Synthesis of [1]Benzothieno[3,2-b][1]benzothiophenes through Iodine-Mediated Sulfur Insertion Reaction.

[1]Benzothieno[3,2-b][1]benzothiophenes (BTBTs) are important molecules that have been extensively studied as high-performance organic field-effect transistors (OFETs). Therefore, it is important to develop a simple synthetic method for these molecules. In this paper, a synthetic method to obtain the BTBTs from 2-arylbenzo[b]thiophenes and elemental sulfur, in which two C-S bonds are formed at once, is described. In this method, molecular iodine plays a very important role as an additive. The role of iodine is discussed in the presumed reaction pathways.

Comparison of masticatory muscle activity between young adults and elderly participants using a novel standardized bite device.

OBJECTIVES: Standardized bite training is required to prevent oral hypofunction in elderly individuals. We aimed to compare masticatory muscle activity between 24 young adults and 16 pre-elderly individuals during a biting task using a novel standardized bite device (BD). METHODS: The BD was made of silicone rubber and included a high-force or low-force plate spring or no plate spring (dummy). The compressive stiffness of the material in each BD was measured using a texture analyzer. All participants performed a biting task 50-times at a rate of 1/s each using the three types of BDs on the right first molar. Electromyographic (EMG) activity was recorded bilaterally from the masseter and temporalis muscles. The variability of each biting training session was calculated as the coefficient of variance (CV) from the EMG activity during each biting task for each muscle. Masticatory muscle fatigue was assessed using a numerical rating scale (NRS). RESULTS: Compressive stiffness was significantly different between each BD (P < 0.001). The CV and NRS scores were not significantly different between the groups. The EMG activities during each bite task in all muscles were not significantly different for any measurement item between the age groups. The EMG activities of high- and low-force BDs in the right temporalis (ipsilateral) muscle were significantly higher than those of the dummy BD (P < 0.001). CONCLUSIONS: Compressive stiffness of the BD affected EMG activity only in the ipsilateral temporalis muscle, but not in the masseter or contralateral temporalis muscles, without any age effect.

A novel primary stability test method for artificial acetabular shells considering vertical load during level walking and shell position.

Uncemented acetabular shell primary stability is essential for optimal clinical outcomes. Push-out testing, rotation testing, and lever-out testing are major evaluation methods of primary stability between the shell and bone. However, these test methods do not consider shell loads during daily activity and shell installation angle. This study proposes a novel evaluation method of acetabular shell primary stability considering load during level walking and acetabular installation angles such as inclination and anteversion. To achieve this, a novel primary stability test apparatus was designed with a shell position of 40° acetabular inclination and 20° anteversion. The vertical load, corresponding to walking load, was set to 3 kN according to ISO 14242-1, which is the wear test standard for artificial hip joints. The vertical load was applied by an air cylinder controlled by a pressure-type electro-pneumatic proportional valve, with the vertical load value monitored by a load cell. Torque was measured when angular displacement was applied in the direction of extension during the application of vertical load. For comparison, we also measured torque using the traditional lever-out test. The novel primary stability test yielded significantly higher primary stabilities; 5.4 times greater than the lever-out test results. The novel primary stability test failure mode was more similar to the clinical failure than the traditional lever-out test. It is suggested that this novel primary stability test method, applying physiological walking loads and extension motions to the acetabular shell, better reflects in vivo primary stability than the traditional lever-out test.

Effect of soft denture liners on complete denture treatments: A systematic review.

