Complications and management of interventional endoscopic ultrasound: A critical review.

In the last decades, Endoscopic ultrasound (EUS) has rapidly grown and evolved from being mainly a diagnostic procedure, to being an interventional and therapeutic tool in several pathological clinical scenarios. With the progressive growth in technical expertise and dedicated devices, interventional endoscopic ultrasound procedures (IEUSP) have shown high rates of technical and clinical success, together with a relatively safe profile. However, the description and the standardization of different and specific types of adverse events (AEs) are still scarce in literature, and, consequently, even less the management of AEs. The aim of this study is to critical review and to describe AEs related to each of the main IEUSP, and to provide an overview on the possible management strategies of endoscopic complications. Future studies and guidelines are surely required to reach a better standardization of different AEs and their best management.

Endoscopic management of malignant biliary obstructions.

Malignant biliary obstruction (MBO), both distal and hilar, represents an ensemble of different clinical conditions frequently encountered in everyday practice. Given the frequent unresectability of the disease at presentation and the increasing indications for neoadjuvant chemotherapy, endoscopic biliary drainage is generally required during the course of the disease. With the widespread use of interventional endoscopic ultrasound (EUS) and the introduction of dedicated devices, EUS-guided biliary drainage has rapidly gained acceptance, together with transpapillary endoscopic biliary drainage and the percutaneous approach. This comprehensive review describes the current role of endoscopy for distal and hilar MBO supported by evidence, with a focus on the current hot topics in this field.

Early Rectal Cancer and Local Excision: A Narrative Review.

A rise in the incidence of early rectal cancer consequent to bowel-screening programs around the world and an increase in the incidence in young adults has led to a growing interest in organ-sparing treatment options. The rectum, being the most distal portion of the large intestine, is a fertile ground for local excision techniques performed with endoscopic or surgical techniques. Moreover, the advancement in endoscopic optical evaluation and the better definition of imaging techniques allow for a more precise local staging of early rectal cancer. Although the local treatment of early rectal cancer seems promising, in clinical practice, a significant number of patients who could benefit from local excision techniques undergo total mesorectal excision (TME) as the first approach. All relevant prospective clinical trials were identified through a computer-assisted search of the PubMed, EMBASE, and Medline databases until January 2024. This review is dedicated to endoscopic and surgical local excision in the treatment of early rectal cancer and highlights its possible role in current and future clinical practice, taking into account surgical completion techniques and chemoradiotherapy.

Efficacy and safety of endoscopic ultrasound-guided hepatico-gastrostomy: a meta-regression analysis.

BACKGROUND AND STUDY AIM: EUS-guided hepaticogastrostomy (EUS-HGS) is a valid option for EUS-guided biliary drainage that has been increasingly used in the last decade. The aims of the study were to provide a systematic review with meta-analysis and meta-regression of features and outcomes of this procedure. METHODS: MEDLINE, Scopus, Web-of-Science, and Cochrane databases were searched for literature pertinent to EUS-HGS. Meta-analysis of proportions and meta-regression of potential modifiers of the main outcome measures were applied. The main outcome was technical success. Secondary outcomes were clinical success and procedure-related adverse events (AEs). RESULTS: Thirty-three studies including 1644 patients were included in the meta-analysis. Malignant biliary obstruction was the underlying cause in almost all (99.6%) cases; the main indications for EUS-HGS were duodenal/papillary invasion (34.8%), surgical altered anatomy (18.4%) and hilar stenosis (16%). Pooled technical success of EUS-HGS was 97.7% (95%-CI: 96.1-99%, I2=0%), the intention to treat (ITT) clinical success was 88.1% (95%-CI: 84.7-91.2%, I2=33.9%) and procedure-related AEs occurred in 12% (95%-CI: 9.8-14.5%, I2=20.4%), being cholangitis/sepsis (2.8%) and bleeding (2.3%) the most frequent. The rate of procedure related AEs was reduced with the use of dedicated stents at the univariable meta regression analysis. Meta-regression showed that technical success and clinical success rates were modified by centers' experience (>4/year). CONCLUSIONS: EUS-HGS represents an effective and safe procedure for EUS-guided biliary drainage in patients with malignant biliary obstruction. Future studies should address the impact of center experience, patient selection, and use of dedicated stents to improve this technique's performance.

