Pichamol Jirapinyo

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.

Endoscopic sclerotherapy for the treatment of weight regain after Roux-en-Y gastric bypass: outcomes, complications, and predictors of response in 575 procedures.

BACKGROUND Weight regain after Roux-en-Y gastric bypass (RYGB) is common. Endoscopic sclerotherapy is increasingly used to treat this weight regain. OBJECTIVES To report safety, outcomes, durability, and predictors of response to sclerotherapy in a large prospective cohort. DESIGN Retrospective analysis of a prospective cohort study of patients with weight regain after RYGB. PATIENTS A total of 231 consecutive patients undergoing 575 sclerotherapy procedures between September 2008 and March 2011. INTERVENTIONS Single or multiple sclerotherapy procedures to inject sodium morrhuate into the rim of the gastrojejunal anastomosis. MAIN OUTCOME MEASUREMENTS We report weight loss, complications, and predictors of response. We also used Kaplan-Meier survival analysis and log-rank test to compare time to continuation of weight regain after sclerotherapy in patients undergoing a single versus multiple sclerotherapy procedures. RESULTS At 6 and 12 months from the last sclerotherapy procedure, weight regain stabilized in 92% and 78% of the cohort, respectively. Those who underwent 2 or 3 sclerotherapy sessions had significantly higher rates of weight regain stabilization than those who underwent a single session (90% vs 60% at 12 months; P = .003). The average weight loss at 6 months from the last sclerotherapy session for the entire cohort was 10 lb (standard deviation 16), representing 18% of the weight regained after RYGB. A subset of 73 patients (32% of the cohort) had greater weight loss at 6 months (26 lb, standard deviation 12), representing 61% of the weight regained. Predictors of a favorable outcome included greater weight regain and the number of sclerotherapy procedures. Bleeding was reported in 2.4% of procedures and transient diastolic blood pressure increases in 15%, without adverse health outcomes. No GI perforations were reported. CONCLUSIONS Endoscopic sclerotherapy appears to be a safe and effective tool for the management of weight regain after RYGB.

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.

Endoscopic Bariatric and Metabolic Therapies: Surgical Analogues and Mechanisms of Action

&NA; Obesity is a worsening pandemic with numerous related comorbid illnesses. Conservative management including lifestyle modification and medications have limited efficacy. In contradistinction, bariatric surgery is effective, however, with substantial cost and non‐negligible morbidity and mortality. As such, a small percentage of eligible patients undergo surgery. Over the past decade, endoscopic bariatric and metabolic therapies have been introduced as a less invasive option for the treatment of obesity and its related comorbid illnesses. This article reviews major endoscopic bariatric and metabolic therapies, their surgical analogues, and proposed mechanisms of action. Clinical trial data for each device also are discussed.

Endoscopic Ultrasound-Guided Pancreatobiliary Endoscopy in Surgically Altered Anatomy

Endoscopic retrograde cholangiopancreatography (ERCP) has become the mainstay of therapy for pancreatobiliary diseases. While ERCP is safe and highly effective in the general population, the procedure remains challenging or impossible in patients with surgically altered anatomy (SAA). Endoscopic ultrasound (EUS) allows transmural access to the bile or pancreatic duct (PD) prior to ductal drainage using ERCP-based techniques. Also known as endosonography-guided cholangiopancreatography (ESCP), the procedure provides multiple advantages over overtube-assisted enteroscopy ERCP or percutaneous or surgical approaches. However, the procedure should only be performed by endoscopists experienced in both EUS and ERCP and with the proper tools. In this review, various EUS-guided diagnostic and therapeutic drainage techniques in patients with SAA are examined. Detailed step-by-step procedural descriptions, technical tips, feasibility, and safety data are also discussed.