PURPOSE: This systematic review examined the effectiveness of soft denture relining (SDR) materials. STUDY SELECTION: A comprehensive search of MEDLINE, Cochrane Library, and ICHUSHI was conducted up to July 26, 2020. Target outcomes were patient satisfaction, oral health-related quality of life (OHRQOL), masticatory ability (MA), denture functional duration, residual ridge resorption (RRR), and microbial contamination. An organization specializing in literature searches performed the reference searches, and two reviewers independently selected the literature sources, extracted the data, and assessed the risk of bias. The reviewers resolved any disagreements concerning the assortment of literature sources through discussion. SDR included acrylic- and silicone-based materials, which were evaluated separately. RESULTS: Reviewers selected 7, 5, 11, 1, 4, and 6 studies to assess patient satisfaction, OHRQOL, MA, functional duration, RRR, and microbial contamination, respectively. The results confirmed that SDR improved patient satisfaction, OHRQOL, MA, and RRR. However, the functional duration of SDR material is shorter than that of hard denture relining (HDR) or acrylic resin material. Furthermore, SDR material is more susceptible to microbial contamination in the long term. The risk of bias for the included studies tended to be high because of specific issues (difficulty in blinding SDR versus HDR). CONCLUSIONS: For patients who wear complete dentures, SDR often provides beneficial outcomes such as pain reduction and recovery from MA. However, caution should be exercised regarding their use owing to insufficient functional duration and the possibility of microbial contamination during long-term use.

Analysis of definite awake bruxism using a portable electromyography device.

PURPOSE: This study aimed to compare awake bruxism events between subjective and objective evaluations using a questionnaire survey and a modified portable electromyography (EMG) device, and to examine correlations between sleep quality and awake bruxism. METHODS: The Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), and awareness of awake bruxism as clarified via interviews were conducted on 34 participants as subjective evaluations. The EMG device was used to record left temporal muscle activity for 6.5 h (from 09:00 to 15:30) and the number of awake bruxism episodes per hour. The participants were then classified into "bruxer" and "non-bruxer" groups based on the number of awake bruxism episodes. RESULTS: The mean number of awake bruxism episodes per hour was 33.6 ± 21.4, and 23% of the participants who reported having no awareness of awake bruxism in the interviews were defined as "bruxers" in the objective evaluations. In the bruxer group, positive correlations were found between the number of awake bruxism episodes and both ESS and PSQI scores. CONCLUSION: These findings suggest that objective measurements using a portable EMG device can increase the diagnostic accuracy for awake bruxism, and that sleep quality is a major risk factor for awake bruxism.

Days of the week and 90-day mortality after esophagectomy: analysis of 33,980 patients from the National Clinical Database.

PURPOSE: The effect of the days of the week on the short-term outcomes after elective surgeries has been suggested; however, such data on esophagectomies remain limited. This study aimed to investigate the association between the day of the week and mortality rates after elective esophagectomy using a large-scale clinical database in Japan. METHODS: The data of elective esophagectomies, registered in the National Clinical Database in Japan, for esophageal cancer treatment between 2012 and 2017 were analyzed. We hypothesized that the later days of the week could have higher odds ratios of death after elective esophagectomy. With 22 relevant clinical variables and days of surgery, 90-day mortality was evaluated using hierarchical logistic regression modeling. RESULTS: Ninety-day mortality rates among 33,980 patients undergoing elective esophagectomy were 1.8% (range, 1.5-2.1%). Surgeries were largely concentrated on earlier days of the week, whereas esophagectomies performed on Fridays accounted for only 11.1% of all cases. Before risk adjustment, lower odds ratios of 90-day mortality were found on Tuesday and a tendency towards lower odds ratios on Thursday. In the hierarchical logistic regression model, 21 independent factors of 90-day mortality were identified. However, the adjusted odds ratios of 90-day mortality for Tuesday, Wednesday, Thursday, and Friday were 0.87, 1.09, 0.85, and 0.88, respectively, revealing no significant difference. CONCLUSION: The results imply that the variation in 90-day mortality rates after esophagectomy on different days of the week may be attributed to differing preoperative risk factors of the patient group rather than the disparity in medical care provided.

Production of infectious reporter murine norovirus by VP2 trans-complementation.