Endoscopic Ultrasound-Guided Drainage of Pancreatic Fluid Collections: Not All Queries Are Already Solved.

Pancreatic fluid collections (PFCs) are well-known complications of acute pancreatitis. The overinfection of these collections leads to a worsening of the prognosis with an increase in the morbidity and mortality rate. The primary strategy for managing infected pancreatic necrosis (IPN) or symptomatic PFCs is a minimally invasive step-up approach, with endosonography-guided (EUS-guided) transmural drainage and debridement as the preferred and less invasive method. Different stents are available to drain PFCs: self-expandable metal stents (SEMSs), double pigtail stents (DPPSs), or lumen-apposing metal stents (LAMSs). In particular, LAMSs are useful when direct endoscopic necrosectomy is needed, as they allow easy access to the necrotic cavity; however, the rate of adverse events is not negligible, and to date, the superiority over DPPSs is still debated. Moreover, the timing for necrosectomy, the drainage technique, and the concurrent medical management are still debated. In this review, we focus attention on indications, timing, techniques, complications, and particularly on aspects that remain under debate concerning the EUS-guided drainage of PFCs.

Endoscopic ultrasound-guided drainage of pancreatic collections with dedicated metal stents: A nationwide, multicenter, propensity score-matched comparison.

BACKGROUND: The new dedicated stents for endoscopic ultrasound (EUS)-guided transluminal drainage of peri­pancreatic fluid collections (PFCs) demonstrated optimal efficacy and safety profiles. AIMS: This study aimed to evaluate the safety, technical and clinical success, and recurrence rate of PFCs drained with Lumen Apposing Metal Stent (LAMS) or Bi-Flanged Metal Stent (BFMS). METHODS: Data from a multicenter series of PFCs treated with LAMS or BFMS at 30 Italian centers during a 5-year period were retrieved. The rate of adverse events (AEs), technical success, clinical success, PFC recurrence were evaluated. To overcome biases, a 1-to-1 match was created using propensity score analysis. RESULTS: Out of 476 patients, 386 were treated with LAMS and 90 with BFMS, with a median follow-up of 290 days (95% CI 244 to 361). Using propensity score matching, 84 patients were assigned to each group. The incidence of AEs did not differ between the two stents (13.1% versus 15.5%, p = 0.29), mainly bleeding or recurrence rate (4.7% versus 3.5%, p = 1). Technical and clinical success in the BFMS and LAMS groups were 92% versus 95% (p = 0.36) and 91% versus 94% (p = 0.64), respectively. CONCLUSION: Our study demonstrates that LAMS and BFMS have comparable safety profiles with similar technical and clinical success rates for EUS-guided PFC drainage.

Outcomes of a 3-Year Prospective Surveillance in Individuals at High Risk of Pancreatic Cancer.

