Impact of Antibiotic Prophylaxis on Infection Rate after Endoscopic Ultrasound Through-the-Needle Biopsy of Pancreatic Cysts: A Propensity Score-Matched Study

Background: Despite weak evidence, antibiotic prophylaxis prior to endoscopic ultrasound-guided through-the-needle biopsy (EUS-TTNB) of pancreatic cystic lesions (PCLs) is routinely used in clinical practice. We aim to compare a group of patients treated with antibiotics before EUS-TTNB of PCLs and a group who did not undergo antimicrobial prophylaxis. Methods: Out of 236 patients with pancreatic cystic lesions referred to two high-volume centers between 2016 and 2021, after propensity score matching, two groups were compared: 98 subjects who underwent EUS-TTNB under antibiotic prophylaxis and 49 subjects without prophylaxis. Results: There was no difference in terms of baseline parameters between groups. Final diagnosis was serous cystadenoma in 36.7% of patients in the group not treated with prophylaxis and in 37.7% of patients in the control group, whereas IPMN and mucinous cystadenoma were diagnosed in 3 (6.1%) and 16 (32.6%) versus 6 (6.1%) and 32 (32.6%) patients in the two groups, respectively (p = 0.23). Overall, the adverse event rate was 6.1% in the group not treated with antibiotic prophylaxis and 5.1% in the control group (p = 0.49). Only a single infectious adverse event occurred in each group (p = 0.48). The diagnostic yields were 89.7% and 90.8% in the two groups (p = 0.7), and the diagnostic accuracy rate was 81.6% in both groups (p = 1.0). Conclusions: Prophylactic antibiotics do not seem to influence the risk of infection, and their routine use should be discouraged.

Efficacy and safety of PD-1/PD-L1 and CTLA-4 immune checkpoint inhibitors in colorectal cancer: a meta-analysis

Aims: To evaluate the efficacy and safety of PD-1/PD-L1 and/or CTLA-4 inhibitors in the treatment of colorectal cancer (CRC) by meta-analysis. Methods: Electronic databases were searched. Eligible studies included investigations of efficacy and safety of anti-PD-1/PD-L1 or anti-CTLA-4 agents in patients with CRC. Corresponding indicators were calculated. Results: A total of 15 articles were included. The pooled objective response rate, overall survival rate, progression-free survival rate and adverse event rate were 33, 56, 46 and 59%, respectively. The objective response rates for CRC with deficient mismatch repair and CRC with proficient mismatch repair were 43 and 3%, respectively, in patients treated with PD-1 inhibitors. Conclusion: The authors' study indicates that PD-1/PD-L1 inhibitors manifest promising clinical responses in the treatment of CRC with deficient mismatch repair with acceptable treatment-related adverse events.

Endoscopic retrograde appendicitis therapy vs. Laparoscopic appendectomy for uncomplicated acute appendicitis

Background and study aims: To assess the efficacy and clinical outcomes of endoscopic retrograde appendicitis therapy (ERAT) versus laparoscopic appendectomy (LA) for patients with uncomplicated acute appendicitis (AA). Patients and methods: We adopted propensity score matching (1:1) to compare ERAT and LA patients with uncomplicated AA from April 2017 to March 2020. We reviewed a total of 2880 patients with suspected acute appendicitis, of whom 422 patients with uncomplicated AA met the matching criteria (ERAT, 79; LA, 343), yielding 78 pairs of patients. Results: The rate of curative treatment within one year after ERAT was 92.1%; 95% CI, [83.8% - 96.3%]. The percentage of Visual Analog Scale (VAS) ≤ 3 at six hours after treatment was 94.7%; 95% CI [87.2% - 97.9%] in the ERAT group, and significantly higher than that in the LA group 83.3%; 95% CI [73.5% - 90.0%]. Median operative/procedure time and median hospital length of stay in the ERAT group were significantly lower compared to the LA group. At one year, the median recurrence time was 50 days (IQRs, 25-127) in the ERAT group. The overall adverse event rate was 24.3%; 95% CI [14.8% - 33.9%] in the LA group and 18.4%; 95% CI [9.7% - 27.1%] in the ERAT group, with no significant difference between the two groups. Conclusions: ERAT is a technically feasible method to treat uncomplicated AA compared to LA.

