Nikhil A. Kumta

Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population.

BACKGROUND AND AIMS Novel endoscopic techniques have been developed as effective treatments for obesity. Recently, reduction of gastric volume via endoscopic placement of full-thickness sutures, termed endoscopic sleeve gastroplasty (ESG), has been described. Our aim was to evaluate the safety, technical feasibility, and clinical outcomes for ESG. PATIENT AND METHODS Between August 2013 and May 2014, ESG was performed on 10 patients using an endoscopic suturing device. Their weight loss, waist circumference, and clinical outcomes were assessed. RESULTS Mean patient age was 43.7 years and mean body mass index (BMI) was 45.2 kg/m(2). There were no significant adverse events noted. After 1 month, 3 months, and 6 months, excess weight loss of 18 %, 26 %, and 30 %, and mean weight loss of 11.5 kg, 19.4 kg, and 33.0 kg, respectively, were observed. The differences observed in mean BMI and waist circumference were 4.9 kg/m(2) (P = 0.0004) and 21.7 cm (P = 0.003), respectively. CONCLUSIONS ESG is effective in achieving weight loss with minimal adverse events. This approach may provide a cost-effective outpatient procedure to add to the steadily growing armamentarium available for treatment of this significant epidemic.

EUS-directed transgastric ERCP for Roux-en-Y gastric bypass anatomy: a minimally invasive approach

BACKGROUND ERCP is challenging in patients with Roux-en-Y gastric bypass. Using EUS to gain access to the excluded stomach and subsequently performing transcutaneous ERCP was described recently. OBJECTIVE We describe our initial experience with an internal EUS-directed transgastric ERCP (EDGE) procedure by using a lumen-apposing metal stent (LAMS). DESIGN Single-center case series. SETTING Tertiary center with expertise in EUS-guided procedures. PATIENTS Five patients with Roux-en-Y gastric bypass underwent EDGE via a LAMS. INTERVENTIONS A linear echoendoscope was used to access the excluded stomach. A LAMS was deployed over a wire to create a gastrogastric or jejunogastric fistula. A duodenoscope was then passed through the LAMS and conventional ERCP was performed. MAIN OUTCOME MEASUREMENTS Technical and clinical success rates as well as adverse events. RESULTS EUS-guided creation of a gastrogastric or jejunogastric fistula via placement of a LAMS was successful in all cases (100%). The ability to perform ERCP through the fashioned fistula during the index procedure was successful in 3 of 5 cases (60%). Two LAMS dislodgments requiring restenting were observed. No major adverse events were observed. No weight regain occurred. The median procedure time was 68.0 minutes. LIMITATIONS Small sample, single-institution experience. CONCLUSION The internal EDGE procedure may offer a cost-effective, minimally invasive option for a common problem in a growing patient demographic. Further refinement of the technique is required to minimize adverse events. ( CLINICAL TRIAL REGISTRATION NUMBER NCT01522573.).

A Large Multicenter Experience With Endoscopic Suturing for Management of Gastrointestinal Defects and Stent Anchorage in 122 Patients: A Retrospective Review.

Goals:To describe a multicenter experience using an endoscopic suturing device for management of gastrointestinal (GI) defects and stent anchorage. Background:Endoscopic closure of GI defects including perforations, fistulas, and anastomotic leaks as well as stent anchorage has improved with technological advances. An endoscopic suturing device (OverStitch; Apollo Endosurgery Inc.) has been used. Study:Retrospective study of consecutive patients who underwent endoscopic suturing for management of GI defects and/or stent anchorage were enrolled between March 2012 and January 2014 at multiple academic medical centers. Data regarding demographic information and outcomes including long-term success were collected. Results:One hundred and twenty-two patients (mean age, 52.6 y; 64.2% females) underwent endoscopic suturing at 8 centers for stent anchorage (n=47; 38.5%), fistulas (n=40; 32.7%), leaks (n=15; 12.3%), and perforations (n=20; 16.4%). A total of 44.2% underwent prior therapy and 97.5% achieved technical success. Immediate clinical success was achieved in 79.5%. Long-term clinical success was noted in 78.8% with mean follow-up of 68 days. Clinical success was 91.4% in stent anchorage, 93% in perforations, 80% in fistulas, but only 27% in anastomotic leak closure. Conclusions:Endoscopic suturing for management of GI defects and stent anchoring is safe and efficacious. Stent migration after stent anchoring was reduced compared with published data. Long-term success without further intervention was achieved in the majority of patients. The role of endoscopic suturing for repair of anastomotic leaks remains unclear given limited success in this retrospective study.

Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients

BACKGROUND & AIMS Endoscopic sleeve gastroplasty (ESG) is an incisionless, minimally invasive bariatric procedure that reduces the length and width of the gastric cavity to facilitate weight loss. We performed a prospective study to evaluate the effects of ESG on total body weight loss and obesity‐related comorbidities. METHODS We collected data from 91 consecutive patients (mean age, 43.86 ± 11.26 years; 68% female) undergoing ESG from August 2013 through March 2016. All patients had a body mass index (BMI) greater than 30 kg/m2 and had failed noninvasive weight‐loss measures or had a BMI greater than 40 kg/m2 and were not considered as surgical candidates or refused surgery. All procedures were performed with a cap‐based flexible endoscopic suturing system to facilitate a triangular pattern of sutures to imbricate the greater curvature of the stomach. Patients were evaluated after 6 months (n = 73), 12 months (n = 53), and 24 months (n = 12) for anthropometric features (BMI, weight, waist circumference, blood pressure) and underwent serologic (hemoglobin A1c), lipid panel, serum triglycerides, and liver function tests. The primary outcomes were total body weight loss at 6, 12, and 24 months. Secondary outcomes were the effects of ESG on metabolic factors (blood pressure, diabetes, hyperlipidemia, steatohepatitis) and safety. RESULTS The patients’ mean BMI before the procedure was 40.7 ± 7.0 kg/m2. Patients had lost 14.4% of their total body weight at 6 months (80% follow‐up rate), 17.6% at 12 months (76% follow‐up rate), and 20.9% at 24 months (66% follow‐up rate) after ESG. At 12 months after ESG, patients had statistically significant reductions in levels of hemoglobin A1c (P = .01), systolic blood pressure (P = .02), waist circumference (P < .001), alanine aminotransferase (P < .001), and serum triglycerides (P = .02). However, there was no significant change in low‐density lipoprotein after vs before ESG (P = .79). There was one serious adverse event (1.1%) (perigastric leak) that occurred that was managed non‐operatively. CONCLUSIONS ESG is a minimally invasive and effective endoscopic weight loss intervention. In addition to sustained total body weight loss up to 24 months, ESG reduced markers of hypertension, diabetes, and hypertriglyceridemia.

Endoscopic ultrasound-directed transgastric ERCP (EDGE) for Roux-en-Y anatomy: a novel technique.

BACKGROUND Patients with Roux-en-Y gastric bypass (RYGB) anatomy pose challenges when endoscopic retrograde cholangiopancreatography (ERCP) is required. Deep enteroscopy-assisted ERCP can allow pancreaticobiliary intervention in these patients, but with limited success. This case series describes endoscopic ultrasound-directed transgastric ERCP (EDGE) for patients following RYGB. METHODS Patients with RYGB anatomy undergoing EDGE at a tertiary care center were included in this prospective single-arm feasibility study. All procedures were performed in two stages. First a 16-Fr percutaneous endoscopic gastrostomy (PEG) was placed in the excluded stomach using endoscopic ultrasound (EUS) guidance. Second, ERCP was performed through the newly fashioned gastrostomy and a transcutaneous fully covered metal esophageal stent. RESULTS Six patients (5 women, 1 man) with RYGB anatomy underwent EDGE. EUS-guided PEG placement was successful in all six patients (100 %). Antegrade ERCP was successful in all six patients (100 %) with the stages being separated by a mean of 5.8 days. The mean procedure times for the two stages were 81 minutes and 98 minutes. Two patients (33 %) had localized PEG site infections that were managed with oral antibiotics. There were no adverse events related to ERCP. CONCLUSIONS EDGE is both feasible and safe to perform in RYGB patients. Given the high success rates of our recent experience, we suspect that this technique can be performed as a one-stage procedure to provide a cost-effective, minimally invasive option for a common problem in a growing patient population.

Eus-guided Versus Percutaneous Gallbladder Drainage: Isn’t It Time to Convert?

Background and Aims: Endoscopic ultrasound–guided drainage (EUS-GLB) is a minimally invasive option for patients with cholecystitis who are poor surgical candidates. Compared with percutaneous drainage (PC-GLB), earlier studies have demonstrated similar efficacy with improved quality of life. We present a multicenter, international experience comparing PC-GLB and EUS-GLB in nonsurgical patients with cholecystitis. Methods: All patients who underwent either PC-GLB drainage or EUS-GLB drainage from 7 centers between January 2010 and December 2015 were included. Technical success was defined as successful placement of a catheter or stent into the gallbladder. Clinical success was defined as resolution of clinical symptoms after intervention. Adverse events, length of stay, and the need for repeat interventions and/or hospitalizations were recorded for all patients. Results: A total of 155 patients were included (mean age 74±14.24 y; range, 31 to 96; 56% male). Forty-two patients underwent EUS-GLB and 113 patients underwent PC-GLB. Technical success was achieved in 40 patients (95%) in the EUS-GLB group and 112 patients (99%) in the PC-GLB group (P=0.179). Clinical success was achieved in 40 patients (95%) in the EUS-GLB group and 97 patients (86%) in the PC-GLB group (P=0.157). There was no difference in hospital readmission rates between the 2 groups (14% vs. 24%; P=0.194). However, there was significantly higher number of patients requiring repeat interventions in the PC-GLB group (n=28, 24%) compared with the EUS-GLB group (n=4, 10%) (P=0.037). There was no difference in adverse events between the 2 groups. Conclusions: EUS-GLB is safe and efficacious, with comparable technical and clinical success rates and no difference in adverse events. In addition, EUS-GLB offers a potential cost-saving benefit and morbidity benefit by demonstrating a decreased number of repeat interventions.