Gastrojejunal anastomotic reduction for weight regain in roux-en-y gastric bypass patients: physiological, behavioral, and anatomical effects of endoscopic suturing and sclerotherapy

BACKGROUND Weight regain is common after Roux-en-Y gastric bypass. OBJECTIVES To assess the mechanisms of weight loss after 2 gastrojejunal anastomotic reduction (GJAR) procedures to treat weight regain. SETTING University hospital, United States. METHODS Forty-three Roux-en-Y gastric bypass patients with weight regain were prospectively enrolled. Weight, ghrelin levels, responses to the 21-item three-factor eating questionnaire, and gastrojejunal anastomotic diameter were assessed. Nine patients underwent endoscopic suturing and 34 patients underwent sclerotherapy. At 3 months, weight, ghrelin levels, eating behavior, and outlet diameter were reassessed. RESULTS Patients were aged 47±10 years and regained 43%±26% of maximal lost weight. Ghrelin levels were 123±106 ng/mL and outlet diameter was 21±6.3 mm. At 3 months, the entire cohort lost 4.1%±5.9% of total weight (TBW) and showed improvement in cognitive eating habits (P<.01). Endoscopic suturing and sclerotherapy patients lost 10.4%±2.2% TBW and 2.7%±5.5% TBW (P<.01), respectively. Suturing and sclerotherapy reduced the outlet diameter by 15.0±6.7 mm and 2.6±5.7 mm (P<.01). Ghrelin levels increased after suturing by 46±55 ng/mL and decreased by 37±110 ng/mL after sclerotherapy (P = .02). Suturing resulted in greater improvement in cognitive eating behavior than sclerotherapy (P = .03). Reduction in outlet size and changes in cognitive and emotional eating behaviors were predictors of weight loss after GJAR on a univariate analysis. On a multivariate analysis, the only predictor of weight loss was a reduction in outlet size (P< .01). CONCLUSIONS Endoscopic suturing resulted in greater reduction in outlet size, improvement in eating behavior, and weight loss than sclerotherapy. Reduction of anastomosis size was a significant predictor of weight loss after GJAR.

Sedation Challenges: Obesity and Sleep Apnea

This article reviews the data for diagnostic and uncomplicated therapeutic upper endoscopy, which show it is safe and effective to perform the procedure under moderate sedation with a combination of benzodiazepine and opioids. For more complex procedures or for superobese patients anesthesia support is recommended. Performing endoscopy in this population should alert providers to plan carefully and individualize sedation plans because there is no objective way to quantify this risk pre-endoscopically.

Patients With Roux-en-Y Gastric Bypass Require Increased Sedation During Upper Endoscopy

BACKGROUND & AIMS After Roux-en-Y gastric bypass (RYGB), many patients experience changes in metabolism that could affect the amount of sedative they require. We assessed whether patients who have vs have not received RYGB have different sedation requirements during esophagogastroduodenoscopy (EGD). METHODS In a retrospective study, we collected data from patients who had received RYGB (n = 200; mean age, 45 years; 188 women; body mass index [BMI], 34.0 ± 7.1 kg/m2) or had not (controls, n = 200; mean age, 45 years; 188 women; BMI, 34.1 ± 7.2 kg/m2) and underwent EGD under conscious sedation from 2005 through 2010; groups were matched for age, sex, and BMI. Sedative doses were compared by using the Student t test. Multivariate linear regression was used to identify factors associated with sedation dose. We performed a subgroup analysis of RYGB patients who underwent EGD before and after RYGB, comparing sedative doses with a paired t test. RESULTS Patients with RYGB were given 132.4 ± 40.4 μg fentanyl and 5.4 ± 1.5 mg midazolam, whereas controls received 108.6 ± 31.6 μg fentanyl (P < .001) and 4.3 ± 1.2 mg midazolam (P < .001). Increased time from RYGB, higher American Society of Anesthesiologists class, and therapeutic procedure were associated with higher doses of sedation (P < .05). Thirty-two patients underwent EGD before and after RYGB. Patients were given 95.0 ± 39.0 μg fentanyl before RYGB and 130.5 ± 41.3 μg fentanyl afterward (P < .05); they were given 4.0 ± 1.0 mg midazolam before RYGB and 5.5 ± 1.7 mg midazolam afterward (P < .05). CONCLUSIONS Patients with RYGB require larger amounts of fentanyl and midazolam during EGD than patients without RYGB, despite similar age, sex, and BMI. Among patients who underwent EGD before and after RYGB, levels of drugs required for sedation increased after gastric bypass, despite weight loss.

