Efficacy, Feasibility, and Safety of the X-Tack Endoscopic HeliX Tacking System: A Multicenter Experience.

BACKGROUND AND AIMS: The application of endoscopic suturing has revolutionized defect closures. Conventional over-the-scope suturing necessitates removal of the scope, placement of the device, and reinsertion. A single channel, single sequence, through-the-scope suturing device has been developed to improve this process. This study aims to describe the efficacy, feasibility, and safety of a through-the-scope suturing device for gastrointestinal defect closure. METHODS: This was a retrospective multicenter study involving 9 centers of consecutive adult patients who underwent suturing using the X-Tack Endoscopic HeliX Tacking System (Apollo Endosurgery). The primary outcomes were technical success and long-term clinical success. Secondary outcomes included adverse events, recurrence, and reintervention rates. RESULTS: In all, 56 patients (mean age 53.8, 33 women) were included. Suturing indications included fistula repair (n=22), leak repair (n=7), polypectomy defect closure (n=12), peroral endoscopic myotomy (POEM) site closure (n=7), perforation repair (n=6), and ulcers (n=2). Patients were followed at a mean duration of 74 days. Overall technical and long-term clinical success rates were 92.9% and 75%, respectively. Both technical and clinical success rates were 100% for polypectomies, POEM-site closures, and ulcers. Success rates were lower for the repair of fistulas (95.5% technical, 54.5% clinical), leaks (57.1%, 28.6%), and perforations (100%, 66.7%). No immediate adverse events were noted. CONCLUSION: This novel, through-the-scope endoscopic suturing system, is a safe and feasible method to repair defects that are ≤3 cm. The efficacy of this device may be better suited for superficial defects as opposed to full-thickness defects. Larger defects will need more sutures and probably a double closure technique to provide a reinforcement layer.

Outcomes of Endoscopic Ultrasound-guided Fine Needle Biopsy Using a Novel Hydrostatic Stylet Tissue Acquisition Technique.

BACKGROUND: Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is frequently used to obtain core samples of solid lesions. Here, we describe and evaluate a novel hydrostatic stylet (HS) technique designed to optimize core sample acquisition, reporting diagnostic yield, efficacy, and safety relative to the conventional stylet slow-pull (SP) technique. METHODS: A novel HS technique was developed and validated retrospectively. Consecutive patients who underwent EUS-FNB with core biopsy of solid lesions through either the HS or SP technique between January 2020 and April 2022 were included. Exclusion criteria included cystic lesions, nonlesional liver biopsies, and specimens sent for cytologic analysis only. Patient and lesion characteristics, number of passes, sample adequacy, and adverse events were compared between the two techniques. RESULTS: A total of 272 patients were included with 138 in the HS group and 134 in the SP group. Lesion size and anatomic distribution were similar in both groups. Compared with the SP approach, the HS technique demonstrated significantly higher sample adequacy (97.8% vs 83.6%, P < 0.001), higher sensitivity (97.1% vs 89.7%, P = 0.03), and lower mean number of passes (1.2 vs 3.3, P < 0.001). Rates and severity of adverse events in the HS group were comparable to the SP group and existing literature. Similar associations were observed in pancreatic and nonpancreatic lesion subanalyses. CONCLUSIONS: The novel HS technique demonstrated excellent biopsy sample adequacy and diagnostic yield while requiring fewer passes to obtain diagnostic specimens compared with a conventional EUS-FNB approach. Further prospective evaluation is needed to confirm these pilot findings and optimize EUS-FNB acquisition techniques.

Preferred techniques for endoscopic ultrasound-guided gastroenterostomy: a survey of expert endosonographers.

