RESUMO
Background: No study has compared EUS-guided radiofrequency ablation (EUS-RFA) plus systemic chemotherapy (CMT) with CMT alone for unresectable pancreatic ductal adenocarcinoma. Methods: This study compared the results of treatment in patients receiving EUS-RFA plus concomitant CMT (group A; n = 14) with those receiving CMT (group B; n = 14) as a pilot study. Results: From July 2017 to August 2018, 4 and 2 patients from groups A and B, respectively, withdrew from the study because of progression of the disease. In total, 10 and 12 patients from groups A and B, respectively, completed the study. All 30 EUS-RFA procedures were successful. Mean maximal tumor diameter before treatment of group A (n = 10) versus B (n = 12) was 62.2 ± 21.0 versus 50.5 ± 22.0 mm, respectively (P = not significant). After treatment, no statistically significant difference in mean maximal tumor diameter was found between both groups. However, in group B, mean maximal tumor diameter was significantly increased from 50.5 ± 22.0 to 56.3 ± 18.7 mm, respectively (P = 0.017). Tumor necrosis occurred in group A versus B at 10 of 10 (100%) versus 6 of 12 (50%) patients, respectively (P = 0.014). After treatment, group A patients could reduce the mean narcotic pain drug dosage at 26.5 mg of morphine equivalent per day (from 63.6 to 37.1 mg, P = 0.022), whereas group B patients could not reduce the dosage of pain-controlled medication. No statistically significant difference in 6-month mortality rate was found. In group A, 1 procedure-related nonsevere adverse event (n = 1 of 30 [3.3%]) occurred in 1 patient (n = 1 of 14 [7.1%]). Conclusions: In this study, the mean tumor diameter of group B was significantly increased after the treatment. Group A had a significantly higher rate of necrosis of tumor and required less narcotic.
RESUMO
BACKGROUND: Data on the use of EUS-guided fine-needle biopsy (EUS-FNB) of solid liver mass (SLM) for pathology is limited. METHODS: To prove superiority of the diagnostic rate of the newly designed modified Menghini-type needle with a beveled side-slot near the needle tip with slot cutting edge directed 20-gauge antegrade bevel (group A) over the original 22-gauge reverse bevel (group B) for EUS-guided fine-needle biopsy (EUS-FNB) of solid liver mass (SLM) in a prospective crossover randomized controlled trial. RESULTS: The overall diagnostic accuracy rate of the 52 passes was 86.5% (45/52) and of group A versus B were 88.5% (23/26) versus 84.6% (22/26), respectively, p = 0.858. Tissue adequacy levels of both groups were not significantly different (grade A: B: C = 18:6:2 versus 16:7:3), p = 0.839). Grading of blood contamination of both groups was not significantly different. However, it was found that the group-A needles could biopsy tissue of significantly longer length than that of the group B; 1.3 cm (SD = 0.76) versus 0.8 cm (SD = 0.54); p = 0.007. CONCLUSION: The use of EUS-FNB of SLM is highly effective with similar levels of efficacy and number of adverse events between both types of needles. THE TRIAL REGISTRATION NUMBER: Thai Clinical Trial Registration No. TCTR2018081002.
