Risk factors for EUS-guided radiofrequency ablation adverse events in patients with pancreatic neoplasms: a large national French study (RAFPAN study).

BACKGROUND AND AIMS: EUS-guided radiofrequency ablation (EUS-RFA) has been described as a potentially curative option for solid and cystic pancreatic neoplasms. We aimed to assess the safety and efficacy of pancreatic EUS-RFA in a large study population. METHODS: A retrospective study retrieving all consecutive patients who underwent pancreatic EUS-RFA during 2019 and 2020 in France was conducted. Indication, procedural characteristics, early and late adverse events (AEs), and clinical outcomes were recorded. Risk factors for AEs and factors related to complete tumor ablation were assessed on univariate and multivariate analyses. RESULTS: One hundred patients (54% men, 64.8 ± 17.6 years old) affected by 104 neoplasms were included. Sixty-four neoplasms were neuroendocrine neoplasms (NENs), 23 were metastases, and 10 were intraductal papillary mucinous neoplasms with mural nodules. No procedure-related mortality was observed, and 22 AEs were reported. Proximity of pancreatic neoplasms (≤1 mm) to the main pancreatic duct was the only independent risk factor for AEs (odds ratio [OR), 4.10; 95% confidence interval [CI), 1.02-15.22; P = .04). Fifty-nine patients (60.2%) achieved a complete tumor response, 31 (31.6%) a partial response, and 9 (9.2%) achieved no response. On multivariate analysis, NENs (OR, 7.95; 95% CI, 1.66-51.79; P < .001) and neoplasm size <20 mm (OR, 5.26; 95% CI, 2.17-14.29; P < .001) were independently related to complete tumor ablation. CONCLUSIONS: The results of this large study confirm an overall acceptable safety profile for pancreatic EUS-RFA. Close proximity (≤1 mm) to the main pancreatic duct represents an independent risk factor for AEs. Good clinical outcomes in terms of tumor ablation were observed, especially for small NENs.

Comparative evaluation of two porcine ex vivo models for training in endoscopic ultrasound-guided drainage of pancreatic fluid collections.

INTRODUCTION: EUS-guided cystoenterostomy (EUCE), a technique used for the drainage of pancreatic pseudocysts and peri-enteric collections, requires specific skills for which dedicated models are needed. Based on a compact EASIE model (Erlangen Active Simulator for Interventional Endoscopy), we developed two ex vivo porcine models of retrogastric cysts and evaluated learning performance within the frame of a structured training program. MATERIAL AND METHODS: The first model was made of porcine colon (i. e. "natural cyst"), the second one with an ostomy bag (i. e. "artificial cyst"). All procedures were achieved with an EUS scope under fluoroscopy. Both models were evaluated prospectively over a 2-day session involving 14 students and five experts. The primary end point was overall satisfaction with each model. RESULTS: The "natural cyst" and "artificial cyst" were prepared within 10 and 16.5 minutes ( P  = 0.78), respectively. Model grading showed a non-significant trend for overall satisfaction in favor of the artificial model ( P  = 0.06). As secondary end points, difference was not significant for impression of realism ( P  = 0.75) whereas the "artificial cyst" was graded significantly better by experts and students in terms of ability to teach procedural steps ( P  = 0.01) and ease of puncture ( P  = 0.03). Moreover, experts considered the ability to improve students' proficiency to be superior with the "artificial cyst" ( P  = 0.008). CONCLUSION: Both "artificial" and "natural cysts" are efficient for EUCE training in terms of overall satisfaction. However, the "artificial cyst" model appears to make the procedure easier with a higher ability to teach procedural steps and improve the students' proficiency. Larger applications of this model are needed to validate as a standard of training.

Amniotic membrane grafts for the prevention of esophageal stricture after circumferential endoscopic submucosal dissection.