Human norovirus (HuNoV) causes gastroenteritis, a disease with no effective therapy or vaccine, and does not grow well in culture. Murine norovirus (MNV) easily replicates in cell cultures and small animals and has often been used as a model to elucidate the structural and functional characteristics of HuNoV. An MNV plasmid-based reverse genetics system was developed to produce the modified recombinant virus. In this study, we attempted to construct the recombinant virus by integrating a foreign gene into MNV ORF3, which encodes the minor structural protein VP2. Deletion of VP2 expression abolished infectious particles from MNV cDNA clones, and supplying exogenous VP2 to the cells rescued the infectivity of cDNA clones without VP2 expression. In addition, the coding sequence of C-terminal ORF3 was essential for cDNA clones compensated with VP2 to produce infectious particles. Furthermore, the recombinant virus with exogenous reporter genes in place of the dispensable region of ORF3 was propagated when VP2 was constitutively supplied. Our findings indicate that foreign genes can be transduced into the norovirus ORF3 region when VP2 is supplied and that successive propagation of modified recombinant norovirus could lead to the development of norovirus-based vaccines or therapeutics.IMPORTANCEIn this study, we revealed that some of the coding regions of ORF3 could be replaced by a foreign gene and infectious virus could be produced when VP2 was supplied. Propagation of this virus depended on VP2 being supplied in trans, indicating that this virus could infect only once. Our findings help to elucidate the functions of VP2 in the virus lifecycle and to develop other caliciviral vectors for recombinant attenuated live enteric virus vaccines or therapeutics tools.

5-year follow-up results of a JCOG1104 (OPAS-1) phase III non-inferiority trial to compare 4 courses and 8 courses of S-1 adjuvant chemotherapy for pathological stage II gastric cancer.

BACKGROUND: Postoperative adjuvant chemotherapy with S-1 for 1 year (corresponding to eight courses) is the standard treatment for pathological stage II gastric cancer. The phase III trial (JCOG1104) investigating the non-inferiority of four courses of S-1 to eight courses was terminated due to futility at the first interim analysis. To confirm the primary results, we reported the results after a 5-years follow-up in JCOG1104. METHODS: Patients histologically diagnosed with stage II gastric cancer after radical gastrectomy were randomly assigned to receive S-1 for eight or four courses. In detail, 80 mg/m2/day S-1 was administered for 4 weeks followed by a 2-week rest as a single course. RESULTS: Between February 16, 2012, and March 19, 2017, 590 patients were enrolled and randomly assigned to 8-course (295 patients) and 4-course (295 patients) regimens. After a 5-years follow-up, the relapse-free survival at 3 years was 92.2% for the 8-course arm and 90.1% for the 4-course arm, and that at 5 years was 87.7% for the 8-course arm and 85.6% for the 4-course arm (hazard ratio 1.265, 95% CI 0.846-1.892). The overall survival at 3 years was 94.9% for the 8-course arm, 93.2% for the 4-course arm, and that at 5 years was 89.7% for the 8-course arm, and 88.6% for the 4-course arm (HR 1.121, 95% CI 0.719-1.749). CONCLUSIONS: The survival of the four-course arm was slightly but consistently inferior to that of the eight-course arm. Eight-course S-1 should thus remain the standard adjuvant chemotherapy for pathological stage II gastric cancer.

Effect of clinical experience and training with visual feedback on standardized palpation outcomes-Potential implications for assessment of jaw muscle sensitivity.

BACKGROUND: The evaluation of muscle pain and sensitivity by manual palpation is an important part of the clinical examination in patients with myalgia. However, the effects of clinical experience and visual feedback on palpation of the masticatory muscles with or without a palpometer are not known. OBJECTIVE: To estimate the effects of clinical experience and visual feedback on the accuracy of palpation in standardized settings. METHODS: Thirty-two dentists (age 35 ± 11 years) classified as either specialists (n = 16) or generalists (n = 16) participated in this experiment. All dentists were instructed to target force levels of 500- or 1000-gf, as determined on an electronic scale using either standardized palpometers or manual palpation (MP). All dentists participated in four different tests: MP, MP with visual feedback (MPVF), palpometer (PAL) and PAL with visual feedback (PALVF). Actual force values for each type of palpation from 0 to 2, 2 to 5 and 0 to 5 s were analysed by calculating target force level. RESULTS: The relative differences during 2-5 and 0-5 s with 1000 gf were significantly lower for generalists than for specialists (p < .05). In generalists and specialists, the coefficients of variation and the relative differences during 2-5 s were significantly lower for PAL and PALVF than for MP (p < .05). CONCLUSIONS: These findings suggest that the use of a palpometer, but not clinical experience with palpation of masticatory muscles, increases the accuracy of palpation, and ≥2 s of palpation with a palpometer is optimal for masticatory muscles.