INTRODUCTION: Pancreatic cancer (PC) surveillance of high-risk individuals (HRI) is becoming more common worldwide, aiming at anticipating PC diagnosis at a preclinical stage. In 2015, the Italian Registry of Families at Risk of Pancreatic Cancer was created. We aimed to assess the prevalence and incidence of pancreatic findings, oncological outcomes, and harms 7 years after the Italian Registry of Families at Risk of Pancreatic Cancer inception, focusing on individuals with at least a 3-year follow-up or developing events before. METHODS: HRI (subjects with a family history or mutation carriers with/without a family history were enrolled in 18 centers). They underwent annual magnetic resonance with cholangiopancreatography or endoscopic ultrasound (NCT04095195). RESULTS: During the study period (June 2015-September 2022), 679 individuals were enrolled. Of these, 524 (77.2%) underwent at least baseline imaging, and 156 (29.8%) with at least a 3-year follow-up or pancreatic malignancy/premalignancy-related events, and represented the study population. The median age was 51 (interquartile range 16) years. Familial PC cases accounted for 81.4% of HRI and individuals with pathogenic variant for 18.6%. Malignant (n = 8) and premalignant (1 PanIN3) lesions were found in 9 individuals. Five of these 8 cases occurred in pathogenic variant carriers, 4 in familial PC cases (2 tested negative at germline testing and 2 others were not tested). Three of the 8 PC were stage I. Five of the 8 PC were resectable, 3 Stage I, all advanced cases being prevalent. The 1-, 2-, and 3-year cumulative hazard of PC was 1.7%, 2.5%, and 3%, respectively. Median overall and disease-free survival of patients with resected PC were 18 and 12 months (95% CI not computable). Considering HRI who underwent baseline imaging, 6 pancreatic neuroendocrine neoplasms (1 resected) and 1 low-yield surgery (low-grade mixed-intraductal papillary mucinous neoplasm) were also reported. DISCUSSION: PC surveillance in a fully public health care system is feasible and safe, and leads to early PC or premalignant lesions diagnoses, mostly at baseline but also over time.

Fully covered versus partially covered self-expandable metal stents for palliation of distal malignant biliary obstruction: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Self-expandable metal stents (SEMSs) are standardly used for distal malignant biliary obstruction (dMBO). Although data suggest that covered versus uncovered SEMSs increase the time to recurrent biliary obstruction (TRBO), no data are available for fully covered (FC) versus partially covered (PC) designs. METHODS: PubMed, Scopus, and Cochrane databases were screened up to January 2023 for studies concerning dMBO treated by an FC- or PC-SEMS and describing adverse events (AEs), recurrences, or TRBO for specific design subpopulations. Pooled proportions or means were calculated using a random-effects model. Several subanalyses were preplanned, including a subanalysis restricted to prospective studies and unresectable diseases. Heterogeneity and publication bias were explored. Standardized differences (d-values) were calculated between groups. RESULTS: From 1290 records, 62 studies (3327 using FC-SEMSs and 2322 using PC-SEMSs) were included. FC- versus PC-SEMSs showed negligible differences in the rate of total AEs (12% vs 9.9%) and all specific AEs, including cholecystitis (2.5% vs 2.6%). In a subanalysis restricted to prospective studies and unresectable diseases, the rate of RBO was comparable between FC-SEMSs (27.3% [95% confidence interval {CI}, 23.7-31.2], I2 = 35.34%) and PC-SEMSs (25.3% [95% CI, 20.2-30.7], I2 = 85.09%), despite small differences (d-values between .186 and .216) in the rate of ingrowth (.5% vs 2.9%) favoring FC-SEMSs and migration (9.8% vs 4.3%) favoring PC-SEMSs. TRBO was shorter for FC-SEMSs (238 days [95% CI, 191-286], I2 = 63.1%) versus PC-SEMSs (369 days [95% CI, 290-449], I2 = 71.9%; d-value = .116). CONCLUSIONS: Despite considerable heterogeneity and small standardized differences, PC-SEMSs consistently exhibited longer TRBO than FC-SEMSs across analyses, without any other differences in AE rates, potentially proposing PC-SEMSs as the standard comparator and TRBO as the primary outcome for future randomized studies on dMBO. (Clinical trial registration number: CRD42023393965.).

Metal stent and percutaneous endoscopic necrosectomy as dual approach for the management of complex walled-off pancreatic necrosis.

Pancreatic fluid collections (PFCs) are one of the local complications of acute pancreatitis and include walled-off pancreatic necrosis (WOPN), which are complex entities with challenging management. The infection of pancreatic necrosis leads to a poorer prognosis, with a growth of the mortality rate up to 30%. The primary strategy for managing PFCs is a minimally invasive step-up approach, with endosonography-guided transmural drainage and debridement as the preferred and less invasive method. Percutaneous drainage (PCD) can be the technique of choice when endoscopic drainage is not feasible, for example for early PFCs without a mature wall or for the anatomic location and extension to the paracolic gutter of the collection. As PCD alone may be ineffective, especially when a great amount of necrosis is present, a percutaneous endoscopic necrosectomy (PEN) has been proposed, showing interesting results. The technique consists of the placement of an esophageal fully or partially covered self-expandable metal stent (SEMS) percutaneously into the collection and a direct debridement can be performed using a flexible endoscope through the SEMS. In this review, we will discuss about the role of metal stent and PEN for the management of complex walled-off pancreatic necrosis.

