Novel Devices for Endoscopic Suturing: Past, Present, and Future.

Endoscopic suturing has been described in many applications, including the approximation of tissue defects, anchoring stents, hemostasis, and primary and secondary bariatric interventions. Primary endobariatric procedures use endoscopic suturing for gastric remodeling with the intention of weight loss. Currently, the only commercially available device in the United States is the OverStitch endoscopic suturing system (Apollo Endosurgery). We describe devices of potential that are currently in design and/or trials as devices for weight loss by gastric remodeling, including USGI incisionless operating platform used for the primary obesity surgery endoluminal 2.0 procedure, Endomina used for the Endomina endoscopic sleeve gastroplasty, and EndoZip.

How to Build an Endobariatric Practice: Set Up, Branding, and Marketing.

In the last decade there has been significant development of novel devices and techniques in the field of endoscopic bariatric and metabolic therapies (EBMTs). Bariatric endoscopy fulfills an unmet need within the current paradigm of obesity management. The expansion of this field is an important step in offering complete care to patients with obesity and metabolic disease. Nevertheless, information, mentorship and guidance through starting a practice in EBMTs are limited. We discuss important considerations when beginning a practice in obesity care with a focus on endobariatrics in a variety of practice settings.

The Future of Endobariatrics: Bridging the Gap.

With the growing global burden of obesity, the field of endobariatrics has emerged as a promising alternative, filling the void between lifestyle interventions with modest efficacy and more invasive surgical procedures. This article explores the latest advancements in endobariatric therapies, encompassing endoscopic sleeve gastroplasty (ESG), intragastric balloons (IGB), endoscopic metabolic therapies, and promising pharmacologic and surgical combination approaches that integrate multiple therapeutic modalities. It also outlines the critical factors and strategic considerations necessary for the successful integration of endobariatric interventions into clinical practice.

Device-assisted enteroscopy: Are we ready to dismiss the spiral?

Motorized spiral enteroscopy (MSE) is the latest advance in device-assisted enteroscopy. Adverse events related to MSE were discussed in a recent large systematic review and meta-analysis and were directly compared with those of balloon enteroscopy in a case-matched study and a randomized controlled trial. Following the real-life application of MSE, an unexpected safety issue emerged regarding esophageal injury and the technique has been withdrawn from the global market, despite encouraging results in terms of diagnostic and therapeutic yield. We conducted an Italian multicenter real-life prospective study, which was prematurely terminated after the withdrawal of MSE from the market. The primary goals were the evaluation of MSE performance (both diagnostic and therapeutic) and its safety in routine endoscopic practice, particularly in the early phase of introduction in the endoscopic unit. A subanalysis, which involved patients who underwent MSE after unsuccessful balloon enteroscopy, demonstrated, for the first time, the promising performance of MSE as a rescue procedure. Given its remarkable performance in clinical practice and its potential role as a backup technique following a previously failed enteroscopy, it may be more appropriate to refine and enhance MSE in the future rather than completely abandoning it.

Endoscopic suturing and clipping devices for defects in the GI tract.

Gastrointestinal luminal defects, including perforations, leaks and fistulae, pose persistent obstacles in endoscopic therapeutic interventions. A variety of endoscopic approaches have been proposed, with through-the-scope clipping (TTSC), over-the-scope clipping (OTSC) and suturing representing the main techniques of tissue apposition. However, the heterogeneity in defect morphology, the technical particularities of different locations in the gastrointestinal (GI) tract and the impact of various parameters on the final outcome, do not allow distinct conclusions and recommendations on the optimal approaches for defect closure, and, thus, current practice is based on endoscopists experience and local availability of devices. This review aims to collect the existing evidence on tissue apposition devices, in order to outline the role of every device on specific indications.

Applications of endoscopic vacuum therapy in the lower gastrointestinal tract: Tips and tricks and a review of the literature.

