Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): a multicentre randomised controlled trial.

BACKGROUND: Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is a novel endoscopic method to palliate malignant gastric outlet obstruction. We aimed to assess whether the use of EUS-GE with a double balloon occluder for malignant gastric outlet obstruction could reduce the need for reintervention within 6 months compared with conventional duodenal stenting. METHODS: The was an international, multicentre, randomised, controlled trial conducted at seven sites in Hong Kong, Belgium, Brazil, India, Italy, and Spain. Consecutive patients (aged ≥18 years) with malignant gastric outlet obstruction due to unresectable primary gastroduodenal or pancreatobiliary malignancies, a gastric outlet obstruction score (GOOS) of 0 (indicating an inability in intake food or liquids orally), and an Eastern Cooperative Oncology Group performance status score of 3 or lower were included and randomly allocated (1:1) to receive either EUS-GE or duodenal stenting. The primary outcome was the 6-month reintervention rate, defined as the percentage of patients requiring additional endoscopic intervention due to stent dysfunction (ie, restenosis of the stent due to tumour ingrowth, tumour overgrowth, or food residue; stent migration; or stent fracture) within 6 months, analysed in the intention-to-treat population. Prespecified secondary outcomes were technical success (successful placement of a stent), clinical success (1-point improvement in gastric outlet obstruction score [GOOS] within 3 days), adverse events within 30 days, death within 30 days, duration of stent patency, GOOS at 1 month, and quality-of-life scores. This study is registered with ClinicalTrials.gov (NCT03823690) and is completed. FINDINGS: Between Dec 1, 2020, and Feb 28, 2022, 185 patients were screened and 97 (46 men and 51 women) were recruited and randomly allocated (48 to the EUS-GE group and 49 to the duodenal stent group). Mean age was 69·5 years (SD 12·6) in the EUS-GE group and 64·8 years (13·0) in the duodenal stent group. All randomly allocated patients completed follow-up and were analysed. Reintervention within 6 months was required in two (4%) patients in the EUS-GE group and 14 (29%) in the duodenal stent group [p=0·0020; risk ratio 0·15 [95% CI 0·04-0·61]). Stent patency was longer in the EUS-GE group (median not reached in either group; HR 0·13 [95% CI 0·08-0·22], log-rank p<0·0001). 1-month GOOS was significantly better in the EUS-GE group (mean 2·41 [SD 0·7]) than the duodenal stent group (1·91 [0·9], p=0·012). There were no statistically significant differences between the EUS-GE and duodenal stent groups in death within 30 days (ten [21%] vs six [12%] patients, respectively, p=0·286), technical success, clinical success, or quality-of-life scores at 1 month. Adverse events occurred 11 (23%) patients in the EUS-GE group and 12 (24%) in the duodenal stent group within 30 days (p=1·00); three cases of pneumonia (two in the EUS-GE group and one in the duodenal stent group) were considered to be procedure related. INTERPRETATION: In patients with malignant gastric outlet obstruction, EUS-GE can reduce the frequency of reintervention, improve stent patency, and result in better patient-reported eating habits compared with duodenal stenting, and the procedure should be used preferentially over duodenal stenting when expertise and required devices are available. FUNDING: Research Grants Council (Hong Kong Special Administrative Region, China) and Sociedad Española de Endoscopia Digestiva.

Successful multidisciplinary urgent management of life-threatening intraprocedural bleeding after EUS-guided fine-needle biopsy of a pulmonary mass.

Video 1Multidisciplinary management of an intraprocedural endobronchial bleeding after EUS-guided transesophageal FNB of a pulmonary mass.

Complete intraperitoneal maldeployment of a lumen-apposing metal stent during EUS-guided gastroenteroanastomosis for malignant gastric outlet obstruction: rescue retrieval with peritoneoscopy through natural orifice transluminal endoscopic surgery.

Video 1Case showing a complete intraperitoneal maldeployment of a lumen-apposing metal stent during EUS-guided gastro-entero-anastomosis for malignant gastric outlet obstruction, which was rescued through a retrieval with peritoneoscopy through natural orifice transluminal endoscopic surgery.

