Evaluation of the advantage of surgeons certified by the endoscopic surgical skill qualification system participating in laparoscopic low anterior rectal resection.

Background: A technical qualification system was developed in 2004 by the Japan Society for Endoscopic Surgery. An analysis of the EnSSURE study on 3188 stage II-III rectal cancer patients, which was performed by including the participation of qualified surgeons as assistants and advisers without restricting their participation as operators, revealed that the participation of technically qualified surgeons in surgery improved the technical and oncological safety of laparoscopic rectal resection. Aim: This secondary retrospective analysis of the EnSSURE study examined the advantage of qualified surgeons participating in laparoscopic low anterior resection (LAR). Methods: The outcomes of low anterior resection were compared between groups with and without the participation of surgeons qualified by the Endoscopic Surgical Skill Qualification System (Q and non-Q groups, respectively). We used propensity score matching to generate paired cohorts at a one-to-one ratio. The postoperative complication rate, short-term results (hemorrhage volume, operative time, number of dissected lymph nodes, open conversion rate, intraoperative complication rate, and R0 resection rate), and long-term results (disease-free survival rate, local recurrence rate, and overall survival rate) were evaluated. Results: The frequencies of postoperative complications, anastomotic bleeding, and intraperitoneal abscess were significantly lower, the operative time was significantly shorter, the postoperative hospital stay was significantly shorter, and the number of dissected lymph nodes was higher in the Q group. No significant differences were observed in disease-free survival, local recurrence, or overall survival rate rates between the groups. Conclusion: The participation of qualified surgeons in LAR is technically advantageous.

Investigation of the impact of COVID-19 on postoperative outcomes using a nationwide Japanese database of patients undergoing laparoscopic distal gastrectomy and low anterior resection for gastric cancer and rectal cancer.

Background: The COVID-19 outbreak made conventional medical care impossible, forcing changes in both healthcare providers and patients. In Japan, COVID-19 infection began spreading in earnest in 2020 and exploded in 2021. There was concern that the medical impact of COVID-19 in 2021 would differ from that in 2020. We aimed to clarify the impact of COVID-19 on mortality and anastomotic leakage in laparoscopic surgery for gastric cancer and rectal cancer in Japan using the National Clinical Database (NCD). Methods: We collected data from patients who underwent laparoscopic distal gastrectomy (LDG) and laparoscopic low anterior resection (LLAR) from January 2018 to December 2021 from the NCD, a web-based surgical registration system in Japan. The number of surgical cases, monthly incidence of mortality and morbidity (anastomotic leakage), standardized mortality ratio (SMR), and standardized morbidity-leakage ratio (SMLR [ratio of observed patients to expected patients calculated using the risk calculator established in the NCD]) were evaluated. Results: The numbers of LDG and LLAR cases continued to decline in the first year of the pandemic in 2020 and were as low in 2021 as in 2020. Although the numbers of robot-assisted LDG and LLAR cases increased, the growth rate was lower than the rate of increase prior to the pandemic. Mortality and anastomotic leakage, two of the most important complications, as assessed by SMR and SMLR, did not worsen during the pandemic in comparison to the pre-pandemic period. Conclusions: Laparoscopic surgeries were performed safely in Japan and were not affected by the COVID-19 pandemic.

Endoscopic treatment of anastomotic leakage after colorectal surgery by using polyglycolic acid sheets and fibrin glue.

We describe the case of a 66-year-old man with an anastomotic fistula after rectal surgery, which was treated colonoscopically using polyglycolic acid sheets and fibrin glue. Polyglycolic acid sheets and fibrin glue have been used in thoracic surgery and otolaryngology to reinforce sutures and prevent air leakage. There have been recent reports of their use in endoscopic surgery for the closure of intraoperative perforations after endoscopic submucosal dissection and for fistula closure after upper gastrointestinal tract surgery. However, anastomotic fistulas in colorectal surgery are difficult to visualize endoscopically and may be difficult to suture with clips due to fibrosis. Polyglycolic acid sheets can be easily trimmed, and the fistula can be easily filled using these sheets; moreover, using fibrin glue to fix the sheets may enable fistula closure in areas that are difficult to visualize endoscopically.

Long-term survival and functional outcomes of laparoscopic surgery for clinical stage I ultra-low rectal cancers located within 5 cm of the anal verge: A prospective phase II trial (Ultimate trial).