Background and study aims Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is an emerging procedure that lacks technical standardization with limited adoption beyond expert centers. We surveyed high-volume endosonographers about the technical aspects of EUS-GE to describe how the procedure is currently performed at expert centers and identify targets for standardization. Methods Invitations to complete an electronic survey were distributed to 21 expert EUS practitioners at 19 U.S. centers. Respondents were surveyed about technical aspects of EUS-GE, indications, efficacy, safety, and attitudes toward the procedure. Results All 21 (100%) invited expert endoscopists completed the survey. Nine (42.9%) reported performing >10 EUS-GEs in the last 12 months. About half (47.6%, 10/21) puncture the target loop prior to lumen-apposing metal stent (LAMS) introduction, most often to confirm the loop is jejunum. No respondents reported guidewire placement prior to LAMS introduction. Most (71.4%, 15/21) do not use a guidewire at any time, while 28.6% (6/21) reported wire placement after distal flange deployment to secure the tract during apposition. Eight (38.1%, 8/21) reported at least one major adverse event, most commonly intraperitoneal LAMS deployment (87.5%, 7/8). Factors most often reported as advantageous for EUS-GE over enteral stenting included lack of papilla interference (33.3%, 7/21) and decreased occlusion risk (23.8%, 5/21). Conclusions Significant variation in performance technique for EUS-GE exists among expert US endoscopists, which may hinder widespread adoption and contribute to inconsistencies in reported patient outcomes. The granularity provided by these survey results may identify areas to focus standardization efforts and guide future studies on developing an ideal EUS-GE protocol.

Benefits of EUS-guided gastroenterostomy over surgical gastrojejunostomy in the palliation of malignant gastric outlet obstruction: a large multicenter experience.

BACKGROUND AND AIMS: Palliation of malignant gastric outlet obstruction (mGOO) allows resumption of peroral intake. Although surgical gastrojejunostomy (SGJ) provides durable relief, it may be associated with a higher morbidity, interfere with chemotherapy, and require an optimum nutritional status. EUS-guided gastroenterostomy (EUS-GE) has emerged as a minimally invasive alternative. We aimed to conduct the largest comparative series to date between EUS-GE and SGJ for mGOO. METHODS: This multicenter retrospective study included consecutive patients undergoing SGJ or EUS-GE at 6 centers. Primary outcomes included time to resumption of oral intake, length of stay (LOS), and mortality. Secondary outcomes included technical and clinical success, reintervention rates, adverse events (AEs), and resumption of chemotherapy. RESULTS: A total of 310 patients were included (EUS-GE, n = 187; SGJ, n = 123). EUS-GE exhibited significantly lower time to resumption of oral intake (1.40 vs 4.06 days, P < .001), at lower albumin levels (2.95 vs 3.33 g/dL, P < .001), and a shorter LOS (5.31 vs 8.54 days, P < .001) compared with SGJ; there was no difference in mortality (48.1% vs 50.4%, P = .78). Technical (97.9% and 100%) and clinical (94.1% vs 94.3%) success was similar in the EUS-GE and SGJ groups, respectively. EUS-GE had lower rates of AEs (13.4% vs 33.3%, P < .001) but higher reintervention rates (15.5% vs 1.63%, P < .001). EUS-GE patients exhibited significantly lower interval time to resumption of chemotherapy (16.6 vs 37.8 days, P < .001). Outcomes between the EUS-GE and laparoscopic (n = 46) surgical approach showed that EUS-GE had shorter interval time to initiation/resumption of oral intake (3.49 vs 1.46 days, P < .001), decreased LOS (9 vs 5.31 days, P < .001), and a lower rate of AEs (11.9% vs 17.9%, P = .003). CONCLUSIONS: This is the largest study to date showing that EUS-GE can be performed among nutritionally deficient patients without affecting the technical and clinical success compared with SGJ. EUS-GE is associated with fewer AEs while allowing earlier resumption of diet and chemotherapy.

EUS-guided liver biopsy using a novel hydrostatic stylet technique.

Video 1Hydrostatic stylet technique for the performance of EUS-guided liver biopsy.

Endoscopic ultrasound-guided ileosigmoidostomy using a lumen-apposing metal stent for palliation of malignant small-bowel obstruction.

Video 1Endoscopic ultrasound-guided ileosigmoidostomy for relief of small bowel obstruction.

Early infection is an independent risk factor for increased mortality in patients with culture-confirmed infected pancreatic necrosis.

