Importance of duodenal stump reinforcement to prevent stump leakage after gastrectomy: a large-scale multicenter retrospective study (KSCC DELICATE study).

BACKGROUND: The significance of reinforcement of the duodenal stump with seromuscular sutures and the effectiveness of reinforced staplers in preventing duodenal stump leakage remain unclear. We aimed to explore the importance of duodenal stump reinforcement and determine the optimal reinforcement method for preventing duodenal stump leakage. METHODS: This retrospective cohort study was conducted between January 1, 2012 and December 31, 2021, with data analyzed between December 1, 2022 and September 30, 2023. This multicenter study across 57 institutes in Japan included 16,475 patients with gastric cancer who underwent radical gastrectomies. Elective open or minimally invasive (laparoscopic or robotic) gastrectomy was performed in patients with gastric cancer. RESULTS: Duodenal stump leakage occurred in 153 (0.93%) of 16,475 patients. The proportions of males, patients aged ≥ 75 years, and ≥ pN1 were higher in patients with duodenal stump leakage than in those without duodenal stump leakage. The incidence of duodenal stump leakage was significantly lower in the group treated with reinforcement by seromuscular sutures or using reinforced stapler than in the group without reinforcement (0.72% vs. 1.19%, p = 0.002). Duodenal stump leakage incidence was also significantly lower in high-volume institutions than in low-volume institutions (0.70% vs. 1.65%, p = 0.047). The rate of duodenal stump leakage-related mortality was 7.8% (12/153). In the multivariate analysis, preoperative asthma and duodenal invasion were identified as independent preoperative risk factors for duodenal stump leakage-related mortality. CONCLUSIONS: The duodenal stump should be reinforced to prevent duodenal stump leakage after radical gastrectomy in patients with gastric cancer.

Prognostic significance of a novel index score based on the inflammation-based prognostic scores of patients with colorectal cancer.

BACKGROUND AND AIM: This study aimed to clarify the prognostic value of various inflammation-based prognostic scores (IBPSs) in patients who underwent radical surgery for colorectal cancer (CRC) and to develop a novel prognostic index using IBPSs and other predictive factors. METHODS: Data of 1157 patients who underwent radical surgery for CRC were reviewed. The predictive value of various IBPSs in determining the CRC prognosis was compared. A novel index score based on the IBPSs and other parameters that were associated with survival in patients with CRC was established, and its usefulness was evaluated. RESULTS: The patients were randomly divided into the training (n = 694) and validation (n = 463) sets. Male sex (P = 0.0001), age ≥ 75 years (P < 0.0001), a carcinoembryonic antigen (CEA) level of > 5 (P = 0.0009), a C-reactive protein/albumin ratio (CAR) of ≥ 0.04 (P = 0.0033), and a prognostic nutritional index (PNI) of < 43.1 (P = 0.0004) were poor independent prognostic factors of overall survival. The novel index score was calculated based on the scores of these five prognostic factors. The Kaplan-Meier survival curves showed that the CRC patients with higher novel index scores in the training and validation datasets had poorer overall survival. CONCLUSIONS: CAR and PNI were superior to other IBPSs for predicting the prognosis of CRC patients. The novel index score established based on sex, age, CEA level, CAR, and PNI can predict the prognosis of CRC with more precise and clearer stratification than the individual parameters alone.

Prevention of Pemetrexed-Induced Rash Using Low-Dose Corticosteroids: A Phase II Study.

BACKGROUND: Rash eruptions are a common side-effect of pemetrexed, for which the administration of 8 mg/day of dexamethasone for 3 days from the day preceding pemetrexed administration is recommended. This study aimed to prospectively assess the effectiveness of prophylactic administration of low-dose dexamethasone for pemetrexed-induced rashes. METHODS: This single-arm, phase II study recruited patients with non-squamous non-small cell lung cancer and malignant pleural mesothelioma scheduled to receive chemotherapy including pemetrexed. Patients received 2 mg of dexamethasone daily from days 2 to 6 after chemotherapy with pemetrexed. The primary endpoint was the 3-week incidence of rash eruptions. RESULTS: Twenty-five patients were enrolled between September 2017 and May 2019. The incidence of rash after 3 weeks was 16.7%. Rashes erupted mainly on the upper half of the body, such as the chest and neck, and were of grades 1 and 2 in 2 patients each. No rashes of grade 3 or higher were observed, and there were no adverse events associated with additional corticosteroids. CONCLUSION: Prophylactic administration of low-dose dexamethasone for 5 days from the day after pemetrexed administration resulted in a milder incidence and severity of rash. These findings may provide a standard preventative strategy for pemetrexed-induced rashes. (Trial identifier: UMIN000025666).