OBJECTIVE: To clarify the long-term oncological outcomes and postoperative anal, urinary, and sexual functions after laparoscopic surgery for clinical stage I very low rectal carcinoma located near the anal canal. SUMMARY BACKGROUND DATA: Laparoscopic surgery is widely applied for rectal cancer; however, concerns remain, with some studies showing poorer outcomes compared to open surgery. METHODS: This single-arm, phase II trial included patients registered preoperatively from 47 institutions in Japan. The planned sample size was 300. The primary endpoint was the 3-year local recurrence rate. Anal, urinary, and sexual functions were evaluated using a prospective questionnaire. RESULTS: Three-hundred patients were registered between January 2014 and March 2017. Anus-preserving surgery was performed in 278 (93%), including 172 who underwent intersphincteric resection (58%) and 106 (36%) who underwent low anterior resection. The 3-year cumulative local recurrence rate was 6.3%. At 3 years postoperatively, 87% of patients used their own anus, and the median incontinence score improved from 12 at 3 months to 8 at 3 years. Only 5% of patients had severe incontinence (incontinence score of 16 points). Postoperative urinary function evaluation showed that International Prostate Symptom Score and Overactive Bladder Symptom Score decreased 1 week after surgery, but recovered to preoperative level 1 month after surgery. International Consultation on Incontinence Questionnaire-Sort Form remained almost stable after surgery. Sexual function evaluation using the International Index of Erectile Function-5 and International Index of Erectile Function-15 revealed that the patients had deteriorated 3 months after surgery but had recovered only slightly by 6 months. CONCLUSIONS: Laparoscopic surgery achieves feasible long-term oncological outcomes and a high rate of anus preservation with moderate anal function, and an acceptable incontinence score. While urinary function recovered rapidly, sexual function showed poor recovery.

Takotsubo cardiomyopathy in Guillain-Barré syndrome.

BACKGROUND AND PURPOSE: Takotsubo cardiomyopathy (TCM) is a serious autonomic complication of Guillain-Barré syndrome (GBS). However, the association between TCM and GBS has not been investigated in detail. We investigated the characteristics of GBS patients with TCM (GBS-TCM). METHODS: Clinical features and anti-ganglioside antibody between the GBS-TCM patients and 62 classical GBS patients without TCM as control patients were compared. RESULTS: Eight GBS-TCM patients were identified, in whom TCM was diagnosed at a mean of 6.5 [range 3-42] days after the onset of GBS. The age at onset of GBS was elder in the GBS-TCM patients than in the control GBS patients (76.5 [56-87] vs. 52 [20-88] years, p < 0.01). Notably, cranial nerve deficits, particularly in the lower cranial nerves, were observed in all GBS-TCM patients (100% vs. 41.9%, p < 0.01). Additionally, the GBS-TCM patients showed a higher GBS disability score at nadir (5 [4-5] vs. 4 [1-5], p < 0.01), and lower Medical Research Council sum scores at admission and nadir (37 [30-44] vs. 48 [12-60] at admission, p < 0.05, and 20 [12-44] vs. 40 [0-60] at nadir, p < 0.05, respectively). Mechanical ventilation was more frequently required in the GBS-TCM patients (62.5% vs. 11.3%, p < 0.01). Three GBS-TCM patients were positive for anti-ganglioside antibodies. CONCLUSIONS: TCM occurred at a relatively early phase of GBS. The characteristics of GBS-TCM were the elder, lower cranial nerve involvements, severe limb weakness, and respiratory failure.

Clinicopathological features and prognosis of primary small bowel adenocarcinoma: a large multicenter analysis of the JSCCR database in Japan.

