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.

Lumen-apposing metal stent through the meshes of duodenal metal stents for palliation of malignant jaundice.

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard procedure for malignant jaundice palliation; however, it can be challenging when a duodenal self-expandable metal stent (SEMS) is already in place. Patients and methods The primary aim of our study was to evaluate the technical feasibility of the placement of a lumen apposing metal stent (LAMS) through the mesh (TTM) of duodenal stents. The secondary aims were to evaluate clinical outcomes and adverse events (AEs) related to the procedures. Results Data from 23 patients (11 F and 12 M; mean age: 69.5 ±â€Š11 years old) were collected. In 17 patients (73.9 %) TTM LAMS placement was performed as first intention, while in six patients (26.1 %) it was performed after a failed ERCP. Thirteen patients (56.5 %) underwent the procedure due to advanced pancreatic head neoplasia. One technical failure was experienced (4.3 %). The TTM LAMS placement led to a significant decrease in the serum levels of bilirubin, ALP, GGT, WBC and CRP. No cases of duodenal SEMS occlusion occurred and no other AEs were observed during the follow-up. Conclusions Concomitant malignant duodenal and biliary obstruction is a challenging condition. Palliation of jaundice using TTM LAMS in patients already treated with duodenal stent is associated to promising technical and clinical outcomes.

Endoscopic ultrasound-guided choledochoduodenostomy with a lumen-apposing metal stent through an uncovered metal duodenal stent.

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) in patients with a preexisting duodenal stent is particularly challenging and has a low success rate. Endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) has been increasingly used as an alternative to percutaneous transhepatic biliary drainage after failed ERCP. EUS-guided choledochoduodenostomy (EUS-CD) and EUS-guided hepaticogastrostomy (EUS-HGS) have been reported to have similar efficacity. Recently, a novel dedicated fully-covered lumen-apposing metal stent (LAMS) has been developed for EUS-CD (Hot AXIOS; Boston Scientific, Massachusetts, United States). It seems that this new device decreases the morbidity of EUS-CD. We present a case in which EUS-CD with LAMS through an uncovered metal duodenal stent was used successfully.

Invitation letter with a standardized form is a reliable tool to exclude increased risk patients from organized fecal immunological testing-based colorectal cancer screening program.

In Europe, screening guidelines for colorectal cancer (CRC) recommend colonoscopy for high-risk patients and fecal immunological testing (FIT) for the standard-risk group. Currently, there is not any validated screening tool to exclude high-risk patients. The aim of the study is to evaluate the validity of exclusion and evaluate the follow-up of patients identified as increased risk for CRC. In this retrospective study using a prospective database, patients at increased risk were identified using the standardized form and then excluded from the FIT screening invitation. A specific questionnaire was sent to all patients at increased risk in order to confirm the reason for the exclusion and evaluate their follow-up. Among 220 695 eligible individuals, 16 693 (7.5%) were excluded after being characterized at increased risk using the standardized form. The questionnaire was sent to these 16.693 excluded patients and completed by 5076 (30.7%) patients. Validity of exclusion was confirmed in 92% of cases. Endoscopic follow-up was in agreement with guideline in 89% of persons at increased risk (inflammatory bowel disease 93%, personal history of CCR 92%, of colonic polyps 82%, family history of CRC 77%). This study suggests that the standardized form is a reliable tool to correctly exclude from the screening program 92% of patients at increased risk for CRC.

Endoscopic ultrasound-guided hepaticogastrostomy versus percutaneous transhepatic drainage for malignant biliary obstruction after failed endoscopic retrograde cholangiopancreatography: a retrospective expertise-based study from two centers.