Endoscopic Management of Bleeding in Altered Anatomy after Upper Gastrointestinal Surgery.

Postoperative non variceal upper gastrointestinal haemorrhage may occur early or late and affect a variable percentage of patients-up to about 2%. Most cases of intraluminal bleeding are an indication for urgent Esophagogastroduodenoscopy (EGD) and require endoscopic haemostatic treatment. In addition to the approach usually adopted in non-variceal upper haemorrhages, these cases may be burdened with difficulties in terms of anastomotic tissue, angled positions, and the risk of further complications. There is also extreme variability related to the type of surgery performed, in the context of oncological disease or bariatric surgery. At the same time, the world of haemostatic devices available in digestive endoscopy is increasing, meeting high efficacy rates and attempting to treat even the most complex cases. Our narrative review summarises the current evidence in terms of different approaches to endoscopic haemostasis in upper bleeding in altered anatomy after surgery, proposing an up-to-date guidance for endoscopic clinicians and at the same time, highlighting areas of future scientific research.

Direct Endoscopic Necrosectomy of a Recurrent Walled-Off Pancreatic Necrosis at High Risk for Severe Bleeding: A Hybrid Technique Using a Dedicated Device.

Direct endoscopic necrosectomy (DEN) is a challenging procedure for the debridement of walled-off pancreatic necrosis (WOPN), which may be complicated by several adverse events, primarily bleeding which may require radiological embolization or even surgery. The lack of dedicated devices for this purpose largely affects the possibility of safely performing DEN which increases the risk of complications. We present the case of a 63 years-old man who underwent an endoscopic ultrasound (EUS)-guided drainage of a WOPN, and who was readmitted one month after stent removal with clinical, endoscopic, and radiological signs of infected necrosis involving the splenic artery. A second EUS-guided drainage was performed, with clear visualization of the arterial vessel in the midst of a large amount of solid necrosis. Due to the high risk of major bleeding during DEN, a hybrid procedure in the angiographic room was performed, in order to identify and avoid, under fluoroscopic control, the splenic artery during the entire procedure guide, which was successfully performed using the EndoRotor system. We hereby review the current literature regarding DEN using the EndoRotor system. The case reported, with a literature overview, may help the management of these patients affected by benign but life-threatening conditions which involve a multidisciplinary setting.

Usefulness of Contrast-Enhanced Endoscopic Ultrasound (CH-EUS) to Guide the Treatment Choice in Superficial Rectal Lesions: A Case Series.

INTRODUCTION: Large rectal lesions can conceal submucosal invasion and cancer nodules. Despite the increasing diffusion of high-definition endoscopes and the importance of an accurate morphological evaluation, a complete assessment in this setting can be challenging. Endoscopic ultrasound (EUS) plays an established role in the locoregional staging of rectal cancer, although this technique has a tendency toward the over-estimation of the loco-regional (T) staging. However, there are still few data on contrast-enhanced endoscopic ultrasound (CH-EUS), especially if this ancillary technique may increase the accuracy for predicting invasive nodules among large rectal lesions. MATERIAL AND METHODS: Consecutive large (≥20 mm) superficial rectal lesions with high-definition endoscopy, characterized by focal areas suggestive for invasive cancer/2B type according to JNET classification, were considered for additional standardized evaluation via CH-EUS with Sonovue ©. RESULTS: From 2020 to 2023, we evaluated 12 consecutive superficial rectal lesions with sizes ranging from 20 to 180 mm. This evaluation provided additional elements to support the therapeutic decision made. Lesions were treated with surgical (3/12) or endoscopic treatment (9/12) according to their morphology and CH-EUS evaluation. CONCLUSION: Contrast-enhanced endoscopic ultrasound can provide an additional evaluation for large and difficult-to-classify rectal lesions. In our experience, CH-EUS staging corresponded to the final pathological stages in 9/12 (75%) lesions, improving the distinction between T1 and T2 lesions. Larger prospective studies and randomized trials should be conducted to support and standardize this approach.

