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Esophageal cancer has an overall five-year survival rate of < 20%. The McKeown esophagectomy is invasive and carries a high risk of anastomotic leakage. Robust prospective outcome data comparing non-placement versus placement of a cervical drainage tube during McKeown esophagectomy are lacking. This study aimed to evaluate whether the placement of a cervical drainage tube is useful. In this randomized controlled, noninferiority trial, 106 patients with histologically proven, surgically resectable esophageal carcinoma were randomized to either placement or non-placement of a cervical drainage tube. The primary outcome was the percentage of Clavien-Dindo grade 2 or higher anastomotic leakage. Secondary outcomes included the duration from surgery to oral intake, hospital stay, and type and dose of analgesics used during hospitalization. Fifty-two and 54 patients were randomized to McKeown esophagectomy with non-placement and placement of a cervical drainage tube, respectively. There was no significant difference in anastomotic leakage rates between the non-placement (12/52 [23%]) and placement (13/54 [24%]) of drainage tube. However, non-inferiority was not demonstrated (risk difference, -0.100 [-0.17, 0.15]; p = 0.0591). There were no significant differences in the secondary outcome measures. Non-inferiority of nonplacement of a drainage tube around the cervical anastomosis after McKeown esophagectomy to placement of that was not demonstrated. Further large multicenter studies are needed.Trial registration: Japan Registry of Clinical Trials (identification number jRCT1052180016).

The newly developed portable oxygen concentrator with an auto-demand oxygen delivery system (auto-DODS) automatically switches between 3 sensitivities according to the negative pressure gradient of inhalation and supplies oxygen only during inhalation. The aim of this study was to verify the effectiveness and safety of auto-demand devices compared with a continuous flow oxygen concentrator, during sleep, in a randomized crossover noninferiority trial. We alternatively used an auto-DODS or a continuous-flow oxygen concentrator, all night on separate days for HOT (Home Oxygen Therapy) patients with nocturnal hypoxemic symptoms. The primary endpoints were the mean value of oxygen saturation (SpO 2 ) over the total sleep time. The secondary endpoints included the efficacy endpoints and the safety endpoints. Regarding the primary endpoint, the difference in SpO 2 between the auto-DODS and continuous flow was 0.835%. Since the upper limit of this difference did not exceed 2.8, which was set as the noninferiority margin, it was shown that the auto-DODS did not reduce SpO 2 by at least 2.8% on average compared to continuous flow. No equipment failure or exacerbation of disease was observed, confirming the safety of the auto-DODS during the night.

Background This is a multicenter, open-label, single-arm clinical trial to evaluate the safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer. Methods The trial will be performed at three university hospitals in Japan. The target number of patients will be 12. The patients will be treated orally with B440 once daily for 5 days followed by 2 days for four consecutive courses (4 weeks, 20 treatments). The low-dose group will receive 800 mg (4 capsules) per dose and the high-dose group will receive 1,600 mg (8 capsules) per dose. The primary outcome will be the number and incidence of DLT cases the start of treatment and Day 28. Secondary outcomes are the presence or absence of a response, the best overall response and PFS. Discussion If this trial shows B440 to be safe and effective, it may lead to a late phase randomized controlled trial in advanced urothelial cancer. Ultimately, we hope to provide a new treatment option for such patients. Trial registration Japan Registry of Clinical Trials (jRCT) identifier: jRCT2051220143. Registered on December 27, 2022.

BackgroundThis study aimed to compare the efficacy of robot-assisted partial nephrectomy for completely endophytic renal tumors with the reported outcomes of conventional laparoscopic partial nephrectomy and investigate the transition of renal function after robot-assisted partial nephrectomy.MethodsWe conducted a prospective, multicenter, single-arm, open-label trial across 17 academic centers in Japan. Patients with endophytic renal tumors classified as cT1, cN0, cM0 were included and underwent robot-assisted partial nephrectomy. We defined two primary outcomes to assess functional and oncological aspects of the procedure, which were represented by the warm ischemic time and positive surgical margin, respectively. Comparisons were made using control values previously reported in laparoscopic partial nephrectomy studies. In the historical control group, the warm ischemia time was 25.2, and the positive surgical margin was 13%.ResultsOur per-protocol analysis included 98 participants. The mean warm ischemic time was 20.3 min (99% confidence interval 18.3–22.3; p < 0.0001 vs. 25.2). None of the 98 participants had a positive surgical margin (99% confidence interval 0–5.3%; p < 0.0001 vs. 13.0%). The renal function ratio of eGFR before and after protocol treatment multiplied by splits was 0.70 (95% confidence interval: 0.66–0.75). Factors such as preoperative eGFR, resected weight, and warm ischemic time influenced the functional loss of the partially nephrectomized kidney after robot-assisted partial nephrectomy.ConclusionsRobot-assisted partial nephrectomy for completely endophytic renal tumors offers a shorter warm ischemia time and comparable positive surgical margin rate compared with conventional laparoscopic partial nephrectomy.