BACKGROUND: The clinicopathological features and prognosis of primary small bowel adenocarcinoma (PSBA), excluding duodenal cancer, remain undetermined due to its rarity in Japan. METHODS: We analyzed 354 patients with 358 PSBAs, between January 2008 and December 2017, at 44 institutions affiliated with the Japanese Society for Cancer of the Colon and Rectum. RESULTS: The median age was 67 years (218 males, 61.6%). The average tumor size was 49.9 (7-100) mm. PSBA sites consisted of jejunum (66.2%) and ileum (30.4%). A total of 219 patients (61.9%) underwent diagnostic small bowel endoscopy, including single-balloon endoscopy, double-balloon endoscopy, and capsule endoscopy before treatment. Nineteen patients (5.4%) had Lynch syndrome, and 272 patients (76.8%) had symptoms at the initial diagnosis. The rates for stages 0, I, II, III, and IV were 5.4%, 2.5%, 27.1%, 26.0%, and 35.6%, respectively. The 5-year overall survival rates at each stage were 92.3%, 60.0%, 75.9%, 61.4%, and 25.5%, respectively, and the 5-year disease-specific survival (DSS) rates were 100%, 75.0%, 84.1%, 59.3%, and 25.6%, respectively. Patients with the PSBA located in the jejunum, with symptoms at the initial diagnosis or advanced clinical stage had a worse prognosis. However, multivariate analysis using Cox-hazard model revealed that clinical stage was the only significant predictor of DSS for patients with PSBA. CONCLUSIONS: Of the patients with PSBA, 76.8% had symptoms at the initial diagnosis, which were often detected at an advanced stage. Detection during the early stages of PSBA is important to ensure a good prognosis.

Outcomes of Metastatic and Unresectable Small Bowel Adenocarcinoma in Japan According to the Treatment Strategy: A Nationwide Observational Study.

PURPOSE: Limited information is available regarding the characteristics and outcomes of stage IV small bowel adenocarcinoma (SBA) in Japan. This study examined the clinical and pathological characteristics and outcomes according to the treatment strategies in patients with stage IV SBA. METHODS: This retrospective observational study used the data of patients with jejunal or ileal adenocarcinoma collected by the Small Bowel Malignant Tumor Project of the Japanese Society for Cancer of the Colon and Rectum. Descriptive statistics were expressed as the mean (standard deviation) or median (range). Survival analysis was performed using Kaplan-Meier curves and pairwise log-rank tests. RESULTS: Data from 128 patients were analyzed. The treatment strategies were chemotherapy alone (26 of 128, 20.3%), surgery alone (including palliative surgery; 21 of 128, 16.4%), surgery + chemotherapy (74 of 128, 57.8%), and best supportive care (7 of 128, 5.5%). The median (range) overall survival was 16 (0-125) months overall, and 11 (1-38) months, 8 (0-80) months, 18 (0-125) months, and 0 (0-1) months for the chemotherapy, surgery, surgery + chemotherapy, and best supportive care groups, respectively. Three main categories of chemotherapeutic regimen were used: a combination of fluoropyrimidine and oxaliplatin (F + Ox), fluoropyrimidine and irinotecan (F + Iri), and single-agent fluoropyrimidine. Among patients treated with chemotherapy, the median (range) OS was 16 (1-106) months overall, and 17 (1-87) months, 29 (7-39) months, and 16 (1-106) months in patients treated with fluoropyrimidine, F + Iri, and F + Ox, respectively. CONCLUSION: Patients treated with surgery, chemotherapy, or both had a better prognosis than those who received best supportive care. Among patients who received chemotherapy, survival did not differ according to the chemotherapeutic regimen.

Effect of Remifentanil on the Tpeak-Tend Interval During Electroconvulsive Therapy.

INTRODUCTION: QT interval dispersion, which reflects the regional heterogeneity of ventricular repolarization, increases during electroconvulsive therapy (ECT). Tpeak-Tend (TpTe) is considered a new marker of the transmural dispersion of ventricular repolarization (TDR). This study aimed to evaluate the effect of remifentanil on TpTe during ECT. METHODS: Forty-two patients who were scheduled to undergo ECT with American Society of Anesthesiologists physical status I or II randomly received 0.1 µg/kg remifentanil (group R: n = 21) or saline (group C: n = 21). After the induction of general anesthesia, we measured the TpTe, TpTe/QT, TpTe/QTc, TpTe/RR, TpTe/√RR and TpTe/3√RR every minute during ECT (QT: QT interval, QTc: corrected QT interval, RR: RR interval). Statistical analysis was performed using two-way analysis of variance (ANOVA). RESULTS: Immediately (T0) and 1 min (T1) after electrical stimulation, the RRs (group C: T0; 654.2 ± 145.9 ms, T1; 657.3 ± 114.8 ms, group R: T0; 849.6 ± 249.3 ms, T1; 885.4 ± 213.6 ms, p < 0.05) were significantly increased, while systolic (group C: T0; 177.1 ± 35 mmHg, group R: T0; 129 ± 27.2 mmHg, p < 0.05) and diastolic blood pressures (group C: T0; 107.1 ± 22.4 mmHg, T1; 101.3 ± 23.2 mmHg, group R: T0; 75.4 ± 19.3 mmHg, T1; 80.6 ± 18.3 mmHg, p < 0.05) were significantly decreased in group R compared to group C. The TpTe/RR was significantly lower at T1 in group R compared to group C (group C: 101.5 ± 28.2, group R: 76.8 ± 21.8, p < 0.05). However, there was no significant difference in TpTe, TpTe/QT, TpTe/QTc, TpTe/√RR or TpTe/3√RR between the two groups throughout the study. CONCLUSION: Pretreatment with remifentanil suppressed the increase of TpTe/RR after electrical stimulation. Our results imply that remifentanil may lead to a decrease in TDR during ECT. TRIAL REGISTRATION: This trial was registered with the University Hospital Medical Information Network (registration number: UMIN000051958).