Effects of Cardiac Massage and ß-Blocker Pretreatment on the Success Rate of Cardiopulmonary Resuscitation Assessed by the Canine Ischemia/Reperfusion-Induced Ventricular Fibrillation Model.

BACKGROUND: Effects of rapid electrical defibrillation and ß-blockade on coronary ischemia/reperfusion-induced ventricular fibrillation (VF) during cardiopulmonary resuscitation (CPR) remain unknown.Methods and Results:After induction of VF by 30 min of ischemia followed by reperfusion, animals were treated with defibrillation alone (Group A, n=13), 2 min of open-chest cardiac massage followed by defibrillation (Group B, n=11), or the same therapy to Group B with propranolol (1 mg/kg, i.v.) treatment before ischemia/reperfusion (Group C, n=11). If return of spontaneous circulation (ROSC) was not attained, each therapy was repeated ≤3 times (Set-1). When ROSC was not obtained within Set-1, cardiac massage was applied to all animals followed by defibrillation, which was repeated ≤3 times (Set-2). ROSC after Set-1 was 8% in Group A, 82% in Group B and 82% in Group C, whereas that after Set-2 was 62% in Group A, 100% in Group B and 82% in Group C. Each animal with ROSC in Groups A (n=8) and B (n=11) showed sinus rhythm, whereas those in Group C (n=9) had sinus rhythm (n=5), atrial fibrillation (n=1), accelerated idioventricular rhythm (n=2) and atrioventricular block (n=1). Post ROSC heart rate and mean arterial pressure were significantly lower in Group C. CONCLUSIONS: Cardiac massage increased the likelihood of ROSC vs. rapid defibrillation, but ß-blocker pretreatment may worsen hemodynamics and electrical stability after ROSC.

Cardiovascular risk factors are associated with augmented thrombogenicity in healthy individuals: analysis using the Total Thrombus-formation Analysis System.

BACKGROUND: Rupture of an atherosclerotic plaque and subsequent exposure of the subendothelial prothrombotic matrix to blood cause arterial thrombosis. Circulating platelets play an indispensable role in the growth of arterial thrombi partially owing to their unique ability to adhere to the subendothelial matrix and to aggregate to each other under flow conditions. Recently, the Total Thrombus-formation Analysis System (T-TAS) was developed for ex vivo analysis of the thrombogenic potential of whole blood samples under flow conditions. Despite the potential clinical utility of the T-TAS in assessing the risk for thrombosis and bleeding, reference intervals for T-TAS analysis in healthy individuals have not been determined. METHODS: In total, 122 whole blood samples were collected from healthy volunteers ranging in age from 25 to 45 years. T-TAS analysis and hematological, physiological, and lifestyle assessments were conducted in these subjects. Whole blood samples anticoagulated with hirudin were perfused into a collagen-coated microchip (PL chip). The time to 10 kPa and the area under the flow pressure curve up to 10 min (AUC10) were analyzed as representative variables for thrombogenic potential. Reference intervals, which were defined as 2.5-97.5 percentiles, were determined. Additionally, univariate and multivariate analyses were performed to identify factors associated with the AUC10 in the T-TAS. RESULTS: The time to 10 kPa and the AUC10 widely varied, even in healthy volunteers. The reference intervals were 1.50-4.02 min and 223.4-456.8, respectively, at a shear rate of 1500 s- 1. Univariate and multivariate analyses showed that platelet counts were most significantly associated with the AUC10 of the T-TAS. The presence of one or more cardiovascular risk factors of a high body mass index, a high pulse pressure, high fasting serum glucose levels, high low-density lipoprotein-cholesterol levels, a history of smoking, and no habitual exercise, had the second largest effect on the AUC10 of the T-TAS. CONCLUSIONS: Healthy volunteers who had any cardiovascular risk factors showed augmented thrombogenicity, even in artificial uniform capillaries, compared with those without any risk factors in the T-TAS.