BACKGROUND: Percutaneous transhepatic biliary drainage (PTBD) is widely performed as a salvage procedure in patients with unresectable malignant obstruction of the common bile duct (CBD) after failed endoscopic retrograde cholangiopancreatography (ERCP) or in case of surgically altered anatomy. Endoscopic ultrasound-guided hepaticogastrostomy (EU-HGS) is a more recently introduced alternative to relieve malignant obstructive jaundice. The aim of this prospective observational study was to compare the outcome, efficacy and adverse events of EU-HGS and PTBD. METHODS: From April 2012 to August 2015, consecutive patients with malignant CBD obstruction who underwent EU-HGS or PTBD in two tertiary-care referral centers were included. The primary endpoint was the clinical success rate. Secondary endpoints were technical success, overall survival, procedure-related adverse events, incidence of adverse events, and reintervention rate. RESULTS: A total of 51 patients (EU-HGS, n = 31; PTBD, n = 20) were included. Median survival was 71 days (range 25-75th percentile; 30-95) for the EU-HGS group and 78 days (range 25-75th percentile; 42-108) for the PTBD group (p = 0.99). Technical success was achieved in all patients in both groups. Clinical success was achieved in 25 (86%) of 31 patients in the EU-HGS group and in 15 (83%) of 20 patients in the PTBD group (p = 0.88). There was no difference in adverse events rates between the two groups (EU-HGS: 16%; PTBD: 10%) (p = 0.69). Four deaths within 1 month (two hemorrhagic and two septic) were considered procedure related (two in the EU-HGS group and two in the PTBD group). Overall reintervention rate was significantly lower after EU-HGS (n = 2) than after PTBD (n = 21) (p = 0.0001). Length of hospital stay was shorter after EU-HGS (8 days versus 15 days; p = 0.002). CONCLUSIONS: EU-HGS can be an effective and safe mini invasive-procedure alternative to PTBD, with similar success and adverse-event rates, but with lower rates of reintervention and length of hospitalization.

Is EUS-guided drainage a suitable alternative technique in case of proximal biliary obstruction?

BACKGROUND: Results of endoscopic ultrasound-guided biliary drainage (EUBD) are unknown in case of proximal stricture. The aim is to assess clinical outcomes of EUBD in patients with malignant hilar obstruction. METHODS: Patients undergoing EUBD with hilar strictures were prospectively included. Primary outcome was clinical success at 7 and 30 days (defined by 50% bilirubin decrease). Secondary outcomes were technical success, procedure-related complications, length of hospital stay, reintervention rate, survival and chemotherapy administration. RESULTS: Eighteen patients with a mean age of 68.8 years were included. On 15 classable stenosis, 7 (47%) were noted Bismuth I-II, 7 (47%) Bismuth III, and 1 (6.7%) Bismuth IV. Reasons for EUBD were surgically modified anatomy in 10 patients (55.6%), impassable stricture at ERCP in 7 (38.9%) and duodenal obstruction in 1 (5.6%). Only hepaticogastrostomy was performed. Clinical success was at day 7 and 30 respectively 72.2% and 68.8%. Technical success was 94%. Complications occurred in 3 (16.7%) patients. Median (range) length of hospital stay was 10 (6-35) days. Reintervention rate was 16.7%. Median (range) survival was 79 (5-390) days. Chemotherapy was possible in 10 (55.6%) patients. CONCLUSIONS: EUBD is feasible for hilar obstruction for surgically altered anatomy or after ERCP failure. Clinical outcome is satisfactory when considering underlying advanced disease, allowing chemotherapy.

Interoperative Biopsy Site Relocalization in Endoluminal Surgery.

Barrett's oesophagus, a premalignant condition of the oesophagus has been on a rise in the recent years. The standard diagnostic protocol for Barrett's involves obtaining biopsies at suspicious regions along the oesophagus. The localization and tracking of these biopsy sites "interoperatively" poses a significant challenge for providing targeted treatments and tracking disease progression. This paper proposes an approach to provide guided navigation and relocalization of the biopsy sites using an electromagnetic tracking system. The characteristic of our approach over existing ones is the integration of an electromagnetic sensor at the flexible endoscope tip, so that the endoscopic camera depth inside the oesophagus can be computed in real time, allowing to retrieve and display an image from a previous exploration at the same depth. We first describe our system setup and methodology for interoperative registration. We then propose three incremental experiments of our approach. First, on synthetic data with realistic noise model to analyze the error bounds of our system. The second on in vivo pig data using an optical tracking system to provide a pseudo ground truth. Accuracy results obtained were consistent with the synthetic experiments despite uncertainty introduced due to breathing motion, and remain inside acceptable error margin according to medical experts. Finally, a third experiment designed using data from pigs to simulate a real task of biopsy site relocalization, and evaluated by ten gastro-intestinal experts. It clearly demonstrated the benefit of our system toward assisted guidance by improving the biopsy site retrieval rate from 47.5% to 94%.