BACKGROUND: Mortality in infected pancreatic necrosis (IPN) is dynamic over the course of the disease, with type and timing of interventions as well as persistent organ failure being key determinants. The timing of infection onset and how it pertains to mortality is not well defined. OBJECTIVES: To determine the association between mortality and the development of early IPN. METHODS: International multicenter retrospective cohort study of patients with IPN, confirmed by a positive microbial culture from (peri) pancreatic collections. The association between timing of infection onset, timing of interventions and mortality were assessed using Cox regression analyses. RESULTS: A total of 743 patients from 19 centers across 3 continents with culture-confirmed IPN from 2000 to 2016 were evaluated, mortality rate was 20.9% (155/734). Early infection was associated with a higher mortality, when early infection occurred within the first 4 weeks from presentation with acute pancreatitis. After adjusting for comorbidity, advanced age, organ failure, enteral nutrition and parenteral nutrition, early infection (≤4 weeks) and early open surgery (≤4 weeks) were associated with increased mortality [HR: 2.45 (95% CI: 1.63-3.67), p < 0.001 and HR: 4.88 (95% CI: 1.70-13.98), p = 0.003, respectively]. There was no association between late open surgery, early or late minimally invasive surgery, early or late percutaneous drainage with mortality (p > 0.05). CONCLUSION: Early infection was associated with increased mortality, independent of interventions. Early surgery remains a strong predictor of excess mortality.

Endoscopic ultrasound-guided gallbladder drainage as a rescue therapy for unresectable malignant biliary obstruction: a multicenter experience.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is often unsuccessful in patients with duodenal stenosis or malignant ampullary infiltration. While endoscopic ultrasound-guided biliary drainage (EUS-BD) has been proposed as an alternative, EUS-guided gallbladder drainage (EUS-GBD) is an attractive option when both approaches fail. We aimed to assess the effectiveness and safety of EUS-GBD as rescue therapy for malignant distal bile duct obstruction. METHODS: A multicenter retrospective study was performed on patients with unresectable malignant distal bile duct obstruction who underwent EUS-GBD between 2014 and 2019 after unsuccessful ERCP and EUS-BD. Clinical success was defined as a decrease in serum bilirubin of > 50 % within 2 weeks. RESULTS: 28 patients were included, with a lumen-apposing metal stent used in 26 (93 %) and a self-expandable metal stent in two (7 %). The technical success rate was 100 %. The clinical success rate was 93 %, with an improvement in bilirubin (7.3 [SD 5.4] pre-procedure vs. 2.8 [SD 1.1] post-procedure; P = 0.001). Delayed adverse events included food impaction of the stent (n = 3), with a further two patients developing cholecystitis and bleeding. CONCLUSION: This study demonstrates the feasibility of gallbladder drainage to relieve malignant distal bile duct obstruction in patients with failed ERCP and EUS-BD.

Full-thickness resection device (FTRD) for treatment of upper gastrointestinal tract lesions: the first international experience.

Background and study aims The Full-Thickness Resection Device (FTRD) provides a novel treatment option for lesions not amenable to conventional endoscopic resection techniques. There are limited data on the efficacy and safety of FTRD for resection of upper gastrointestinal tract (GIT) lesions. Patients and methods This was an international multicenter retrospective study, including patients who had an endoscopic resection of an upper GIT lesion using the FTRD between January 2017 and February 2019. Results Fifty-six patients from 13 centers were included. The most common lesions were mesenchymal neoplasms (n = 23, 41 %), adenomas (n = 7, 13 %), and hamartomas (n = 6, 11 %). Eighty-four percent of lesions were located in the stomach, and 14 % in the duodenum. The average size of lesions was 14 mm (range 3 to 33 mm). Deployment of the FTRD was technically successful in 93 % of patients (n = 52) leading to complete and partial resection in 43 (77 %) and 9 (16 %) patients, respectively. Overall, the FTRD led to negative histological margins (R0 resection) in 38 (68 %) of patients. A total of 12 (21 %) mild or moderate adverse events (AEs) were reported. Follow-up endoscopy was performed in 31 patients (55 %), on average 88 days after the procedure (IQR 68-138 days). Of these, 30 patients (97 %) did not have any residual or recurrent lesion on endoscopic examination and biopsy, with residual adenoma in one patient (3 %). Conclusions Our results suggest a high technical success rate and an acceptable histologically complete resection rate, with a low risk of AEs and early recurrence for FTRD resection of upper GIT lesions.

