Intragastric Balloon Versus Endoscopic Sleeve Gastroplasty for the Treatment of Obesity: a Systematic Review and Meta-analysis.

BACKGROUND: We aimed to individually evaluate IGB and ESG procedures and compare the efficacy, durability, and safety of these procedures. METHODS: Bibliographic databases were systematically searched for studies investigating the use of IGB and ESG for the treatment of obesity. Studies reporting percent total weight loss (%TWL) or percent excess weight loss (%EWL) with at least 12 months of follow-up were included. RESULTS: A total of 28 studies were included in the final analysis. Only 1 study directly compared ESG to IGB, 9 studies evaluated ESG alone, while 18 studies evaluated IGB. At 12-month follow-up after ESG, mean %TWL was 17.51 (95% CI 16.44-18.58), and %EWL was 60.51 (95% CI 54.39-66.64). Mean %TWL and %EWL after IGB at 12 months was 10.35 (95% CI 8.38-12.32) and 29.65 (95% CI 25.40-33.91), respectively. Mean %TWL and %EWL after IGB were significantly decreased at 18 or 24 months compared to 6 months indicating weight regain after IGB removal. ESG achieved significantly superior weight loss compared to IGB, the difference in mean %TWL was 7.33 (95% CI 5.22-9.44, p value = 0.0001) at 12 months. Serious adverse events were observed in < 5% for both procedures. CONCLUSION: Although ESG and IGB are safe and effective for weight loss, our study suggests that ESG results in more significant and sustained weight loss. Nevertheless, a variety of approaches are essential to care for this underserved population, and there are several factors other than weight loss that should be considered in selecting the ideal therapy for individual patients.

Safety and efficacy of endoscopic sleeve gastroplasty worldwide for treatment of obesity: a systematic review and meta-analysis.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) has gained momentum as a promising, minimally invasive bariatric therapy worldwide. OBJECTIVE: We performed the first comprehensive systematic review and meta-analysis of studies to evaluate the efficacy, safety, and procedural technique of ESG. METHODS: Bibliographic databases were systematically searched for studies assessing patients who underwent ESG for the treatment of obesity. Studies were included if they reported percent total weight loss or percent excess weight loss and the incidence of serious adverse events. Studies with <15 patients, follow-up period <6 months, and overlapping patients were excluded. RESULTS: Eight observational studies with 1859 patients were included. Pooled mean percent total weight loss at 6, 12, and 24 months was 14.86 (95% confidence interval [CI]: 13.83-15.90), 16.43 (95%CI: 15.23-17.63), and 20.01 (95%CI: 16.92-23.11), respectively. Pooled mean percent excess weight loss at 6, 12, and 24 months was 55.75 (95%CI: 50.61-60.89), 61.84 (95%CI: 54.75-68.93), and 60.40 (95%CI: 48.88-71.92), respectively. The pooled incidence of serious adverse events was 2.26% (95%CI 1.25-4.03) and no mortality was reported. Gastrointestinal bleeding and perigastric fluid collection were the most common reported serious adverse events; however, the pooled incidence of both was <1%. Variations in procedural technique were seen, but the full-thickness nature of suturing was reported in all studies. A layer of reinforcement sutures was performed in the majority of studies (n = 6). Limitations include the lack of controlled studies, long-term follow-up data, and standardization of technique. CONCLUSION: ESG, a minimally invasive bariatric therapy, is reproducible among centers worldwide with effective weight loss and favorable safety profile outcomes. Controlled studies would be valuable to further corroborate these findings.

Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial.