The Effect of Prone Positioning as Postoperative Physiotherapy to Prevent Atelectasis After Hepatectomy.

BACKGROUND: The incidences of postoperative pulmonary complications (PPCs) such as atelectasis, pneumonia and pleural effusion after major surgery range from <1 to 23%. Atelectasis after abdominal surgery increases the duration of hospitalization and short-term mortality rate, but there are few reports about atelectasis after hepatectomy. The effectiveness of prone position drainage as physiotherapy has been reported, but it remains unclarified whether prone positioning prevents atelectasis after hepatectomy. This study aimed to evaluate the effect of the prone position on the incidence of atelectasis after hepatectomy. METHODS: We retrospectively analyzed the incidence of PPCs after hepatectomy at a single center. Patients were divided into two cohorts. The earlier cohort (n = 165) underwent hepatectomy between January 2016 and March 2018 and was analyzed to identify the risk factors for atelectasis and short-term outcomes; the later cohort (n = 51) underwent hepatectomy between April 2018 and March 2019 and underwent prone position drainage in addition to regular mobilization postoperatively. The incidences of PPCs were compared between the two cohorts. RESULTS: Independent risk factors for atelectasis were anesthetic duration (P = 0.016), operation time (P = 0.046) and open surgery (P = 0.011). The incidence of atelectasis was significantly lower in the later cohort (9.8%) than the earlier cohort (34.5%, P < 0.001). Moreover, the later cohort had a significantly shorter duration of oxygen support (P < 0.001) and postoperative hospitalization (P < 0.001). After propensity score-matching, the incidence of atelectasis remained significantly lower in the later cohort (P = 0.027). CONCLUSION: Prone position drainage may decrease the incidence of atelectasis after hepatectomy and improve the short-term outcomes.

Perioperative complications of abdominal surgery in smokers.

PURPOSE: This study examined the association between smoking and perioperative complications of laparoscopic abdominal surgery and whether these complications were reduced with ≥ 4 weeks of preoperative smoking cessation. METHODS: A total of 555 patients who underwent gastric and colorectal cancer surgeries under general anesthesia were divided into the following groups retrospectively: 290 individuals without smoking history (NS group), 144 previous smokers (stopped smoking more than 8 weeks before surgery, PS group), and 121 current smokers (CS group) divided to two groups according to preoperative smoking cessation for < 4 (CS1, n = 76) and 4-8 weeks (CS2, n = 45). RESULTS: When compared with the NS group, postoperative hospitalization duration was significantly longer in the CS1 group (p < 0.01), whereas differences between the CS2 or PS groups and NS group were not significant. The total number of postoperative complications was higher in all groups of smoking than in NS group, independent on preoperative smoking cessation; however, suture failure was significantly more frequent only in CS1 group. Although pack-years did not significantly affect complication rates in smokers, duration of smoking cessation time in PS group was a negative predictor of postoperative complications. CONCLUSION: Providing more than 4 weeks of smoking cessation before gastrointestinal surgery can reduce the duration of hospitalization and rate of suture failure.

Usability of Intraoperative Fluorescence Imaging with Indocyanine Green During Laparoscopic Cholecystectomy After Percutaneous Transhepatic Gallbladder Drainage.