Multicenter evaluation of the clinical utility of laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass.

BACKGROUND AND AIMS: The obesity epidemic has led to increased use of Roux-en-Y gastric bypass (RYGB). These patients have an increased incidence of pancreaticobiliary diseases, yet standard ERCP is not possible because of surgically altered gastroduodenal anatomy. Laparoscopy-assisted ERCP (LA-ERCP) has been proposed as an option, but supporting data are derived from single-center small case series. Therefore, we conducted a large multicenter study to evaluate the feasibility, safety, and outcomes of LA-ERCP. METHODS: This is a retrospective cohort study of adult patients with RYGB who underwent LA-ERCP in 34 centers. Data on demographics, indications, procedure success, and adverse events were collected. Procedure success was defined when all the following were achieved: reaching the papilla, cannulating the desired duct, and providing endoscopic therapy as clinically indicated. RESULTS: A total of 579 patients (median age, 51; 84% women) were included. Indication for LA-ERCP was biliary in 89%, pancreatic in 8%, and both in 3%. Procedure success was achieved in 98%. Median total procedure time was 152 minutes (interquartile range [IQR], 109-210), with a median ERCP time of 40 minutes (IQR, 28-56). Median hospital stay was 2 days (IQR, 1-3). Adverse events were 18% (laparoscopy related, 10%; ERCP related, 7%; both, 1%) with the clear majority (92%) classified as mild/moderate, whereas 8% were severe and 1 death occurred. CONCLUSIONS: Our large multicenter study indicates that LA-ERCP in patients with RYGB is feasible with a high procedure success rate comparable with that of standard ERCP in patients with normal anatomy. The ERCP-related adverse events rate is comparable with conventional ERCP, but the overall adverse event rate was higher because of the added laparoscopy-related events.

Selected Endoscopic Gastric Devices for Obesity.

This article focuses on the stomach target devices that are currently in various stages of development. Approved intragastric balloons, devices targeting small bowel and aspiration techniques, are described in other contributions to this issue. Bariatric endoscopic devices targeting the stomach directly alter gastric physiology and promote weight loss by potentially changing functional gastric volume, gastric emptying, gastric wall compliance, neurohormonal signaling, and, thereby, satiety. Many stomach-targeting devices are on the horizon for clinical use, and further study will determine the safety and efficacy for clinical use.

Endoscopic Devices for Obesity.

The obesity epidemic, recognized by the World Health Organization in 1997, refers to the rising incidence of obesity worldwide. Lifestyle modification and pharmacotherapy are often ineffective long-term solutions; bariatric surgery remains the gold standard for long-term obesity weight loss. Despite the reported benefits, it has been estimated that only 1% of obese patients will undergo surgery. Endoscopic treatment for obesity represents a potential cost-effective, accessible, minimally invasive procedure that can function as a bridge or alternative intervention to bariatric surgery. We review the current endoscopic bariatric devices including space occupying devices, endoscopic gastroplasty, aspiration technology, post-bariatric surgery endoscopic revision, and obesity-related NOTES procedures. Given the diverse devices already FDA approved and in development, we discuss the future directions of endoscopic therapies for obesity.

Drug eluting biliary stents to decrease stent failure rates: A review of the literature.

Biliary stenting is clinically effective in relieving both malignant and non-malignant obstructions. However, there are high failure rates associated with tumor ingrowth and epithelial overgrowth as well as internally from biofilm development and subsequent clogging. Within the last decade, the use of prophylactic drug eluting stents as a means to reduce stent failure has been investigated. In this review we provide an overview of the current research on drug eluting biliary stents. While there is limited human trial data regarding the clinical benefit of drug eluting biliary stents in preventing stent obstruction, recent research suggests promise regarding their safety and potential efficacy.

A Case of Clostridium septicum Aortitis With Concomitant Adenocarcinoma of the Cecum.