BACKGROUND: The AspireAssist is the first Food and Drug Administration-approved endoluminal device indicated for treatment of class II and III obesity. OBJECTIVES: We earlier reported 1-year results of the PATHWAY study. Here, we report 4-year outcomes. SETTING: United States-based, 10-center, randomized controlled trial involving 171 participants with the treatment arm receiving Aspiration Therapy (AT) plus Lifestyle Therapy and the control arm receiving Lifestyle Therapy (2:1 randomization). METHODS: AT participants were permitted to continue in the study for an additional year up to a maximum of 5 years providing they maintained at least 10% total weight loss (TWL) from baseline at each year end. For AT participants who continued the study, 5 medical monitoring visits were provided at weeks 60, 68, 76, 90, and 104 and thereafter once every 13 weeks up to week 260. Exclusion criteria were a history of eating disorder or evidence of eating disorder on a validated questionnaire. Follow-up weight, quality of life, and co-morbidities were compared with the baseline levels. In addition, rates of serious adverse event, persistent fistula, withdrawal, and A-tube replacement were reported. All analyses were performed using a per-protocol analysis. RESULTS: Of the 82 AT participants who completed 1 year, 58 continued to this phase of the trial. Mean baseline body mass index of these 58 patients was 41.6 ± 4.5 kg/m2. At the end of first year (at the beginning of the follow-up study), these 58 patients had a body mass index of 34.1 ± 5.4 kg/m2 and had achieved an 18.3 ± 8.0% TWL. On a per protocol basis, patients experienced 14.2%, 15.3%, 16.6%, and 18.7% TWL at 1, 2, 3, and 4 years, respectively (P < .01 for all). Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Improvements in quality of life scores and select cardiometabolic parameters were also maintained through 4 years. There were 2 serious adverse events reported in the second through fourth years, both of which resolved with removal or replacement of the A tube. Two persistent fistulas required surgical repair, representing approximately 2% of all tube removals. There were no clinically significant metabolic or electrolytes disorders observed, nor any evidence for development of any eating disorders. CONCLUSIONS: The results of this midterm study have shown that AT is a safe, effective, and durable weight loss alternative for people with class II and III obesity and who are willing to commit to using the therapy and adhere to adjustments in eating behavior.

Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial.

OBJECTIVES: The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling. METHODS: In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m2 were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42.2±5.1 kg/m2) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m2). The co-primary end points were mean percent excess weight loss and the proportion of participants who achieved at least a 25% excess weight loss. RESULTS: At 52 weeks, participants in the AspireAssist group, on a modified intent-to-treat basis, had lost a mean (±s.d.) of 31.5±26.7% of their excess body weight (12.1±9.6% total body weight), whereas those in the Lifestyle Counseling group had lost a mean of 9.8±15.5% of their excess body weight (3.5±6.0% total body weight) (P<0.001). A total of 58.6% of participants in the AspireAssist group and 15.3% of participants in the Lifestyle Counseling group lost at least 25% of their excess body weight (P<0.001). The most frequently reported adverse events were abdominal pain and discomfort in the perioperative period and peristomal granulation tissue and peristomal irritation in the postoperative period. Serious adverse events were reported in 3.6% of participants in the AspireAssist group. CONCLUSIONS: The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.

Opened Proton Pump Inhibitor Capsules Reduce Time to Healing Compared With Intact Capsules for Marginal Ulceration Following Roux-en-Y Gastric Bypass.

