional computed tomography and operative videos of the dorsal landmark using three-dimensional computed tomography was 79% (19/24). The operative time of No. 11p lymph node dissection was significantly shorter in the three-dimensional computed tomography group than in the non-three-dimensional computed tomography group (7.7 versus 15.8 min, P = 0.044). CONCLUSION: The accuracy of predicting the dorsal landmark of No. 11p lymph node using three-dimensional computed tomography was extremely high. Preoperative simulation with three-dimensional computed tomography was useful in shortening the operative time of No. 11p lymph node dissection.

Laparoscopic gastrectomy with lymph node dissection for the treatment of remnant stomach gastrointestinal stromal tumors in incomplete-type Carney's triad: a case report.

BACKGROUND: We report a rare case of gastrointestinal stromal tumors (GISTs) in Carney's triad, successfully treated using laparoscopic gastrectomy with lymph node dissection after chemotherapy. CASE PRESENTATION: A 21-year-old woman presented to our hospital for treatment of recurrent GISTs. The patient had been admitted for treatment 11 years prior, with black stools being the chief presenting complaint at that time. On examination at that time, multiple submucosal tumors in the pyloric antrum and multiple pulmonary tumors had been observed. She underwent open partial gastrectomy, and the diagnosis of GISTs was confirmed. She was administered tyrosine kinase inhibitors to treat lung metastases from 2 months after surgery. Due to the increasing size of the lung tumors, a right upper lobectomy was performed 9 years after the index gastric surgery. Histopathological examination of the lung specimen, in combination with re-examination of the gastric specimens, was indicative of incomplete-type Carney's triad. Eleven years after the index gastric surgery, multiple GISTs were observed in her entire stomach. Tumor biopsy revealed a succinate dehydrogenase deficiency, confirming the diagnosis of recurrent GISTs. For treatment, the patient underwent laparoscopic completion gastrectomy, with D1 plus lymph node dissection. CONCLUSION: This is a first case report of completion gastrectomy performed laparoscopically for the treatment of GISTs associated with incomplete-type Carney's triad. The recurrent GISTs developed over a protracted period of 11 years from the index gastric surgery to tumor recurrence.

Three-dimensional laparoscopic vision improves forceps motion more in the depth direction than in the horizontal direction: An analysis of data from prospective randomized controlled trials.

INTRODUCTION: Three-dimensional (3D) laparoscopic vision can improve depth perception. However, it is a question whether 3D vision can improve motion in the depth direction. The aim of this study was to compare the impact of 3D vision on forceps motion in the depth and horizontal directions. METHODS: All data were obtained from our previous two studies, where, in total, 40 novices and 20 moderately experienced surgeons participated. A simple phantom task was performed in a training box. The participants were randomly assigned to two groups. Specifically, one group performed the task five times initially under a two-dimensional (2D) system, and the other group started under a 3D system. Both groups then performed the same task five times under the alternative system. Performances were recorded by an optical position tracker. We separately evaluated forceps motion in the x-, y-, and z-axis directions. RESULTS: Compared with the findings for 2D vision, the forceps path lengths were significantly decreased among novices and moderately experienced surgeons in almost all tasks under 3D vision. In a comparison of the path length ratio (3D/2D) in each direction, larger reduction was observed for the depth direction among novices, whereas no significant directional difference was noted among moderately experienced surgeons. CONCLUSIONS: For novices, 3D laparoscopic vision improves depth perception and may give shorter forceps movement in the depth direction even for simple tasks.

Thoracoscopic retrosternal gastric conduit resection in the supine position for gastric tube cancer.

INTRODUCTION: Recent advances in the treatment for esophageal cancer have improved the prognosis after esophagectomy, but they have led to an increased incidence of gastric tube cancer. In most patients who underwent retrosternal reconstruction, median sternotomy is performed; it is associated with a risk of postoperative bleeding and osteomyelitis, and pain often negatively affects respiration. Here, we report the first case of thoracoscopic retrosternal gastric conduit resection in the supine position (TRGR-S). MATERIALS AND SURGICAL TECHNIQUE: A 75-year-old male patient was placed in the supine position. Four ports were placed in the left chest wall. The gastric tube was separated from the epicardium, sternum, and left brachiocephalic vein. Because of adhesions between the gastric tube and the right pleura, combined resection of the right pleura was performed. The dorsal side of the gastric tube was dissected before the ventral side, enabling the gastric tube to be suspended from the back of the sternum and, thus, making it easier to expose the surgical field. Next, pedicled jejunal reconstruction via the presternal route was performed. There were no postoperative complications. The pathological diagnosis was signet ring cell carcinoma (pT1b, pN0, M0, pStage I), indicating R0 resection. DISCUSSION: TRGR-S does not require sternotomy, reducing the risk of postoperative bleeding and osteomyelitis. In the presence of adhesions, TRGR-S is safe and provides a good surgical view. It is also reliable procedure for resection of retrosternal gastric tube cancer, and it is ergonomic for surgeons.

Tooth Loss Predicts Long-Term Prognosis of Esophageal Cancer After Esophagectomy.

