Showing papers by "Marc Giovannini published in 2022"

Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline

Abstract: Institutions 1 Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium 2 Department of Gastroenterology and Hepatology, Amsterdam UMC, Vrije Universiteit Amsterdam, AGEM Institute, Amsterdam, The Netherlands 3 Department of Gastroenterology and Hepatology, Imelda General Hospital, Bonheiden, Belgium 4 Department of Gastroenterology and Hepatology, Leeds Teaching Hospital NHS Trust, Leeds, UK 5 Department of Medical Gastroenterology, Asian Institute of Gastroenterology Hospitals, Gachibowli, Hyderabad, India 6 Gastroenterology Department, Colentina Clinical Hospital, Bucharest, Romania 7 Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic 8 Department of Surgery, Department of Gastroenterology and Hepatology, and Department of Advanced Interventional Endoscopy, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium 9 Department of Gastroenterology and Hepatology, Université catholique de Louvain, CHU UCL Namur, Yvoir, Belgium 10 Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA 11 Pancreatobiliary Endoscopy and Endosonography Division, IRCCS San Raffaele Scientific Institute, Milan, Italy 12 Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, and Center for Endoscopic Research Therapeutics and Training (CERTT), Catholic University, Rome, Italy 13 Paoli-Calmettes Institute, Department of Gastrointestinal Disease, Marseille, France 14 Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland, USA 15 Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, California, USA 16 Department of Gastroenterology, Aix-Marseille Université, APHM, Hôpital Nord, Marseille, France 17 Gastroenterology Department, Hospital Universitario Rio Hortega, Valladolid, Spain 18 Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands

Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review.

Abstract: 1: ESGE recommends a prolonged course of a prophylactic broad-spectrum antibiotic in patients with ascites who are undergoing therapeutic endoscopic ultrasound (EUS) procedures.Strong recommendation, low quality evidence. 2: ESGE recommends placement of partially or fully covered self-expandable metal stents during EUS-guided hepaticogastrostomy for biliary drainage in malignant disease.Strong recommendation, moderate quality evidence. 3: ESGE recommends EUS-guided pancreatic duct (PD) drainage should only be performed in high volume expert centers, owing to the complexity of this technique and the high risk of adverse events.Strong recommendation, low quality evidence. 4: ESGE recommends a stepwise approach to EUS-guided PD drainage in patients with favorable anatomy, starting with rendezvous-assisted endoscopic retrograde pancreatography (RV-ERP), followed by antegrade or transmural drainage only when RV-ERP fails or is not feasible.Strong recommendation, low quality evidence. 5: ESGE suggests performing transduodenal EUS-guided gallbladder drainage with a lumen-apposing metal stent (LAMS), rather than using the transgastric route, as this may reduce the risk of stent dysfunction.Weak recommendation, low quality evidence. 6: ESGE recommends using saline instillation for small-bowel distension during EUS-guided gastroenterostomy.Strong recommendation, low quality evidence. 7: ESGE recommends the use of saline instillation with a 19G needle and an electrocautery-enhanced LAMS for EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) procedures.Strong recommendation, low quality evidence. 8: ESGE recommends the use of either 15- or 20-mm LAMSs for EDGE, with a preference for 20-mm LAMSs when considering a same-session ERCP.Strong recommendation, low quality evidence.

Management of asymptomatic sporadic non-functioning pancreatic neuroendocrine neoplasms no larger than 2 cm: interim analysis of prospective ASPEN trial.

