Motorised spiral enteroscopy: first prospective clinical feasibility study.

OBJECTIVE: Currently available methods for small bowel endoscopy are often time consuming; motorised PowerSpiral Enteroscopy (PSE) is a further development of spiral enteroscopy to facilitate the approach to the small bowel. The aim of this bicentric prospective trial was to study feasibility and yield of peroral PSE. DESIGN: Consecutive patients with suspected small bowel disease and indication for antegrade enteroscopy were included in two tertiary referral centres. Primary objective was diagnostic yield of antegrade PSE. Secondary objectives included technical success (defined as successful endoscope insertion at least to ligament of Treitz), depth of maximum insertion (DMI), median insertion time to DMI, rate of therapeutic procedures and adverse events. RESULTS: During a 30-month period, 140 procedures were performed on 132 patients (58 female, 74 male; median age: 68 (20-100) years) under general anaesthesia. Overall diagnostic yield of PSE was 74.2%; with 68.2% of procedures including some form of endotherapy. Technical success rate of PSE was 97%; median DMI was 450 cm (0-600) with a median insertion time to DMI of 25 min (3-122). Antegrade panenteroscopy to the cecum was achieved in 14 cases (10.6%). Overall adverse event (AE) rate was 14.4%; two major serious AEs occurred (1.5%), one delayed perforation, one bleeding from Mallory-Weiss lesion. CONCLUSION: This pilot clinical trial demonstrates that PSE is effective for diagnostic and therapeutic antegrade enteroscopy and may compare favourably with traditional methods of deep enteroscopy in ease of use and procedural duration. More comparative data are required to assess clinical application and safety of PSE. TRIAL REGISTRATION NUMBER: NCT02965209.

Novel Negative Pressure Protective Box in Upper Digestive Endoscopy: A Prospective Case Series.

In the context of the Severe Acute Respiratory Syndrome Coronavirus 2 pandemic, we have developed a novel negative pressure aerosol protector for upper endoscopy (TRACEY). TRACEY is the first endoscopic enclosure to have passed stringent testing for aerosol protection. The following describes its clinical use in a single-center prospective case series. Overall, 15 patients were included. All endoscopic procedures were successful without premature removal of TRACEY. In addition, its use did not lead to significant patient discomfort, technical hinderance, or adverse events. TRACEY seems to offer a safe and easy to use aerosol protection for upper endoscopy and a potential Severe Acute Respiratory Syndrome Coronavirus 2 mitigation strategy in endoscopy.

Association between time to stent dysfunction and the anti-tumour effect of systemic chemotherapy following stent placement in patients with pancreaticobiliary cancers and malignant gastric outlet obstruction: a retrospective cohort study.

BACKGROUND: Malignant gastric outlet obstruction (MGOO) occasionally occurs due to pancreaticobiliary cancer. Endoscopic duodenal stenting (DS) is a common treatment for MGOO. However, it has been reported that DS does not have sufficient patency time for it to be used in patients who have a potentially increased lifespan. Nowadays, systemic chemotherapy for pancreaticobiliary cancer has developed, and its anti-tumour effect would make time to stent dysfunction longer. Therefore, we retrospectively evaluated the association between objective response to systemic chemotherapy, followed by DS and time to stent dysfunction in patients with advanced pancreaticobiliary cancer. METHODS: This retrospective study included 109 patients with advanced pancreaticobiliary cancer who received systemic chemotherapy after DS. Patients who showed complete or partial response were defined as responders. The rest were defined as non-responders. Time to stent dysfunction was compared between responders and non-responders using the landmark analysis at 2 months after DS. Death without recurrence of MGOO was considered as a competing risk for time to stent dysfunction. RESULTS: Combination and monotherapy regimens were adopted for 46 and 63 patients, respectively. Median progression-free survival and overall survival were 3.2 months (95% confidence interval [CI], 2.4-4.0) and 6.0 months (95% CI, 4.6-7.3). Objective response was observed in 21 patients (19.3%). Median time to stent dysfunction was 12.5 months (95% CI, 8.4-16.5) in the entire cohort. In 89 patients, responders had a lower cumulative incidence of stent dysfunction than non-responders: 9.5 and 19.1% at 6 months, and 19.0 and 27.9% at 1-year, respectively. There was difference of time to stent dysfunction between responders and non-responders among patients who received combination regimen as the first-line treatment with p-value of 0.009: cumulative incidence was 0 and 42.9% at 6 months, and 9.3 and 57.1% at 1-year, respectively. CONCLUSIONS: Longer time to stent dysfunction is expected when systemic chemotherapy following DS suppresses tumour progression; DS is slated to be a standard treatment for MGOO even in patients with pancreaticobiliary cancer and a long lifespan.