BACKGROUND & AIMS: Marginal ulceration, or ulceration at the gastrojejunal anastomosis, is a common complication of Roux-en-Y gastric bypass (RYGB). Acidity likely contributes to the pathophysiology, and proton pump inhibitors (PPIs) frequently are prescribed for treatment. However, patients with gastric bypass only have a small gastric pouch and rapid small-bowel transit, which limits the opportunity for capsule breakdown and PPI absorption. Soluble PPIs (open capsules [OCs]) might be absorbed more easily than intact capsules (ICs). We compared time to ulcer healing, number of endoscopic procedures, and use of health care for patients with marginal ulceration who received PPIs in OC vs IC form. METHODS: We performed a retrospective study of 164 patients diagnosed with marginal ulceration who underwent RYGB at the Brigham and Women's Hospital from 2000 through 2015. Patients received high-dose PPIs and underwent repeat endoscopy every 3 months until ulcer healing was confirmed. We used time-to-event analysis with a Cox proportional hazards model to evaluate the association between mode of PPI administration and time to ulcer healing, in addition to Cox multivariate regression analysis. Total charge (procedural and maintenance) was determined by comparison of categorized charges incurred from time of ulcer diagnosis to resolution. The primary outcome was time to healing of marginal ulceration in RYGB patients receiving high-dose PPIs in OC vs IC form. RESULTS: A total of 162 patients were included (115 received OC and 49 received IC). All patients were followed up until ulcer healing was confirmed. The median time to ulcer healing was 91.0 days for the OC group vs 342.0 days for the IC group (P < .001). OC was the only independent predictor of time to ulcer healing (P < .001) when we controlled for known risk factors. The number of endoscopic procedures (P = .02) and overall health care utilization (P = .05) were lower in the OC than the IC group. CONCLUSIONS: Patients with marginal ulceration after RYGB who receive OC PPIs have shorter ulcer healing times, fewer endoscopic procedures, and use less health care resources compared with patients who receive IC PPIs. Given these results and the high prevalence of marginal ulceration in this patient population, the use of OC PPIs is a low-risk, low-cost alternative that should be considered.

EUS-guided intrahepatic portosystemic shunt with direct portal pressure measurements: a novel alternative to transjugular intrahepatic portosystemic shunting.

BACKGROUND AND AIMS: Transjugular intrahepatic portosystemic shunting involves the creation of a low-resistance channel between the portal vein (PV) and the hepatic vein (HV), and is routinely performed under angiography. The aims were to evaluate (1) safety and technical feasibility; (2) procedural duration; and (3) subjective workload assessment of EUS-guided intrahepatic portosystemic shunt (EIPS). METHODS: Five Yorkshire pigs were used in the study. The HV or inferior vena cava (IVC) was identified using a linear-array echoendoscope and accessed with a 19-G FNA needle preloaded with a digital pressure wire. Mean pressure was recorded. The needle was advanced into the PV, where pressure measurements were again taken, and ultimately exchanged over a guidewire. A lumen-apposing metal stent was deployed under EUS and fluoroscopic guidance, with distal and proximal ends positioned inside the PV and HV (IVC), respectively. Dilation was performed, and pressure measurements repeated. The National Aeronautics and Space Administration (NASA) Task Load Index (TLI) was scored. Animals survived 2 weeks before necropsy. RESULTS: EIPS was successful in 5 out of 5 pigs. Mean time required for EUS identification, needle access, pressure measurement, and stent placement was 43 (31-55) minutes. NASA TLI scores revealed moderate workload. Mean baseline pressure measurements were PV 7.0 (5-9) and HV/IVC 5.0 (3-7) mm Hg and PV 6.3 (5-7) and HV/IVC 6.0 (4-7) mm Hg after. All animals survived 2 weeks. No bleeding was seen on necropsy. CONCLUSIONS: This study demonstrates the technical feasibility of EIPS using LAMS, with direct portal pressure measurement, in a survival model. In addition, the procedure was performed quickly with moderate technical demand.

A standardized method for endoscopic necrosectomy improves complication and mortality rates.

OBJECTIVES: Endoscopic necrosectomy is effective in the treatment of walled-off necrosis (WON), and is preferred to surgical approaches, however complication and mortality rates remain high with few centers regularly employing the technique. Lack of a standardized approach may also contribute to these limitations. METHODS: Prior to the study, a multidisciplinary team applied standardized care assessment and management plan principles to develop and optimize a systematic approach for the management of WON. Preoperative, postoperative, and endoscopic management were standardized. Patient preparation, room set-up, technical features (EUS-guidance, cold-access with balloon dilation, fragmentation of necrosis on the initial procedure, antibiotic lavage, double pigtail stents), and discontinuation of PPIs to encourage auto-digestion of necrosis were included. This study employed a consecutive prospective clinical registry to assess the clinical outcomes of this standardized approach. RESULTS: 60 consecutive patients underwent 1.58 ± 0.1 necrosectomies, with debridement accomplished on the initial procedure in 98.3%. 39 patients (65%) required only one session. Clinical resolution occurred in 86.7%, with radiologic confirmation. Percutaneous drainage was required in 8 patients during follow-up, and 4 of these later required surgery. Serious adverse events occurred in 3.3% of patients, and there was no mortality. CONCLUSIONS: The standardized technique employed in this series was associated with lower rates of adverse events, morbidity, and mortality than prior large series. Use of a systematic approach, and integrating elements of this method may improve the risk profile of endoscopic necrosectomy and allow broader adoption.