A Systematic Review of Endoscopic Treatments for Concomitant Malignant Biliary Obstruction and Malignant Gastric Outlet Obstruction and the Outstanding Role of Endoscopic Ultrasound-Guided Therapies.

BACKGROUND: The treatments for cancer palliation in patients with concomitant malignant biliary obstruction (MBO) and gastric outlet obstruction (MGOO) are still under investigation due to the lack of evidence available in the medical literature. We performed a systematic search and critical review to investigate efficacy and safety among patients with MBO and MGOO undergoing both endoscopic ultrasound-guided biliary drainage (EUS-BD) and MGOO endoscopic treatment. METHODS: A systematic literature search was performed in PubMed, MEDLINE, EMBASE, and the Cochrane Library. EUS-BD included both transduodenal and transgastric techniques. Treatment of MGOO included duodenal stenting or EUS-GEA (gastroenteroanastomosis). Outcomes of interest were technical success, clinical success, and rate of adverse events (AEs) in patients undergoing double treatment in the same session or within one week. RESULTS: 11 studies were included in the systematic review for a total number of 337 patients, 150 of whom had concurrent MBO and MGOO treatment, fulfilling the time criteria. MGOO was treated by duodenal stenting (self-expandable metal stents) in 10 studies, and in one study by EUS-GEA. EUS-BD had a mean technical success of 96.4% (CI 95%, 92.18-98.99) and a mean clinical success of 84.96% (CI 95%, 67.99-96.26). The average frequency of AEs for EUS-BD was 28.73% (CI 95%, 9.12-48.33). Clinical success for duodenal stenting was 90% vs. 100% for EUS-GEA. CONCLUSIONS: EUS-BD could become the preferred drainage in the case of double endoscopic treatment of concomitant MBO and MGOO in the near future, with the promising EUS-GEA becoming a valid option for MGOO treatment in these patients.

Digital single-operator cholangioscopy in diagnostic and therapeutic bilio-pancreatic diseases: A prospective, multicenter study.

BACKGROUND AND AIM: Digital single-operator cholangioscopy (D-SOC) is an endoscopic procedure that is increasingly used for the management of bilio-pancreatic diseases. We aimed to investigate the efficacy and safety of D-SOC for diagnostic and therapeutic indications. METHODS: This is a multicenter, prospective study(January 2016-June 2019) across eighteen tertiary centers. The primary outcome was procedural success of D-SOC. Secondary outcomes were: D-SOC visual assessment and diagnostic yield of SpyBite biopsy in cases of biliary strictures, stone clearance rate in cases of difficult biliary stones, rate of adverse events(AEs) for all indications. RESULTS: D-SOC was performed in 369 patients (201(54,5%) diagnostic and 168(45,5%)therapeutic). Overall, procedural success rate was achieved in 360(97,6%) patients. The sensitivity, specificity, PPV, NPV and accuracy in biliary strictures were: 88,5%, 77,3%, 83,3%, 84,1% and 83,6% for D-SOC visual impression; 80,2%, 92,6%, 95,1%, 72,5% and 84,7% for the SpyBite biopsy, respectively. For difficult biliary stones, complete duct clearance was obtained in 92,1% patients (82,1% in a single session). Overall, AEs occurred in 37(10%) cases.The grade of AEs was mild or moderate for all cases, except one which was fatal. CONCLUSION: D-SOC is effective for diagnostic and therapeutic indications.Most of the AEs were minor and managed conservatively, even though a fatal event has happened that is not negligible and should be considered before using D-SOC.

Transesophageal endoscopic ultrasound in the diagnosis of the lung masses: a multicenter experience with fine-needle aspiration and fine-needle biopsy needles.

