Endoscopic approaches to the management of hemorrhoids.

PURPOSE OF REVIEW: To review the literature within the last 5 years on the current status and future perspectives of the endoscopic management of internal hemorrhoids. RECENT FINDINGS: Despite the large burden of hemorrhoidal diseases, research in this area, particularly on endoscopic approaches for treatment, has been slow. Within the last 5 years, data has been published on the novel cap-assisted endoscopic sclerotherapy (CAES), which will continue to gain attention in the future. Rubber band ligation has been adopted by the endoscopist as endoscopic rubber band ligation (ERBL), demonstrating satisfactory results in treating symptomatic hemorrhoids, although mild postprocedure complications are common. Data is needed on head-to-head comparisons between ERBL, endoscopic sclerotherapy, and CAES. Other methods, such as coagulation, are understudied and should be explored further in the endoscopic setting. Meaningful comparisons between treatment methods for internal hemorrhoids have been difficult because of variations in interventional techniques and methods, differences in the grading of hemorrhoids, and lack of standardization of clinical trials. The Goligher classification alone is inadequate for determining the management of symptomatic hemorrhoids and this warrants revision. SUMMARY: Gastroenterologists are poised to assume a greater role in the management of internal hemorrhoids with flexible endoscopy. Current endoscopic treatment options require further study.

Incidence, severity, and mortality of post-ERCP pancreatitis: an updated systematic review and meta-analysis of 145 randomized controlled trials.

BACKGROUND AND AIMS: The incidence, severity, and mortality of post-ERCP pancreatitis (PEP) largely remain unknown with changing trends in ERCP use, indication, and techniques. We sought to determine the incidence, severity, and mortality of PEP in consecutive and high-risk patients based on a systemic review and meta-analysis of patients in placebo and no-stent arms of randomized control trials (RCTs). METHODS: The MEDLINE, Embase, and Cochrane databases were searched from the inception of each database to June 2022 to identify full-text RCTs evaluating PEP prophylaxes. The incidence, severity, and mortality of PEP from the placebo or no-stent arms of RCTs were recorded for consecutive and high-risk patients. A random-effects meta-analysis for a proportions model was used to calculate PEP incidence, severity, and mortality. RESULTS: One hundred forty-five RCTs were found with 19,038 patients in the placebo or no-stent arms. The overall cumulative incidence of PEP was 10.2% (95% confidence interval [CI], 9.3-11.3), predominantly among the academic centers conducting such RCTs. The cumulative incidences of severe PEP and mortality were .5% (95% CI, .3-.7) and .2% (95% CI, .08-.3), respectively, across 91 RCTs with 14,441 patients. The cumulative incidences of PEP and severe PEP were 14.1% (95% CI, 11.5-17.2) and .8% (95% CI, .4-1.6), respectively, with a mortality rate of .2% (95% CI, 0-.3) across 35 RCTs with 3733 patients at high risk of PEP. The overall trend for the incidence of PEP among patients randomized to placebo or no-stent arms of RCTs has remained unchanged from 1977 to 2022 (P = .48). CONCLUSIONS: The overall incidence of PEP is 10.2% but is 14.1% among high-risk patients based on this systematic review of placebo or no-stent arms of 145 RCTs; this rate has not changed between 1977 and 2022. Severe PEP and mortality from PEP are relatively uncommon.

Impact of genetic testing and smoking on the distribution of risk factors in patients with recurrent acute and chronic pancreatitis.

OBJECTIVE: The aim of the present study is to assess the impact of smoking dose and duration on the distribution of risk factor(s) in patients with RAP and CP, and the impact of genetic testing on the distribution of risk factor(s) in patients with idiopathic RAP and CP. METHODS: All adult patients with RAP and CP referred to a multidisciplinary pancreatitis clinic between 2010 and 2017 were evaluated. Risk factors included alcohol and smoking, hypertriglyceridemia, biliary, and other etiologies. Genetic testing was only pursued in patients with idiopathic RAP or CP. RESULTS: Among the 1770 patients evaluated, 167 had RAP and 303 had CP. After genetic testing and smoking, the most common risk factors for RAP and CP were pathogenic variant(s) (23%) and the combination of alcohol and smoking (23%), respectively. Genetic testing and smoking assessment decreased the proportion of patients with alcoholic RAP from 17% to 5%, alcoholic CP from 33% to 10%, idiopathic RAP from 49% to 12%, and idiopathic CP from 54% to 14%. Pathogenic CFTR variants were the most common variant in patients with RAP (51%) and CP (43%). Among the 68 patients with pancreas divisum, other risk factor(s) were identified in 72%. CONCLUSION: Genetic testing and a detailed assessment of smoking dose and duration reduce the proportion of patients with alcoholic and idiopathic pancreatitis. Other risk factor(s) for pancreatitis are found in the majority of patients with pancreas divisum further questioning its role as an independent risk factor.1. What is the current knowledge?Approximately 30% of patients with pancreatitis have no clear risk factor(s) and are categorized as having an idiopathic etiology.Pathogenic variant(s) as well as smoking dose and duration are well-established risk factors for recurrent acute and chronic pancreatitis but are not widely recognized or incorporated into clinical practice.2. What is new here?Genetic testing and a detailed assessment of smoking dose and duration reduced the proportion of patients with alcoholic and idiopathic acute recurrent and chronic pancreatitis.Approximately three-fourths of patients with pancreas divisum have a risk factor for pancreatitis.