Clostridium septicum aortitis is a rare infection that is strongly associated with underlying adenocarcinoma of the colon. We report a case of a 73-year-old woman with peripheral vascular disease who presented after 4 weeks of severe abdominal pain. Abdominal computed tomography showed thickening of the cecal wall and gas in the aortic wall. Colonoscopy revealed a large ulcerated moderately differentiated adenocarcinoma in the cecum. Blood cultures grew Clostridium septicum. The patient was offered surgical intervention but refused; she was treated with antibiotics and discharged home where she died 1 week later.

Prediction of malignancy in cystic neoplasms of the pancreas: a population-based cohort study.

OBJECTIVES: Pancreatic cystic neoplasms (PCNs) are being detected with increased frequency. The aims of this study were to determine the incidence of malignancy and develop an imaging-based system for prediction of malignancy in PCN. METHODS: We conducted a retrospective cohort study of patients ≥18 years of age with confirmed PCN from January 2005 to December 2010 in a community-based integrated care setting in Southern California. Patients with history of acute or chronic pancreatitis were excluded. Malignancy diagnosed within 3 months of cyst diagnosis was considered as pre-existing. Subsequent incidence of malignancy during surveillance was calculated based on person-time at risk. Age- and gender-adjusted standardized incidence ratio (SIR) was calculated with the non-cyst reference population. Recursive partitioning was used to develop a risk prediction model based on cyst imaging features. RESULTS: We identified 1,815 patients with confirmed PCN. A total of 53 (2.9%) of patients were diagnosed with cyst-related malignancy during the study period. The surveillance cohort consisted of 1,735 patients with median follow-up of 23.4 months. Incidence of malignancy was 0.4% per year during surveillance. The overall age- and gender-adjusted SIR for pancreatic malignancy was 35.0 (95% confidence level 26.6, 46.0). Using recursive partitioning, we stratified patients into low (<1%), intermediate (1-5%), and high (9-14%) risk of harboring malignant PCN based on four cross-sectional imaging features: size, pancreatic duct dilatation, septations with calcification as well as growth. Area under the receiver operator characteristic curve for the prediction model was 0.822 (training) and 0.808 (testing). CONCLUSIONS: Risk of pancreatic malignancy was lower than previous reports from surgical series but was still significantly higher than the reference population. A risk stratification system based on established imaging criteria may help guide future management decisions for patients with PCN.

Cyst features and risk of malignancy in intraductal papillary mucinous neoplasms of the pancreas: a meta-analysis.

BACKGROUND & AIMS: International guidelines for the management of intraductal papillary mucinous neoplasms (IPMNs) of the pancreas recommend surgical resection of those with specific characteristics. We performed a meta-analysis to evaluate the risk of malignancy associated with each of these features of IPMNs. METHODS: We performed a comprehensive search of MEDLINE from January 1, 1996, to November 11, 2011, for studies that included any of the features mentioned in the consensus guidelines for surgical resection of main duct and branch duct IPMNs. Data were analyzed from 41 studies for the following features: cyst size greater than 3 cm, the presence of mural nodules, dilated main pancreatic duct, symptoms, and main duct vs branch duct IPMNs. Malignant IPMNs were defined as those with carcinoma in situ or more advanced histology. A separate meta-analysis was performed for each risk factor to calculate pooled odds ratios (ORs). A random-effects model was used, based on the assumption of variation among study populations. RESULTS: The risks of malignancy associated with individual cyst features were as follows: cyst size greater than 3 cm (OR, 62.4; 95% confidence interval [CI], 30.8-126.3), presence of a mural nodule (OR, 9.3; 95% CI, 5.3-16.1), dilatation of the main pancreatic duct (OR, 7.27; 95% CI, 3.0-17.4), and main vs branch duct IPMN (OR, 4.7; 95% CI, 3.3-6.9). There was a moderate level of heterogeneity among studies (I(2) range, 34-67). CONCLUSIONS: Based on a meta-analysis, cyst features proposed by the international guidelines for resection of IPMN were highly associated with malignancy. However, based on our findings, not all cyst features should be weighted equally when considering risk of malignancy; cyst size greater than 3 cm was associated most strongly with malignant IPMN.