Prospective evaluation of a simplified narrowband imaging scoring system for a differential diagnosis of colorectal lesions.

BACKGROUND: Narrowband imaging (NBI) allows characterization of colorectal polyps during endoscopy; however, this is underutilized by most US physicians. The aim of this study was to assess diagnostic performance of an NBI scoring system, based on the NBI international colorectal endoscopic classification, and determine a threshold score yielding the highest negative predictive value (NPV) in the characterization of colorectal neoplasia. METHODS: During colonoscopy, colorectal lesions were scored using the NBI scoring system on a 0-3 scale for NBI findings. All lesions were biopsied or endoscopically removed for pathological examinations. RESULTS: Two hundred and three patients were enrolled, and a total of 156 colorectal lesions were detected in 67 patients. Diagnostic yields under white light mode showed limited diagnostic performance [accuracy 75.6 % (68.9-82.3), sensitivity 69.2 % (58.6-78.3), specificity 84.6 % (73.1-92.0), positive predictive value (PPV) 86.3 % (75.8-92.9), NPV 66.3 % (55.0-76.0)]. Of NBI threshold scores from 1 to 3 for the diagnosis of neoplastic lesion, the score of ≥1 resulted in an accuracy of 88.5 % (83.5-93.5), sensitivity of 97.8 % (91.5-96.6), and specificity of 75.4 % (62.9-84.9), with PPV of 84.8 % (76.1-90.8) and NPV of 96.1 % (85.4-99.3). CONCLUSIONS: The threshold value of ≥1 in this simplified NBI scoring system yielded the highest sensitivity and NPV for non-adenomatous colorectal polyps. This scoring system is simple to apply and is superior to white light endoscopy.

International multicenter experience with an over-the-scope clipping device for endoscopic management of GI defects (with video).

BACKGROUND: The over-the-scope clip (OTSC) provides more durable and full-thickness closure as compared with standard clips. Only case reports and small case series have reported on outcomes of OTSC closure of GI defects. OBJECTIVE: To describe a large, multicenter experience with OTSCs for the management of GI defects. Secondary goals were to determine success rate by type of defect and type of therapy and to determine predictors of treatment outcomes. DESIGN: Multicenter, retrospective study. SETTING: Multiple, international, academic centers. PATIENTS: Consecutive patients who underwent attempted OTSC placement for GI defects, either as a primary or as a rescue therapy. INTERVENTIONS: OTSC placement to attempt closure of GI defects. MAIN OUTCOME MEASUREMENTS: Long-term success of the procedure. RESULTS: A total of 188 patients (108 fistulae, 48 perforations, 32 leaks) were included. Long-term success was achieved in 60.2% of patients during a median follow-up of 146 days. Rate of successful closure of perforations (90%) and leaks (73.3%) was significantly higher than that of fistulae (42.9%) (P < .05). Long-term success was significantly higher when OTSCs were applied as primary therapy (primary 69.1% vs rescue 46.9%; P = .004). On multivariate analysis, patients who had OTSC placement for perforations and leaks had significantly higher long-term success compared with those who had fistulae (OR 51.4 and 8.36, respectively). LIMITATIONS: Retrospective design and multiple operators with variable expertise with the OTSC device. CONCLUSION: OTSC is safe and effective therapy for closure of GI defects. Clinical success is best achieved in patients undergoing closure of perforations or leaks when OTSC is used for primary or rescue therapy. Type of defect is the best predictor of successful long-term closure.