Combined Efficacy of Systemically Acting Diclofenac Sodium Patch and Alpha-2-Delta Calcium Channel Ligand in Chronic Low Back Pain: Subanalysis of a Phase III Study.

INTRODUCTION: Chronic low back pain often comprises mixed pain types and involves multiple factors. Therefore, we hypothesized that the systemic transdermal formulation of diclofenac sodium (DF systemic patch), which is effective for nociceptive pain, and an α2δ Ca2+ channel ligand, which is effective for neuropathic pain, would have additive effects in the treatment of chronic low back pain. METHODS: From among participants in a randomized, double-blind, placebo-controlled study of DF systemic patch (75 or 150 mg) applied once daily for 2 weeks in patients with chronic low back pain, we performed a subpopulation analysis of those who were concomitantly treated with an α2δ Ca2+ channel ligand during the study period. The efficacy endpoint was pain intensity score on a visual analog scale (VAS). RESULTS: The difference (95% confidence interval) in the least square mean pain VAS score between patients in the 150-mg combination group, who were treated with 150-mg DF systemic patch and an α2δ Ca2+ channel ligand (n = 11), and those in the non-combination group, who were treated with placebo patch and α2δ Ca2+ channel ligand (n = 22), was - 15.09 mm (- 26.45, - 3.73). Because the upper limit of the 95% confidence interval was less than zero, this result indicates that the pain VAS score improved more in the 150-mg combination group than in the non-combination group (placebo group). CONCLUSIONS: The combination of the DF systemic patch and an α2δ Ca2+ channel ligand may be more effective than α2δ Ca2+ channel ligand monotherapy for controlling chronic low back pain. TRIAL REGISTRATION NUMBERS: JPRN-JapicCTI-205134 and jRCT2080225040.

Specialty-Certified Colorectal Surgeons Demonstrate Favorable Short-term Surgical Outcomes for Laparoscopic Low Anterior Resection: Assessment of a Japanese Nationwide Database.