Abstract: Stefano Partelli , Sara Massironi , Alessandro Zerbi, Patricia Niccoli, Wooil Kwon , Luca Landoni, Francesco Panzuto, Ales Tomazic, Alberto Bongiovanni, Gregory Kaltsas, Alain Sauvanet, Emilio Bertani, Vincenzo Mazzaferro , Martyn Caplin, Thomas Armstrong, Martin O. Weickert, John Ramage, Eva Segelov , Giovanni Butturini, Stefan Staettner, Mauro Cives, Andrea Frilling, Carol Anne Moulton, Jin He , Florian Boesch, Andreas Selberheer, Orit Twito, Antonio Castaldi , Claudio G. De Angelis, Sebastien Gaujoux , Katharina Holzer, Colin H. Wilson, Hussein Almeamar, Emanuel Vigia, Francesca Muffatti, Martina Lucà, Andrea Lania, Jacques Ewald, Hongbeom Kim , Roberto Salvia, Maria Rinzivillo, Alojz Smid, Andrea Gardini, Marina Tsoli, Olivia Hentic, Samuele Colombo, Davide Citterio, Christos Toumpanakis, Emma Ramsey, Harpal S. Randeva, Ray Srirajaskanthan, Daniel Croagh, Paolo Regi, Silvia Gasteiger, Pietro Invernizzi, Cristina Ridolfi, Marc Giovannini, Jin-Young Jang, Claudio Bassi and Massimo Falconi*

EUS-guided hepaticogastrostomy in patients with obstructive jaundice after failed or impossible endoscopic retrograde drainage: A multicenter, randomized phase II Study

Abstract: Background and Objectives: Over the last two decades, EUS-guided hepaticogastrostomy (EUS-HGS) has emerged as a therapeutic alternative for patients with biliary obstruction and failed ERCP. Percutaneous transhepatic biliary drainage (PTBD) as the gold standard is associated with relevant morbidity and need for re-intervention. The aim of our work was to evaluate in a phase II study the safety and efficacy profile of EUS-HGS. A PTBD arm was considered a control group. Patients and Methods: We conducted a prospective, randomized, noncomparative phase II study in three French tertiary centers involving patients with benign or malignant obstructive jaundice after failure of ERCP. Patients were randomized to either PTBD or EUS-HGS. Results: Fifty-six patients (mean age 64 years) have been included between 2011 and 2015. Twenty-one underwent PTBD and thirty-five were drained using EUS-HGS. An interim analysis after the inclusion of 41 patients revealed an unexpected high 30-day morbidity rate for PTBD (13 out of 21 patients), justifying to stop randomization and inclusion in this control arm in 2013. The primary objective was reached with 10 out of the 35 EUS-HGS patients (28.6%) having observed complications (90%-level bilateral exact binomial confidence interval [CI] [16.4%–43.6%], left-sided exact binomial test to the objectified 50% unacceptable rate P = 0.0083). Both methods achieved comparable technical success rate (TSR) and clinical success rate (CSR) (TSR: PTBD 100% vs. EUS-HGS 94.3%, P = 0.28; CSR: PTBD 66.7% vs. EUS-HGS 80%, P = 0.35). Long-term follow-up showed EUS-HGS patients being at lower risk for re-intervention (relative risk = 0.47, 95% CI [0.27–0.83]). Conclusion: In cases of ERCP failure, EUS-HGS is a valuable alternative for biliary drainage with a high TSR and CSR. PTBD is associated with an unacceptable 30-day morbidity rate, whereas EUS-HGS seems to have a decent safety profile, suggesting that it may be the treatment of choice in appropriately selected patients.

Endoscopic ultrasound-guided radiofrequency ablation for pancreatic insulinoma: experience in two tertiary centers

Abstract: Aims Insulinoma is the most frequent functional neuroendocrine tumor of the pancreas and preserving surgery its treatment of choice. Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) is a novel and promising technique that induces tissue necrosis of localized lesions. This study presents a preliminary clinical experience in treating pancreatic insulinomas<2 cm by EUS-RFA, focusing on safety and efficacy.