Facilitating endoscopic submucosal dissection: the suture-pulley method significantly improves procedure time and minimizes technical difficulty compared with conventional technique: an ex vivo study (with video).

BACKGROUND: The lack of countertraction in endoscopic submucosal dissection (ESD) results in increased technical demand and procedure time. Although the suture-pulley method for countertraction has been reported, its effectiveness compared with the traditional ESD technique remains unclear. OBJECTIVE: To objectively analyze efficacy of countertraction using the suture-pulley method for ESD. DESIGN: Prospective ex vivo animal study. SETTING: Animal laboratory. INTERVENTIONS: Twenty simulated gastric lesions were created in porcine stomachs by using a standard circular template 30 mm in diameter. In the control arm (n = 10), ESD was performed by using the standard technique. In the suture-pulley arm (N = 10), a circumferential incision was made, and an endoscopic suturing device was used to place the suture pulley. MAIN OUTCOME MEASUREMENTS: The primary outcome of this study was total procedure time. RESULTS: The median total procedure time with the suture-pulley method was significantly shorter than the traditional ESD technique (median, 25% to 75%, interquartile range [IQR]: 531 seconds [474.3-549.3 seconds] vs 845 seconds [656.3-1547.5 seconds], P < .001). The median time (IQR) for suture-pulley placement was 160.5 seconds (150.0-168.8 seconds). Although there was a significantly longer procedure time for proximal versus middle/lower stomach lesions with traditional ESD (median, 1601 seconds; IQR, 1547.5-1708.8 seconds vs median, 663 seconds; IQR, 627.5-681.8 seconds; P = .01), there was no significant difference in procedure time for lesions of various locations when using the suture-pulley method. Compared with traditional ESD, the suture-pulley method was less demanding in all categories evaluated by the NASA Task Load Index. LIMITATIONS: Ex vivo study. CONCLUSIONS: The suture-pulley method facilitates direct visualization of the submucosal layer during ESD and significantly reduces procedure time and technical difficulty. In addition, the benefit of the suture-pulley method was seen for both simple and more complicated ESDs.

Development and initial validation of an endoscopic part-task training box.

BACKGROUND AND STUDY AIMS: There is currently no objective and validated methodology available to assess the progress of endoscopy trainees or to determine when technical competence has been achieved. The aims of the current study were to develop an endoscopic part-task simulator and to assess scoring system validity. METHODS: Fundamental endoscopic skills were determined via kinematic analysis, literature review, and expert interviews. Simulator prototypes and scoring systems were developed to reflect these skills. Validity evidence for content, internal structure, and response process was evaluated. RESULTS: The final training box consisted of five modules (knob control, torque, retroflexion, polypectomy, and navigation and loop reduction). A total of 5 minutes were permitted per module with extra points for early completion. Content validity index (CVI)-realism was 0.88, CVI-relevance was 1.00, and CVI-representativeness was 0.88, giving a composite CVI of 0.92. Overall, 82 % of participants considered the simulator to be capable of differentiating between ability levels, and 93 % thought the simulator should be used to assess ability prior to performing procedures in patients. Inter-item assessment revealed correlations from 0.67 to 0.93, suggesting that tasks were sufficiently correlated to assess the same underlying construct, with each task remaining independent. Each module represented 16.0 % - 26.1 % of the total score, suggesting that no module contributed disproportionately to the composite score. Average box scores were 272.6 and 284.4 (P = 0.94) when performed sequentially, and average score for all participants with proctor 1 was 297.6 and 308.1 with proctor 2 (P = 0.94), suggesting reproducibility and minimal error associated with test administration. CONCLUSION: A part-task training box and scoring system were developed to assess fundamental endoscopic skills, and validity evidence regarding content, internal structure, and response process was demonstrated.

A novel magnetic countertraction device for endoscopic submucosal dissection significantly reduces procedure time and minimizes technical difficulty.