The Use of PuraStat® in the Management of Walled-Off Pancreatic Necrosis Drained Using Lumen-Apposing Metal Stents: A Case Series.

Background and Objectives: Bleeding is one of the most feared and frequent adverse events in the case of EUS-guided drainage of WOPN using lumen-apposing metal stents (LAMSs) and of direct endoscopic necrosectomy (DEN). When it occurs, its management is still controversial. In the last few years, PuraStat, a novel hemostatic peptide gel has been introduced, expanding the toolbox of the endoscopic hemostatic agents. The aim of this case series was to evaluate the safety and efficacy of PuraStat in preventing and controlling bleeding of WOPN drainage using LAMSs. Materials and Methods: This is a multicenter, retrospective pilot study from three high-volume centers in Italy, including all consecutive patients treated with the novel hemostatic peptide gel after LAMSs placement for the drainage of symptomatic WOPN between 2019 and 2022. Results: A total of 10 patients were included. All patients underwent at least one session of DEN. Technical success of PuraStat was achieved in 100% of patients. In seven cases PuraStat was placed for post-DEN bleeding prevention, with one patient experiencing bleeding after DEN. In three cases, on the other hand, PuraStat was placed to manage active bleeding: two cases of oozing were successfully controlled with gel application, and a massive spurting from a retroperitoneal vessel required subsequent angiography. No re-bleeding occurred. No PuraStat-related adverse events were reported. Conclusions: This novel peptide gel could represent a promising hemostatic device, both in preventing and managing active bleeding after EUS-guided drainage of WON. Further prospective studies are needed to confirm its efficacy.

Endoscopic Management of Postoperative Esophageal and Upper GI Defects-A Narrative Review.

Anastomotic defects are deleterious complications after either oncologic or bariatric surgery, leading to high morbidity and mortality. Besides surgical revision in early stages or instable patients, endoscopic treatment has become the mainstay. To date, many options for endoscopic treatment in this setting exist, including fully covered metal stent placement, endoscopic vacuum therapy (EVT), endoscopic internal drainage with pigtail placement (EID), leak closure with through the scope or over the scope clips, endoluminal suturing, fibrin glue sealing and a combination of all these techniques. Current evidence is mostly based on retrospective single and multicenter studies. No guidelines exist in this important field. Treatment options have to be chosen upon each case individually, taking into account clinical and anatomic criteria, such as timing, size, infectious wound complications and hemodynamic stability. Local expertise and availability of treatment devices need to be taken into account whenever choosing a treatment strategy. This review aimed to present current treatment options in terms of effectiveness, advantages and disadvantages in order to guide the clinician for his decision making. Additionally, we aimed to provide a treatment algorithm.

Endoscopic ultrasound-guided fine-needle biopsy with or without macroscopic on-site evaluation: a randomized controlled noninferiority trial.