Endoscopic gastrointestinal anastomoses with lumen-apposing metal stents: predictors of technical success.

BACKGROUND: Lumen-apposing metal stents (LAMS) may be inserted to create gastrointestinal anastomoses under endoscopic ultrasound (EUS) guidance. This new technique has mostly been evaluated as treatment for gastric outlet obstruction (GOO), especially of malignant origin. Technical success was high in the few and small available studies. Aim of this study was to report our experience with this technique and to identify predictors of success in the setting of a large teaching hospital in Germany. METHODS: All subsequent patients who underwent EUS-guided gastrointestinal anastomosis with LAMS from 02/2016 to 08/2019 were included. We performed a retrospective chart analysis including technical procedural details, basic demographic, and health characteristics. Technical success was defined as successful insertion of LAMS. In patients with GOO, the GOO Scoring System was used; an improvement ≥ 1 point was defined as clinical success. RESULTS: Thirty-five patients (22 female, median age: 79 years) were included. Indication for the anastomosis was malignant GOO in 33 patients. In ten patients LAMS was inserted over a guidewire, in 22 patients direct puncture with the electrocautery delivery system of LAMS was performed, and other techniques were used in two patients. Technical success rate was 80.0%. Adverse events occurred in 14.3%. Clinical success rate was 74.3%. Technical success increased and procedure time decreased significantly during the study period. Distance between the two lumina connected with LAMS was significantly shorter (median: 9 mm) in patients with technical success compared to those without (median: 20 mm, P = 0.004). This distance was identified as predictor of success on multivariate analysis. CONCLUSIONS: EUS-guided gastrointestinal anastomosis with LAMS is an emerging technique. Its success mainly depends on the distance between the two lumina that are going to be connected by the LAMS and is influenced by the endoscopist's experience.

SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopy.

BACKGROUND: Confocal laser endomicroscopy (CLE) is a novel endoscopic adjunct that allows real-time in vivo histological examination of mucosal surfaces. By using intravenous or topical fluorescent agents, CLE highlights certain mucosal elements that facilitate an optical biopsy in real time. CLE technology has been used in different organ systems including the gastrointestinal tract. There has been numerous studies evaluating this technology in gastrointestinal endoscopy, our aim was to evaluate the safety, value, and efficacy of this technology in the gastrointestinal tract. METHODS: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee (TAVAC) performed a PubMed/Medline database search of clinical studies involving CLE in May of 2018. The literature search used combinations of the keywords: confocal laser endomicroscopy, pCLE, Cellvizio, in vivo microscopy, optical histology, advanced endoscopic imaging, and optical diagnosis. Bibliographies of key references were searched for relevant studies not covered by the PubMed search. Case reports and small case series were excluded. The manufacturer's website was also used to identify key references. The United States Food and Drug Administration (U.S. FDA) Manufacturer And User facility and Device Experience (MAUDE) database was searched for reports regarding the device malfunction or injuries. RESULTS: The technology offers an excellent safety profile with rare adverse events related to the use of fluorescent agents. It has been shown to increase the detection of dysplastic Barrett's esophagus, gastric intraepithelial neoplasia/early gastric cancer, and dysplasia associated with inflammatory bowel disease when compared to standard screening protocols. It also aids in the differentiation and classification of colorectal polyps, indeterminate biliary strictures, and pancreatic cystic lesions. CONCLUSIONS: CLE has an excellent safety profile. CLE can increase the diagnostic accuracy in a number of gastrointestinal pathologies.