Endoscopic vacuum therapy (EVT) is an established technique for the treatment of rectal wall defects and especially anastomotic leaks. A wide range of EVT devices, both handmade and commercially available, allow for their successful placement even in small defects and difficult localizations. Reported success rates range between 85 and 97 %, while periintervenional morbidity is low and major adverse events are very rare. EVT has proven its effectiveness in the lower gastrointestinal tract and is now considered first line treatment for pelvic anastomotic leaks. This narrative review summarizes the current literature on EVT in the lower gastrointestinal tract, focusing on its indications, technical aspects and results, and offers tips and tricks for its clinical applications.

Multi-modality management of defects in the gastrointestinal tract: Where the endoscope meets the scalpel: Endoscopic vacuum therapy in the upper gastrointestinal tract.

BACKGROUND: Transmural defects in the upper gastrointestinal (GI) tract, such as anastomotic leakage and oesophageal perforations, are associated with significant morbidity and mortality risks. Endoscopic vacuum therapy (EVT) is an efficient and safe treatment option for these patients. With the growing use of EVT in the upper GI tract, it is important to share expertise on the topic. AIM: This review explores the emerging role of endoscopic vacuum therapy (EVT) as treatment for transmural defects in the upper GI tract. An overview of the mechanism and procedures, outcomes in current literature and challenges of implementation and application are discussed. CONCLUSION: EVT exhibits great efficacy and safety for the treatment of transmural defects in the upper GI tract. Current use of EVT is mostly experience-based, emphasizing the importance of sharing expertise and performing research to unlock its full potential.

Disposable Gastrointestinal Scopes: A Systematic Review.

OBJECTIVE: Endoscopes are an essential tool in the diagnosis, screening, and treatment of gastrointestinal diseases. In 2019, the Food and Drug Administration issued a news release, recommending that duodenoscope manufacturers and health care facilities phase out fully reusable duodenoscopes with fixed endcaps in lieu of duodenoscopes that are either fully disposable or those that contain disposable endcaps. With this study, we systematically reviewed the published literature on single-use disposable gastrointestinal scopes to describe the current state of the literature and provide summary recommendations on the role of disposable gastrointestinal endoscopes. MATERIALS AND METHODS: For our inclusion criteria, we searched for studies that were published in the year 2015 and afterward. We performed a literature search in PubMed using the keywords, "disposable," "reusable," "choledochoscope," "colonoscope," "duodenoscope," "esophagoscope," "gastroscope," and "sigmoidoscope." After our review, we identified our final article set, including 13 articles relating to disposable scopes, published from 2015 to 2023. RESULTS: In this review, we show 13 articles discussing the infection rate, functionality, safety, and affordability of disposable gastrointestinal scopes in comparison to reusable gastrointestinal scopes. Of the 3 articles that discussed infection rates (by Forbes and colleagues, Ridtitid and colleagues, and Ofosu and colleagues), each demonstrated a decreased risk of infection in disposable gastrointestinal scopes. Functionality was another common theme among these articles. Six articles (by Muthusamy and colleagues, Bang and colleagues, Lisotti and colleagues, Ross and colleagues, Kang and colleagues, and Forbes and colleagues) demonstrated comparable functionality of disposable scopes to reusable scopes. The most reported functionality issue in disposable scopes was decreased camera resolution. Disposable scopes also showed comparable safety profiles compared with reusable scopes. Six articles (by Kalipershad and colleagues, Muthusamy and colleagues, Bang and colleagues, Lisotti and colleagues, Luo and colleagues, and Huynh and colleagues) showed comparable rates of AEs, whereas 1 article (by Ofosu and colleagues) demonstrated increased rates of AEs with disposable scopes. Lastly, a cost analysis was looked at in 3 of the articles. Two articles (by Larsen et al and Ross and colleagues) remarked that further research is needed to understand the cost of disposable scopes, whereas 1 article (by Kang and colleagues) showed a favorable cost analysis. CONCLUSIONS: After a review of the literature published since the 2015 Food and Drug Administration safety communication, disposable scopes have been shown to be effective in decreasing infection risks while maintaining similar safety profiles to conventional reusable scopes. However, more research is required to compare disposable and reusable scopes in terms of functionality and cost-effectiveness.