A novel case of biliary common bile duct reconstruction by the rendezvous technique using endoscopic cholangioscopy and percutaneous cholangioscopy

Abstract: Biliary tract injuries during cholecystectomy are a rare, but not exceptional, adverse event, with severe consequences. The Strasberg classification with Bismuth modification is most frequently used to classify biliary tract injuries [1, 2]. Expertise in endoscopic, radiologic, and surgical management is required, especially for major biliary tract injuries [3]. A transhepatic-endoscopic approach is useful in difficult cases [4, 5]. We aim to describe a new solution after failure of the standard rendezvous technique, namely double cholangioscopy rendezvous. A 21-year-old woman developed jaundice 3 months after she underwent cholecystectomy for lithiasis. The patient was referred to our center after undergoing an initial endoscopic retrograde cholangiopancreatography (ERCP), which was unsuccessful because of a blockage below the hilum (Strasberg–Bismuth E2) (▶Fig. 1). A repeat ERCP attempt also resulted in failure, and external percutaneous drainage was required, with an 8.5-Fr drain placed. The patient’s jaundice subsequently decreased. A joint decision was made by the gastroenterologists and surgeons to perform the rendezvous technique to avoid a hepaticojejunostomy with a high risk of secondary stricture because of its proximity to the convergence. The first attempt made at this procedure was unsuccessful, and the 8.5-Fr percutaneous drain was replaced with a 12-Fr drain (▶Fig. 2 a). A second attempt using simultaneous percutaneous cholangioscopy and ERCP was scheduled for a few days later (▶Video 1), but this repeat classical rendezvous technique was a failE-Videos

Anatomic and hemodynamic findings during endoscopic ultrasound-guided angiography of gastric varices: a note of caution for endoscopic ultrasound-guided therapy

Abstract: Endoscopic ultrasound (EUS)-guided therapy of gastric varices, first reported as the use of a cyanoacrylate (CYA) injection [1], now includes the deployment of coils without CYA [2] and the combined method, involving deployment of one to two coils followed by an injection of CYA [3]. Regardless of the method used, EUSguided therapy of gastric varices is increasingly performed because of its safety profile and accuracy. EUS-guided angiography can be used to assess fluidodynamics, the anatomy of gastric varices, and gastrorenal shunt (GRS) patency. We present some of our findings after EUS-guided angiography, injecting hydrosoluble or liposoluble contrast through 19-gauge needles in the perforating feeding vein, during EUS-guided therapy of gastric varices with coil deployment only (▶Fig. 1). ▶Video 1 shows four examples of our findings. Case A shows high blood flow clearing the contrast immediately. Case B shows the contrast flowing through five coils towards the GRS and the inferior vena cava (IVC). Case C shows the liposoluble contrast (Lipiodol) seeming to be retained after deploying sixteen coils but some droplets passing to the GRS and the IVC. Case D shows the passage of contrast through five coils towards the GRS and IVC. In all of these cases, gastric variceal obliteration was achieved. These findings could explain the results of two studies that used CYA mixed with Lipiodol and performed a chest computed tomography scan after the EUS-guided procedure [4, 5]. One study found a 47% rate of asymptomatic pulmonary glue embolism after EUS-guided injection of CYA [4]. The other study, which compared endoscopic injection of CYA with the EUS-guided combined technique (coil + CYA), found asymptomatic pulmonary glue embolism in 50% and 25% of patients, respectively [5]. The rationale for the use of CYA after deploying coils is that the glue is trapped by the coils. However, some studies [4, 5] and the cases shown in ▶Video 1 raise a note of caution on the use of CYA. EUSguided angiography evaluates fluidodynamic behavior of hydrosoluble/liposoluble contrasts, providing an insight into the behavior of any substance injected in such large, high flow blood vessels, even when multiple coils have previously been deployed, and would be helpful if EUSE-Videos

Efficiency of an endoscopic resection strategy for management of submucosal tumors < 20 mm in the upper gastrointestinal tract