BACKGROUND AND STUDY AIMS: In endoscopic submucosal dissection (ESD), effective countertraction may overcome the current drawbacks of longer procedure times and increased technical demands. The objective of this study was to compare the efficacy of ESD using a novel magnetic countertraction device with that of the traditional technique. METHODS: Each ESD was performed on simulated gastric lesions of 30 mm diameter created at five different locations. In total, 10 ESDs were performed using this novel device and 10 were performed by the standard technique. RESULTS: The magnetic countertraction device allowed directional tissue manipulation and exposure of the submucosal space. The total procedure time was 605 ± 303.7 seconds in the countertraction group vs. 1082 ± 515.9 seconds in the control group (P = 0.021). CONCLUSIONS: This study demonstrated that using a novel magnetic countertraction device during ESD is technically feasible and enables the operator to dynamically manipulate countertraction such that the submucosal layer is visualized directly. Use of this device significantly reduced procedure time compared with conventional ESD techniques.

Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery.

BACKGROUND & AIMS: Weight regain or insufficient loss after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction (TORe). METHODS: Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed. RESULTS: Subjects who received TORe had a significantly greater mean percentage weight loss from baseline (3.5%; 95% confidence interval, 1.8%-5.3%) than controls (0.4%; 95% confidence interval, 2.3% weight gain to 3.0% weight loss) (P = .021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls (3.9% and 0.2%, respectively; P = .014). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls (P = .019). The TORe group had reduced systolic and diastolic blood pressure (P < .001) and a trend toward improved metabolic indices. In addition, 85% of the TORe group reported compliance with the healthy lifestyle eating program, compared with 53.8% of controls; 83% of TORe subjects said they would undergo the procedure again, and 78% said they would recommend the procedure to a friend. The groups had similar frequencies of adverse events. CONCLUSIONS: A multicenter randomized trial provides Level I evidence that TORe reduces weight regain after RYGB. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. TORe is one approach to avoid weight regain; a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are required for long-term results. ClinicalTrials.gov identifier: NCT00394212.

Magnetic pancreaticobiliary stents and retrieval system: obviating the need for repeat endoscopy (with video).

BACKGROUND: Plastic stents are routinely placed in the pancreaticobiliary system to facilitate drainage. A second endoscopy is often required for stent removal. We have developed magnetic pancreaticobiliary stents that can be removed by using an external hand-held magnet, thereby obviating the need for a second endoscopy. OBJECTIVE: To develop and test magnetic pancreaticobiliary stents and retrieval system in ex-vivo and in-vivo porcine models. SETTING: Animal laboratory. DESIGN: Benchtop and animal study. ANIMALS: 5 pigs. INTERVENTIONS: Design: Computer simulations determined both the optimal design of cylindrical magnets attached to the distal aspect of existing plastic stents and the optimal design of the external hand-held magnet. Benchtop ex-vivo experiments measured magnetic force to validate the design. In-vivo analysis: In 5 Yorkshire pigs, magnetic stents were deployed into the common bile duct by using a conventional duodenoscope. An external hand-held magnet was applied for stent removal. Stent insertion and removal times were recorded. MAIN OUTCOME MEASUREMENTS: Technical feasibility. RESULTS: Magnetic stents of varying lengths and calibers were successfully created. In ex-vivo testing, the capture distance was 10.0 cm. During in-vivo testing, the magnetic stents were inserted and removed easily. The mean insertion and removal times were 3.2 minutes and 33 seconds, respectively. LIMITATIONS: Animal study, small numbers. CONCLUSIONS: Magnetic pancreaticobiliary stents and associated retrieval system were successfully designed and tested in the acute porcine model. An external, noninvasive means of stent removal potentially obviates the need for a second endoscopy, which could represent a major gain both for patients and in health care savings.

An implantable wireless biosensor for the immediate detection of upper GI bleeding: a new fluorescein-based tool for diagnosis and surveillance (with video).