BACKGROUND: There are few studies on the impact of a colorectal-specific technically certified surgeon on good surgical outcomes for laparoscopic low anterior resection in the real world. OBJECTIVE: To evaluate the short-term outcomes of laparoscopic low anterior resection with the participation of a certified colorectal surgeon. DESIGN: This was a retrospective cohort study using a Japanese nationwide database. SETTING: This study was conducted as a project for the Japan Society of Endoscopic Surgery and the Japanese Society of Gastroenterological Surgery. PATIENTS: This study included 41,741 patients listed in the National Clinical Database who underwent laparoscopic low anterior resection performed by certified, noncertified, and colorectal-specific certified surgeons, according to the Endoscopic Surgical Skill Qualification System, from 2016 to 2018. MAIN OUTCOME MEASURES: Operative mortality rate and anastomotic leak rate were the primary outcome measures. RESULTS: Overall 30-day mortality and operative mortality were 0.2% and 0.3%, respectively, without significant differences between all kinds of certified and noncertified surgeon groups. Overall anastomotic leak rate was 9.3%, with a significant difference between the 2 groups. Colorectal- and stomach-certified groups had lower 30-day mortality and operative mortality than the biliary-certified and noncertified groups. The anastomotic leak rate was the lowest in the colorectal-certified group. Based on a logistic regression analysis using the risk-adjusted model, operative mortality was significantly higher in the biliary-certified group than in the colorectal-certified group. Moreover, anastomotic leak rate was significantly lower in the colorectal-certified group than in the stomach-certified and noncertified groups. LIMITATIONS: This study was a retrospective study, and there was a possibility of different definitions of anastomotic leak due to the use of a nationwide database. CONCLUSIONS: The participation of a colorectal-specific certified surgeon may decrease the risk of operative mortality and anastomotic leak for laparoscopic low anterior resection. CIRUJANO COLORRECTAL ALTAMENTE CALIFICADO PROVOCA RESULTADOS QUIRRGICOS FAVORABLES A CORTO PLAZO PARA LA RESECCIN ANTERIOR BAJA LAPAROSCPICA EVALUACIN DE LA BASE DE DATOS NACIONAL JAPONESA: ANTECEDENTES:Hay pocos estudios sobre el impacto de un cirujano certificado técnicamente especializado en cáncer colorrectal con un buen resultado quirúrgico para la resección anterior baja laparoscópica en el mundo real.OBJETIVO:Evaluar los resultados a corto plazo de la resección anterior baja laparoscópica con la participación de un cirujano colorrectal certificado.DISEÑO:Este fue un estudio de cohorte retrospectivo que utilizó una base de datos nacional japonesa.AJUSTE:Este estudio se realizó como un proyecto para la Sociedad Japonesa de Cirugía Endoscópica y la Sociedad Japonesa de Cirugía Gastroenterológica.PACIENTES:este estudio incluyó a 41 741 pacientes incluidos en la base de datos clínica nacional que se sometieron a una resección anterior baja laparoscópica realizada por cirujanos certificados, no certificados y certificados específicamente colorrectales, según el Sistema de calificación de habilidades quirúrgicas endoscópicas de 2016 a 2018.PRINCIPALES MEDIDAS DE RESULTADO:La tasa de mortalidad operatoria y la tasa de fuga anastomótica fueron los resultados primarios.RESULTADOS:La mortalidad general a los 30 días y la mortalidad operatoria fueron del 0,2 % y el 0,3 %, respectivamente, sin diferencias significativas entre los grupos de todos los tipos de cirujanos certificados y no certificados. La tasa global de fuga anastomótica fue del 9,3 %, con una diferencia significativa entre los dos grupos. Los grupos con certificación colorrectal y estomacal tuvieron una mortalidad a los 30 días y una mortalidad operatoria más bajas que los grupos con certificación biliar y sin certificación. La tasa de fuga anastomótica fue la más baja en el grupo certificado colorrectal. Con base en un análisis de regresión logística utilizando el modelo ajustado por riesgo, la mortalidad operatoria fue significativamente más alta en el grupo con certificación biliar que en el grupo con certificación colorrectal. Además, la tasa de fuga anastomótica fue significativamente más baja en el grupo con certificación colorrectal que en los grupos con certificación estomacal y sin certificación.LIMITACIONES:Este estudio fue retrospectivo y existía la posibilidad de diferentes definiciones de fuga anastomótica debido al uso de una base de datos nacional.CONCLUSIONES:La participación de un cirujano certificado en video específico colorrectal puede disminuir el riesgo de mortalidad operatoria y fuga anastomótica para la resección anterior baja laparoscópica. (Traducción-Dr. Mauricio Santamaria ).

Early-onset Cervical Myelitis after COVID-19 Vaccination.

A 33-year-old woman developed paresthesia in her right thumb approximately 30 minutes after receiving the BNT162b2 (Pfizer-BioNTech) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. The paresthesia gradually spread to her right-side limbs and trunk, and cervical magnetic resonance imaging (MRI) revealed a localized lesion in the right dorsal column. After glucocorticoid therapy, her symptoms and MRI findings improved. Although disease developing less than 24 hours after vaccination is considered an unlikely cause of immuno-associated adverse events following vaccination, we discuss the possible mechanisms involved in early-onset central nervous system inflammation after vaccination in view of preexisting immunopathological susceptibility.

Appendiceal cancer showing a submucosal tumor-like morphology in the ascending colon on colonoscopy: a case report.