Abstract: Background and study aims The histologic diagnosis of submucosal tumors (SMTs) < 20 mm is challenging. Monitoring is the main option offered, but compliance is debatable. Endoscopic resection (ER) of malignant SMTs or those with an uncertain diagnosis is an alternative that has already been reported about and proposed in our center. The aims of this study were to confirm the safety of this resection strategy and to perform long-term follow-up of malignant SMTs after resection. Patients and methods All patients who underwent ER for SMTs < 2 cm in a single center between 2007 and 2019 were included retrospectively. Patients were classified into two groups according to the need for postresection follow-up: benign SMTs (B-SMTs) and follow-up SMTs (FU-SMTs). Results One hundred and one patients were included. The mean tumor size was 16.7 mm. In total, 92 of 101 SMTs had an uncertain diagnosis. Macroscopic resection was completed for 95 SMTs (93.1 %), with en bloc resection in 94 (92.1%). The morbidity rate was 3 %, with no mortality. A total of 84 of 101 SMTs (84 %) were B-SMTs and did not need monitoring, and 17 SMTs (19.7 %) were FU-SMTs (8 gastrointestinal stromal tumors, 6 neuroendocrine tumors, and 3 others). No relapse was reported in the FU-SMT group, with a median follow-up duration of 33 months [4–127] (61 months [17–127] for the gastrointestinal stroma tumor group). Conclusions The study results suggest ER is a potentially reliable and effective strategy for upper gastrointestinal tract SMTs < 20 mm. Although the strategy needs further validation in advanced care units, it could eliminate the need for long-term monitoring, therefore targeting such follow-up efforts to patients with FU-SMTs.

EUS-guided drainage of the pancreatic duct for the treatment of postoperative stenosis of pancreatico-digestive anastomosis or pancreatic duct stenosis complicating chronic pancreatitis: Experience at a tertiary care center

Abstract: Background and Objectives: For the treatment of pancreatic duct stenosis due to chronic pancreatitis (CP) or postoperative (PO) stenosis, endoscopic procedures are usually the first choice. In cases of failure of the recommended treatment by ERCP, anastomosis between the Wirsung duct and the stomach or duodenum can be performed under EUS guidance. The objective of this retrospective study was to compare the outcomes of pancreatico-gastric or pancreaticoduodenal anastomosis under EUS for PO stenosis versus CP stenosis. Subjects and Methods: This was a retrospective, single-center, consecutive case study of patients who underwent EUS-guided Wirsungo-gastric/bulbar anastomosis. Results: Forty-three patients were included. Twenty-one patients underwent treatment for PO stenosis, and 22 patients underwent treatment for CP stenosis. The technical success rate was 95.3% (41/43), with 100% in cases of PO stenosis and 90.9% in cases of CP stenosis. The clinical success rate was 72.5% (29/40): 75% (15/20) in cases of PO stenosis and 70% (14/20) in cases of CP stenosis. The overall morbidity rate was 34.9% (15/43). The main complication was postprocedural pain, occurring in 20.9% (9/443) of patients. The rate of stent migration or obstruction was 27.9% (12/43). There was no difference in patient outcomes or morbidity according to the etiology of the stenosis. The median follow-up duration in this study was 14 months. Conclusions: EUS-guided Wirsungo-gastric/duodenal anastomosis is a feasible, minimally invasive, safe, and relatively effective procedure. The rates of technical success, clinical success, and complications were not different between patients with PO and CP stenosis. However, the follow-up period was too short to assess recurrent symptoms in these patients.

Endoscopic papillectomy for ampullary lesions in patients with familial adenomatous polyposis compared with sporadic lesions: a propensity score-matched cohort

