BACKGROUND:Prophylactic complete closure of mucosal defects after resection of gastrointestinal lesions is key to reducing delayed bleeding, but complete closure for large defects can be challenging with conventional through-the-scope clips (TTSC). The introduction of a TTSC with anchor prongs offers ability to approximate margins of larger defects. OBJECTIVE:The study objective was to evaluate prophylactic complete closure after polypectomy, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD) in large (≥ 20 mm) nonpedunculated colorectal lesions (LNPCLs). METHODS:We conducted a multicenter, single-arm prospective cohort study of the TTSC with anchor prongs for prophylactic closure after EMR/polypectomy or ESD for LNPCLs. Patients were followed for 30 days after the index procedure. The primary outcome was the rate of complete closure of the defect. Other outcomes were the rate of delayed (postprocedural) bleeding, and rate of serious adverse events (SAEs). RESULTS:One hundred five eligible patients were enrolled. Ninety-nine (94.3%) defects had complete closure, with rates of 93.0% (80/86) for EMR/polypectomy and 100.0% (19/19) for ESD procedures. Delayed bleeding occurred in 2 (1.9%) patients by 30 days after the index procedure. Eight (7.6%) patients had ≥ 1 SAE, including bleeding (2 patients), perforation (1), microperforation (1), aspiration (1), nausea (1), and post-polypectomy syndrome (1). CONCLUSION:Prophylactic use of the TTSC with anchor prongs achieved a 94% rate of complete defect closure after EMR/polypectomy or ESD for LNPCLs. The rate of delayed bleeding after closure in this cohort was 1.9%. A prospective RCT is ongoing to further evaluate the clinical outcomes of a TTSC with anchor prongs used for prophylactic closure. TRIAL REGISTRATION:ClinicalTrials.gov number, NCT05653843.
BACKGROUND:Prophylactic opioid rescue therapy is often used to manage cancer-related pain. However, the effect of prophylactic rescue therapy in suppressing increases in breakthrough pain due to body movements has not yet been investigated. Therefore, this study aimed to compare the efficacy and safety of prophylactic rescue therapy before and after administration. METHODS:This multicenter, retrospective survey was conducted in Japan. Participants were patients with cancer who received prophylactic strong opioid rescue therapy for the first time. The primary endpoint was the suppression of an increase in pain, assessed using a Numerical Rating Scale (NRS), before and after administration of prophylactic rescue due to body movement. RESULTS:The overall analysis (193 cases) showed that prophylactic rescue suppressed the increase in the median NRS value by 3.00 (interquartile range: 1.00-4.00, p < 0.001). In addition, subgroup analysis by purpose (meals/bathing/rehabilitation/radiation therapy/others) also showed a significant reduction in the increase in NRS, with all categories exhibiting a decrease of 2.00 or more. CONCLUSIONS:Prophylactic opioid rescue with appropriate patient selection can effectively suppress breakthrough pain caused by body movement.
PURPOSE:This study investigated the efficacy and safety of pembrolizumab and necitumumab as first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC) who had ≥50% programmed death-ligand 1 (PD-L1) expression. PATIENTS AND METHODS:This nonrandomized, multicenter, open-label, single-arm phase II trial included patients with previously untreated advanced NSCLC who had a PD-L1 tumor proportion score of ≥50%. Patients received pembrolizumab and necitumumab every 3 weeks for up to 35 cycles. The primary endpoint was the investigator-assessed objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. RESULTS:The sample comprised 50 patients (38 men, 12 women; median age: 72 years, range: 51-90 years). The ORR was 76.0% (95% confidence intervals: 61.9-86.9; P < 0.0001), with complete and partial response rates of 2.0% and 74.0%, respectively. Moreover, 10.0% and 8.0% of the patients had stable and progressive disease, respectively, whereas 6.0% could not be evaluated. The median PFS was 15.7 months, whereas the median OS was not reached at the time of analysis. The most common treatment-related adverse events were rash (64.0%) and hypomagnesemia (60.0%). Grade 3 interstitial lung disease occurred in five patients (10.0%), and grade 5 cardiac arrest occurred in one patient (2.0%). CONCLUSIONS:The pembrolizumab and necitumumab combination exhibited a promising ORR of 76.0% with a manageable safety profile in patients with NSCLC who had high PD-L1 expression. These findings highlight the need for further research on this regimen for patients with advanced NSCLC who have high PD-L1 expression.
BACKGROUND:As a first step to prevent recurrent laryngeal nerve (RLN) palsy, we have developed an artificial intelligence (AI)-based anatomical recognition system for critical anatomical structures in robot-assisted minimally invasive esophagectomy (RAMIE). In the present study, we investigated whether AI would enable surgeons to rapidly recognize the RLN. PATIENTS AND METHODS:Five surgical videos of RAMIE were used to validate the AI. The confidence level (CL) was established as a new criterion to define how confidently surgeons recognize the RLN and stratified into three levels: CL0 is the level when looking for RLN candidates; CL1, after recognizing a candidate but before confirming it as the RLN; CL2, after confirming that the candidate is the RLN. Eight trainee surgeons watched the original and AI-enhanced videos with an interval of > 4 weeks, and they were instructed to declare the RLN's location at the start of CL1 and CL2. The time to CL1 and CL2 from the beginning of RLN lymph node dissection with and without AI were compared. RESULTS:In all cases, the average time to CL1 and CL2 of the right and left RLN recognition was reduced by using AI. Particularly, in the right RLN recognition, significant differences were found between the surgeons using and not using AI (CL1, 134 vs. 178 s, p < 0.001; CL2, 233 vs. 325 s, p < 0.001). CONCLUSIONS:This study demonstrated that AI would enable surgeons not only to rapidly identify the RLN but also to enhance their confidence in its identification.