Few reports have described a submucosal tumor (SMT)-like colon tumor together with appendiceal cancer. Moreover, some appendiceal tumors may exhibit a cecal protuberance. Here, we report an uncommon case of appendiceal cancer with an SMT-like tumor, which was a protuberant lesion in the ascending colon. To our knowledge, this is the first report in Japan. Our case was a 50-year-old man with an ascending colon tumor presented at our hospital for further evaluation of this lesion. This was discovered as a cystic lesion near the ascending colon on colonoscopy. Our initial diagnosis was an ascending colon SMT-like tumor, and our treatment strategy was laparoscopic resection. The differential diagnosis was appendiceal cancer or mucocele. Postoperative pathological findings led to a diagnosis of adenocarcinoma of the appendix. The postoperative course was uneventful, and the patient was followed up with computed tomography and blood sampling on an outpatient basis.

Remimazolam Compared to Propofol for Total Intravenous Anesthesia with Remifentanil on the Recovery of Psychomotor Function: A Randomized Controlled Trial.

INTRODUCTION: This study aimed to compare remimazolam to propofol in psychomotor recovery after total intravenous anesthesia (TIVA) using the Trieger dot test. METHODS: Sixty-six patients who were scheduled to undergo endoscopic sinus surgery with American Society of Anesthesiologists (ASA) physical status I or II were randomly allocated to the remimazolam (group R) or propofol group (group P). In group R, all patients received flumazenil postoperatively. After discontinuation of anesthetic agents, the time to eye opening, response to verbal commands, extubation, and discharge from the operation room were measured. Psychomotor recovery was assessed using the Trieger dot test before induction and at 0, 30, 60, 90, 120, 150, and 180 min after anesthesia. RESULTS: The time to eye opening, response to verbal commands, extubation, and discharge from the operation room were significantly longer in group P compared to group R (group P: 9.8 ± 3.2 min, 11.5 ± 3.4 min, 12.7 ± 3.4 min, 18.1 ± 4.2 min; group R: 6.5 ± 2 min, 7.3 ± 2.6 min, 8.4 ± 2.9 min, 13.2 ± 3.2 min; respectively, p < 0.05). In the Trieger dot test, the number of dots missed was significantly increased in group R compared to group P at 30, 60, 90, and 120 min after discharge from the operation room (group R: 20.5 ± 9.3, 16 ± 8.8, 14.9 ± 11.1, 14.3 ± 10.8; group P: 14.6 ± 7.8, 10 ± 7.1, 8.7 ± 7.3, 7.3 ± 5.7; respectively, p < 0.05). The maximum distance of dots missed was significantly increased in group R compared to group P at 30 min after discharge from the operation room (group R: 3.9 ± 2.8; group P: 2.7 ± 1.6; p < 0.05). CONCLUSION: Our results suggest that remimazolam with flumazenil leads to rapid recovery following anesthesia; however, it may cause delayed psychomotor decline. CLINICAL TRIAL REGISTRATION: This trial is registered with the University Hospital Medical Information Network (registration number UMIN000044900).

The clinical impact of COVID-19 on endoscopic surgery in Japan: Analysis of data from the National Clinical Database.

Aim: This study aimed to evaluate the impact of the coronavirus disease (COVID-19) pandemic on elective endoscopic surgeries in Japan using the National Clinical Database. Methods: We retrospectively analyzed the clinicopathological factors and surgical outcomes of laparoscopic cholecystectomy (LC), laparoscopic distal gastrectomy (LDG), and laparoscopic low anterior resection (LLAR) and compared the monthly numbers of each procedure performed in 2020 with those in 2018 and 2019. The degree of infection in prefectures was classified into low and high groups. Results: In 2020, the number of LCs (except for acute cholecystitis) was 76 079 (93.0% of that in 2019), the number of LDGs was 14 271 (85.9% of that in 2019), and the number of LLARs was 19 570 (88.1% of that in 2019). Although the number of robot-assisted LDG and LLAR cases increased in 2020, the growth rate was mild compared with that in 2019. There was little difference in the number of cases in the degree of infection in the prefectures. The numbers of LC, LDG, and LLAR cases decreased from May to June and recovered gradually. In late 2020, the proportion of T4 and N2 cases of gastric cancer and the number of T4 cases of rectal cancer increased compared with those in 2019. There was little difference between the proportions of postoperative complications and mortality in the three procedures between 2019 and 2020. Conclusion: The number of endoscopic surgeries decreased in 2020 as a result of the COVID-19 pandemic. However, the procedures were performed safely in Japan.

Enhanced Clinical Utility of Molecular Budding Signature as a Recurrence Risk Determinant in Stage II and III Colon Cancer Patients.