Development and Validation of a Mucosal Impedance Contour Analysis System to Distinguish Esophageal Disorders.

BACKGROUND & AIMS: Diagnostic testing for chronic esophageal disorders relies on histopathology analysis of biopsies or uncomfortable transnasal catheters or wireless pH monitoring, which capture abnormal intraluminal refluxate. We therefore developed a balloon mucosal impedance (MI) catheter system that instantly detects changes in esophageal mucosal integrity during endoscopy over a long segment of the esophagus. We performed a prospective study to evaluate the ability of a balloon-incorporated MI catheter to detect and evaluate esophageal disorders, including gastroesophageal reflux disease (GERD) and eosinophilic esophagitis (EoE). METHODS: We performed a prospective study of 69 patients undergoing esophagogastroduodenoscopy with or without wireless pH monitoring. Patients were classified as having GERD (erosive esophagitis or abnormal pH; n = 24), EoE (confirmed with pathology analysis of tissues from both distal and proximal esophagus; n = 21), or non-GERD (normal results from esophagogastroduodenoscopy and pH tests; n = 24). Receiver operating characteristic curves and area under the operating characteristic curve (AUC) were used to compare the accuracy of balloon MI in diagnosis. Probabilities of assignment to each group (GERD, non-GERD, or EoE) were estimated using multinomial logistic regression. Association between MI patterns and diagnoses were validated using data from patients seen at 3 separate institutions. RESULTS: MI pattern along the esophageal axis differed significantly (P < .01) among patients with GERD, EoE, and non-GERD. Patients with non-GERD had higher MI values along all measured segments. The MI pattern for GERD was easily distinguished from that of EoE: in patients with GERD, MI values were low in the distal esophagus and normalized along the proximal esophagus, whereas in patients with EoE, measurements were low in all segments of the esophagus. Intercept and rate of rise of MI value (slope) as distance increased from the squamocolumnar junction identified patients with GERD with an AUC = 0.67, patients with EoE with an AUC = 0.84, and patients with non-GERD with an AUC = 0.83 in the development cohort. One patient had an adverse event (reported mild chest pain after the procedure) and was discharged from the hospital without further events. CONCLUSIONS: We developed a balloon MI catheter system that instantly detects changes in esophageal mucosal integrity during endoscopy and found it to be safe and able to identify patients with GERD, EoE, or non-GERD. We validated our findings in a separate cohort for patients. ClinicalTrials.gov ID NCT03103789.

Endoscopic retrieval of magnetic foreign body ingestions with a nasal bridle: description of a novel technique (with video).

BACKGROUND AND AIMS: Accidental and intentional foreign body ingestions are common and frequently require endoscopic intervention. Sharp metallic objects pose a risk of perforation to the entire GI tract and are often difficult to visualize among food and other matter in the stomach. METHODS: Three patients with histories of multiple ingestions are considered. Metallic foreign bodies can be easily removed using a nasal bridle. A snare and magnetic catheter are used as endoscopic tools to extract various metallic items. RESULTS: The bridle technique was used in 68 endoscopies in 3 patients who presented numerous times for foreign body ingestions. The technique was successful in 66 of the 68 procedures, with no adverse events. CONCLUSIONS: The bridle technique is an easy and effective way to remove metallic foreign bodies and has many advantages over traditional, mechanical modes of foreign body retrieval.

Novel modified endoscopic mucosal resection of large GI lesions (> 20 mm) using an external additional working channel (AWC) may improve R0 resection rate: initial clinical experience.