Efficacy and safety of neoadjuvant nab-paclitaxel plus gemcitabine therapy in patients with borderline resectable pancreatic cancer: A multicenter single-arm phase II study (NAC-GA trial).

Background: Nab-paclitaxel plus gemcitabine is a standard treatment for metastatic/locally advanced pancreatic cancer. The effectiveness of neoadjuvant therapy with nab-paclitaxel plus gemcitabine (GnP-NAT) in patients with borderline resectable pancreatic cancer (BRPC) remains unclear. Patients and Methods: This single-arm phase II trial included 61 patients with BRPC that were treated with two cycles of GnP-NAT, (nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2), on days 1, 8, and 15 over a 4-week period, which comprised one cycle. The primary endpoint was overall survival time. In the absence of disease progression, patients underwent planned pancreatectomy. Results: Median overall survival, the primary endpoint, was 25.2 months, and the median recurrence-free survival was 12.3 months. The overall rate of grade 3/4 events was 73.8%. One patient, who had a history of radiation therapy for past esophageal cancer, died from exacerbation via pneumonia. The overall resection rate was 73.8% (n = 45), and the R0 resection rate was 63.9% (n = 39). Overall, postoperative complications were found in 19 patients (42%) with 24 events, and nine patients (20%) with nine events ≥ grade IIIa, based on Dindo's classification. Conclusions: This protocol treatment is thought to be a feasible, safe, and promising treatment regimen, but we caution against its use in patients with a history of interstitial lung disease and/or prior pulmonary irradiation. The survival data from this study suggest the need for further investigations of GnP-NAT efficacy in patients with BRPC, as well as prospective evaluation of adverse events. Clinical Trial Registration: UMIN Clinical Trials Registry, UMIN000024154 and ClinicalTrials.gov, NCT02926183.

[Resection of Chest Wall Metastasis from Rectal Mucinous Carcinoma-A Case Report].

An 81-year-old woman with rectal mucinous carcinoma underwent a laparoscopic low anterior resection in February 2019, followed by chemotherapy using XELOX plus Bev. The adjuvant chemotherapy was discontinued due to interstitial pneumonia. During a follow-up consultation 2 years later, chest computed tomography(CT)imaging revealed a nodule in her right lung(S9). Based on a radiological diagnosis of metastasis and considering her history of rectal cancer, a partial resection of the right lung was executed. One year after the pulmonary resection, a growing nodule in her right lateral chest wall was detected. A metastatic chest wall tumor was suspected, and a right chest wall tumor resection at the 5th and 6th ribs was performed. A rectal mucinous carcinoma metastasis was diagnosed using histopathological examination. The postoperative course was good, and she was discharged from hospital on the 10th day. To conclude, there are few reported cases of rectal cancer chest wall metastasis, and a further accumulation of similar cases is necessary for the development of treatment options.

Synthesis of [1]Benzothieno[2,3-b][1]benzothiophenes from 3-Arylbenzo[b]thiophenes through Iodine-Mediated Sulfur Insertion Reaction.

The reaction of 3-arylbenzo[b]thiophenes and elemental sulfur to obtain [1]benzothieno[2,3-b][1]benzothiophenes (BTBTs) is reported. The addition of molecular iodine is essential for the reaction. In previous reactions that used 1,1-diarylethylenes as the starting material, side products that were difficult to separate were generated. The present reaction does not produce such side products and is therefore advantageous for obtaining BTBTs in high yield and purity.

Addition of docetaxel to S-1 results in significantly superior 5-year survival outcomes in Stage III gastric cancer: a final report of the JACCRO GC-07 study.