For treating patients with refractory chronic spontaneous urticaria (CSU) resistant to standard doses of 2 generation H1-antihistamines (H1AH) the International and Japanese guidelines recommend increasing H1AH dose. The latter also recommends switching to a different H1AH. This study explored if the efficacy of the standard dose of bilastine 20 mg is non-inferior to that of double-dose of H1AH in patients with refractory CSU. This phase IV, multicenter, open-label, randomized, parallel-group trial evaluated the efficacy and safety of switching treatment to bilastine compared to treatment with a 2-fold dose of H1AH in patients with CSU refractory to standard dose H1AH. The primary endpoint was the mean total symptom score (TSS) at Day 5-7 after the start of administration. Treatment efficacy and safety were evaluated in 128 patients (bilastine, n=64; 2-fold dose of H1AH, n=64). The mean TSS at Day 5-7 after the start of administration was smaller than the non-inferiority margin of 0.8, demonstrating non-inferiority of the bilastine switching group to the double-dose H1AH group (0.17 (95% CI -0.32, 0.67)). No difference in Japanese version of Epworth Sleepiness Scale (JESS), DLQI, and urticaria activity score over 7 consecutive days (UAS7) was observed between the two groups. There were no serious adverse events in either group. H1AH-related adverse events occurred in 5 subjects (8 cases) and 2 subjects (3 cases) in the double-dose H1AH and bilastine groups, respectively. Switching treatment to bilastine demonstrated non-inferiority to a double-dose of H1AH in terms of efficacy in patients with CSU refractory to standard dose H1AH with a favorable safety profile. https://jrct.niph.go.jp/latest-detail/jRCTs051180105, identifier jRCTs051180105.

IntroductionXeroderma pigmentosum (XP) is a rare intractable disease without a fundamental treatment, presenting with severe photosensitivity, freckle-like pigmented and depigmented maculae and numerous skin cancers before the age of 10 years without strict sun protection. About 70% of the patients exhibit extremely severe sunburn reactions and most of them develop neurological symptoms, including sensorineural hearing impairment and progressive peripheral and central nervous disorders beginning from childhood ages. In the preclinical study, we found that N-acetyl-5-methoxytryptamine was effective in suppressing skin tumour development in addition to improvement of auditory brainstem response in chronically ultraviolet-irradiated XP-A model mice.Methods and analysisOn the bases of the preclinical study, we conduct a clinical trial on the efficacy of NPC-15 for patients with XP with exaggerated sunburn reaction type by a multicentre, double-blinded placebo-controlled, two-group crossover study followed by a 52 weeks open study.Ethics and disseminationEthics approval is overseen by the Kobe University Institutional Review Board and Osaka Medical and Pharmaceutical University Institutional Review Board, and the study is conducted in accordance with the approved protocol. All participants will be required to provide written informed consent. Findings will be disseminated through scientific and professional conferences and peer-reviewed journal publications. The data sets generated during the study will be available from the corresponding author on reasonable request.Trial registration numberjRCTs051210181.

IntroductionIn-vivo fluorescence imaging techniques using indocyanine green (ICG) to identify liver tumours and hepatic segment boundaries have been recently developed. The purpose of this study is to evaluate the efficacy of fusion ICG-fluorescence imaging for navigation during hepatectomy.Methods and analysisThis will be an exploratory single-arm clinical trial; patients with liver tumours will undergo hepatectomy using the ICG-fluorescence imaging system. In total, 110 patients with liver tumours scheduled for elective hepatectomy will be included in this study. Preoperatively, ICG will be intravenously injected at a dose of 0.5 mg/kg body weight within 2 days. To detect liver tumours intraoperatively, the hepatic surface will be initially observed using the ICG-fluorescence imaging system. After identifying and clamping the portal pedicle corresponding to the hepatic segments, including the liver tumours to be resected, additional ICG will be injected intravenously at a dose of 0.5 mg/kg body weight to identify the boundaries of the hepatic segments. The primary outcome measure will be the success or failure of the ICG-fluorescence imaging system in identifying hepatic segments. The secondary outcomes will be the success or failure in identifying liver tumours, liver function indicators, operative time, blood loss, rate of postoperative complications and recurrence-free survival. The findings obtained through this study are expected to help to establish the utility of ICG-fluorescence imaging systems, and therefore contribute to prognostic outcome improvements in patients undergoing hepatectomy for various causes.Ethics and disseminationThe protocol has been approved by the Kobe University Clinical Research Ethical Committee. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration numberUMIN000031054 and jRCT1051180070