Endoscopic outcomes using a novel through-the-scope tack and suture system for gastrointestinal defect closure: a systematic review and meta-analysis.

BACKGROUND: Closure of gastrointestinal defects can reduce postprocedural adverse events. Over-the-scope clips and an over-the-scope suturing system are widely available, yet their use may be limited by defect size, location, operator skill level, and need to reinsert the endoscope with the device attached. The introduction of a through-the-scope helix tack suture system (TTSS) allows for closure of large irregular defects using a gastroscope or colonoscope, without the need for endoscope withdrawal. Since its approval 3 years ago, only a handful of studies have explored outcomes using this novel device. METHODS: Multiple databases were searched for studies looking at TTSS closure from inception until August 2023. The primary outcomes were the success of TTSS alone and TTSS with clips for complete defect closure. Secondary outcomes included complete closure based on procedure type (endoscopic mucosal resection [EMR], endoscopic submucosal dissection [ESD]) and adverse events. RESULTS: Eight studies met the inclusion criteria (449 patients, mean defect size 34.3 mm). Complete defect closure rates for TTSS alone and TTSS with adjunctive clips were 77.2% (95%CI 66.4-85.3; I2=79%) and 95.2% (95%CI 90.3-97.7; I2=42.5%), respectively. Complete defect closure rates for EMR and ESD were 99.2% (95%CI 94.3-99.9; I2 = 0%) and 92.1% (95%CI 85-96; I2=0%), respectively. The adverse event rate was 5.4% (95%CI 2.7-10.3; I2=55%). CONCLUSION: TTSS is a novel device for closure of postprocedural defects, with relatively high technical and clinical success rates. Comparative studies of closure devices are needed.

Comparison of the performance of MS enteroscope series and Japanese double- and single-balloon enteroscopes.

BACKGROUND: Small intestine disease endangers human health and is not easy to locate and diagnose. AIM: To observe the effect of the MS series of small intestine endoscopes on the gastrointestinal tract, the changes in serum gastrin levels and intestinal tissue, and the time required for the examination. METHODS: In vivo experiments in 20 Living pigs were conducted, Bowel preparation was routinely performed, Intravenous anesthesia with propofol and ketamine was applied, the condition of the small intestine was observed and the detection time of the MS series of small intestine endoscopes were recorded, The changes in intestinal tissue using the MS series of small intestine endoscopes observed and compared before and after the examination, Venous blood (3-5 mL) from pigs was collected before and after the experiment; changes in intestinal tissue after use of the MS series of small intestine endoscopes observed after examination. After completion of each type of small intestine endoscope experiment, the pigs were allowed to rest and the next type of small intestine endoscope experiment was performed after 15 days of normal feeding. The detection time data of the single-balloon small intestine endoscope and double-balloon small intestine endoscope were collected from four hospitals. RESULTS: One case of Ascarislumbricoides, one of suspected Crohn's disease, one small intestinal diverticulum and one anesthesia accident were observed in pigs. The small intestine showed no differences in the MS series of small intestine endoscopes and there were no differences in serum gastrin between the groups (P > 0.05). The time required for inspection was recorded, and the overall detection time for the Japanese small intestine endoscopes was approximately 1.68 ± 0.16 h. CONCLUSION: Intestinal ascariasis is a common disease in pigs. Some pigs have abnormal intestinal variation. After continuous upgrade and improvement, the MS-3 and MS-4 small intestine endoscope appear superior in terms of detection time.

Non-invasive laparoscopic detection of small tumors of the digestive tract using inductive sensors of proximity.