BACKGROUND AND AIMS: The prevention of esophageal strictures following circumferential mucosal resection remains a major clinical challenge. Human amniotic membrane (AM) is an easily available material, which is widely used in ophthalmology due to its wound healing, anti-inflammatory and anti-fibrotic properties. We studied the effect of AM grafts in the prevention of esophageal stricture after endoscopic submucosal dissection (ESD) in a swine model. ANIMALS AND METHODS: In this prospective, randomized controlled trial, 20 swine underwent a 5 cm-long circumferential ESD of the lower esophagus. In the AM Group (n = 10), amniotic membrane grafts were placed on esophageal stents; a subgroup of 5 swine (AM 1 group) was sacrificed on day 14, whereas the other 5 animals (AM 2 group) were kept alive. The esophageal stent (ES) group (n = 5) had ES placement alone after ESD. Another 5 animals served as a control group with only ESD. RESULTS: The prevalence of symptomatic strictures at day 14 was significantly reduced in the AM group and ES groups vs. the control group (33%, 40% and 100%, respectively, p = 0.03); mean esophageal diameter was 5.8±3.6 mm, 6.8±3.3 mm, and 2.6±1.7 mm for AM, ES, and control groups, respectively. Median (range) esophageal fibrosis thickness was 0.87 mm (0.78-1.72), 1.19 mm (0.28-1.95), and 1.65 mm (0.7-1.79) for AM 1, ES, and control groups, respectively. All animals had developed esophageal strictures by day 35. CONCLUSIONS: The anti-fibrotic effect of AM on esophageal wound healing after ESD delayed the development of esophageal stricture in our model. However, this benefit was of limited duration in the conditions of our study.

Esophageal circumferential en bloc endoscopic submucosal dissection: assessment of a new technique.

BACKGROUND: Endoscopic esophageal piecemeal mucosectomy for high-grade dysplasia on Barrett's esophagus leads to suboptimal histologic evaluation, as well as recurrence on remaining mucosa. Circumferential en bloc mucosal resection would significantly improve the management of dysplastic Barrett's esophagus. Our aim was to describe a new method of esophageal circumferential endoscopic en bloc submucosal dissection (CESD) in a swine model. METHODS: After submucosal injection, circumferential incision was performed at each end of the esophageal segment to be removed. Mechanical submucosal dissection was performed from the proximal to the distal incision, using a mucosectomy cap over the endoscope. The removed mucosal ring was retrieved. Clinical, endoscopic, and histologic data were prospectively collected. RESULTS: Esophageal CESD was conducted on 5 pigs. A median mucosal length of 6.5 cm (range, 4 to 8 cm) was removed in the lower third of the esophagus. The mean duration of the procedure was 36 minutes (range, 17 to 80 min). No procedure-related complication, including perforation, was observed. All animals exhibited a mild esophageal stricture at day 7, and a severe symptomatic stricture at day 14. Necropsy confirmed endoscopic findings with cicatricial fibrotic strictures. On histologic examination, an inflammatory cell infiltrate, diffuse fibrosis reaching the muscular layer, and incomplete reepithelialization were observed. CONCLUSIONS: CESD enables expeditious resection and thorough examination of large segments of esophageal mucosa in safe procedural conditions, but esophageal strictures occur in the majority of the cases. Efficient methods for stricture prevention are needed for this technique to be developed in humans.

Effectiveness of combined endoscopic ultrasound-guided fine-needle aspiration biopsy and stenting in patients with suspected pancreatic cancer.

BACKGROUND: Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) can be coupled with endoscopic retrograde cholangiopancreatography in the same setting when biliary and/or duodenal stenting are required. AIMS: Our aim was to examine the effectiveness of EUS-FNA combined with stenting during the same session in patients with pancreatic cancer. METHODS: Consecutive patients referred for EUS-FNA of a pancreatic mass with symptoms of biliary (±upper digestive) obstruction were included. Consecutive patients undergoing biliary and/or duodenal stenting without EUS-FNA during the same period were used as controls. Procedure-related complications were the primary outcome measure. Duration of the procedure, ability to achieve biliary/duodenal stenting, the yield of EUS-FNA, and clinical outcomes were evaluated. RESULTS: A total of 122 patients underwent combined EUS-FNA and stenting and 68 underwent stenting alone (control group). In the combined group, histological proof of cancer was obtained in 88.52% at first EUS-FNA and 95.08% after a second EUS-FNA. Biliary stent placement was successful in 97.5 and 98% in the combined and the control groups, respectively. There was no statistical difference between the groups for length of stay after endoscopy and for procedure-related mortality and morbidity within 30 days. The median time from endoscopy to chemotherapy in the combined group was 12 days. CONCLUSION: Combined EUS-FNA and biliary and/or duodenal stenting is feasible in almost all patients with suspected pancreatic cancer, with no additional hazard and a high histological yield.