Efficacy of Twice a Day Bismuth Quadruple Therapy for Second-Line Treatment of Helicobacter pylori Infection

Bismuth quadruple therapy (BQT) is an effective treatment for Helicobacter pylori infection. However, frequent dosing schedules of BQT regimen often compromise drug adherence and may affect treatment outcomes. This retrospective study aimed to investigate the efficacy of twice-daily BQT compared to that of four times a day therapy. From August 2018 to November 2020, adult patients who failed first-line standard triple therapy and underwent BQT were eligible. Patients were categorized into two groups according to dosing schedule: (i) the BQT group (n = 213) who received standard BQT administered four times a day; and (ii) the BQTb group (n = 141) who received proton pump inhibitor, bismuth 600 mg, metronidazole 500 mg, and tetracycline 1 g twice a day. The eradication rate did not differ between the BQT (92.5%) and the BQTb groups (90.1%) (p = 0.441). Adherence and adverse event rate were similar between the two groups. Multivariate analysis showed that current smoking was associated with eradication failure; however, dosing frequency was not associated with the efficacy of eradication therapy. This study suggested that twice a day BQT is as effective as four times a day therapy for second-line treatment of H. pylori infection.

Characteristics of Adverse Events in Bee Venom Therapy Reported in South Korea: A Survey Study

This study was aimed at investigating Korean patients’ experience with bee venom therapy (BVT) and providing evidence to enhance BVT safety. Thus, an anonymous online survey was conducted between August 22 and 28, 2018. Five hundred respondents who underwent pharmacopuncture (PA) within one year were surveyed (sample error: 95 ± 4.38%). Of these, 32 respondents were excluded and 468 were evaluated. Of the 468, 61 reported experiencing adverse events after PA. The adverse event rate was higher in the BV-PA(Bee venom-Pharmacopuncture) group than in the non-A group; however, intergroup differences were insignificant. There were no significant differences in mild symptom intensity between the BV-PA and non-BV-PA groups (p = 0.572). However, there was a significant intergroup difference in severe symptom intensity (p < 0.001). Additionally, the BV-PA and non-BV-PA groups did not significantly differ in their level of satisfaction either overall or in terms of effectiveness and safety (p = 0.414, p = 0.339, and p = 0.675, respectively). Furthermore, the BV-PA and non-BV-PA groups did not differ regarding intent to re-treat (p = 0.722). Severe adverse events such as anaphylactic shock were not reported; however, BVT practitioners should be cautious when applying it.

PEDT-9 A study of NovoTTF-100A to expand the regulatory indication for childhood glioblastoma through a pediatric clinical trial based on the Advanced Medical Care system

Background: Tumor-treating fields (TTF) are alternating electric fields applied continuously to the brain by attaching 2-pair arrays on the scalp. Although TTF therapy has demonstrated efficacy against supratentorial glioblastoma (GBM) in adults, its safety and efficacy in children have not been confirmed. In Japan, off-label use of medical devices is almost impossible because the national health insurance system does not cover the cost of off-label use of drugs and medical devices. Therefore, TTF therapy cannot be applied to the treatment of pediatric GBM. [Objectives] The investigator-initiated clinical trial aims to expand regulatory approval of TTF therapy for pediatric GBM treatment based on safety and exploratory efficacy data. Methods: Patients aging between 5 and 17 years with histopathological diagnosis of GBM (either newly diagnosed or first-recurrence), which located in the supratentorial region would be included. All the patients will receive TTF therapy for 28 days per course for up to 26 courses until the end-of-therapy criteria are met. The primary endpoint is the adverse event rate with causality. The secondary endpoints include various time-to-event measures and QoL. In total ten patients will be enrolled. Current Status: Discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) led to a tentative consensus that the accumulated data on the efficacy of NovoTTF-100A for adult GBM may be extrapolatable to pediatric GBM if the trial is able to demonstrate efficacy equivalent to that found in previous, adult studies. On the other hand, the combination of the pediatric safety data gathered in this trial and the findings of international studies, including clinical trials and post-marketing surveillance studies, may expedite approval of the device for pediatric GBM treatment. The trial started patient enrollment in April, 2021 with the supervision of the Advanced Medical Care administration system and is currently awaiting the first eligible patient.