BACKGROUND: Patients with persistent symptoms of acute cholecystitis for >72 h who cannot undergo urgent laparoscopic cholecystectomy (LC) often undergo percutaneous transhepatic gallbladder drainage (PTGBD) and delayed LC. However, intraoperative near-infrared fluorescence with indocyanine green (ICG) has recently become available in various surgical settings. Therefore, we evaluated the usability of intraoperative fluorescence imaging with ICG for LC after PTGBD in patients with acute cholecystitis. METHODS: The preoperative and postoperative clinical characteristics of patients who underwent LC after PTGBD were retrospectively analyzed. RESULTS: In total, 130 patients were reviewed. Intraoperative ICG fluorescence imaging was used in 39 (30.0%) patients, and none developed adverse reactions. Patients with ICG fluorescence imaging had a significantly shorter operative time (129 ± 46 vs. 150 ± 56 min, p = 0.0455), markedly lower conversion rate (2.6% vs. 22.0%, p = 0.0017), and lower proportion of subtotal cholecystectomy (0.0% vs. 6.6%, p = 0.0359) than patients without ICG fluorescence imaging. Independent risk factors for conversion to laparotomy during LC after PTGBD were the performance of PTGBD after 48 h from onset (OR 3.52; 95% CI 1.11-12.21; p = 0.0322), an unremoved PTGBD tube on LC (4.48, 1.46-15.00, p = 0.0084), and surgery without ICG (8.00, 1.28-159.47, p = 0.0231). CONCLUSION: Intraoperative ICG fluorescence imaging produced better surgical outcomes without any adverse reactions. Early performance of PTGBD and intraoperative ICG fluorescence imaging can reduce the surgical difficulties in LC after PTGBD for acute cholecystitis.

Factors Affecting the Absorption of Midazolam to the Extracorporeal Membrane Oxygenation Circuit.

Sedatives are administered during extracorporeal membrane oxygenation (ECMO) therapy to ensure patient safety, reduce the metabolic rate and correct the oxygen supply-demand balance. However, the concentrations of sedatives can be decreased due to absorption into the circuit. This study examined factors affecting the absorption of a commonly used sedative, midazolam (MDZ). Using multiple ex vivo simulation models, three factors that may influence MDZ levels in the ECMO circuit were examined: polyvinyl chloride (PVC) tubing in the circuit, use of a membrane oxygenator in the circuit, and heparin coating of the circuit. We also assessed changes in drug concentration when MDZ was re-injected in a circuit. The MDZ level decreased to approximately 60% of the initial concentration in simulated circuits within the first 30 minutes. The strongest factor in this phenomenon was contact with the PVC tubing. Membrane oxygenator use tended to increase MDZ loss, whereas heparin circuit coating had no influence on MDZ absorption. Similar results were obtained when a second dose of MDZ was injected to the second-use circuits.

Effects of moxifloxacin on the proarrhythmic surrogate markers in healthy Filipino subjects: Exposure-response modeling using ECG data of thorough QT/QTc study.

Effects of moxifloxacin on QTc as well as proarrhythmic surrogate markers including J-Tpeakc, Tpeak-Tend and short-term variability (STV) of repolarization were examined by using both standard E14 time-based evaluation and exposure-response modeling. The study was conducted with a single-blind, randomized, single-dose, placebo-controlled and two-period cross-over design in healthy Filipino subjects. QT interval was corrected by Fridericia's formula (QTcF). In the E14 time-based evaluation of ECG data, the largest ΔΔQTcF with 90% confidence interval was 14.1 ms (11.2-16.9) with Cmax of 3.39 µg/mL at 3 h post-dose (n = 69; male: 35, female: 34), indicating a positive effect on the QTcF. Moxifloxacin significantly increased the ΔΔJ-Tpeakc and ΔΔTpeak-Tend, whereas the ΔΔSTV was not altered. Meanwhile in the exposure-response modeling of the same ECG data, the slope of moxifloxacin plasma concentration-ΔΔQTcF relationship was 4.84 ms per µg/mL and the predicted ΔΔQTcF with 90% confidence interval was 13.8 ms (13.1-15.1) at Cmax, also indicating a positive effect on the QTcF. Importantly, results in each proarrhythmic surrogate marker obtained by the exposure-response modeling also showed high similarity to those obtained by the E14 statistical evaluation. Thus, these results of moxifloxacin may become a guide to estimate proarrhythmic potential of new chemical entities.