BACKGROUND: Early recurrent hemorrhage after endoscopic intervention for acute upper GI bleeding (UGIB) can approach 20% and leads to increased morbidity and mortality. Little has changed over the past several decades regarding immediate posthemorrhage surveillance, and there has likewise been no significant improvement in outcomes. OBJECTIVE: To develop and test an endoscopically implantable wireless biosensor for real-time detection of fluorescein-labeled blood in ex vivo and in vivo porcine models of UGIB. SETTING: Animal laboratory. DESIGN: Benchtop and acute animal studies. SUBJECTS: Five pigs. INTERVENTIONS: UGIB models were surgically created in living pigs. Biosensors were endoscopically deployed in the stomach using standard endoscopic clips. The ability to detect acute UGIB and estimated blood loss leading to biosensor activation were recorded. Feasibility of wireless data transmission out of the body to an external computer and cell phone was assessed. MAIN OUTCOME MEASUREMENTS: Technical feasibility and immediate complications. RESULTS: A porcine UGIB model was successfully created. Biosensors were able to detect all acute bleeding events and wirelessly transmit out of the body, and successfully sent an emergency text message to the intended cell phone in all cases. Average estimated blood loss leading to biosensor activation was 30 mL (10-75 mL). LIMITATIONS: Animal study; small numbers. CONCLUSIONS: An endoscopically implantable wireless biosensor successfully detected acute hemorrhage in a porcine UGIB model and sent an emergency cell-phone alert in real time.

Current status of endoluminal bariatric procedures for primary and revision indications.

Endoscopic bariatric procedures are gaining traction as possible minimally invasive treatment modalities for obesity. This article focuses on the various endoscopic devices and procedures that pertain to primary and revisional treatments. Additionally, the article discusses the potential for applying these various devices and procedures to other points of intervention, including early intervention, bridge to surgery, and primary metabolic treatment (eg, diabetes management). Devices that are currently in human use are preferentially discussed, followed by references to devices that may see clinical use in the near future.

Smart Self-Assembling MagnetS for ENdoscopy (SAMSEN) for transoral endoscopic creation of immediate gastrojejunostomy (with video).

BACKGROUND: Gastrojejunostomy is important for palliation of malignant gastric outlet obstruction and surgical obesity procedures. A less-invasive endoscopic technique for gastrojejunostomy creation is conceptually attractive. Our group has developed a compression anastomosis technology based on endoscopically delivered self-assembling magnets for endoscopy (SAMSEN) to create an instant, large-caliber gastrojejunostomy. OBJECTIVE: To develop and evaluate an endoscopic means of gastrojejunostomy creation by using SAMSEN. SETTING: Developmental laboratory and animal facility. DESIGN: Animal study and human cadaveric study. SUBJECTS: Yorkshire pigs (7 cadaver, 5 acute); human (1 cadaver). INTERVENTIONS: A transoral procedure for SAMSEN delivery was developed in porcine and human cadaver models. Subsequently, gastrojejunostomy creation by using SAMSEN was performed in 5 acute pigs. The endoscope was advanced into the peritoneal cavity through the gastrotomy, and a segment of the small bowel was grasped and pulled closer to the stomach. An enterotomy was created, and a custom overtube was advanced into the small bowel for deployment of the first magnetic assembly. Next, a reciprocal magnetic assembly was deployed in the stomach. The 2 magnetic systems were mated under fluoroscopic and endoscopic guidance. Contrast studies assessed for gastrojejunostomy leak. Immediate necropsies were performed. MAIN OUTCOME MEASUREMENTS: Technical feasibility and complications. RESULTS: Gastrojejunostomy creation by using SAMSEN was successful in all 5 animals. Deep enteroscopy was performed through the stoma without difficulty. No leaks were identified on contrast evaluation. At necropsy, the magnets were properly deployed and robustly coupled together, resistant to vigorous tissue manipulation. LIMITATIONS: Acute animal study. CONCLUSIONS: Endoscopic creation of immediate gastrojejunostomy by using SAMSEN is technically feasible.