Preclinical endoscopic training using a part-task simulator: learning curve assessment and determination of threshold score for advancement to clinical endoscopy

BackgroundPreclinical simulator training has the potential to decrease endoscopic procedure time and patient discomfort. This study aims to characterize the learning curve of endoscopic novices in a part-task simulator and propose a threshold score for advancement to initial clinical cases.MethodsTwenty novices with no prior endoscopic experience underwent repeated endoscopic simulator sessions using the part-task simulator. Simulator scores were collected; their inverse was averaged and fit to an exponential curve. The incremental improvement after each session was calculated. Plateau was defined as the session after which incremental improvement in simulator score model was less than 5%. Additionally, all participants filled out questionnaires regarding simulator experience after sessions 1, 5, 10, 15, and 20. A visual analog scale and NASA task load index were used to assess levels of comfort and demand.ResultsTwenty novices underwent 400 simulator sessions. Mean simulator scores at sessions 1, 5, 10, 15, and 20 were 78.5 ± 5.95, 176.5 ± 17.7, 275.55 ± 23.56, 347 ± 26.49, and 441.11 ± 38.14. The best fit exponential model was [time/score] = 26.1 × [session #]−0.615; r2 = 0.99. This corresponded to an incremental improvement in score of 35% after the first session, 22% after the second, 16% after the third and so on. Incremental improvement dropped below 5% after the 12th session corresponding to the predicted score of 265. Simulator training was related to higher comfort maneuvering an endoscope and increased readiness for supervised clinical endoscopy, both plateauing between sessions 10 and 15. Mental demand, physical demand, and frustration levels decreased with increased simulator training.ConclusionPreclinical training using an endoscopic part-task simulator appears to increase comfort level and decrease mental and physical demand associated with endoscopy. Based on a rigorous model, we recommend that novices complete a minimum of 12 training sessions and obtain a simulator score of at least 265 to be best prepared for clinical endoscopy.

Effect of the Duodenal-Jejunal Bypass Liner on Glycemic Control in Patients With Type 2 Diabetes With Obesity: A Meta-analysis With Secondary Analysis on Weight Loss and Hormonal Changes

OBJECTIVE Duodenal-jejunal bypass liner (DJBL) is an endoscopic device that may mimic small bowel mechanisms of Roux-en-Y gastric bypass (RYGB). Previous studies have demonstrated the efficacy of DJBL at inducing weight loss. We assessed the effect of DJBL on glycemic control in patients with type 2 diabetes (T2D) with obesity. RESEARCH DESIGN AND METHODS Data sources included MEDLINE, EMBASE, and Web of Science through 1 July 2017. Included were published studies that assessed DJBL outcomes in obese T2D patients. RESULTS Primary outcomes were change in HbA1c and HOMA of insulin resistance (HOMA-IR). Secondary outcomes were change in weight and gut hormones glucose-dependent insulinotropic peptide (GIP), glucagon-like peptide 1 (GLP-1), peptide YY (PYY), and ghrelin. Seventeen studies were included. At explant, HbA1c decreased by 1.3% [95% CI 1.0, 1.6] and HOMA-IR decreased by 4.6 [2.9, 6.3]. Compared with control subjects, DJBL subjects had greater HbA1c reduction by 0.9% [0.5, 1.3]. Six months after explant, HbA1c remained lower than baseline by 0.9% [0.6, 1.2]. At explant, patients lost 11.3 kg [10.3, 12.2], corresponding to a BMI reduction of 4.1 kg/m2 [3.4, 4.9], total weight loss of 18.9% [7.2, 30.6], and excess weight loss of 36.9% [29.2, 44.6]. The amount of weight loss remained significant at 1 year postexplantation. After DJBL, GIP decreased, whereas GLP-1, PYY, and ghrelin increased. CONCLUSIONS DJBL improves glycemic control and insulin resistance in T2D patients with obesity. DJBL also appears to induce significant weight loss in this population. Additionally, changes in gut hormones suggest mechanisms similar to RYGB. Study limitations included heterogeneity among studies.