BACKGROUND: En-bloc resection of large, flat dysplastic mucosal lesions of the luminal GI tract can be challenging. In order to improve the efficacy of resection for lesions ≥2 cm and to optimize R0 resection rates of lesions suspected of harboring high-grade dysplasia or early adenocarcinoma, a novel grasp and snare EMR technique utilizing a novel over the scope additional accessory channel, termed EMR Plus (EMR+), was developed. The aim of this pilot study is to describe the early safety and efficacy data from the first in human clinical cases. METHODS: A novel external over-the-scope additional working channel (AWC) (Ovesco, Tuebingen, Germany) was utilized for the EMR+ procedure, allowing a second endoscopic device to be used through the AWC while using otherwise standard endoscopic equipment. The EMR+ technique allows tissue retraction and a degree of triangulation during endoscopic resection. We performed EMR+ procedure in 6 patients between 02/2018-12/2018 for lesions in the upper and lower GI tract. RESULTS: The EMR+ technique utilizing the AWC was performed successfully in 6 resection procedures of the upper and/or lower GI tract in 6 patients in 2 endoscopy centers. All resections were performed successfully with the EMR+ technique, all achieving an R0 resection. No severe adverse events occurred in any of the procedures. CONCLUSIONS: The EMR+ technique, utilizing an additional working channel, had an acceptable safety and efficacy profile in this preliminary study demonstrating it's first use in humans. This technique may allow an additional option to providers to remove complex, large mucosal-based lesions in the GI tract using standard endoscopic equipment and a novel AWC device.

In vivo real-time diagnosis of endoscopic ultrasound-guided needle-based confocal laser endomicroscopy in gastric subepithelial lesions.

BACKGROUND AND AIM: The effect of real-time analysis of needle-based confocal laser endomicroscopy (nCLE) for gastric subepithelial lesions (SELs) on the diagnostic value is unclear. The study aimed to investigate the diagnostic efficacy of real-time nCLE for gastric SELs and to assess the technical aspects and safety of real-time nCLE. METHODS: Consecutive patients with gastric SELs ≥ 1 cm were prospectively investigated by endoscopic ultrasound (EUS), followed by nCLE. During EUS-nCLE, real-time nCLE diagnosis was made by an expert endoscopist. The procedure-relative adverse events were assessed and recorded. One-month washout period later, nCLE videos were reviewed off-line by the same endoscopist. The nCLE diagnoses were compared with corresponding pathological results. Additionally, image quality and interobserver agreements for the criteria were evaluated by three experienced endomicroscopists. RESULTS: Except for one failing to be punctured, 60 patients completed EUS-nCLE procedures successfully. Real-time nCLE had high diagnostic accuracies of ≥ 88.3% for gastric SELs. There were no significant differences between real-time and off-line nCLE diagnoses for gastric SELs (P > 0.05). The overall accuracy of real-time nCLE for diagnosis of gastric SELs was 86.7%. There were no procedure-relative adverse events occurred. In addition, the mean image quality score was 3.6 (1 = poor and 5 = excellent). The interobserver agreement was "almost perfect" for ectopic pancreas and "substantial" for gastrointestinal stromal tumor, leiomyoma, and carcinoma. CONCLUSIONS: Endoscopic ultrasound-nCLE could provide in vivo real-time diagnostic imaging with a high diagnostic accuracy. Meanwhile, real-time nCLE was feasible and had a satisfactory safety profile.

Over-the-scope clip management of non-acute, full-thickness gastrointestinal defects.

