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.

Vital signs among emergency department trauma patients in the setting of alcohol or drug use.

INTRODUCTION: The incidence of alcohol use among trauma patients has been estimated at 19-55%. This study was undertaken to identify any relationship between vital signs and alcohol and drug use among Emergency Department (ED) patients with trauma. METHODS: In this retrospective case control study, eligible subjects included trauma patients ages 18 and over, with trauma and drug or alcohol use, between 2018 and 2022. The control group was comprised of trauma patients ages 18 and over, with trauma and no drug or alcohol use, who were matched by Injury Severity Score (ISS). Vital signs on ED arrival were compared among patients with and without alcohol use, and with and without recreational drug use. RESULTS: Among 16,159 eligible trauma subjects, 5,323 had tests available for drugs and alcohol of whom 2,750 had complete ISS and vital signs data. 684 subjects were identified with alcohol intoxication, 707 subjects were identified with recreational drug use. Patients with alcohol use had lower mean systolic blood pressure (Mean=133, SD=26.7), compared to patients without alcohol use (Mean=143, SD=29.4) (p < 0.001). Patients with alcohol use had higher mean heart rate (Mean=93, SD=19.9) compared to patients without alcohol use (Mean=91, SD=19.7) (p = 0.01). Patients with recreational drug use had lower mean systolic blood pressure (Mean=137, SD=28.5) compared to patients without drug use (Mean=143, SD=29.6) (p < 0.001). Patients with drug use had higher mean heart rate (Mean=94, SD=22.8), compared to patients without drug use (Mean=91, SD=20.0) (p = 0.002). Cannabinoids were associated with lower SBP (Case Mean=136 (25.4) vs. Control Mean=141 (31.0), p = 0.009). Opioids were associated with lower SBP (Case Mean=138 (28.0) vs. Control Mean=145 (29.4), p = 0.01). Benzodiazepines were associated with increased HR and decreased SBP and RR. CONCLUSIONS: There appear to be no clinically relevant differences in vital signs among trauma patients with drug use and/or alcohol use, compared to patients without drug or alcohol use. Abnormal vital signs should not be prematurely attributed solely to acute substance intoxication before fully evaluating for associated traumatic injuries.

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.

Global prospective case series of ERCPs using a single-use duodenoscope.

BACKGROUND: The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. METHODS: 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). RESULTS: Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis. CONCLUSIONS: In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.

Acute worsening of gastric outlet obstruction following EUS-guided gastrojejunal bypass.

Video 1Presentation and treatment of an unusual acute worsening of gastric outlet obstruction following EUS-guided gastrojejunal bypass.

Clinical outcomes and learning curve for ERCP during advanced endoscopy training: a comparison of supine versus prone positioning.

BACKGROUND AND AIMS: No studies have evaluated trainees' outcomes when learning ERCP with patients in the supine and prone positions simultaneously. We aimed to assess whether patient position impacts procedural outcomes and learning curve. METHODS: We prospectively evaluated patients undergoing ERCP by a supervised advanced endoscopy trainee (AET) at a tertiary care center. Adult patients with native papillae were included. The AET was universally given 5 attempts per cannulation. Outcomes were evaluated quarterly. RESULTS: Successful cannulation was achieved in 44 supine (69%) and 17 prone (68%) patients (P = .95). Although mean time to reach the papilla was shorter in the supine patient position, time to biliary cannulation (7.8 vs 9.4 minutes, P = .53) and number of attempts were similar. A stepwise increase was seen in cannulation rates throughout the academic year (P < .01) and increased more in supine patients (P = .01). Procedure and total room times were shorter in supine patients. CONCLUSIONS: Shorter procedure and room turnover times and a comparable cannulation rate were found for supine versus prone ERCP.

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

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

Referral for Dietary Intervention in Celiac Disease Is Low among Gastroenterologists and Primary Care Providers.