Abstract: BACKGROUND Familial-adenomatous-polyposis (FAP) is a rare inherited cancer predisposition syndrome. The treatment for FAP-related ampullary lesions (AL) is challenging and the role of endoscopic papillectomy (EP) is not elucidated yet. Data of FAP associated AL are limited and showed, at least in part, inconclusive results. We retrospectively analyzed the outcomes of EP in matched cohorts of FAP-related and sporadic ampullary lesions (SAL). METHODS The ESAP study included 1422 EPs. A propensity-score matching (nearest-neighbor-method) including age, gender, comorbidity, histologic subtype and size was performed. Main outcomes were complete resection (R0), technical success, complications and recurrence. RESULTS Propensity-score-based matching identified 202 patients (101 FAP, 101 SAL) with comparable baseline characteristics. FAP-patients were mainly asymptomatic (79.2% [95%CI 71.2-87.3] vs. 46.5% [95%CI 36.6-56.4]), p<0.001). The initial R0-rate was significantly lower in FAP-patients (63.4% [95%CI 53.8-72.9] vs. 83.2% [95%CI 75.8-90.6], p=0.001). After repeated (mean: 1.30 per patient) interventions, R0 was comparable (FAP 93.1% [95%CI 88.0-98.1] vs. SAL 97.0% [95%CI 93.7-100], p=0.194). The overall complication rate was 28.7%. Pancreatitis and bleeding were most common adverse events in both groups. Severe complications were very rare (3.5%). Twenty-one patients in the FAP-group (20.8% [95%CI 12.7-28.8]) and sixteen patients in the SAL-group (15.8% [95%CI 8.6-23.1], p=0.363) had a reccurence . Recurrences occurred later in FAP-patients (25 [95%CI 18.3-31.7] vs. 2 [95%CI CI 0.06-3.9] months). CONCLUSIONS EP is safe and effective in FAP-related ampullary lesions Criteria for endoscopic resection of AL can be extended to FAP-patients. FAP-patients have a life-time risk to relapse even after complete resection and require long-time-surveillance.

Evaluation of the ex-vivo porcine simulator on EUS-guided cystogastrostomy using lumen-apposing metal stent training

Abstract: Bckground and Objectives: EUS-guided cystogastrostomy is a well-established advanced endoscopic technique with a steep-learning curve which necessitates an ex-vivo simulator that would allow for adequate training. The aim of this study is to evaluate the feasibility of the model in allowing training for EUS-guided cystogastrostomy using lumen-apposing metal stent (LAMS). Subjects and Methods: The model was created by ROEYA Training Center, Egypt, using native porcine tissue to create fluid collections simulating both cystic and solid lesions. It was designed and tested in advance while the hydrogel was added on-site. The simulator was evaluated prospectively in five training sessions involving 17 international experts. The task was to successfully deploy the LAMS to drain the created cyst. After using the simulator, the experts were asked to fill a questionnaire to assess their experience. The primary endpoint was overall satisfaction with the model as a training tool. Results: All of the experts were satisfied with the model as a tool to train endoscopists for the technique. 76.5% (n = 11) of the experts thought the model to be moderately realistic. Proper visualization was reported by 94.1% of the experts. All experts believed the lesions to be either slightly like or very similar to real lesions. The model was graded “easy” in difficulty by 11 of the experts. Conclusions: In all parameters assessed, the experts thought the model to be a useful tool for future training. This preliminary study suggests that the aforementioned simulator can be used to train endoscopists on using LAMS in a risk-free environment.

Evaluation of the ex-vivo porcine simulator on EUS-guided cystogastrostomy using lumen-apposing metal stent training.

Abstract: Bckground and Objectives EUS-guided cystogastrostomy is a well-established advanced endoscopic technique with a steep-learning curve which necessitates an ex-vivo simulator that would allow for adequate training. The aim of this study is to evaluate the feasibility of the model in allowing training for EUS-guided cystogastrostomy using lumen-apposing metal stent (LAMS). Subjects and Methods The model was created by ROEYA Training Center, Egypt, using native porcine tissue to create fluid collections simulating both cystic and solid lesions. It was designed and tested in advance while the hydrogel was added on-site. The simulator was evaluated prospectively in five training sessions involving 17 international experts. The task was to successfully deploy the LAMS to drain the created cyst. After using the simulator, the experts were asked to fill a questionnaire to assess their experience. The primary endpoint was overall satisfaction with the model as a training tool. Results All of the experts were satisfied with the model as a tool to train endoscopists for the technique. 76.5% (n = 11) of the experts thought the model to be moderately realistic. Proper visualization was reported by 94.1% of the experts. All experts believed the lesions to be either slightly like or very similar to real lesions. The model was graded "easy" in difficulty by 11 of the experts. Conclusions In all parameters assessed, the experts thought the model to be a useful tool for future training. This preliminary study suggests that the aforementioned simulator can be used to train endoscopists on using LAMS in a risk-free environment.