BACKGROUND : The advantage of using the macroscopic on-site evaluation (MOSE) technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) performed with 22G Franseen needles has not been investigated. We aimed to compare EUS-FNB with MOSE vs. EUS-FNB performed with three needle passes. METHODS : This randomized trial involved 10 Italian referral centers. Consecutive patients referred for EUS-FNB of pancreatic or nonpancreatic solid lesions were included in the study and randomized to the two groups. MOSE was performed by gross visualization of the collected material by the endoscopists and considered adequate when a white/yellowish aggregate core longer than 10 mm was retrieved. The primary outcome was diagnostic accuracy. Secondary outcomes were specimen adequacy, number of needle passes, and safety. RESULTS : 370 patients with 234 pancreatic lesions (63.2 %) and 136 nonpancreatic lesions (36.8 %) were randomized (190 EUS-FNB with MOSE and 180 with standard EUS-FNB). No statistically significant differences were found between EUS-FNB with MOSE and conventional EUS-FNB in terms of diagnostic accuracy (90.0 % [95 %CI 84.8 %-93.9 %] vs. 87.8 % [95 %CI 82.1 %-92.2 %]; P = 0.49), sample adequacy (93.1 % [95 %CI 88.6 %-96.3 %] vs. 95.5 % [95 %CI 91.4 %-98 %]; P = 0.31), and rate of adverse events (2.6 % vs. 1.1 %; P = 0.28). The median number of passes was significantly lower in the EUS-FNB with MOSE group (1 vs. 3; P < 0.001). CONCLUSIONS : The accuracy of EUS-FNB with MOSE is noninferior to that of EUS-FNB with three needle passes. MOSE reliably assesses sample adequacy and reduces the number of needle passes required to obtain the diagnosis with a 22G Franseen needle.

Dysbiosis and Gastrointestinal Surgery: Current Insights and Future Research.

Surgery of the gastrointestinal tract can result in deep changes among the gut commensals in terms of abundance, function and health consequences. Elective colorectal surgery can occur for neoplastic or inflammatory bowel disease; in these settings, microbiota imbalance is described as a preoperative condition, and it is linked to post-operative complications, as well. The study of bariatric patients led to several insights into the role of gut microbiota in obesity and after major surgical injuries. Preoperative dysbiosis and post-surgical microbiota reassessment are still poorly understood, and they could become a key part of preventing post-surgical complications. In the current review, we outline the most recent literature regarding agents and molecular pathways involved in pre- and post-operative dysbiosis in patients undergoing gastrointestinal surgery. Defining the standard method for microbiota assessment in these patients could set up the future approach and clinical practice.

A case of cystic paraduodenal pancreatitis with gastric outlet obstruction: technical pitfalls in EUS-guided gastroenteroanastomosis.

Video 1Technical pitfalls in EUS-guided gastroenteroanastomosis in an 84-year-old man with gastric outlet obstruction owing to cystic paraduodenal pancreatitis.

Determinants of outcomes of transmural EUS-guided gallbladder drainage: systematic review with proportion meta-analysis and meta-regression.

BACKGROUND AND AIMS: Transmural EUS-guided gallbladder drainage (EUS-GBD) has been increasingly used in the treatment of gallbladder diseases. Aims of the study were to provide a comprehensive meta-analysis and meta-regression of features and outcomes of this procedure. METHODS: MEDLINE, Scopus, Web of science, and Cochrane databases were searched for literature pertinent to transmural EUS-GBD up to May 2021. Random-effect meta-analysis of proportions and meta-regression of potential modifiers of outcome measures considered were applied. Outcome measures were technical success rate, overall clinical success, and procedure-related adverse events (AEs). RESULTS: Twenty-seven articles were identified including 1004 patients enrolled between February 2009 and February 2020. Acute cholecystitis was present in 98.7% of cases. Pooled technical success was 98.0% (95% CI 96.3, 99.3; heterogeneity: 23.6%), the overall clinical success was 95.4% (95% CI 92.8, 97.5; heterogeneity: 35.3%), and procedure-related AEs occurred in 14.8% (95% CI 8.8, 21.8; heterogeneity: 82.4%), being stent malfunction/dislodgement the most frequent (3.5%). Procedural-related mortality was 1‰. Meta-regression showed that center experience proxied to > 10 cases/year increased the technical success rate (odds ratio [OR]: 2.84; 95% CI 1.06, 7.59) and the overall clinical success (OR: 3.52; 95% CI 1.33, 9.33). The use of anti-migrating devices also increased the overall clinical success (OR: 2.16; 95% CI 1.07, 4.36) while reducing procedure-related AEs (OR: 0.36; 95% CI 0.14, 0.98). CONCLUSION: Physicians' experience and anti-migrating devices are the main determinants of main clinical outcomes after EUS-GBD, suggesting that treatment in expert centers would optimize results.