BACKGROUND: Strict adherence to a gluten-free diet is the only known effective treatment for celiac disease currently. Multiple organizations recommend follow-up with a dietitian and guideline-directed management after diagnosis. Few studies have evaluated follow-up post diagnosis. However, these do not include a systematic process for monitoring dietary referral among celiac disease patients. We sought to evaluate and compare the frequency of early dietary referral and guideline-directed preventive care and management for celiac disease patients managed by gastroenterologists and primary care providers. METHODS: A retrospective chart review of celiac disease patients receiving care at a single tertiary care facility. Our primary outcome was to compare the frequency of dietary intervention between gastroenterologists and primary care providers in an outpatient setting after initial diagnosis. Multivariate analysis was performed to determine associated factors for referral for dietary intervention and recommended follow-up lab work. RESULTS: 261 patients were included in the study, 81.6% were followed by gastroenterologist and only 51% were seen by a dietitian. Patients following up with gastroenterologists had higher odds of referral for dietary intervention on multivariate analysis (OR 3.29, p value <0.003). Only 16% of all patients completed appropriate guideline-directed follow-up care. CONCLUSIONS: Dietary intervention and follow-up of preventive care lab work were low in celiac disease patients. There is an opportunity for further education of both primary care providers and gastroenterologists on the importance of early dietary referral and appropriate medical management at follow-up.

Impact of Adjunctive Pharmacotherapy With Intragastric Balloons for the Treatment of Obesity.

BACKGROUND: We conducted this study to compare the weight loss outcome of intragastric balloons (IGBs) in conjunction with pharmacotherapy vs IGB and intensive lifestyle changes alone. METHODS: This was a multicenter, non-randomized, retrospective study involving 4 academic hospitals. Patients underwent IGB placement with or without concomitant anti-obesity pharmacotherapy. The primary outcome was percent total weight loss (TBWL) after IGB placement at 6 and 12 months. RESULTS: This study included 102 patients, with 23 patients (mean age 46.6 years, 82.6% female) treated with IGB/pharmacotherapy and 79 patients (mean age 46.0 years, 88.6% female) treated with IGB/lifestyle modifications. Patients had a 100% follow-up rate at 6 and 12 months. At 6 months following IGB placement, both groups achieved a similar %TBWL. At 12 months, %TBWL was greater in the IGB/pharmacotherapy group (12.6% ± 1.2 vs 9.7% ± 0.7, P = .04). 65.2% of patients achieved ≥10% TBWL at 12 months in the IGB/pharmacotherapy group, compared to 38.0% in the IGB/lifestyle group (P < .05). The proportion of patients that achieved ≥15% weight loss at 12 months was also significantly different between the IGB/pharmacotherapy and IGB/lifestyle groups (30.4% vs 20.3%, P < .05). DISCUSSION: IGB with concomitant use of pharmacotherapy did not improve weight loss while the IGB was in place compared to IGB and lifestyle changes. However, patients receiving IGB with pharmacotherapy did have greater weight loss and diminished weight regain after balloon removal compared to those receiving just IGB and lifestyle changes.

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.

Peroral endoscopic myotomy for a residual Zenker's diverticulum following endoscopic myotomy.

Video 1Peroral endoscopic myotomy for a residual Zenker's diverticulum following endoscopic myotomy.

AGA Clinical Practice Update on Endoscopic Management of Perforations in Gastrointestinal Tract: Expert Review.