Watch-and-wait policy versus rituximab-combined chemotherapy in Japanese patients with intestinal follicular lymphoma.

BACKGROUND AND AIM: Few reports have demonstrated the effectiveness of treatments for intestinal follicular lymphoma (FL) because of the limited number of patients who undergo comprehensive small intestinal examinations. This study compared the efficacy of rituximab-combined chemotherapy in patients with asymptomatic and low tumor burden (LTB) intestinal FL, according to the criteria of the Groupe d'Etude des Lymphomes Folliculaires, with that of a "watch and wait" (W&W) approach. METHODS: The endoscopic examination for entire gastrointestinal tracts was performed in 29 Japanese patients with intestinal FL. These patients had CD21-positive follicular dendritic cells arranged in a duodenal pattern. In a prospective, two-center, open-label trial, this study evaluated the efficacy of rituximab-combined chemotherapy ([cyclophosphamide, doxorubicin, vincristine, and prednisone] or [cyclophosphamide, vincristine, and prednisone]) and prolonged treatment with rituximab (R-Chemo+prolongedR) in 14 patients and compared their outcomes with those of 15 patients managed with a W&W approach. RESULTS: Four patients managed with the W&W plan showed worsening macroscopic findings, lesion area enlargement, or clinical stage progression but stayed on this plan because they had LTB and experienced no changes in bowel function. In the R-Chemo+prolongedR group, all patients achieved complete remission; recurrence occurred in one patient, who was subsequently managed with the W&W plan because of LTB. There were no significant differences in progression-free survival between the two groups (P = 0.1045). Overall survival was 100% in both groups. CONCLUSIONS: The prognoses of patients with asymptomatic intestinal FL and LTB who were managed with a W&W strategy were comparable with those of patients receiving R-Chemo+prolongedR.

Evaluation of the Benefits of De-Escalation for Patients with Sepsis in the Emergency Intensive Care Unit.

PURPOSE: Although the 2016 Japanese guidelines for the management of sepsis recommend de-escalation of treatment after identification of the causative pathogen, adherence to this practice remain unknown. The objective of this study was to evaluate the benefits of de-escalating treatment for sepsis patients at an advanced critical care and emergency medical centre. METHODS: Based on electronic patient information, 85 patients who were transported to the centre by ambulance, and diagnosed with sepsis between January 2008 and September 2013 were enrolled and evaluated. Patients were divided into two groups with and without de-escalation, and comparisons were conducted for several variables, including length of hospital stay, and length of antibiotic administration. Two types of subgroup analysis were conducted between patients with septic shock or positive blood cultures. Statistical analysis was conducted using chi-square and Mann-Whitney U tests. RESULTS: The length of hospital stay after diagnosis was significantly shorter for the de-escalation group than for the non-de-escalation group. In the subgroup analysis, de-escalation for blood culture-positive patients was beneficial in terms of the length of hospital stay and length of antibiotic administration. CONCLUSIONS: The findings of this study suggest that sepsis treatment de-escalation is beneficial for treatment efficacy and appropriate use of antibiotics. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.

Assessment of potential risk factors for new onset disabling low back pain in Japanese workers: findings from the CUPID (cultural and psychosocial influences on disability) study.

