Efficacy of Reinforced Stapler for Preventing Postoperative Pancreatic Fistula After Minimally Invasive Distal Pancreatectomy.

BACKGROUND/AIM: Although minimally invasive distal pancreatectomy (MIDP) has become a treatment option for benign and malignant pancreatic tumors, the safety and efficacy of reinforced staplers in MIDP remain controversial. The present study was performed to evaluate the safety of reinforced staplers in MIDP and identify the risk factors for postoperative pancreatic fistula (POPF) after MIDP with reinforced staplers. PATIENTS AND METHODS: In total, 92 consecutive patients who underwent MIDP at NHO Kyushu Medical Center from July 2016 to August 2023 were enrolled in this retrospective study. In all patients, a reinforced black cartridge triple-row stapler (Covidien Japan, Tokyo, Japan) was used during MIDP. The primary endpoint was the incidence of clinically relevant POPF. The risk factors for POPF were evaluated using multivariate analysis. RESULTS: Among the 92 patients, 74 underwent laparoscopic distal pancreatectomy and 18 underwent robot-assisted distal pancreatectomy. Clinically relevant POPF occurred in seven (7.6%) of 92 patients. The rate of severe complications (Clavien-Dindo grade ≥III) was 10.8%, and the mortality rate was 0%. The median postoperative hospital stay was 14 days. Multivariate logistic regression analysis showed that the independent risk factor for clinically relevant POPF after MIDP with a reinforced stapler was a body mass index of ≥22.6 kg/m2 (p=0.050, odds ratio=7.60). CONCLUSION: This study confirmed the safety and efficacy of reinforced staplers for preventing POPF after MIDP. A high body mass index was the only risk factor for clinically relevant POPF after MIDP with a reinforced stapler.

A Phase 2, Prospective, Multicenter, Single-Arm Trial of Transarterial Chemoembolization Therapy in Combination Strategy with Lenvatinib in Patients with Unresectable Intermediate-Stage Hepatocellular Carcinoma: TACTICS-L Trial.

Introduction: Transarterial chemoembolization (TACE) is the standard treatment for unresectable intermediate-stage hepatocellular carcinoma (HCC), but recurrence after TACE is common. The present phase 2, prospective, multicenter, single-arm trial, the TACTICS-L trial, investigated the efficacy and safety of TACE plus lenvatinib (LEN), a drug that more strongly promotes vascular normalization and has a better objective response rate (ORR) than sorafenib (jRCTs031180074). Methods: Participants were patients with HCC who had not previously received systemic therapy, hepatic arterial infusion chemotherapy, or immunotherapy and who were ineligible for resection or percutaneous ablation therapy. LEN was to be administered 14-21 days before the first TACE, stopped 2 days before TACE, and resumed 3 days after TACE. Key inclusion criteria were unresectable HCC, Child-Pugh A liver function, 0-2 prior TACE sessions, tumor size ≤10 cm, number of tumors ≤10, and ECOG performance status 0-1. Key exclusion criteria were vascular invasion and extrahepatic spread. The primary endpoint was progression-free survival (PFS) by RECICL, and secondary endpoints were time to untreatable progression, ORR, overall survival (OS), and safety. Results: A total of 62 HCC patients were enrolled in this trial. The median age was 72 years, 77.4% of patients were men, and 95.2% had PS 0. The primary endpoint of median PFS was 28.0 months (90% confidence interval [CI] 25.1-31.0) after a minimum 24 months of follow-up. The secondary endpoint of median OS was not reached (90% CI 35.5 months-NR). LEN-TACE achieved a high response rate and high complete response (CR) rate (4 weeks after the first TACE: ORR 79.0%, CR rate 53.2%; best response: ORR 88.7%, CR rate 67.7%) by RECICL. Exploratory subgroup analyses showed that the characteristics of responders/nonresponders (ORR and CR rate) were similar and that LEN-TACE would be effective in all subgroups, including the population in whom TACE alone would be less likely to be curative (e.g., patients with the non-simple nodular type or a high tumor burden). The relative dose intensity of LEN before the first TACE was important for achieving higher CR rate/ORR by LEN-TACE. No new safety concerns were observed. Conclusion: The results of this trial provide encouraging evidence, supporting the efficacy and favorable safety profile of LEN-TACE in patients who are ineligible for locoregional therapy.