PURPOSE: A phase III trial comparing S-1 and docetaxel with S-1 alone as postoperative chemotherapy for pathologically Stage III gastric cancer was conducted and clarified the superiority of the doublet in terms of 3-year relapse-free survival as the primary endpoint (67.7% versus 57.4%, hazard ratio [HR] 0.715, 95% confidence interval [CI] 0.587-0.871; p = 0.0008). This final report analyzed 5-year survival outcomes along with the incidence and pattern of late recurrences. PATIENTS AND METHODS: Patients with histologically confirmed Stage III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were randomly assigned to receive adjuvant chemotherapy with either S-1 plus docetaxel or S-1 alone. The same 912 patients who were evaluated for 3-year survival outcomes in the previous report were analyzed. RESULTS: Five-year overall survival rate of the S-1 plus docetaxel group (67.91%) was significantly superior to that in the S-1 group (60.27%; HR 0.752, 95% CI 0.613-0.922; p = 0.0059). The incidence of late recurrence at > 3 years after randomization was similar in both groups (7.3% versus 7.2%). Peritoneal dissemination was the most common pattern of late recurrence. Addition of docetaxel significantly suppressed relapse through the lymphatic (6.8% [95% CI 4.52-9.17] versus 15% [95% CI 11.76-18.30]; p < 0.0001) and hematogenous (10.2% [95% CI 7.37-12.94] versus 15.7% [95% CI 12.36-19.01]; p < 0.0137) pathways throughout the 5 years of follow-up. CONCLUSION: The survival benefit of postoperative chemotherapy with S-1 and docetaxel in terms of 5-year overall survival rate was confirmed for patients with pathologically Stage III gastric cancer, although late recurrences were not prevented.

Clinical Possibility of Caenorhabditis elegans as a Novel Evaluation Tool for Esophageal Cancer Patients Receiving Chemotherapy: A Prospective Study.

BACKGROUND: The nematode Caenorhabditis elegans (C. elegans) possesses a sophisticated sense of smell and is used for a novel cancer screening test that utilizes the chemotaxis index. We designed a single-institution, prospective study to confirm the ability of Nematode Nose (N-NOSE) to determine preoperative chemotherapy's efficacy for esophageal cancer patients. PATIENTS AND METHODS: We investigated the predictability of N-NOSE screening for the clinical effects of preoperative chemotherapy for esophageal cancer patients receiving radical surgery. The index reduction score (IRS) was calculated via the chemotaxis of C. elegans at three points: before treatment, before surgery, and after surgery, and its clinical relevance was examined. RESULT: Thirty-nine patients with esophageal cancer were enrolled from August 2020 to December 2021, and 30 patients receiving radical surgery were examined. Complete response or partial response was achieved in 23 cases (76.7%). When the target of the treatment effect was complete response only, the prediction accuracies of the IRS calculated by area under the curve was 0.85 (95% Confidence interval: 0.62-1) in clinically achieving complete response group, and the sensitivity and specificity were 1 and 0.63, respectively. CONCLUSION: Index reduction score using N-NOSE screening may reflect the efficacy of chemotherapy for esophageal cancer patients. A large-scale prospective study at multiple centers is desired in the future.

Neutralizing activity of intravenous immune globulin products against enterovirus D68 strains isolated in Japan.

BACKGROUND: Enterovirus D68 (EV-D68), belonging to Enterovirus D, is a unique human enterovirus mainly associated with common respiratory diseases. However, EV-D68 can cause severe respiratory diseases, and EV-D68 endemic is epidemiologically linked to current global epidemic of acute flaccid myelitis. METHODS: In this study, we measured neutralizing antibody titers against six clinical EV-D68 isolates in nine intravenous immune globulin (IVIG) products commercially available in Japan to assess their potential as therapeutic options for severe EV-D68 infection. RESULTS: Seven IVIG products manufactured from Japanese donors contained high neutralizing antibody titers (IC50 = 0.22-85.01 µg/mL) against all six EV-D68 strains. Apparent differences in neutralizing titers among the six EV-D68 strains were observed for all IVIG products derived from Japanese and non-Japanese blood donors. CONCLUSIONS: High levels of EV-D68-neutralizing antibodies in IVIG products manufactured from Japanese donors suggest that anti-EV-D68 antibodies are maintained in the Japanese donor population similarly as found in foreign blood donors. Apparent differences in neutralizing antibody titers against the six EV-D68 strains suggest distinct antigenicity among the strains used in this study regardless of the genetic similarity of EV-D68.

The potential effect of ethyl alcohol elution from liner type denture adhesives on breath alcohol concentration and determination of drunk driving.