The precise location of gastric and colorectal tumors is of paramount importance for the oncological surgeon as it dictates the limits of resection and the extent of lymphadenectomy. However, this task proves sometimes to be very challenging, especially in the laparoscopic setting when the tumors are small, have a soft texture, and do not invade the serosa. In this view, our research team has developed a new instrument adapted to minimally-invasive surgery, and manipulated solely by the operating surgeon which has the potential to locate precisely tumors of the digestive tract. It consists of an inductive proximity sensor and an electronic block encapsulated into an autoclavable stainless-steel cage that works in tandem with an endoscopic hemostatic clip whose structure was modified to increase detectability. By scanning the serosal side of the colon or stomach, the instrument is capable to accurately pinpoint the location of the clip placed previously during diagnostic endoscopy on the normal bowel mucosa, adjacent to the tumor. In the current in-vivo experiments performed on large animals, the modified clips were transported without difficulties to the point of interest and attached to the mucosa of the bowel. Using a laparoscopic approach, the detection rate of this system reached 65% when the sensor scanned the bowel at a speed of 0.3 cm/s, and applying slight pressure on the serosa. This value increased to 95% when the sensor was guided directly on the point of clip attachment. The detection rate dropped sharply when the scanning speed exceeded 1 cm/s and when the sensor-clip distance exceeded the cut-off value of 3 mm. In conclusion, the proposed detection system demonstrated its potential to offer a swift and convenient solution for the digestive laparoscopic surgeons, however its detection range still needs to be improved to render it useful for the clinical setting.

Feasibility of endoscopic hand suturing on rectal anastomoses in ex vivo porcine models.

Prevention of postoperative anastomotic leakage in rectal surgery is still required. This study investigated the feasibility of endoscopic hand suturing (EHS) on rectal anastomosis ex vivo. By using isolated porcine colon, we prepared ten anastomoses 6-10 cm from the virtual anus. Then, we sutured anastomoses intraluminally by EHS, which involved a continuous suturing method in 5 cases and a nodule suturing method with extra corporeal ligation in 5 cases. Completeness of suturing, number of stitches, procedure time and presence of stenosis were investigated. Furthermore, the degree of stenosis was compared between the two suturing methods. In all cases, EHS were successfully completed. The median number of stitches and procedure time was 8 and 5.8 min, respectively. Stenosis was created in all continuous suturing cases whereas none was seen in nodule suturing cases. The shortening rate was significantly greater in the continuous suturing method than in the nodule suturing method. Intraluminal reinforcement of rectal anastomosis by EHS using nodule suturing with extra corporeal ligation is feasible without stenosis, which may be helpful as a countermeasure against possible postoperative anastomotic leakage in rectal surgery.

Individually designed fully covered self-expandable metal stents for pediatric refractory benign esophageal strictures.

To share our institutional experience of placing individually designed fully covered self-expandable metal stents (FCSEMSs) for the treatment of refractory benign esophageal strictures (RBESs) in pediatric patients. A 10-year retrospective study between May 2009 and July 2020 that includes 14 children with RBESs who were treated with individually designed FCSEMSs. Patients were followed-up regularly after stent placement to observe the improvement of vomiting and dysphagia, changes in stenosis diameter and complications. A total of 20 stents were successfully placed in 14 patients. During a follow-up period ranging from 5 to 83 months, except for one 4-year-old child who could not endure chest pain, the remaining 13 patients all benefited from stenting. Their Ogilvie & Atkinson scores improved from grade III-IV to grade 0-I, and the diameters of the stenosis' were enlarged from 2-5 mm to 9-14 mm. Two patients developed restenosis and granulation tissue hyperplasia was found in 2 patients and stent migration and malapposition in 2 patients with esophageal perforations that required further endoscopic intervention. The use of FCSEMS for RBES is safe and effective in selected pediatric patients. Rationally designed stents and timely management of postoperative complications are critical to ensure the success of this new method.