BACKGROUND: A molecular budding signature (MBS), which consists of seven tumor budding-related genes, was recently presented as a prominent prognostic indicator in colon cancer (CC) using microarray data acquired from frozen specimens. This study aimed to confirm the predictive power of MBS for recurrence risk based on formalin-fixed, paraffin-embedded (FFPE) materials. METHODS: This research utilized the same microarray data from a prior multicenter study using FFPE whole tissue sections, which retrospectively reviewed 232 stage II CC patients without adjuvant chemotherapy and 302 stage III CC patients with adjuvant chemotherapy. All patients underwent upfront curative surgery without neoadjuvant therapy between 2009 and 2012. An MBS score was calculated using the mean of log2 [each signal] of seven genes (MSLN, SLC4A11, WNT11, SCEL, RUNX2, MGAT3, and FOXC1) as described before. RESULTS: The MBS-low group exhibited a better relapse-free survival (RFS) than the MBS-high group in stage II (P = 0.0077) and in stage III CC patients (P = 0.0003). Multivariate analyses revealed that the MBS score was an independent prognostic factor in both stage II (P = 0.0257) and stage III patients (P = 0.0022). Especially among T4, N2, or both (high-risk) stage III patients, the MBS-low group demonstrated markedly better RFS compared with the MBS-high group (P = 0.0013). CONCLUSIONS: This study confirmed the predictive power of the MBS for recurrence risk by employing FFPE materials in stage II/III CC patients.

Genome-Wide Association Study Identifies Genetic Polymorphisms Associated with Estimated Minimum Effective Concentration of Fentanyl in Patients Undergoing Laparoscopic-Assisted Colectomy.

Sensitivity to opioids varies widely among individuals. To identify potential candidate single-nucleotide polymorphisms (SNPs) that may significantly contribute to individual differences in the minimum effective concentration (MEC) of an opioid, fentanyl, we conducted a three-stage genome-wide association study (GWAS) using whole-genome genotyping arrays in 350 patients who underwent laparoscopic-assisted colectomy. To estimate the MEC of fentanyl, plasma and effect-site concentrations of fentanyl over the 24 h postoperative period were estimated with a pharmacokinetic simulation model based on initial bolus doses and subsequent patient-controlled analgesia doses of fentanyl. Plasma and effect-site MECs of fentanyl were indicated by fentanyl concentrations, estimated immediately before each patient-controlled analgesia dose. The GWAS revealed that an intergenic SNP, rs966775, that mapped to 5p13 had significant associations with the plasma MEC averaged over the 6 h postoperative period and the effect-site MEC averaged over the 12 h postoperative period. The minor G allele of rs966775 was associated with increases in these MECs of fentanyl. The nearest protein-coding gene around this SNP was DRD1, encoding the dopamine D1 receptor. In the gene-based analysis, the association was significant for the SERP2 gene in the dominant model. Our findings provide valuable information for personalized pain treatment after laparoscopic-assisted colectomy.

New Scale Predicting Distant Recurrence in Locally Advanced Lower Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy.

BACKGROUND/AIM: Neoadjuvant chemoradiotherapy (nCRT) for locally advanced lower rectal cancer (LALRC) is effective in preventing locoregional recurrence; however, it is less effective for preventing distant recurrence. This study aimed to evaluate a new scale for predicting distant recurrence before administering nCRT. PATIENTS AND METHODS: Sixty-three patients underwent nCRT for LALRC between 2009 and 2016 at the Tokyo Women's Medical University. Of these, 51 consecutive patients who underwent curative surgery were enrolled in this study. Patients with ≥cT3 status or cN-positive LALRC were classified into three groups before nCRT based on the neutrophil-to-lymphocyte ratio (NLR) and lymphocyte-to-monocyte ratio (LMR): high-risk, NLR ≥3.2 and LMR <5.0; intermediate-risk, NLR <3.2 and LMR ≥5.0 or NLR ≥3.2 and LMR <5.0; and low-risk, NLR <3.2 and LMR ≥5.0. Independent risk factors associated with distant relapse-free survival were analysed using the Cox proportional hazards model. Relapse-free survival from distant metastasis was evaluated using the log-rank test. RESULTS: Patient characteristics and tumour-associated factors were not significantly different between the groups. Distant recurrence in the high-, intermediate-, and low-risk groups was 61.5%, 42.9%, and 20.8% (p=0.046), respectively. In the multivariate analysis, the new scale was an independent risk factor for distant relapse-free survival (high-risk vs. low-risk groups, p=0.004 and intermediate-risk vs. low-risk groups, p=0.055). The 3-year distant relapse-free survival rate in the high-, intermediate-, and low-risk groups was 38.5%, 56.3%, and 81.7% (p=0.028), respectively. CONCLUSION: A new scale combining the pre-nCRT NLR and LMR was independently associated with distant relapse-free survival. The new scale for LALRC may aid selection for total neoadjuvant chemotherapy.