Background/purpose: The application of liner type denture adhesives containing ethyl alcohol (EtOH) may result in the person being considered a drunk driver, which is a social problem. This study measured the amount of EtOH loss from the materials and its effect on breath alcohol concentration (BrAC). Materials and methods: The amount of EtOH loss of three liner type denture adhesives was measured using a gas chromatograph-mass spectrometer. Five specimens were measured for each material. The BrAC of ten participants who wore the palatal plate lined with the material having the highest amount of EtOH elution was also determined using an alcohol detector every 5 min for 60 min. The threshold for drunk driving was a BrAC of 0.15 mg/L or more. Results: Significant differences were found in the amount of EtOH elution among the three materials. For all materials, the elution amount from the start of immersion to 30 min was significantly larger than that of the following 30 min (P < 0.05). BrAC values of the participants reached their maxima 5 min after insertion of the materials, and 80% of participants surpassed the threshold for drunk driving. However, no participants reached the threshold for drunk driving after 50 min. Conclusion: The results suggest that a determination of drunk drinking will not be made when 1 h or more has passed after insertion of a denture lined with a liner type denture adhesive into the mouth, though a determination of drunk driving may exist due to EtOH from the materials.

[Three Cases of Appendiceal Goblet Cell Adenocarcinoma in Our Institution].

Appendiceal goblet cell adenocarcinoma(AGCA)is a newly designated pathological term adopted in the 5th edition of the WHO classification. It is synonymous with goblet cell carcinoid, which was previously categorized as a part of appendiceal carcinoid. However, since 2018, it has been classified as a subtype of adenocarcinoma. We have experienced 3 cases of this relatively rare tumor, of which 2 were initially diagnosed with acute appendicitis and were diagnosed with AGCA by pathological examination after an emergency appendectomy. Each of them underwent additional ileocolic resection with lymph node dissection as the second surgery. In the 3rd case, an appendiceal tumor was detected during preoperative examinations for an ovarian tumor. Staging laparoscopy revealed comorbid peritoneal dissemination, and only the appendix and right ovary were removed in the consecutive surgery. The ovarian tumor was pathologically diagnosed as a metastasis of AGCA. In this case, the introduction of oxaliplatin-based systemic chemotherapy after surgery achieved a complete response after more than 2 years. Although no recurrence has been observed in all 3 cases to date, AGCA is considered highly malignant compared to conventional appendiceal carcinoids. Therefore, it is crucial to practice multidisciplinary treatments, including sufficient radical surgery based on a precise diagnosis of AGCA, as is performed for advanced colorectal cancer.

Effect of Four Main Gastrectomy Procedures for Proximal Gastric Cancer on Patient Quality of Life: A Nationwide Multi-Institutional Study.

PURPOSE: This study aimed to examine the effects of 4 main types of gastrectomy for proximal gastric cancer on postoperative symptoms, living status, and quality of life (QOL) using the Postgastrectomy Syndrome Assessment Scale-45 (PGSAS-45). MATERIALS AND METHODS: We surveyed 1,685 patients with upper one-third gastric cancer who underwent total gastrectomy (TG; n=1,020), proximal gastrectomy (PG; n=518), TG with jejunal pouch reconstruction (TGJP; n=93), or small remnant distal gastrectomy (SRDG; n=54). The 19 main outcome measures (MOMs) of the PGSAS-45 were compared using the analysis of means (ANOM), and the general QOL score was calculated for each gastrectomy type. RESULTS: Patients who underwent TG experienced the lowest postoperative QOL. ANOM showed that 10 MOMs were worse in patients with TG. Four MOMs improved in patients with PG, while 1 worsened. One MOM was improved in patients with TGJP versus 8 MOMs in patients with SRDG. The general QOL scores were as follows: SRDG (+39 points), TGJP (+6 points), PG (+3 points), and TG (-1 point). CONCLUSIONS: The TG group experienced the greatest decline in postoperative QOL. SRDG and PG, which preserve part of the stomach without compromising curability, and TGJP, which is used when TG is required, enhance the postoperative QOL of patients with proximal gastric cancer. When selecting the optimal gastrectomy method, it is essential to understand the characteristics of each and actively incorporate guidance to improve postoperative QOL.

Effects of the COVID-19 pandemic on gastroenterological surgeries in 2020: A study using the National Clinical Database of Japan.