BACKGROUND: Most studies of risk factors for new low back pain (LBP) have been conducted in Western populations, but because of cultural and environmental differences, the impact of causal factors may not be the same in other countries. We used longitudinal data from the Cultural and Psychosocial Influences on Disability (CUPID) study to assess risk factors for new onset of disabling LBP among Japanese workers. METHODS: Data came from a 1-year prospective follow-up of nurses, office workers, sales/marketing personnel, and transportation workers, initially aged 20-59 years, who were employed in or near Tokyo. A baseline questionnaire included items on past history of LBP, personal characteristics, ergonomic work demands, and work-related psychosocial factors. Further information about LBP was collected at follow-up. Analysis was restricted to participants who had been free from LBP during the 12 months before baseline. Logistic regression was used to assess baseline risk factors for new onset of disabling LBP (i.e. LBP that had interfered with work) during the 12 months of follow-up. RESULTS: Among 955 participants free from LBP during the 12 months before baseline, 58 (6.1%) reported a new episode of disabling LBP during the 12-month follow-up period. After mutual adjustment in a multivariate logistic regression analysis, which included the four factors that showed associations individually (p < 0.1) in analyses adjusted only for gender and age, the highest odds ratio (OR) was for past history of LBP (2.8, 95% [confidence interval {CI}]: 1.6-4.9), followed by working ≥60 h per week (1.8, 95% CI: 1.0-3.5) and lifting weights ≥25 kg by hand (1.6, 95% CI: 0.9-3.0). When past history of LBP was excluded from the model, ORs for the remaining risk factors were virtually unchanged. CONCLUSIONS: Our findings suggest that among Japanese workers, as elsewhere, past history of LBP is a major risk factor for the development of new episodes of disabling back pain. They give limited support to the association with occupational lifting that has been observed in earlier research, both in Japan and in Western countries. In addition, they suggest a possible role of long working hours, which merits further investigation.

The role of "watch and wait" in intestinal follicular lymphoma in rituximab era.

OBJECTIVE: There is no consensus regarding the best treatment for intestinal follicular lymphoma (FL). We used "watch and wait" for patients with intestinal FL with low-tumor-burden (LTB) criteria and without mass formation causing bowel obstruction. We investigated the overall survival (OS) and time to treatment required (TTR). METHODS: Thirty-three intestinal FL patients [clinical stage (CS) I:16, II1:0, II2:7, IV:10; median observation period: 45.5 months, range: 13-110 months] were diagnosed via endoscopy. Detailed clinical and pathological examinations were performed, and neoplastic process behavior was monitored. RESULTS: All of the 33 patients were WHO grade 1. FL lesions in the digestive tract were found frequently in the second-fourth portion of the duodenum in 91% of the patients; 87% of those patients had lesions in a broader area including the small intestine. Two patients had an enlargement of the area of the lesions and a worsening of the macroscopic findings. Three patients had CS progression; however, these remained within the indication for "watch and wait." Two patients with transformation into diffuse large B-cell lymphoma received rituximab and chemotherapy, which led to complete remission. The OS was 100%. The time to treatment required (TTR) was 49 months in one patient and 37 months in one patient. CONCLUSION: Intestinal FL in CS I-IV with broad infiltration of the digestive tract meeting the criteria for LTB had a remarkably slow course. This study suggests that "watch and wait" is appropriate for the treatment of LTB intestinal FL even in the era of rituximab.

Clinical Significance of SIP1 and E-cadherin in Patients with Esophageal Squamous Cell Carcinoma.

BACKGROUND: Epithelial-mesenchymal transition (EMT), when epithelial cells convert to mesenchymal cells, influences cancer invasion and metastasis. Smad interacting protein 1 (SIP1) is an EMT trigger, which is inversely correlated with E-cadherin in some carcinomas. To elucidate the role of SIP1 in esophageal squamous cell carcinoma (ESCC), the status of EMT and the clinicopathological features were evaluated. METHODS: Immunohistochemical (IHC) analyses of 111 human ESCC tissue specimens for SIP1 and E-cadherin were performed, and the relationships between the expression and clinicopathological features were evaluated. RESULTS: IHC analyses of esophageal tumors showed the expression of SIP1 and E-cadherin to be significantly inversely correlated. Significant correlations between the SIP1 expression and clinicopathological variables such as differentiation, depth of invasion, vascular invasion, and pathological stage were also seen. Conversely, tumors with a weak expression of E-cadherin tended to exhibit greater histological differentiation. Logistic regression analyses revealed a positive SIP1 expression, lymphatic invasion, and vascular invasion to be factors predicting lymph node (LN) metastasis. Univariate survival analyses revealed a positive SIP1 expression predicted a poorer overall survival than a negative expression. CONCLUSION: These results suggest that SIP1 is correlated with LN metastasis and may therefore be an independent marker for metastasis in patients with ESCC.

[Treatment of Tension Pneumothorax during Total Right Breast Extirpation and Reconstruction with a Flap of the Latissimus Dorsi Muscle].