BACKGROUND: Oral health is associated with various diseases, including cancer. Tooth loss is a simple and objective index of oral health. OBJECTIVE: The purpose of this study was to investigate the association between preoperative tooth loss and esophageal cancer prognosis after esophagectomy. METHODS: This study included 191 patients who underwent esophagectomy for esophageal cancer after perioperative dental evaluation and oral care at Kobe University Hospital from April 2011 to March 2016. Patients were divided into two groups: Group A (tooth loss < 7) and Group B (tooth loss ≥ 7). Three-year overall survival (OS) and multivariate analysis were performed, along with subgroup analysis for elderly patients (age ≥ 65 years). RESULTS: The 3-year OS rate was 68.1% in Group A (104 patients) and 49.2% in Group B (87 patients). Group A had significantly higher OS than Group B (p = 0.002), and there were no significant differences in sex and clinical T or N stage between the two groups. However, the mean age of Group A was younger than that of Group B (64.2 vs. 68.5 years; p = 0.0002). Among elderly patients, the 3-year OS rate was 68.2% in Group A (55 patients) and 45.1% in Group B (65 patients) [p = 0.003]. Multivariate analysis that included age demonstrated that tooth loss is an independent prognostic factor (hazard ratio 1.87, 95% confidence interval 1.22-2.87), in addition to clinical T stage and preoperative serum albumin. CONCLUSION: Tooth loss is an independent prognostic factor for esophageal cancer after esophagectomy.

Anesthetic Management of a Patient With Restless Legs Syndrome: A Case Report.

Restless legs syndrome (RLS) is a neurological sensory disorder associated with sensory and motor symptoms that most commonly occur at night and during periods of rest. It is characterized by altered or abnormal sensations primarily in the legs and the urge to move the associated limbs. Perioperative procedures, including general anesthesia, can cause exacerbations of RLS. This is a case report of a suspected RLS exacerbation in a 22-year-old woman who had no formal diagnosis of RLS despite reporting symptoms that met all essential diagnostic criteria by the International RLS Study Group. Despite her previous diagnoses of dehydration induced-muscle pain or nocturnal cramps, we suspected her to have RLS. The patient underwent general anesthesia for a bilateral sagittal split ramus osteotomy using a combined inhalational and intravenous anesthetic technique with sevoflurane, propofol, remifentanil, and dexmedetomidine. After successful completion of the surgery and returning to the ward, she began moving her lower extremities and complaining of unpleasant sensations in both ankles. Bed rest exacerbated the suspected RLS symptoms despite a continuous infusion of dexmedetomidine. The RLS symptoms continued to worsen and spread to her upper extremities. After increasing the dexmedetomidine infusion from 0.2 to 0.4 µg/kg/h, almost all symptoms improved, and she slept for 3 hours. Upon awakening, the unpleasant sensations were completely relieved by walking and stretching. The patient was formally diagnosed with RLS by a neurologist after discharge. In this case, an infusion of dexmedetomidine was helpful in successfully managing a suspected exacerbation of RLS.

Skeletal muscle loss after laparoscopic gastrectomy assessed by measuring the total psoas area.

PURPOSE: Skeletal muscle loss after gastrectomy can worsen patients' quality of life and prognosis. Laparoscopic gastrectomy is less invasive than open gastrectomy and has become commonly performed. However, the degree of skeletal muscle loss after laparoscopic procedures remains unclear. We herein report the degree and risk factors of psoas muscle loss after laparoscopic gastrectomy for gastric cancer. METHODS: The total psoas area (TPA) on computed tomography of 50 consecutive patients who underwent laparoscopic total gastrectomy (LTG) and 167 consecutive patients who underwent laparoscopic distal gastrectomy (LDG) for gastric cancer was retrospectively evaluated at one postoperative year. The TPA loss was compared between LDG and LTG and univariate and multivariate analyses were performed to identify the risk factors for TPA loss > 10%. RESULTS: The median TPA decrease rate was 5.9% in the LDG group and 15.6% in the LTG group. LTG and postoperative respiratory complications were independent factors associated with a severe TPA loss of > 10%. In the LTG group, no independent factors were identified in a multivariate analysis. In the LDG group, postoperative complications were identified as an independent risk factor for TPA loss > 10%. CONCLUSIONS: Laparoscopic gastrectomy leads to postoperative TPA loss, especially in patients who underwent LTG and had postoperative respiratory complications. Postoperative complications after LDG were also a risk factor for TPA loss.

Non-placement versus placement of a drainage tube around the cervical anastomosis in McKeown esophagectomy: study protocol for a randomized controlled trial.