Esophageal Stenting With Sutures: Time to Redefine Our Standards?

Background and Study Aims: Migration is the most common complication of the fully covered metallic self-expanding esophageal stent (FCSEMS). Recent studies have demonstrated migration rates between 30% and 60%. The aim of this study was to determine the effect of fixation of the FCSEMS by endoscopic suturing on migration rate. Patient and Methods: Patients who underwent stent placement for esophageal strictures and leaks over the last year were captured and reviewed retrospectively. Group A, cases, were patients who underwent suture placement and group B, controls, were patients who had stents without sutures. Basic demographics, indications, and adverse events (AEs) were collected. Kaplan-Meier analysis and Cox regression modeling were conducted to determine estimates and predictors of stent migration in patients with and without suture placement. Results: Thirty-seven patients (18 males, 48.65%), mean age 57.2 years (±16.3 y), were treated with esophageal FCSEMS. A total of 17 patients received sutures (group A) and 20 patients received stents without sutures (group B). Stent migration was noted in a total of 13 of the 37 patients (35%) [2 (11%) in group A and 11 (55%) in group B]. Using Kaplan-Meier analysis and log-rank analysis, fixation of the stent with suturing reduced the risk of migration (P=0.04). There were no AEs directly related to suture placement. Conclusions: Anchoring of the upper flare of the FCSEMS with endoscopic sutures is technically feasible and significantly reduces stent migration rate when compared with no suturing, and is a safe procedure with very low AEs rates.

International collaborative study on EUS-guided gallbladder drainage: Are we ready for prime time?

BACKGROUND Cholecystectomy remains the gold standard treatment of cholecystitis. Endoscopic treatment of cholecystitis includes transpapillary gallbladder drainage. Recently, endoscopic ultrasound-guided transmural drainage of the gallbladder (EUS-GBD) has been reported. This study reports the cumulative experience of an international group performing EUS-GBD. METHODS Cases of EUS-GBD from January 2012 to November 2013 from 3 tertiary-care institutions were captured in a registry. Patient demographics, disease characteristics, procedural and clinical outcomes were recorded. RESULTS 35 patients (15 malignant, 20 benign) were included. Median age was 81 years (SD=13.76 years), sixteen (46%) were males. Median follow-up was 91.5 days (SD=157 days). Transmural access was obtained from the stomach (n=17) or duodenum (n=18). Stents placed included plastic (n=6), metal (n=20), or combination (n=7). Technical success was achieved in 91.4% (n=32). Immediate adverse events (14%) included: bleeding, stent migration, cholecystitis and hemoperitoneum. Delayed adverse events (11%) included abscess formation and recurrence of cholecystitis. Long-term clinical success rate was 89%. Stent type and puncture site were not associated with immediate (p=0.88, p=0.62), or long-term (p=0.47, p=0.27) success. CONCLUSIONS EUS-GBD appears to be feasible, safe, and effective. Prospective studies are needed to confirm these findings and identify the best technique to use. CLINICAL TRIAL REGISTRATION NCT01522573.

Peroral endoscopic myotomy: establishing a new program.

Achalasia is an esophageal motility disorder characterized by incomplete relaxation of the lower esophageal sphincter (LES) and aperistalsis of the esophageal body. Treatment of achalasia is aimed at decreasing the resting pressure in the LES. Peroral endoscopic myotomy (POEM), derived from natural orifice transluminal endoscopic surgery (NOTES) and advances in endoscopic submucosal dissection (ESD), presents a novel, minimally invasive, and curative endoscopic treatment for achalasia. POEM involves an esophageal mucosal incision followed by creation of a submucosal tunnel crossing the esophagogastric junction and myotomy before closure of the mucosal incision. Although the procedure is technically demanding and requires a certain degree of skill and competency, treatment success is high (90%) with low complication rates. Since the first described POEM in humans in 2010, it has been used increasingly at centers worldwide. This article reviews available published clinical studies demonstrating POEM efficacy and safety in order to present a proposal on how to establish a dedicated POEM program and reach base proficiency for the procedure.

New Devices and Techniques for Handling Adverse Events: Claw, Suture, or Cover?

Increasingly invasive therapeutic endoscopic procedures and laparoscopic surgeries have resulted in endoscopists being challenged more frequently with perforations, fistulas, and anastomotic leakages, for which nonsurgical closure is desired. Devices and techniques are available and in development for endoscopic closure of gastrointestinal wall defects. Currently available devices with excellent clinical success rates include the over-the-scope clip and an endoscopic suturing system. Another device, the cardiac septal defect occluder, has been adapted for use in the gastrointestinal tract. Extensive endoscopic knowledge, a highly trained endoscopy team, and the availability of devices and equipment are required to manage complications endoscopically.