A patient developed tension pneumothorax during surgery. A 56-year-old woman with right breast cancer and axillary gland metastasis, was to undergo total right breast extirpation/axillary gland dissection, flap collection from the latissimus dorsi muscle, and reconstruction with this flap. During total right breast extirpation/axillary gland dissection, there were no problems, but the arterial blood oxygen saturation (SpO2) fell after the start of flap collection. After the start of reconstruction, SpO2 was reduced again. In the right lung field, no respiratory sound was heard, and chest X-ray showed right tension pneumothorax. A right thoracic drain was inserted and surgery was completed as scheduled. Thoracic CT did not reveal any abnormal findings, such as a brassiere, the day after surgery.

Efficacy and histologic frequencies of endoscopic ultrasonography-guided tissue acquisition using conventional fine-needle aspiration needles for gastric subepithelial hypoechoic mass.

Introduction/Purpose: For gastric subepithelial lesions (GSELs) showing a hypoechoic mass (HM) on endoscopic ultrasonography (EUS) imaging, the utility of EUS-guided tissue acquisition using conventional fine-needle aspiration needles (EUS-TA-CFNAN) and the frequency of histological types remain unclear. This study aimed to examine this issue. Methods: This prospective observational study enrolled 291 consecutive patients who underwent EUS-TA-CFNAN for GSELs showing an HM (GSELHM) on EUS imaging. Immunohistochemical analysis was performed for all EUS-TA-CFNAN and surgically resected specimens. The main outcome measures were the technical results of EUS-TA-CFNAN and the frequency of histological types in GSELHM. Results: The endoscopic ultrasound-guided tissue acquisition using conventional fine-needle aspiration needle diagnosis rate for GSELHM was 80.1% (95% confidence interval [CI]: 75.0-84.5, 233/291). It was significantly lower for antrum (P = 0.004) and lesions smaller than 2 cm (P = 0.003). There were no adverse events. The immunohistochemical diagnoses of EUS-TA-CFNAN included 149 cases of gastrointestinal stromal tumour (GIST) (51.2%), 48 cases of leiomyoma (16.5%), 11 cases of schwannoma (3.8%), 8 cases of the ectopic pancreas (2.7%), 5 cases of subepithelial lesion like cancer (1.7%), 12 cases of other lesions (4.1%), and 58 cases of undiagnosable lesions (19.9%). The frequency of malignant or potentially malignant tumour in GSELHM was 55.0% (95% CI: 49.1-60.8, 160/291). Surgery was performed in 149 patients according to the conclusive EUS-TA-CFNAN results, in which the diagnostic accuracy of EUS-TA-CFNAN was 97.3% (95% CI: 94.7-99.9, 145/149). Conclusion: The use of EUS-TA-CFNAN for GSELHMs is safe and accurate. Gastric subepithelial lesions showing a hypoechoic mass have a reasonably high possibility of containing malignant or potentially malignant tumours, including GISTs.

Risk Factors of Postoperative Complication and Hospital Mortality after Colorectal Perforation Surgery.

Objectives: Colorectal perforation is associated with high morbidity and mortality rates after surgery. We investigated various clinical features of patients who underwent emergency surgery for colorectal perforation and explored the risk factors for postoperative complications and hospital mortality. Methods: Data from 147 patients who underwent surgery for colorectal perforation were retrospectively reviewed. We investigated various clinical and operative factors, including inflammation-based prognostic scores (IBPSs), and evaluated the risk factors for postoperative complications and hospital mortality due to colorectal perforation. Results: Among 147 patients, the most frequent postoperative complication was wound infection (32 cases, 21.8%), followed by intra-abdominal abscesses (27 cases, 18.4%) after surgery for colorectal perforation. Time from onset to surgery ≥ 2 days (Hazard ratio [HR] = 2.810, p = 0.0383) and prognostic nutritional index (PNI) < 30 (HR = 3.190, p = 0.0488) were identified as risk factors for intra-abdominal abscess, while neutrophil-lymphocyte ratio (NLR) < 6.15 (HR = 5.020, p = 0.0009) was identified as a risk factor for wound infection. Time from onset to surgery ≥ 2 days (HR = 7.713, p = 0.0492), severe postoperative complications (Clavien-Dindo grade ≥ IIIa) (HR = 10.98, p = 0.0281), and platelet-lymphocyte ratio (PLR) < 144 (HR = 18.84, p = 0.0190) were independent predictive factors for hospital mortality. Conclusions: Time from onset to surgery and IBPSs such as PNI, NLR, and PLR, may be associated with postoperative complications and hospital mortality due to colorectal perforation.