BACKGROUND: Endoscopic management of full-thickness gastrointestinal tract defects (FTGID) has become an attractive management strategy, as it avoids the morbidity of surgery. We have previously described the short-term outcomes of over-the-scope clip management of 22 patients with non-acute FTGID. This study updates our prior findings with a larger sample size and longer follow-up period. METHODS: A retrospective analysis of prospectively collected data was conducted. All patients undergoing over-the-scope clip management of FTGID between 2013 and 2019 were identified. Acute perforations immediately managed and FTGID requiring endoscopic suturing were excluded. Patient demographics, endoscopic adjunct therapies, number of endoscopic interventions, and need for operative management were evaluated. Success was strictly defined as complete FTGID closure. RESULTS: We identified 92 patients with 117 FTGID (65 fistulae and 52 leaks); 27.2% had more than one FTGID managed simultaneously. The OTSC device (Ovesco Endoscopy, Tubingen, Germany) was utilized in all cases. Additional closure attempts were required in 22.2% of defects. With a median follow-up period of 5.5 months, overall defect closure success rate was 66.1% (55.0% fistulae vs. 79.6% leaks, p = 0.007). There were four mortalities from causes unrelated to the FTGID. Only 14.9% of patients with FTGID underwent operative management. There were no complications related to endoscopic intervention and no patients required urgent surgical intervention. CONCLUSIONS: Over-the-scope clip management of FTGID represents a safe alternative to potentially morbid operative intervention. When strictly defining success as complete closure of all FTGID, endoscopy was successful in 64.4% of patients with only a small minority of patients ultimately requiring surgery.

Endoscopic Nasoenteral Feeding Tube Fixation with Hemoclip Reduces Tube Dislodgement.

BACKGROUND/AIMS: Spontaneous retrograde migration of nasoenteral feeding tubes is common in clinical practice. The aim of the present study was to evaluate the effectiveness of nasoenteral feeding tube tip fixation with hemoclips to prevent tube dislodgement. METHODS: We retrospectively reviewed patients who underwent insertion of an endoscopic nasoenteral feeding tube with or without tube tip fixation with hemoclips at the Asan Medical Center in Korea from January 2016 to December 2017. We compared the incidence of tube dislodgment and procedure-related complications between the two groups. RESULTS: Of the total 225 procedures, 72 were performed using the clip-assisted method, while 153 were performed using the standard non-clip-assisted method. Tube dislodgement occurred in two (2.8%) cases in the clipping group and in 26 (17.0%) in the non-clipping group (p = 0.003). Non-clipping group had a sevenfold higher risk of tube dislodgement compared to clipping group after adjustments in multivariable logistic regression (adjusted OR 7.97, 95% CI 1.82-35.00). The procedure time was not significantly different between the two groups (17.6 ± 8.5 min in the clipping group vs. 17.8 ± 9.4 min in the non-clipping group, p = 0.872). In addition, procedure-related complications, such as bleeding, aspiration pneumonia, Mallory-Weiss tear, ileus, and tube obstruction, were not different between the two groups. Achieving target calorie intake took 10.4 ± 10.5 days in the clipping group and 7.9 ± 7.9 days in the non-clipping group (p = 0.293). CONCLUSION: Clip-assisted fixation of nasoenteral feeding tube was effective in preventing tube dislodgement.

Feasibility of needlescopic surgery for colorectal cancer: safety and learning curve for Japanese Endoscopic Surgical Skill Qualification System-unqualified young surgeons.

BACKGROUND: Needlescopic surgery (NS) is a minimally invasive technique for colorectal cancer. NS may be easier to perform than other minimally invasive surgery such as single-incision laparoscopic surgery and natural orifice transluminal endoscopic surgery because the port setting is the same while the shafts are thinner than in conventional laparoscopic surgery. We evaluated the capability of introducing this surgery for sigmoid and rectosigmoid colon cancer by assessing the learning curve in Japanese Endoscopic Surgical Skill Qualification System (JESSQS)-unqualified surgeons. METHODS: In this retrospective study, 112 cases of sigmoidectomy and anterior resection were performed by NS from October 2011 to December 2015 in our institution. Surgical outcomes including operation time, blood loss, postoperative hospital stay, perioperative complications, and overall survival were compared between JESSQS-qualified surgeons (Group A) and JESSQS-unqualified surgeons (Group B). The learning curve for NS was established using the average operation times in JESSQS-unqualified surgeons. RESULTS: Groups A and B comprised of 41 and 71 patients, respectively. Ninety patients underwent sigmoidectomy and 22 patients underwent anterior resection. No conversion to open surgery occurred. The operation time was significantly shorter in Group A than B (P = 0.0080). There were no significant differences in blood loss, the postoperative hospital stay, perioperative complications, or overall survival between the two groups. These variables were similar even when NS was considered relatively difficult, as in patients with obesity (body mass index of ≥ 25 kg/m2), bulky tumors (tumor size of ≥ 50 mm), and stage III/IV cancer. The average operation time in JESSQS-unqualified young surgeons was significantly shorter in the ninth and tenth cases than in the first and second cases of NS (P = 0.0282). CONCLUSIONS: NS for sigmoid and rectosigmoid colon cancer was performed safely by both JESSQS-qualified surgeons and JESSQS-unqualified surgeons. Even JESSQS-unqualified young surgeons might be able to quickly learn NS techniques.