BEST PRACTICE ADVICE 1: For all procedures, especially procedures carrying an increased risk for perforation, a thorough discussion between the endoscopist and the patient (preferably together with the patient's family) should include details of the procedural techniques and risks involved. BEST PRACTICE ADVICE 2: The area of perforation should be kept clean to prevent any spillage of gastrointestinal contents into the perforation by aspirating liquids and, if necessary, changing the patient position to bring the perforation into a non-dependent location while minimizing insufflation of carbon dioxide to avoid compartment syndrome. BEST PRACTICE ADVICE 3: Use of carbon dioxide for insufflation is encouraged for all endoscopic procedures, especially any endoscopic procedure with increased risk of perforation. If available, carbon dioxide should be used for all endoscopic procedures. BEST PRACTICE ADVICE 4: All endoscopists should be aware of the procedures that carry an increased risk for perforation such as any dilation, foreign body removal, any per oral endoscopic myotomy (Zenker's, esophageal, pyloric), stricture incision, thermal coagulation for hemostasis or tumor ablation, percutaneous endoscopic gastrostomy, ampullectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), endoluminal stenting with self-expanding metal stent (SEMS), full-thickness endoscopic resection, endoscopic retrograde cholangiopancreatography (ERCP) in surgically altered anatomy, endoscopic ultrasound (EUS)-guided biliary and pancreatic access, EUS-guided cystogastrostomy, and endoscopic gastroenterostomy using a lumen apposing metal stent (LAMS). BEST PRACTICE ADVICE 5: Urgent surgical consultation should be highly considered in all cases with perforation even when endoscopic repair is technically successful. BEST PRACTICE ADVICE 6: For all upper gastrointestinal perforations, the patient should be considered to be admitted for observation, receive intravenous fluids, be kept nothing by mouth, receive broad-spectrum antibiotics (to cover Gram-negative and anaerobic organisms), nasogastric tube (NGT) placement (albeit some exceptions), and surgical consultation. BEST PRACTICE ADVICE 7: For upper gastrointestinal tract perforations, a water-soluble upper gastrointestinal series should be considered to confirm the absence of continuing leak at the perforation site before initiating a clear liquid diet. BEST PRACTICE ADVICE 8: Endoscopic closure of esophageal perforations should be pursued when feasible, utilizing through-the-scope clips (TTSCs) or over-the-scope clips (OTSCs) for perforations <2 cm and endoscopic suturing for perforations >2 cm, reserving esophageal stenting with SEMS for cases where primary closure is not possible. BEST PRACTICE ADVICE 9: Endoscopic closure of gastric perforations should be pursued when feasible, utilizing TTSCs or OTSCs for perforations <2 cm and endoscopic suturing or combination of TTSCs and endoloop for perforations >2 cm. BEST PRACTICE ADVICE 10: For large type 1 duodenal perforations (lateral duodenal wall tear >3 cm), being cognizant of the difficulty in closing them endoscopically, urgent surgical consultation should be made while the feasibility of endoscopic closure is assessed. BEST PRACTICE ADVICE 11: Because type 2 periampullary (retroperitoneal) perforations are subtle and can be easily missed, the endoscopist should carefully assess the gas pattern on fluoroscopy to avoid delays in treatment and request a computed tomography scan if there is a concern for such a perforation; identified perforations of this type at the time of ERCP may be closed with TTSCs if feasible and/or by placing a fully covered SEMS into the bile duct across the ampulla. BEST PRACTICE ADVICE 12: For the management of large duodenal polyps, endoscopic mucosal resection (EMR) should only be performed by experienced endoscopists and endoscopic submucosal dissection (ESD) only by experts because both EMR and ESD in the duodenum require proficiency in resection and mucosal defect closure techniques to manage immediate and/or delayed perforations (caused by the proteolytic enzymes of the pancreas). BEST PRACTICE ADVICE 13: Endoscopists should be aware that colon perforations occurring during diagnostic colonoscopy are most commonly located in the sigmoid colon due to direct trauma from forceful advancement of the colonoscope. Such tears recognized at the time of colonoscopy may be closed by TTSCs or OTSCs if the bowel preparation is good and the patient is stable. BEST PRACTICE ADVICE 14: Although colon perforation is responsive to various endoscopic tools such as TTSC, OTSC, and endoscopic suturing, perforations in the right colon, especially in the cecum, have been relegated to using only TTSCs because of inability to reach the site of the perforation with an endoscopic suturing device or OTSC if the colon is tortuous or unclean. Recently a new suture-based device for defect closure has been introduced allowing deep submucosal and intramuscular enhanced fixation through a standard gastroscope or colonoscope. BEST PRACTICE ADVICE 15: Patients with perforations who are hemodynamically unstable or who have suffered a delayed perforation with peritoneal signs or frank peritonitis should be surgically managed without any attempt at endoscopic closure. BEST PRACTICE ADVICE 16: In any adverse event including perforation, it is paramount to ensure accurate documentation, prompt discussion with the patient and family, and swift reporting to the quality officer (or equivalent) and risk management team of the institution (in major adverse events).

Management of early gastric cancer meeting criteria for endoscopic resection: US population-based study.

Background and study aims The goal of this study was to assess surgical resection (SR) of early gastric cancer (EGC) fitting Japanese Gastric Cancer Association (JGCA) endoscopic resection (ER) criteria. Patients and methods We analyzed EGC data from the national Surveillance, Epidemiology, and End Results (SEER) database from 2010 to 2015. Results A total of 2219 EGC cases were identified (1074 T1a and 1145 T1b). Of them, 409 met absolute criteria, 219 met expanded 1, 529 expanded 2, and 229 expanded 3. 259 lesions were treated endoscopically while 1007 were surgically resected (20.5 % vs 79.5 %, P  = 0.0001). Temporal analysis showed that the frequency of ER steadily increased while SR proportionally decreased during the study period. Cox proportion regression analysis adjusting for confound variables (including age, gender, and race) showed no significant difference in the risk of mortality following either surgery or endoscopy. Conclusions EGC can be safely treated with ER. However, EGC meeting JGCA ER criteria is largely treated with SR in the United States.