BACKGROUND AND AIM: Intraparenchymal lung masses inaccessible through bronchoscopy or endobronchial ultrasound guidance pose a diagnostic challenge. Furthermore, some fragile or hypoxic patients may be poor candidates for transbronchial approaches. Endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/FNB) offers a potential diagnostic approach to lung cancers adjacent to the esophagus. We aimed to evaluate the feasibility, accuracy, and safety of trans-esophageal EUS-FNA/FNB for tissue sampling of pulmonary nodules. METHODS: We retrospectively analyzed data from patients with pulmonary lesions who underwent EUS-FNA/FNB between March 2015 and August 2021 at eight Italian endoscopic referral centers. RESULTS: A total of 47 patients (36 male; mean age 64.47 ± 9.05 years) were included (22 EUS-FNAs and 25 EUS-FNBs). Overall diagnostic accuracy rate was 88.9% (76.3-96.2%). The sensitivity and diagnostic accuracy were superior for EUS FNB sampling versus EUS-FNA (100% vs. 78.73%); P = 0.05, and (100% vs. 78.57%); P = 0.05, respectively. Additionally, sample adequacy was superior for EUS-FNB sampling versus EUS-FNA (100% vs. 78.5%); P = 0.05. Multivariate logistic regression analysis for diagnostic accuracy showed nodule size at the cutoff of 15 mm (OR 2.29, 1.04-5.5, P = 0.05) and use of FNB needle (OR 4.33, 1.05-6.31, P = 0.05) as significant predictors of higher diagnostic accuracy. There were no procedure-related adverse events. CONCLUSION: This study highlights the efficacy and safety of EUS-FNA/FNB as a minimally invasive procedure for diagnosing and staging peri-esophageal parenchymal lung lesions. The diagnostic yield of EUS-FNB was superior to EUS-FNA.

Exposed endoscopic full-thickness resection for duodenal submucosal tumors: Current status and future perspectives.

Exposed endoscopic full-thickness resection (EFTR), with or without laparoscopic assistance, is an emergent natural orifice transluminal endoscopic surgery technique with promising safety and efficacy for the management of gastrointestinal submucosal tumors (SMTs) arising from the muscularis propria (MP), especially of the gastric wall. To date, evidence concerning duodenal exposed EFTR is lacking, mainly due to both the technical difficulty involved because of the special duodenal anatomy and concerns about safety and effectiveness of transmural wall defect closure. However, given the non-negligible morbidity and mortality associated with duodenal surgery, the recent availability of dedicated endoscopic tools for tissue-approximation capable to realize full-thickness defect closure could help in promoting the adoption of this endosurgical technique among referral centers. The aim of our study was to review the current evidence concerning exposed EFTR with or without laparoscopic assistance for the treatment of MP-arising duodenal SMTs.

Exposed endoscopic full-thickness resection without laparoscopic assistance for gastric submucosal tumors: A systematic review and pooled analysis.

BACKGROUND: Exposed endoscopic full-thickness resection (Eo-EFTR) is emerging as a promising minimally invasive alternative to surgery for the treatment of deep gastric submucosal tumors (G-SMTs). However, literature concerning this subject is heterogeneous and data mostly come from relatively small retrospective studies. AIMS: We aimed to perform a pooled analysis of published data with regard to gastric Eo-EFTR, providing a pooled estimate of technical and clinical outcomes. METHODS: The protocol was registered in PROSPERO. MEDLINE and EMBASE databases were searched for studies published from 1998 to 2020. The primary outcomes were complete resection and surgical conversion rates. The secondary outcomes were overall and selected major adverse events rates. The Forest plots on primary and secondary endpoints were produced based on fixed and random effect models. RESULTS: Nineteen studies including 952 Eo-EFTR-treated G-SMTs were included. The pooled estimate of the complete resection rate and surgical conversion rates was 99.3% and 0.09%, respectively. The pooled estimate of overall major adverse events, delayed bleeding, delayed perforation and peritonitis, abdominal abscess and/or abdominal infection was 0.29%, 0.14%, 0.14%, and 0.12%, respectively. CONCLUSION: Gastric Eo-EFTR has a high rate of complete resection with a low surgical conversion rate. It appears to be relatively safe and might represent a non-inferior minimally invasive alternative to surgery in selected cases.

Closure techniques in exposed endoscopic full-thickness resection: Overview and future perspectives in the endoscopic suturing era.

