Endoscopic treatment of ERF leads to 45.5% of successful endoscopic closure and 55.5% of functional success, depending on fistula's orifice size. After 6 months without healing, the chances for success dramatically decrease.
Background and Aims
After 2 doses, the efficacy of anti‐SARS‐CoV‐2 vaccination seems to be lower in solid organ transplant recipients than in the immunocompetent population. The objective of this study was to determine the humoral response rate after vaccination, including with a booster dose, and to identify risk factors for non‐responsiveness in liver transplant recipients.
Methods
We included all patients seen in consultation in two French liver transplant centres between January 1, 2021, and March 15, 2021.
Results
598 liver transplant recipients were enrolled and 327 were included for analysis. Sixteen patients received one dose, 63 patients two doses and 248 patients three doses. Anti‐SARS‐Cov‐2 antibodies were detected in 242 out of 327 (74.0%) liver transplant patients after vaccination. Considering an optimal serologic response defined as an antibody titre >260 BAU/ml, 172 patients (52.6%) were responders. Mycophenolate mofetil (MMF) treatment was an independent risk factor for a failure to develop anti‐SARS‐CoV‐2 antibodies after vaccination (OR 0.458; 95%CI 0.258–0.813;
p =
.008). Conversely, male gender (OR 2.247, 95%CI 1.194–4.227;
p =
.012) and receiving an mRNA vaccine (vs a non‐mRNA vaccine) (OR 4.107, 95%CI 1.145–14.731;
p =
.030) were independent predictive factors for developing an optimal humoral response after vaccination. None of the patients who received the vaccine experienced any serious adverse events.
Conclusions
Even after a third booster dose, response rate to vaccination is decreased in liver transplant recipients. MMF appears to be a major determinant of seroconversion and optimal response to vaccination in these patients.
Background: Nab-paclitaxel/gemcitabine (AG) and FOLFIRINOX (FFX) are promising drugs in metastatic pancreatic cancer (MPC). This study evaluated a new first-line sequential treatment (AG followed by FFX) in MPC that might overcome resistance to primary therapy and delay tumor progression. Patients and methods: Patients with histologically/cytologically confirmed MPC were included in a multicentric trial receiving AG (day 1, 8 and 15) followed by FFX (day 29 and 43). In phase Ib, three dose-levels were tested for maximum tolerated dose (MTD) and recommended phase II dose. In phase II, the main outcome was the objective response rate (ORR) and secondarily safety, progression-free survival (PFS) and overall survival (OS). Results: In phase Ib, we included 33 patients (31 assessable) of median age 61.0 years (range 42-75 years) and represented by 54.8% males. Five dose-limiting toxicities were reported without any death. The main grade 3/4 toxicities were neutropenia with spontaneous resolution (35.5%/32.3%), venous thromboembolism (grade 3: 22.6%) and thrombopenia (grade 3: 29.0%), while the MTD was not reached. In phase II, we included 58 patients of median age 60 years (range 34-72 years), 50% males and with Eastern Cooperative Oncology Group stage score 0 and 1 of 37.9% and 62.1%, respectively. They received a median of 4 (1-9) cycles in 8.5 months (0.5-19.8 months). The ORR was 64.9% [95% confidence interval (CI) 51.1% to 77.1%], and neurotoxicity was remarkably low. The main grade 3-4 toxicities were venous thromboembolism, thrombopenia, neutropenia/febrile neutropenia, nausea, diarrhea, weight loss and asthenia without any death. Tumor response was complete in 3.5% and partial in 61.4%, while disease was stable in 19.3% and progressive in 15.8% of patients. The median PFS was 10.5 months (95% CI 6.0-12.5 months) and median OS was 15.1 months (95% CI 10.6-20.1 months). Conclusion: Sequential AG and FFX showed acceptable toxicity as first-line treatment with no limiting neurotoxicity, while high response rate and survival justify randomized trials.
Background: Gastric per oral endoscopic esophageal myotomy (G-POEM) is a promising procedure to treat refractory gastroparesis. The safety profile of G-POEM is an important topic because gastroparesis is a functional pathology, with a procedure whose effectiveness is between 50 and 65% depending on the studies. Objectives: We present this retrospective multicenter study, with the aim of establishing a safety profile, focusing on serious adverse events (AEs). Design: This was a multicenter observational cohort study conducted in five French expert centers. Methods: All patients who underwent G-POEM for refractory gastroparesis between 2015 and 2021 were included for analysis. AEs were classified into per endoscopic, early postoperative, and late postoperative, up to 1 month. Their severity was assessed using Dindo–Clavien and American Society for Gastrointestinal Endoscopy classification. The primary objective was to evaluate the rate of G-POEM severe AEs. Secondary objectives were to document other postoperative AEs, and to identify predictive factors. Results: In all, 217 patients were included: 81 men and 136 women, mean age 52 ± 17 years. The average procedural time was 44 ± 14 min (12–78). The average hospital stay was 3.7 ± 2.3 days. The AEs rate classified as Clavien–Dindo ⩾3 was 0.4% (one delayed bleeding requiring blood transfusion and endoscopic management). There were no deaths or patients admitted to intensive care unit. The rates of mucosotomy and capnoperitoneum were 3.7 and 1.8%, respectively, without clinical consequences. Most patients (81.5%) did not experience any AE. Three cases of dumping syndrome occurred, quickly managed by dietary measures. Conclusion: Our study confirms the safety of G-POEM with less than 0.5% of serious AEs, medically managed. This outcome makes this a procedure to have a good benefit–risk ratio.
Background Biomarkers are urgently needed for pancreatic ductal adenocarcinoma (PDAC). Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the cornerstone for diagnosing PDAC. We developed a method for discovery of PDAC biomarkers using the discarded EUS-FNA liquid.
Methods This retrospective study included 58 patients with suspected pancreatic lesions who underwent EUS-FNA. Protein extracts from EUS-FNA liquid were analyzed by mass spectrometry. Proteomic and clinical data were modeled by supervised statistical learning to identify protein markers and clinical variables that distinguish PDAC.
Results Statistical modeling revealed a protein signature for PDAC screening that achieved high sensitivity and specificity (0.92, 95 % confidence interval [CI] 0.79–0.98, and 0.85, 95 %CI 0.67–0.93, respectively). We also developed a protein signature score (PSS) to guide PDAC diagnosis. In combination with patient age, the PSS achieved 100 % certainty in correctly identifying PDAC patients > 54 years. In addition, 3 /4 inconclusive EUS-FNA biopsies were correctly identified using PSS.
Conclusions EUS-FNA-derived fluid is a rich source of PDAC proteins with biomarker potential. The PSS requires further validation and verification of the feasibility of measuring these proteins in patient sera.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.