Early healing of transcolonic and transgastric natural orifice transluminal endoscopic surgery access sites.

BACKGROUND: Natural Orifice Transluminal Endoscopic Surgery (NOTES) is a developing, minimally invasive surgical approach whose potential benefits are being investigated. Little is known about secure access site closure and early healing kinetics of transvisceral access. STUDY DESIGN: Transvisceral access incisions were created in the colon (C-NOTES, n = 8) and stomach (G-NOTES, n = 8) for peritoneal exploration. Incisions were closed primarily with endoloops, endoclips, or t-tags. Macroscopic and histologic analyses performed on postoperative day 7 assessed gross appearance, granulation tissue, inflammation, ulceration, and complications. RESULTS: Macroscopically, incisions appeared closed without intraperitoneal spillage. Incisions closed by endoloop and t-tags showed intense granulation tissue fill of defect despite partial (G-NOTES, n = 3) and transmural ulceration (C-NOTES, n = 8; G-NOTES, n = 3). Of the 30 t-tags applied, 40% broke or deployed into the peritoneal cavity. Endoclip closures (C-NOTES, n = 1; G-NOTES, n = 1) did not show histologic mucosal continuity. Healing complications included transmural necrosis (C-NOTES, n = 1; G-NOTES, n = 1), foreign body material (C-NOTES, n = 3; G-NOTES, n = 2), and microabscesses (G-NOTES, n = 1). CONCLUSIONS: This study provides a reproducible model to assess noninvasive repair of planned visceral perforations. Of investigated technologies, endoloop closure was favored for transcolonic incisions, and t-tags with omental patch for transgastric incisions, although these have significant limitations. Endoclips were inadequate for primary closure, but may be useful as an adjunctive closure modality. Additional studies are needed to examine visceral repair at later time points, as they will help determine the quality and kinetics of repair of a variety of incision closure strategies. This study demonstrates the need for improved technologies to more reliably close visceral transluminal defects.

Efficacy of a reverse-phase polymer as a submucosal injection solution for EMR: a comparative study (with video).

INTRODUCTION: Reverse-phase polymers undergo a temperature-dependent liquid-to-gel transition that may provide a more durable cushion for EMR and could yield improvements in safety and efficacy. OBJECTIVE: Our purpose was to assess the efficacy of poloxamer solution PS137-25 as a submucosal injection. DESIGN: Comparative study among 3 different solutions for EMR using ex vivo and in vivo porcine models. INTERVENTIONS: A total of 120 gastric submucosal cushions were performed in fresh ex vivo porcine stomachs with saline solution 0.9% (n = 40), hydroxypropyl methylcellulose (HPMC) (n = 40), and PS137-25 (n = 40). Five in vivo porcine colon EMRs were then performed. MAIN OUTCOME MEASUREMENTS: Height and duration of submucosal cushions were measured in the ex vivo model, and the usefulness of reverse-phase polymers was assessed by in vivo en bloc resection. RESULTS: Ex vivo: The height of mucosal elevation was greater with PS137-25 (10.3 +/- 2.2 mm) than with saline solution (8.3 +/- 2.6 mm) or HPMC (9.05 +/- 2.3 mm, not significant). All submucosal elevations with PS137-25 lasted longer (more than 20 minutes) than with saline solution (20.9 +/- 11 minutes, P < .01) or HPMC (89 +/- 32 minutes, P < .01). After 120 minutes, the elevations obtained with PS137-25 showed no differences in size, shape, or consistency from initial measurements. In vivo: All 5 EMRs were successfully performed after 1 injection of PS137-25. No repeat injections were needed. During resection, a large gel cushion was noted. CONCLUSIONS: Mucosal elevation with PS137-25 is more durable than with other substances, with no changes in size or consistency observed over 120 minutes. Additionally, reverse-phase polymers performed well in in vivo colon EMRs. These results suggest that reverse-phase polymers may provide increased safety and efficacy for EMR procedures.