BACKGROUND: Esophagectomy with extended lymphadenectomy remains the mainstay of treatment for localized esophageal cancer. Currently, transthoracic and abdominal esophagectomy with cervical anastomosis (McKeown esophagectomy) is a frequently used technique in Japan. However, cervical anastomosis is still an invasive procedure with a high incidence of anastomotic leakage. The use of a drainage tube to treat anastomotic leakage is effective, but the routine placement of a closed suction drain around the anastomosis at the end of the operation remains controversial. The objective of this study is to evaluate the postoperative anastomotic leakage rate, duration to oral intake, hospital stay, and analgesic use with nonplacement of a cervical drainage tube as an alternative to placement of a cervical drainage tube. METHODS: This is an investigator-initiated, investigator-driven, open-label, randomized controlled parallel-group, noninferiority trial. All adult patients (aged ≥20 and ≤85 years) with histologically proven, surgically resectable (cT1-3 N0-3 M0) squamous cell carcinoma, adenosquamous cell carcinoma, or basaloid squamous cell carcinoma of the intrathoracic esophagus, and European Clinical Oncology Group performance status 0, 1, or 2 are assessed for eligibility. Patients (n = 110) with resectable esophageal cancer who provide informed consent in the outpatient clinic are randomized to either nonplacement of a cervical drainage tube (n = 55) or placement of a cervical drainage tube (n = 55). The primary outcome is the percentage of Clavien-Dindo grade 2 or higher anastomotic leakage. DISCUSSION: This is the first randomized controlled trial comparing nonplacement versus placement of a cervical drainage tube during McKeown esophagectomy with regards to the usefulness of a drain for anastomotic leakage. If our hypothesis is correct, nonplacement of a cervical drainage tube will be recommended because it is associated with a similar anastomotic leakage rate but less pain than placement of a cervical drainage tube. TRIAL REGISTRATION: UMIN-CTR, 000031244. Registered on 1 May 2018.

Lymphopenia predicts poor prognosis in older gastric cancer patients after curative gastrectomy.

AIM: Total lymphocyte count in preoperative peripheral blood is associated with prognosis in various cancers. The predictive value of preoperative total lymphocyte count for survival was assessed in older gastric cancer patients after gastrectomy. METHODS: A total of 200 gastric cancer patients aged ≥75 years who underwent curative resection from 2000 to 2014 were included in this retrospective study. The cut-off value of total lymphocyte count in preoperative peripheral blood was determined using receiver operating characteristic curve analysis, and the association with prognosis was examined. RESULTS: The cut-off value of total lymphocyte count was 1462/µL, and 94 patients were classified as low total lymphocyte count patients and 106 patients were classified as high total lymphocyte count patients. In univariate analysis, American Society of Anesthesiologists score ≥3, Charlson Comorbidity Index ≥3, total lymphocyte count <1462/µL, stage III, open approach, total gastrectomy, splenectomy and infectious complication were significantly associated with overall survival. In multivariate analysis, total lymphocyte count <1462/µL (P = 0.003), American Society of Anesthesiologists score ≥3 (P = 0.01) and stage III (P = 0.017) were independent prognostic factors. Low total lymphocyte count significantly reduced overall survival in stage I (P = 0.037) and II (P = 0.009) patients, but not stage III patients (P = 0.29). CONCLUSION: Total lymphocyte count in preoperative peripheral blood can predict postoperative survival of older patients with relatively early-stage gastric cancer. Geriatr Gerontol Int 2019; 19: 1215-1219.

Treatment Strategy for Rectal Cancer Patients With Inguinal Lymph Node Metastasis.

BACKGROUND/AIM: To investigate the impact of inguinal lymph node dissection (ILND) following neoadjuvant chemoradiotherapy (NACRT) for rectal cancer patients with ILN metastasis. PATIENTS AND METHODS: Forty-three patients with rectal cancer underwent NACRT followed by curative surgery between January 2005 and December 2016. Seven patients underwent ILND after NACRT for clinically-positive ILN metastasis (ILND (+) group), while the remaining 36 did not receive ILND for clinically negative ILN metastasis (ILND (-) group). Their outcomes were retrospectively analyzed. RESULTS: Only one patient in the ILND (+) group had a local recurrence at six years after surgery. The 5-year recurrence-free survival was 100% and 65.4% in the ILND (+) and ILND (-) groups, respectively (p=0.09), and the 5-year overall survival was 100% and 83.2%, respectively (p=0.32). CONCLUSION: ILND following NACRT seems effective for rectal cancer patients with ILN metastasis.

Anesthetic Management of Patient With Dravet Syndrome: A Case Report.

Dravet syndrome (DS) is a rare and severe form of epilepsy that begins in infancy. This is particularly burdensome because repeated epileptic seizures lead to cognitive decline. We describe the case of a 12-year-old girl who was diagnosed with DS and was scheduled to have gingival reduction around her mandibular molars. Despite the patient being intellectually disabled, she was able to cooperate somewhat during medical procedures, including intravenous cannulation. Under the assumption that the major problem with anesthesia for DS would be the regulation of body temperature-induced seizures, we used body temperature management equipment to maintain the patient's body temperature during the procedure. We opted for intravenous sedation and administered a total dose of 4.5 mg midazolam throughout the procedure. Anesthesia was completed within 1 hour and 20 minutes without any adverse events. To the best of our knowledge, no previous studies have documented the anesthetic management of DS. In this case, no adverse events occurred perioperatively. However, the patient's temperature rose to that which indicated a slight fever despite the use of a standard cooling technique.