Skill-qualified surgeons positively affect short-term outcomes after laparoscopic gastrectomy for gastric cancer: a survey of the National Clinical Database of Japan.

BACKGROUND: Proficiency of the operating surgeon is one of the most critical factors potentially associated with reductions in complications and surgery-related mortality. With video-rating systems having shown potential for assessing laparoscopic surgeons' proficiency, the Endoscopic Surgical Skill Qualification System (ESSQS) was developed by the Japan Society for Endoscopic Surgery to subjectively assess the proficiency of laparoscopic surgeons by rating applicants' non-edited case videos. We conducted a study to evaluate how ESSQS skill-qualified (SQ) surgeon involvement influences short-term outcomes of laparoscopic gastrectomy performed for gastric cancer. METHODS: Data from the National Clinical Database regarding laparoscopic distal and total gastrectomy performed for gastric cancer between January 2016 and December 2018 were analyzed. Operative mortality, defined as 30-day mortality or 90-day in-hospital mortality, and anastomotic leakage rates were compared per involvement vs. non-involvement of an SQ surgeon. Outcomes were also compared per involvement of a gastrectomy-, colectomy-, or cholecystectomy-qualified surgeon. The association between the area of qualification and operative mortality/anastomotic leakage was also analyzed with a generalized estimating equation logistic regression model used to account for patient-level risk factors and institutional differences. RESULTS: Of 104,093 laparoscopic distal gastrectomies, 52,143 were suitable for inclusion in the study; 30,366 (58.2%) were performed by an SQ surgeon. Of 43,978 laparoscopic total gastrectomies, 10,326 were suitable for inclusion; 6501 (63.0%) were performed by an SQ surgeon. Gastrectomy-qualified surgeons outperformed non-SQ surgeons in terms of both operative mortality and anastomotic leakage. They also outperformed cholecystectomy- and colectomy-qualified surgeons in terms of operative mortality or anastomotic leakage in distal and total gastrectomy, respectively. CONCLUSION: The ESSQS appears to discriminate laparoscopic surgeons who can be expected to achieve significantly improved gastrectomy outcomes.

Systemically Acting Diclofenac Sodium Patch for Control of Low Back Pain: A Randomized, Double-Blind, Placebo-Controlled Study in Japan.

INTRODUCTION: Nonsteroidal antiinflammatory drugs (NSAIDs) are commonly used for pain disorders such as low back pain and exist in multiple formulations; however, no systemically acting transdermal formulations are available for low back pain. Transdermal formulations can be safely administered even to patients with trouble swallowing or at risk of aspiration, and without regard to the effect of food on drug absorption. Unlike locally acting formulations, systemically acting transdermal formulations need not be applied at the target site, so dosing is simple and the burden is not on one area of the skin. A patch with the systemically acting NSAID diclofenac sodium is approved in Japan for treatment of cancer-related pain, and we hypothesized that it would be useful for controlling low back pain. METHODS: This randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of diclofenac sodium patch in Japanese patients with low back pain. Eligible patients were randomized to receive diclofenac sodium patch 75 mg or 150 mg or placebo once daily for 2 weeks. The primary endpoint was pain intensity assessed on a visual analog scale (VAS). RESULTS: Primary analysis of the primary endpoint showed that both doses of the diclofenac sodium patch (150 mg and 75 mg) were superior to placebo in terms of absolute change from baseline in mean 3-day VAS score after 2 weeks' treatment; the mean difference between the active and placebo treatments in this variable was -5.67 [95% confidence interval (CI) -9.34 to -2.00] mm in the 150 mg group and -5.68 (95% CI -9.34 to -2.01) mm in the 75 mg group. Most adverse events were mild. No serious adverse events occurred. CONCLUSION: In Japanese patients, diclofenac sodium patch is effective for the relief of low back pain and is well tolerated. TRIAL REGISTRATION: JPRN number, JPRN-JapicCTI-205134.