We report a 77-year-old woman with rapid progression of a second cancer of the remnant distal bile duct after R0 resection for bile duct cancer. Initially, she was referred to us for localized cancer in the mid-area of the common bile duct without pancreaticobiliary maljunction. We performed common bile duct resection and hepaticojejunostomy with lymph node dissection. The tumor was pT1N1M0 by TNM staging. Six months later, CT newly revealed a mass in the residual distal bile duct. Endoscopic retrograde cholangiography showed an elevated tumor near the distal bile duct’s upper edge and a well-defined tumor in the inferior part of the distal bile duct. Subtotal stomach-preserving pancreatoduodenectomy was performed 8 months after the first operation. Postoperative pathological examination of both lesions indicated well-differentiated adenocarcinoma. No continuation was noted between the two cancers in the mucosal or subepithelial layer. Repeated surgical resection resulted in a pathologically curative treatment.

Purpose This study aimed to evaluate the efficacy of indocyanine green (ICG)-fluorescence imaging for the identification of hepatic boundaries during liver resection and its advantages in surgical outcomes over conventional methods. Methods This prospective, exploratory, single-arm clinical trial included 47 patients with liver tumors who underwent liver resection using ICG-fluorescence imaging (ICG-LR) between 2019 and 2020. The primary outcome measure was the successful identification of hepatic boundaries during liver resection, from the perspective of both the hepatic surface and intrahepatic boundary, using ICG-fluorescence imaging. The secondary outcomes comprised surgical outcomes. Using propensity score matching (PSM), the surgical outcomes were subsequently compared between the ICG-LR group and patients who underwent conventional liver resection (C-LR, n  = 100) between 2017 and 2018. Results Hepatic boundaries were successfully identified in 28 patients (60%; 95% confidence interval, 45–72%), including 21 and 7 who underwent anatomical and non-anatomical liver resection, respectively. After PSM, 40 patients were included in each of the ICG-LR and C-LR groups. The surgical outcomes were similar between the groups. Subsequently, surgical outcomes were compared between the groups focusing on anatomical liver resection. After PSM, 21 patients were included in each group. The ICG-LR group had a lower rate of Clavien–Dindo grade ≥ IIIa complications (0% vs. 24%; P  = 0.017), including ascites and bile leak, and a shorter hospital stay (12 vs. 14 days, P  = 0.041) than the C-LR group did. Conclusion ICG-fluorescence imaging could be used to recognize hepatic boundaries during liver transection. Additionally, ICG-LR may be useful in preventing severe liver-associated complications. Trial registration number This study is registered at the UMIN Clinical Trials Registry: UMIN0000180139 and Japan Registry of Clinical Trials: jRCT1051180070. The Registration Data Set is available at https://jrct.niph.go.jp/ .

Background Although preoperative biliary drainage in jaundiced patients is controversial, external biliary drainage (EBD) is beneficial for infection control in patients with biliary cancers. When EBD is performed, additional bile replacement (BR) has the benefit of improving impaired intestinal barrier function, but the detailed mechanism remains unknown. We examined the effect of bile replacement on immune functions over the duration of BR in jaundiced patients. Methods Fifteen patients were enrolled into this prospective study. BR was started soon after the total serum bilirubin concentration reached 5.0 mg/dl and was continued for 14 days. Drained bile was given two times orally (2 × 100 ml/day). Concanavalin A (Con A)- and phytohemagglutinin (PHA)-stimulated lymphocyte proliferation and serum diamine oxidase (DAO) activity were measured before starting and during BR. Twenty patients with EBD and no BR were analyzed as a control group. Results Serum liver enzymes, prothrombin time–international normalized ratio (PT-INR), and responses to Con A and PHA gradually improved over the 14 days of BR, but percentages of lymphocytes and DAO levels did not. PT-INR, and Con A and PHA responses did not improve during EBD in the control group. PT-INR significantly decreased in patients with a greater fraction of their drained bile replaced. Conclusions Our results indicate that preoperative BR using as large a quantity of bile as possible is useful for improving blood coagulability and cellular immunity in patients with EBD.