Safety and effectiveness of levodopa-carbidopa intestinal gel for advanced Parkinson's disease: A large single-center study.

BACKGROUND: Treatment with levodopa-carbidopa intestinal gel (LCIG) can effectively relieve motor and non-motor symptoms in advanced Parkinson's disease (PD). However, adverse events (AEs) are frequent. OBJECTIVE: To describe AEs associated with LCIG treatment and the main reasons for treatment discontinuation. We also looked for factors that were potentially predictive of serious AEs and assessed the effectiveness of and satisfaction with LCIG. METHOD: We retrospectively analyzed data on AEs in patients treated with LCIG at a French university medical center. For patients still receiving treatment at last follow-up, effectiveness was assessed according to the Clinical Global Impression (CGI) scale and the Movement Disorders Society - Unified Parkinson's Disease Rating Scale motor score. RESULTS: Of the 63 patients treated with LCIG for a mean (range) of 19 months (8-47), 57 (90%) experienced at least one AE (340 AEs in total). Most of the AEs (in 69.8% of the patients) were related to percutaneous endoscopic gastrostomy with a jejunal tube (PEG-J) or affected the gastrointestinal tract (granuloma, leakage, or a local infection). Device-related AEs (such as PEG-J removal and device occlusion) were frequent (in 63.5% of patients). Forty-three patients (68%) required at least one additional endoscopic procedure. Dopatherapy-related AEs occurred in 30 patients (48%). Most of the AEs occurred long after treatment initiations, and only a small proportion led to discontinuation. On the CGI scale, 53 patients (84.4%) considered that their condition had improved during LCIG treatment. CONCLUSION: Despite the high frequency of AEs, patients with advanced PD gain clinical benefit from treatment with LCIG. This treatment requires a competent, multidisciplinary team on site.

AEG-SEED position paper for the resumption of endoscopic activity after the peak phase of the COVID-19 pandemic. / Documento de posicionamiento AEG-SEED para el reinicio de la actividad endoscópica tras la fase pico de la pandemia de COVID-19.

INTRODUCTION: The COVID-19 pandemic has led to the suspension of programmed activity in most of the Endoscopy Units in our environment. The aim of this document is to facilitate the resumption of elective endoscopic activity in an efficient and safe manner. MATERIAL AND METHODS: A series of questions considered to be of clinical and logistical relevance were formulated. In order to elaborate the answers, a structured bibliographic search was carried out in the main databases and the recommendations of the main Public Health and Digestive Endoscopy institutions were reviewed. The final recommendations were agreed upon through telematic means. RESULTS: A total of 33 recommendations were made. The main aspects discussed are: 1) Reassessment and prioritization of the indication, 2) Restructuring of spaces, schedules and health personnel, 3) Screening for infection, 4) Hygiene measures and personal protective equipment. CONCLUSION: The AEG and SEED recommend restarting endoscopic activity in a phased, safe manner, adapted to local resources and the epidemiological situation of SARS-CoV-2 infection.

[Recommendations of the Society of Gastroenterology of Peru to avoid the spread of SARS-CoV-2 through digestive endoscopy procedures]. / Recomendaciones de la Sociedad de Gastroenterología del Perú para evitar la propagación del SARS-CoV-2 a través de procedimientos de endoscopía digestiva.

