Michele B. Ryan

Evaluation of an endoscopic suturing device for transoral outlet reduction in patients with weight regain following Roux-en-Y gastric bypass

BACKGROUND AND STUDY AIMS A dilated gastrojejunal anastomosis (GJA) is thought to be associated with weight regain in patients with Roux-en-Y gastric bypass (RYGB). Due to a high rate of perioperative morbidity, surgical revision is not generally performed. The aim of this study was to assess the technical feasibility, safety, and early outcomes of a procedure using a commercially available endoscopic suturing device to reduce the diameter of the GJA. PATIENTS AND METHODS This was a retrospective analysis of 25 consecutive patients who underwent transoral outlet reduction (TORe) for dilated GJA and weight regain. An endoscopic suturing device was used to place sutures at the margin of the GJA in order to reduce its aperture. On chart review, clinical data were available at 3, 6, and 12 months. RESULTS Patients had regained a mean of 24 kg from their weight loss nadir and had a mean body mass index of 43 kg/m2 at the time of endoscopic revision. Average anastomosis diameter was 26.4 mm. Technical success was achieved in all patients (100 %) with a mean reduction in anastomosis diameter to 6 mm (range 3 - 10 mm), representing a 77.3 % reduction. The mean weight loss in successful cases was 11.5 kg, 11.7 kg, and 10.8 kg at 3, 6, and 12 months, respectively. There were no major complications. CONCLUSION This case series demonstrated the technical feasibility, safety, and efficacy of performing gastrojejunostomy reduction using a commercially available endoscopic suturing device. This technique may represent an effective and minimally invasive option for the management of weight regain in patients with RYGB.

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.

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.

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.

M1359 Restore: Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction: A Double-Blind, Sham-Controlled Multicenter Study for Treatment of Inadequate Weight Loss or Weight Regain Following Roux-en-Y Gastric Bypass

Background and aims: Roux-en-Y gastric bypass technique (RYGBP) by inducing bacterial stasis could promote small intestinal bacterial overgrowth (SIBO). In a previous study performed in 146 patients with morbid obesity (1) we found an increase in the prevalence of SIBO compared to healthy subjects 17.1% vs.2.5% (p=0.03). The aim of this study was to evaluate prospectively the prevalence of SIBO in a larger population of patients withmorbid obesity, before and after bariatric surgery and its potential effect on vitamin deficiencies after surgery. Patients and methods: from October 2001 to July 2009, a glucose hydrogen (H2) breath test (BT, positive if fasting breath H2 concentration > 20 ppm and or increase > 10 ppm over baseline within the first 2 hours) was proposed to all obese patients referred for bariatric surgery (BMI > 40 kg/m 2 or > 35 in association with comorbidities) before and after bariatric surgery to assess the presence of SIBO. Vitamin levels (B12, B1, PP) were measured while vitamin supplementation was systematically prescribed after RYGBP. Results(mean ± SE, median (IQR) : 378 patients (336 women (88.9%), 39.6± 11.7 yrs, BMI : 45.7±6.3 kg/m 2 ) were included : 357 patients had a preoperative BT that was positive in 55 cases (15.4%), negative in 290 cases (81,2%) and doubtful or uninterpretable in 12 cases (3.4%). Twenty patients had BT after gastric banding [time since surgery 36 months (26-47), weight loss 22.9±14.1 kg] that was negative in 18 cases (90%) and positive in 2 cases (10%) (p = NS compared with preoperative situation). Sixty-five patients had a BT after RYGBP [time since surgery 9.2 months (6.8-23), weight loss 34.4± 11.5 kg] that was negative in 39 cases (60%) and positive in 26 cases (40%) (p<0.001 compared with preoperative situation). After RYGBP the percentage of patients with or without vitamin deficiencies was not different in patients with positive or negative BT (p = NS). Conclusion: in this study with a large number of patients, we confirm the presence of SIBO in 15% of patients with morbid obesity. After gastric banding, there is no increase in this prevalence while after RYGBP it increases to 40% of patients. In patients with systematic vitamin supplementation, a positive BT is not associated with an increase in the frequency of vitamin deficiencies. (1) Sabate et al. Obes Surg 2008 ; 18:371-377

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.

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 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.

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.

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.