Validity of laparoscopic surgery for lower gastrointestinal perforations.

INTRODUCTION: This study aimed to clarify the validity of laparoscopic surgery for lower gastrointestinal perforation by comparing the clinical outcomes of laparoscopic and open emergency surgery. METHODS: We reviewed the data of patients who underwent surgery for lower gastrointestinal perforation. Patients were categorized into two groups: the laparoscopic group who underwent laparoscopic surgery, and the open group who underwent laparotomy. Clinical and operative outcomes between the two groups were evaluated. RESULTS: A total of 219 patients were included in the study. There were 66 and 153 patients with small bowel and colorectal perforations, respectively. The median operative time in the laparoscopic group was shorter than that in the open group (126 min vs. 146 min, p = .049). The mean amount of intraoperative blood loss was significantly lower in the laparoscopic group (50.4 mL vs. 400.1 mL, p < .001). The incidence of postoperative complication was higher in the open group (20.0% vs. 66.5%, p < .001), especially wound infection (0% vs. 26.3%, p = .002). Median hospital stays were 14 days and 24 days in the laparoscopic and open groups, respectively (p < .001). In the laparoscopic group, hospital mortality was 0%. CONCLUSIONS: The laparoscopic approach for small bowel and colorectal perforation in an emergency setting is a safe procedure in carefully selected patients and may contribute to decreased intraoperative blood loss, shortened hospital stay, and decreased incidence of postoperative complications, especially wound infection.

An Attempt to Replicate Randomized Trials of Diabetes Treatments Using a Japanese Administrative Claims and Health Checkup Database: A Feasibility Study.

BACKGROUND: Use of real-world evidence (RWE) has been limited for evaluating effectiveness because of the lack of confidence in its reliability. Examining whether a rigorously designed observational study using real-world data (RWD) can reproduce the results of a randomized controlled trial (RCT) will provide insights into the implementation of high-quality RWE studies that can produce valid conclusions. OBJECTIVE: We aimed to replicate published RCTs using a Japanese claims and health checkup database and examine whether the emulated RWE studies' results agree with those of the original RCTs. METHODS: We selected three RCTs on diabetes medications for replication in patients with type 2 diabetes. The study outcome was either the change or percentage change in HbA1c levels from baseline. We designed three observational studies using the RWD to mimic the critical study elements of the respective RCTs as closely as possible. We performed 1:1 propensity score nearest-neighbor matching to balance the groups for potential confounders. The differences in outcomes between the groups and their 95% confidence intervals (CIs) were calculated in each RWE study, and the results were compared with those of the RCT. RESULTS: Patient characteristics, such as age, sex, and duration of diabetes, differed between the RWE studies and RCTs. In Trial 1 emulation, the percentage changes in HbA1c levels were larger in the treatment group than in the comparator group (difference -6.21, 95% confidence interval (CI) -11.01 to -1.40). In Trial 2, the change in HbA1c level was larger in the treatment group (difference -0.01; 95% CI -0.25 to 0.23), and in Trial 3, it was smaller in the treatment group (difference 0.46; 95% CI -0.01 to 0.94). These results did not show regulatory or estimate agreement with the RCTs. CONCLUSIONS: None of the three emulated RWE studies using this claims and health checkup database reproduced the same conclusions as the RCTs. These discrepancies could largely be attributed to design differences between RWE studies and RCTs, primarily due to the lack of necessary data in the database. This particular RWD source may not be the best fit for evaluating treatment effects using laboratory data as the study outcome.