Aim: This study aimed to investigate the effect of the coronavirus disease pandemic on the number of surgeries for gastroenterological cancer cases in Japan. Methods: The data recorded in the National Clinical Database of Japan between 2018 and 2020 were utilized for this study. Five specific surgeries for primary cancers and surgery for acute diffuse peritonitis were considered the primary endpoints. We divided the study period into the prepandemic and postpandemic (after April 2020) periods and examined the number of surgeries in relation to clinical factors. Results: Overall, 228 860 surgeries were analyzed. Among the five primary cancer surgeries, the number of distal gastrectomies for gastric cancer decreased the most (to 81.0% of the monthly number in the prepandemic period), followed by that of low anterior resections for rectal cancer (91.4%). In contrast, the number of pancreaticoduodenectomies for pancreatic cancer increased by 7.1%, while that of surgeries for peritonitis remained stable. This trend was observed nationwide. We also noted a marked reduction in the number of distal gastrectomy (to 72.5%), low anterior resection (84.0%), and esophagectomy (88.8%) procedures for T1 tumors. The noncurative resection rate and mortalities were low despite the increased proportion of T4 tumors and older patients. Conclusion: A marked reduction in surgeries for gastric and rectal cancers with early T factors may reflect prioritization of surgeries and reduction in cancer screenings. Although the quality of the surgery was maintained in terms of reduced mortalities and morbidities, the long-term effects of this pandemic should be monitored.

Five-Year Survival Outcomes of Laparoscopy-Assisted vs Open Distal Gastrectomy for Advanced Gastric Cancer: The JLSSG0901 Randomized Clinical Trial.

Importance: Evidence of implementation of laparoscopic gastrectomy for locally advanced gastric cancer is currently insufficient, as the primary end point in previous prospective studies was evaluated at a median follow-up time of 3 years. More robust evidence is necessary to verify noninferiority of laparoscopic gastrectomy. Objective: To compare 5-year survival outcomes between laparoscopy-assisted distal gastrectomy (LADG) and open distal gastrectomy (ODG) with D2 lymph node dissection for locally advanced gastric cancer. Design, Setting, and Participants: This was a multicenter, open-label, noninferiority, prospective randomized clinical trial. Between November 26, 2009, and July 29, 2016, eligible patients with histologically proven gastric carcinoma from 37 institutes in Japan were enrolled. Two interim analyses and final analysis were performed in October 2014, May 2018, and November 2021, respectively. Interventions: Patients were randomly assigned (1:1) to either the ODG or LADG group. The procedures were performed exclusively by qualified surgeons. Main Outcomes and Measures: The primary end point was 5-year relapse-free survival, and the noninferiority margin for the hazard ratio (HR) was set at 1.31. The secondary end points were 5-year overall survival and safety. Results: A total of 502 patients were included in the full-analysis set: 254 (50.6%) in the ODG group and 248 (49.4%) in the LADG group. Patients in the ODG group had a median (IQR) age of 67 (33-80) years and included 168 males (66.1%). Patients in the LADG group had a median (IQR) age of 64 (34-80) years and included 169 males (68.1%). No significant differences were observed in severe postoperative complications between the 2 groups in the safety analysis (ODG, 4.7% [11 of 233] vs LADG, 3.5% [8 of 227]; P = .64). The median (IQR) follow-up for all patients after randomization was 67.9 (60.3-92.0) months. The 5-year relapse-free survival was 73.9% (95% CI, 68.7%-79.5%) and 75.7% (95% CI, 70.5%-81.2%) for the ODG and LADG groups, respectively, and the HR was 0.96 (90% CI, 0.72-1.26; noninferiority 1-sided P = .03). Further, no significant difference was observed in overall survival time between the 2 groups, and the HR was 0.83 (95% CI, 0.57-1.21; P = .34). The pattern of recurrence was similar between the 2 groups. Conclusions and Relevance: Results of this study show that on the basis of 5-year follow-up data, LADG with D2 lymph node dissection for locally advanced gastric cancer, when performed by qualified surgeons, was proved noninferior to ODG. This laparoscopic approach could become a standard treatment for locally advanced gastric cancer. Trial Registration: UMIN Clinical Trial Registry: UMIN000003420.