Exposed endoscopic full-thickness resection (EFTR) without laparoscopic assistance is a minimally invasive natural orifice transluminal endoscopic surgery technique that is emerging as a promising effective and safe alternative to surgery for the treatment of muscularis propria-originating gastric submucosal tumors. To date, various techniques have been used for the closure of the transmural post-EFTR defect, mainly consisting in clip- and endoloop-assisted closure methods. However, the recent advent of dedicated tools capable of providing full-thickness defect suture could further improve the efficacy and safety of the exposed EFTR procedure. The aim of our review was to evaluate the efficacy and safety of the different closure methods adopted in gastric-exposed EFTR without laparoscopic assistance, also considering the recent advent of flexible endoscopic suturing.

Gastrointestinal exposed endoscopic full-thickness resection in the era of endoscopic suturing: a retrospective single-center case series.

INTRODUCTION: Exposed endoscopic full thickness resection (EFTR) is a minimally invasive technique that has shown promising efficacy and safety in the removal of both gastrointestinal (GI) submucosal tumors (SMTs) arising from the muscularis propria (MP) and select epithelial tumors (ETs) unsuitable for conventional resection techniques. Given the chance of realizing endosurgical full-thickness suturing, the Endoscopic Suturing System (ESS) can be used to close wall defects in this setting. However, data concerning its use in EFTR are still limited. AIM: This study was conducted to evaluate the safety and efficacy of exposed EFTR with defect closure using the ESS for the removal of both GI SMTs and select ETs unsuitable for conventional resection techniques. MATERIAL AND METHODS: This was a retrospective, single-center, observational cohort study of patients who underwent GI exposed EFTR. RESULTS: Seven patients (M : F 6 : 1) with a mean age of 56 ±14.5 years were identified. The indications were MP-originating SMTs of the stomach (n = 2) and duodenum (n = 2), and from submucosa of the rectum (n = 1), and 2 ETs of the rectum. Exposed EFTR and defect closure were successfully performed in 6/7 patients. One case was converted to laparoscopic gastric wedge resection due to technical unfeasibility. We performed an R0 resection in all cases, with the exception of 1 case of rectal EFTR. No macroscopic recurrence was detected at 6-month endoscopic follow-up. CONCLUSIONS: GI exposed EFTR with defect closure by the ESS appears to be feasible, effective, and safe in referral centers. Further studies are necessary to clarify the role of the ESS for post-EFTR wall defect closure.

Endoscopic ultrasound-guided biliary drainage of malignant stenosis, not treatable with endoscopic retrograde cholangiopancreatography: a single-center, prospective observational study.

Background and study aims The therapeutic role of endoscopic ultrasound (EUS) evolved in recent decade,s opening a new chapter in the field of endoscopic biliary drainage (BD). EUS-BD has emerged as a new mini-invasive technique for neoplastic jaundice not amenable to endoscopic retrograde cholangiopancreatography (ERCP). The primary study aims were to assess the clinical efficacy of EUS-BD using an electrocautery-enhanced lumen apposing metal stent (ECE-LAMS) in patients with malignant biliary obstruction with failed\unfeasible ERCP and the adverse event (AE) rate. The secondary aims were to evaluate the technical success and incidence of jaundice recurrence. Patients and methods Data from All patients referred to our tertiary-care Institute with obstructive jaundice due to unresectable malignant distal biliary stricture and unfeasible\failed ERCP, were prospectively recorded from January 2015 to February 2018. The procedures were performed by a single-step ECE-LAMS (AXIOS-EC, Boston Scientific) placement, from the upper gut lumen to the biliary tree, for definitive biliary decompression. Results Twenty-one patients were consecutively enrolled. Mean pre-procedure common bile duct diameter was 16 mm and the bilirubin level was 13.9 mg/dL (range 3.8-29.5). LAMS was positioned from the duodenal bulb (n = 19) to gastric antrum (n = 2). We registered a 100 % of technical and clinical success. No AEs occurred. We observed a single case of delayed AE consisting of a buried LAMS, which was successfully resolved endoscopically. Conclusions Despite the limits of being non-comparative, our study shows outcomes in a homogeneous population in terms of indications and technique. EUS-BD with dedicated ECE-LAMS is associated with extremely good clinical efficacy and safety and can be considered as an alternative in cases of failed/unfeasible ERCP.