Impact of fiducial markers placement on the delineation of target volumes in radiation therapy for oesophageal cancer: FIDUCOR study

Abstract: Purpose This prospective monocentric phase II study (FIDUCOR-study, NCT02526134) aimed to assess the impact of fiducial markers (FMs) implantation on conformal chemo-radiation therapy (CRT) planning in oesophageal carcinoma (EC) patients. Methods/materials Fifteen EC patients were enrolled in the study. Each patient underwent two simulation CT-scans before (CT1) and after (CT2) FMs implantation, in the same position. FMs (3 mm length gold markers, preloaded in a 22G needle) were implanted after sedation, under endoscopic ultrasound (EUS) and X-Ray guidance, and were placed at the tumor’s extremities, and in the visible lymph nodes. Target delineation and treatment plan were both performed first on CT1 with the assistance of diagnosis CT, gastroscopy and EUS details, and second on CT2 using FMs and CT-data. The value of FMs implantation was assessed by the difference of growth-tumor-volume (GTV) and clinical-target-volume (CTV) between CT1-based and CT2-based delineation. A significant difference was defined as a ≥5 mm-difference on axial(x) or coronal(y) slices, a ≥10mm-difference on sagittal slices, or a ≥20%-difference in GTV. The impact on dose distribution in organs at risk (OAR) (lung, heart, liver) was also studied. Results Between 09/2014 and 12/2015, 15 patients could achieve fiducial procedures, without any complication. One FM migration occurred. We observed a significant modification of the GTV-dimension in 100% of the cases (15/15, 95%CI: [78.2;100.0]), mainly due to a difference in sagittal dimension with a mean variation of 11.2 mm and a difference> 10 mm for 8/15 patients (53.3%). One patient had a significant isocenter displacement as high as 20 mm. The oesophagus tumor was not seen on the CT-scan in one patient due to its small size. One patient had a distant lymph node metastasis not visible on CT-scan. We observed no significant impact on OAR distribution. Conclusion In our study, FMs-implantation under EUS had a positive impact on accurate volume definition in EC-patients (modification of GTV in 15/15 patients). Close cooperation between gastroenterologist and radiation oncologist has the potential to improve local treatment of oesophageal carcinoma.

Reply to the letter to the editor

Abstract: We thank Dr Rimbas and his colleagues for their interest in our case series on endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) of nonfunctional pancreatic neuroendocrine tumors (NFpNETs) ≤2 cm in 27 patients. Regarding the rate of complications, Rimbas and colleagues questioned whether EUS-RFA treatment was justified in lesions with a size of 9–10 mm. Adverse events occurred during the first nine procedures. In the absence of significant technical modifications, we suggest that there is a learning curve effect with a better proficiency after a certain number of procedures. As such, the morbidity rate today might be lower than reported in our case series. The morbidity rate of pancreatic surgery, in contrast, is considerable. Therefore, current guidelines consider surveillance as a reasonable alternative strategy for G1 or low-grade G2 pNETs ≤2 cm. However, several observational studies showed that approximately one-fifth of small NFpNETs progressed during follow-up, and the rate of secondary surgery ranges between 3% and 25%, with potential high morbidity and without alternative curative treatment by EUS-RFA. As a result, we are not convinced that endoscopic treatment should be reserved for pancreatic head lesions. More prospective studies are needed, but the technique is very promising. As the risk of malignancy in small NFpNETs is estimated to be 5–8%, careful patient selection is mandatory, and patients with metastatic lymph nodes have to be excluded, as is the case for parenchymalsparing surgery. In conclusion, we think that EUS-RFA is the current treatment of choice for G1 pNETs ≤2 cm, as it has an excellent efficacy and an acceptable safety profile, whereas surveillance of these potentially malignant lesions is associated with considerable costs and patient anxiety. Authors declare no conflict of interest for this article.