Adverse Events Following COVID-19 Vaccine in Patients Previously Injected with Facial Filler: Scoping Review and Case Report

The “Vaccines and Related Biological Products Advisory Committee 17 December 2020 Meeting Briefing Document”, formulated by the FDA, reported three cases of swelling in areas previously injected with HA filler, introducing the possible relationship between a COVID-19 vaccine and adverse events in areas previously injected with HA fillers. The aim of this research is to report a case of an adverse event following a COVID-19 vaccine in a patient previously injected with facial filler. Furthermore, a scoping review on the same topic was performed. The research was carried out on the electronic databases PubMed, Cochrane Library, Web of Science, Google Scholar and Scopus. The selection process identified four articles as eligible for inclusion in the review. Nineteen patients, including the described case report, who experienced an adverse event following a COVID-19 vaccine in areas previously injected with facial filler were identified. Adverse events following a COVID-19 vaccine in patients previously injected with facial filler appear to be rare. A high BDDE cross-linking rate and/or a low-molecular-weight hyaluronic acid filler may have a higher tardive adverse event rate when triggered.

Early Versus Delayed Microdiscectomy for Chronic Sciatica Lasting 4–12 Months Secondary to Lumbar Disc Herniation: A Secondary Analysis of a Randomized Controlled Trial

Objectives To compare the effect of delaying surgery on clinical outcome in patients with chronic sciatica secondary to lumbar disc herniation. Methods Patients with sciatica lasting 4–12 months and lumbar disc herniation at the L4–L5 or L5–S1 level were randomized to undergo microdiscectomy (early surgery) or to receive 6 months of nonoperative treatment followed by surgery if needed (delayed surgery). Outcomes were leg pain, Oswestry Disability Index score (ODI), back pain, SF–36 physical component (PCS) and mental component (MCS) summary scores, employment, and satisfaction measured preoperatively and at 6 weeks, 3 months, 6 months, and 1 year after surgery. Results Of the 64 patients in the early surgery group, 56 underwent microdiscectomy an average of 3 ± 2 weeks after enrollment. Of the 64 patients randomized to nonoperative care, 22 patients underwent delayed surgery an average of 53 ± 24 weeks after enrollment. The early surgery group experienced less leg pain than the delayed surgery group, which was the primary outcome, at 6 months after surgery (early surgery 2.8 ± .4 vs delayed surgery 4.8 ± .7; difference, 2.0; 95% confidence interval, .5–3.5). The overall estimated mean difference between groups significantly favored early surgery for leg pain, ODI, SF36-PCS, and back pain. The adverse event rate was similar between groups. Conclusions Patients presenting with chronic sciatica treated with delayed surgery after prolonging standardized non-operative care have inferior outcomes compared to those that undergo expedited surgery.

Stent Applications for Palliative Treatment in Advanced Stage Esophageal Cancers

Background and Aim. Endoscopic stenting is a generally safe and effective palliative treatment for esophageal malignancies. In this study, we aimed to present endoscopic stent applications, adverse events, and relative advantages of covered versus uncovered stents in our center. Methods. We examined cases of endoscopic stenting for palliative treatment of advanced stage esophageal cancers between January 2014 and July 2019. Age, gender, location of mass, adverse events, survival time, and stent type were evaluated. Outcomes of fully covered and uncovered self-expanding stents were compared with regard to adverse events, including stent migration and occlusion. Results. The mean age of the patients was 66.4 ± 1 , 52 were male, and 8 were female. Patients were followed up for a mean of 133 days. The most common complication due to stenting was migration. 13 patients developed adverse events. Migration was the most common adverse event, occurring in 8 (13%) patients. Although the migration rate of fully covered stents was higher than uncovered stents, there was no statistically significant difference ( p = 0.47 ). Stent occlusion was observed in 4 patients. In three cases, it was due to the tumor; an uncovered stent was placed again in these cases. Food-related occlusion developed in one patient. There was no statistical difference in terms of overall adverse event rate when comparing fully covered stents to uncovered stents ( p = 0.68 ). Conclusion. Endoscopic stenting is a viable palliative method with low morbidity and mortality in experienced centers. Though there are relative advantages with covered versus uncovered stents in individual cases, the overall adverse event rate is low and relatively similar.