Endoscopic management of post-surgical GI wall defects with the overstitch endosuturing system: a single-center experience.

BACKGROUND AND AIMS: Post-GI surgical wall defects are frequent and life-threatening complications, with limited literature regarding current treatment. This case series aims to assess the safety, feasibility, and outcomes of endoluminal therapy with the overstitch endoscopic suturing system (Apollo Endosurgery Inc, Austin). MATERIALS AND METHODS: All patients who underwent endoscopic suturing for post-surgical wall defect management at IRCCS-ISMETT Palermo from October 2017 until January 2019 were retrospectively enrolled. Stratification therapy was applied according to the clinical scenario, time from surgery to endoscopic intervention, and structural condition of the wall defect layers (tissue status and suture feasibility). The therapeutic endoscopic strategy was divided into three groups (A: pure endoscopic direct suture; B: combined therapy with endoscopic direct suture + FC-SEMS placement + anchoring; C: FC-SEMS placement + anchoring). Success was considered the resolution of symptoms and the presence of a regular intestinal transit after a period of 4-6 weeks. RESULTS: Twenty (20) patients (male/female 7/13; mean age 54 ± 13.43 years) were included in the study (group A: 9 patients, group B: 7 patients, group C: 4 patients). The types of operative procedures were bariatric (9/20), post-tracheostomy (3/20), post-operative GI surgery (8/20). The post-surgical defects were predominantly intermediate and chronic (24-72 h: 1/20; 3-30 days: 13/20; > 30 days: 6/20). The overall clinical success was 80% (17/20 patients), with a success of 94% (16/17 patients) when excluding the three cases of tracheo-esophageal fistula. No evidence of migration was detected. The only complication was short stenosis of the distal esophagus, present in 4 patients (19%) and successfully treated with a novel lumen-apposing metal stent. CONCLUSIONS: In our experience, considering the absence of clear guidelines, the endoluminal approach with the overstich endoscopic suturing system is a valid alternative to conventional therapy, offering mini-invasiveness, and presenting promising opportunities in terms of technical feasibility and clinical efficacy.

International multicenter comprehensive analysis of adverse events associated with lumen-apposing metal stent placement for pancreatic fluid collection drainage.

BACKGROUND AND AIMS: High rates of technical and clinical success were reported for lumen-apposing metal stent (LAMS) placement for peripancreatic fluid collection (PFC) drainage. However, data on the adverse event (AE) rates are heterogeneous. The aim of this study was to evaluate the incidence, severity, management, and risk factors of AEs related to the use of LAMSs for drainage of PFCs in a large cohort of patients. METHODS: This is a multicenter, international, retrospective review from 15 centers of all patients who underwent placement of LAMSs for the management of PFCs. A nested case-control study was conducted in patients with (case) or without (control) AEs. RESULTS: Three hundred thirty-three procedures in 328 patients were performed (5 patients treated with 2 LAMSs). Technical success was achieved in 321 patients (97.9%). Three hundred four patients were finally included in the study (7 excluded for lost to follow-up information; 10 excluded for deaths unrelated to LAMSs). The rate of clinical success was 89.5%. Seventy-nine LAMS-related AEs occurred in 74 of 304 patients (24.3%), after a mean time of 25.3 days (median, 18 days; interquartile range, 6-30) classified as 20 (25.3%) mild, 54 (68.4%) moderate, or 5 (6.3%) severe. On multivariable analysis compared with control subjects, cases were more likely to have walled-off necrosis (WON) versus pancreatic pseudocysts (odds ratio, 2.18; 95% confidence interval, 1.09-4.46; P = .028), whereas cases were less likely to have undergone tract (balloon) dilation (yes vs no; odds ratio, .47; 95% confidence interval, .22-.93; P = .034). CONCLUSIONS: Data from this large international retrospective study confirm that the use of LAMSs for management of PFCs has excellent technical and good clinical success rates. The rate of AEs, however, is not negligible and should be carefully considered before using these stents for drainage of PFCs and in particular for WON. Further prospective studies are needed to confirm these findings. (Clinical trial registration number: NCT03544008.).