Do we need postoperative chemotherapy after preoperative FOLFIRINOX in resected borderline or locally advanced pancreatic cancer? A retrospective analysis.

Abstract: 4150 Background: Pancreatic ductal adenocarcinoma (PDAC) has poor outcome and surgical resection remains the only curative treatment. Post-operative (Post-Op) chemotherapy (CT) improves survival and FOLFIRINOX (FFX) regimen is the standard of care. Increasing number of patients with borderline resectable (BL) or locally advanced (LA) disease are treated with pre-operative (Pre-Op) CT with FFX. However, the benefit of Post-Op CT after Pre-Op FFX remains unclear. The aim of this study was to analyze the impact on survival of Post-Op CT in patients with resected BL or LA PDAC after Pre-Op FFX CT. Methods: 116 consecutive patients treated at the Institut Paoli-Calmettes comprehensive cancer center between 2014 and 2020 were retrospectively analyzed. All patients underwent pancreatectomy after Pre-Op FFX for a BL or LA PDAC. Patients who progressed or died within 3 months after surgery were excluded from the analysis. We compared median relapse-free survival (mRFS) and median overall survival (mOS) defined by time from surgery to relapse or death in patients who received or not Post-Op CT. Results: 116 patients (80% BL, 20% LA) were included: 82 received Post-Op CT (CT+) and 34 did not (CT-). The median number of Pre-Op FFX cycles was 4 in the CT+ group vs 6 in the CT- group. 24 (29.3%) patients received Post-Op FFX, 37 (45.1%) received Gemcitabine, 9 (11%) received Gemcitabine + Capecitabine, and 9 (11%) received a 5FU-based CT. Median time between surgery and first Post-Op CT cycle was 63 days. No difference in mRFS nor in mOS were found between CT+ and CT- groups: mRFS 15.0 vs 13.6 months, HR 1.1 [IC95% 0.69–1.77] and mOS 33.8 vs 36.1 months, HR 0.94 [IC95% 0.55–1.60]. Among patients with pathologic node positive disease (N+) (n = 79), mRFS was 13.9 months in the CT+ group vs 6.9 months in the CT- group (HR 0.68 [IC 0.35 – 1.19]), and mOS was 31.8 months in the CT+ group vs 16.5 months in the CT- group (HR 0.96 [IC95% 0.51-1.81]). Patients who received peri-operative (Peri-Op) FFX (n = 24) experienced longer mOS compared to patients who received Gemcitabine Post-Op CT: NR vs 33.8 months, HR 0.45 [IC95% 0.25-1.02]. Patients who received Peri-Op CT for a total of six months or more (n = 31) had increased mOS (55 vs 32 months, HR 0.61 [IC 95% 0.37- 1.11] and mRFS (16 vs 14 months HR 0.80, [IC95% 0.50 -1.31]) than patients receiving less than 6 months Peri-Op CT (n = 85) Conclusions: Post-Op CT does not clearly impact survival in BL or LA pancreatic cancer pretreated with Pre-Op FFX. We observed a trend in the N+ population for a survival benefit. Peri-Op FFX was associated with longer survival than Gemcitabine Post-Op regimen. Further randomized data are needed to assess the impact of Peri-Op FFX for these patients

Correction: Efficiency of an endoscopic resection strategy in the management of submucosal tumors less than 20 mm in size and located in the upper gastrointestina

Abstract: [This corrects the article DOI: 10.1055/a-1783-8675.].