N-acetylcysteine for the prevention of stricture after circumferential endoscopic submucosal dissection of the esophagus: a randomized trial in a porcine model.

BACKGROUND: Circumferential endoscopic submucosal dissection (CESD) of the esophagus would allow for both the eradication of Barrett's esophagus and its related complications, such as advanced neoplasia. However, such procedures generally induce inflammatory repair resulting in a fibrotic stricture. N-acetylcysteine (NAC) is an antioxidant that has shown some efficacy against pulmonary and hepatic fibrosis. The aim of our study was to evaluate the benefit of NAC in the prevention of esophageal cicatricial stricture after CESD in a swine model. ANIMALS AND METHODS: Two groups of six pigs each were subjected to general anesthesia and CESD: after randomization, a first group received an oral NAC treatment regimen of 100 mg/kg/day, initiated one week before the procedure, whereas a second group was followed without any prophylactic treatment. Follow-up endoscopies took place seven, fourteen, twenty-one, and twenty-eight days after CESD. Necropsy, histological assessment of esophageal inflammation, and fibrosis were performed on day 28. RESULTS: The median esophageal lumen diameter on day 21 (main judgment criterion) was 4 mm (range 2 to 5) in group 1 and 3 mm (range 1 to 7) in group 2 (P = 0.95). No significant difference was observed between the two groups regarding clinical evaluation (time before onset of clinically significant esophageal obstruction), number of dilations, esophageal inflammation and fibrosis, or oxidative stress damage on immunohistochemistry. CONCLUSIONS: Despite its antioxidant effect, systemic administration of NAC did not show significant benefit on esophageal fibrosis in our animal model of esophageal wound healing within the experimental conditions of this study. Since the administered doses were relatively high, it seems unlikely that NAC might be a valuable option for the prevention of post-endoscopic esophageal stricture.

Mediastinal tuberculosis in an adult patient with cystic fibrosis.

Tuberculosis (TB) is rarely observed in cystic fibrosis (CF) patients. We report the first case of mediastinal TB, associated with leg pain and skin rash, in an adult patient with CF, and discuss factors suggestive of TB in the course of CF.

Temporary placement of partially covered self-expandable metal stents for anastomotic biliary strictures after liver transplantation: a prospective, multicenter study.

BACKGROUND: Management of anastomotic biliary strictures after liver transplantation deserves optimization. OBJECTIVE: To evaluate placement and removal of partially covered self-expandable metal stents (PCSEMSs) in this setting. DESIGN: Prospective, multicenter, uncontrolled study. SETTING: Three French academic hospitals with liver transplantation units and tertiary referral endoscopy centers. PATIENTS: Twenty-two patients (18 men, 4 women, aged 49.7 ± 12 years) with anastomotic biliary stricture. Seventeen (77.3%) presented stricture recurrence after plastic stenting. INTERVENTIONS: PCSEMSs were placed across the stricture for 2 months and then removed. Patients were followed by clinical examination and liver function tests 1, 3, 6, 9, and 12 months after PCSEMS removal. MAIN OUTCOME MEASUREMENT: The ability to remove PCSEMS. RESULTS: PCSEMS placement was successful in all patients, after sphincterotomy in 21 patients. Stent-related complications included minor pancreatitis (3 patients), transient pain (1 patient), and cholangitis (1 patient). Stent removal was achieved in all patients but 2 whose stents had migrated distally. Partial stent dislocation was noted in 5 patients (upward in 4, downward in 1). Complications associated with stent removal were minor, including self-contained hemorrhage (1 patient) and fever (1 patient). The stricture persisted at the end of treatment in 3 patients (13.6%), all of whom had stent migration or dislocation. Recurrence of anastomotic stricture after initial success occurred in 9 of 19 patients (47.4%) within 3.5 ± 2.1 months. Sustained stricture resolution was observed in 10 of 19 patients (52.6%), 45.6% from an intent-to-treat perspective. LIMITATIONS: Uncontrolled study with limited follow-up. CONCLUSIONS: Temporary placement and removal of PCSEMSs in anastomotic biliary strictures after liver transplantation is feasible, although sometimes demanding. Stent migration may impair final outcome.