The SARS-CoV-2 coronavirus produces the disease called COVID-19, currently spreading in a rapidly evolving pandemic. It can be transmitted by contact, drops and aerosols, and has been isolated from gastrointestinal secretions and faeces. During digestive endoscopy, transmission by any of these mechanisms could occur. It is recommended to limit digestive endoscopy to cases of digestive bleeding, severe dysphagia, foreign body in the digestive tract, biliary obstruction with intractable pain or cholangitis, pseudocyst or complicated encapsulated pancreatic necrosis, gastrointestinal obstruction, and cases at risk of deterioration over time. It is recommended to screen patients based on temperature, symptoms, and epidemiological factors to classify them according to their risk of infection. For procedures in low risk patients, personnel must wear a disposable gown, gloves, eye or face shield, standard surgical mask, disposable hat, disposable shoe covers. In cases of intermediate or high risk, or confirmed COVID-19, protection should be increased using disposable waterproof gown, N95 respirator or similar, and double glove. In case of shortage it may be necessary to reuse N95 respirators for up to 5 uses, following CDC recommendations for donning, removing and storing to prevent secondary contact contamination. Likewise, all protective equipment should be put on and removed according to CDC recommendations. The presence of personnel in endoscopy should be limited to the bare minimum. Said personnel must have daily temperature control and if it is above 37.3ºC, the corresponding evaluation must be carried out. After each procedure, the stretcher and room surfaces should be properly disinfected. High-level disinfection of endoscopes eliminates SARS-CoV-2.

Evolution of Endoscopic Bariatric Devices: From Development to Practice.

OBJECTIVES: To familiarize medical providers with the Food and Drug Administration approval process for antiobesity devices and to provide a brief overview of current and promising endoscopy-based bariatric devices. METHODS: Literature review of published scholarly articles. RESULTS: There has been a rapid development of novel endoscopic bariatric therapies in recent years, resulting in the approval of multiple devices. Several promising endoscopic strategies are currently under investigation and review. The Food and Drug Administration has laid down an objective-tiered model to review antiobesity device applications. DISCUSSION: Endoscopic bariatric devices provide a new and promising paradigm in obesity management both as first-line therapy and as adjunctive treatment to medical and surgical strategies. Physicians who plan to offer endoscopic bariatric therapy in their practice need appropriate understanding of the regulatory processes involved in the development and approval of such devices.

Efficacy and safety of over-the-scope clips for gastrointestinal bleeding: a systematic review and meta-analysis.

BACKGROUND: The over-the-scope clip (OTSC) has been increasingly utilized for the management of gastrointestinal (GI) bleeding. Limited efficacy data are currently available from large-scale studies. METHODS: An electronic database search was conducted for eligible articles using OTSCs for hemostasis in GI bleeding. The primary outcome was the rate of definitive hemostasis after primary hemostasis and without rebleeding at follow-up. Secondary outcomes were: primary technical success, primary clinical success, rebleeding, and failure rates. Pooled rates were expressed as proportions of patients with events over total patients, 95 % confidence limits (CI) with heterogeneity, and P values of < 0.05 for significance. RESULTS: A total of 21 studies (n = 851) were analyzed (62.2 % males), with a median patient age of 69.7 years. The definitive hemostasis rate was 87.8 % (95 %CI 83.7 % - 92 %) after a median follow-up of 56 days. The OTSC was successfully deployed in 97.8 % of patients (95 %CI 96.7 % - 98.9 %) and the primary clinical success rate was 96.6 % (95 %CI 95.1 % - 98.2 %). Rebleeding was seen in 10.3 % of patients (95 %CI 6.5 % - 14.1 %). The failure rate of OTSCs was 9 % (95 %CI 5.2 % - 12.8 %) when used as first-line treatment and 26 % (95 %CI 16.1 % - 36.0 %) when used as second-line treatment. CONCLUSION: This systematic review showed high rates of definitive hemostasis, technical success, and clinical success, along with low rebleeding rates when OTSCs were used for the treatment of GI bleeding. The lack of randomized controlled trials of OTSC vs. other therapies makes comparison with conventional treatment difficult.