Radiofrequency ablation of malignant cervical lymph nodes: an unusual treatment for dysphagia

Abstract: Radiofrequency ablation (RFA) has been used for the treatment of nonfunctional pancreatic neuroendocrine tumors (PNETs) < 2 cm [1], functional PNETs (insulinoma) [2], pancreatic metastasis of kidney cancer [3], and isolated cases of intraductal papillary mucinous neoplasm (IPMN) with worrisome features [4]. We describe the use of RFA to treat a compressive cervical lymph node causing dysphagia (▶Video 1). A 64-year-old woman undergoing palliative care for metastatic cervical cancer was treated with several lines of chemotherapy (cisplatin-paclitaxel, capecitabine, vinorelbine, paclitaxel, carboplatin, topotecan). The patient presented rapidonset, dysphagia progressing to grade IV due to a large cervical area lymph node metastasis. The patient had already undergone radiotherapy on the cervical area during the management of her disease. The stenosis was also too close to Killian’s triangle to place an esophageal stent. After discussion with the patient and because she could not swallow her own saliva without discomfort, we proposed the use of endoscopic ultrasoundguided RFA on the cervical area lymph nodes. RFA was performed with a therapeutic linear echoendoscope under carbon dioxide insufflation using EUS-RFA (Starmed/ TaeWoong Medical, Gimpo, South Korea). The procedure was performed with the patient sedated and intubated. Radiofrequency power was typically applied (50W) until the appearance of hyperechoic bubbles. The patient underwent one session of RFA, with two total RFA shots administered. Clinicians should be careful to not perform RFA too close to the esophageal wall to avoid potential fistula. The goal of the treatment was necrosis of the posterior part of the lymph node. After 2 days, the dysphasia was reduced to grade I. After 4 months, the patient received only supportive care owing to disease progression. RFA is a promising minimally invasive technique mainly described for PNETs, but additional applications are expected.

EUS-guided hepaticogastrostomy in patients with obstructive jaundice after failed or impossible endoscopic retrograde drainage: A multicenter, randomized phase II Study

Abstract: ABSTRACT Background and Objectives: Over the last two decades, EUS-guided hepaticogastrostomy (EUS-HGS) has emerged as a therapeutic alternative for patients with biliary obstruction and failed ERCP. Percutaneous transhepatic biliary drainage (PTBD) as the gold standard is associated with relevant morbidity and need for re-intervention. The aim of our work was to evaluate in a phase II study the safety and efficacy profile of EUS-HGS. A PTBD arm was considered a control group. Patients and Methods: We conducted a prospective, randomized, noncomparative phase II study in three French tertiary centers involving patients with benign or malignant obstructive jaundice after failure of ERCP. Patients were randomized to either PTBD or EUS-HGS. Results: Fifty-six patients (mean age 64 years) have been included between 2011 and 2015. Twenty-one underwent PTBD and thirty-five were drained using EUS-HGS. An interim analysis after the inclusion of 41 patients revealed an unexpected high 30-day morbidity rate for PTBD (13 out of 21 patients), justifying to stop randomization and inclusion in this control arm in 2013. The primary objective was reached with 10 out of the 35 EUS-HGS patients (28.6%) having observed complications (90%-level bilateral exact binomial confidence interval [CI] [16.4%–43.6%], left-sided exact binomial test to the objectified 50% unacceptable rate P = 0.0083). Both methods achieved comparable technical success rate (TSR) and clinical success rate (CSR) (TSR: PTBD 100% vs. EUS-HGS 94.3%, P = 0.28; CSR: PTBD 66.7% vs. EUS-HGS 80%, P = 0.35). Long-term follow-up showed EUS-HGS patients being at lower risk for re-intervention (relative risk = 0.47, 95% CI [0.27–0.83]). Conclusion: In cases of ERCP failure, EUS-HGS is a valuable alternative for biliary drainage with a high TSR and CSR. PTBD is associated with an unacceptable 30-day morbidity rate, whereas EUS-HGS seems to have a decent safety profile, suggesting that it may be the treatment of choice in appropriately selected patients.