AGA Clinical Practice Update on Evaluation and Management of Early Complications After Bariatric/Metabolic Surgery: Expert Review.

DESCRIPTION: Endoscopic techniques are paramount in the identification and management of complications after surgery, though collaboration with other specialties is obligatory. Unfortunately, the evaluation and treatment algorithms are not standardized and there is a paucity of high-quality prospective studies to provide clarity regarding the best approach. The purpose of this clinical practice update is to apprise the clinician with respect to the endoscopic evaluation and management of patients with early (<90 days) complications after undergoing bariatric/metabolic surgery. METHODS: The best practice advice outlined in this expert review are based on available published evidence, including observational studies and systematic reviews, and incorporates expert opinion where applicable. BEST PRACTICE ADVICE 1: Clinicians performing endoscopic approaches to treat early major postoperative complications should do so in a multidisciplinary manner with interventional radiology and bariatric/metabolic surgery co-managing the patient. Daily communication is advised. BEST PRACTICE ADVICE 2: Clinicians embarking on incorporating endoscopic management of bariatric/metabolic surgical complications into their clinical practice should have a comprehensive knowledge of the indications, contraindications, risks, benefits, and outcomes of each of the endoscopic treatment techniques. They should also have knowledge of the risks and benefits of alternative methods such as surgical and interventional radiological based approaches. BEST PRACTICE ADVICE 3: Clinicians incorporating endoscopic management of bariatric/metabolic surgical complications into their clinical practice should have expertise in interventional endoscopy techniques, including but not limited to: using concomitant fluoroscopy, stent deployment and retrieval, managing stenosis, and managing percutaneous drains. BEST PRACTICE ADVICE 4: Clinicians should screen all patients undergoing endoscopic management of bariatric/metabolic surgical complications and dietary intolerance for comorbid medical (nutrient deficiencies, infection, pulmonary embolism) and psychological (depression, anxiety) conditions. BEST PRACTICE ADVICE 5: Endoscopic approaches to managing complications of bariatric/metabolic surgery may be considered for patients in the immediate, early and late postoperative periods depending on hemodynamic stability. BEST PRACTICE ADVICE 6: Clinicians incorporating endoscopic management of bariatric/metabolic surgical complications into their clinical practice should have a detailed understanding of the pathophysiologic mechanisms initiating and perpetuating conditions such as staple-line leaks. This will allow for a prompt diagnosis and appropriate therapy to be targeted not only at the area of interest, but also any concomitant downstream stenosis. BEST PRACTICE ADVICE 7: Clinicians should recognize that the goal for endoscopic management of staple-line leaks are often not necessarily initial closure of the leak site, but rather techniques to promote drainage of material from the perigastric collection into the gastric lumen such that the leak site closes by secondary intention.

Endoscopic gastrointestinal anastomosis: a review of established techniques.

Technologic advancements in the field of therapeutic endoscopy have led to the development of minimally invasive techniques to create GI anastomosis without requiring surgery. Examples of the potential clinical applications include bypassing malignant and benign gastric outlet obstruction, providing access to the pancreatobiliary tree in those who have undergone Roux-en-Y gastric bypass, and relieving pancreatobiliary symptoms in afferent loop syndrome. Endoscopic GI anastomosis is less invasive and less expensive than surgical approaches, result in improved outcomes, and therefore are more appealing to patients and providers. The aim of this review is to present the evolution of luminal endoscopic gastroenteric and enteroenteric anastomosis dating back to the first compression devices and to describe the clinical techniques being used today, such as magnets, natural orifice transluminal endoscopic surgery, and EUS-guided techniques. Through continued innovation, endoscopic interventions will rise to the forefront of the therapeutic arsenal available for patients requiring GI anastomosis.

Endoscopic sleeve gastroplasty plus liraglutide versus endoscopic sleeve gastroplasty alone for weight loss.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) has been shown to be effective for inducing weight loss. The efficacy of liraglutide, a glucagon-like peptide-1 agonist, to augment weight loss after ESG is unknown. This study aims to evaluate the efficacy of ESG and liraglutide (ESG-L) compared with ESG alone. METHODS: This was a retrospective study of prospectively collected data from patients undergoing ESG at 3 outpatient clinics in Brazil between November 2017 and July 2018. Liraglutide was offered to all patients 5 months after ESG. Patients who opted to take liraglutide (ESG-L) were matched 1:1 to patients who declined it (ESG). The primary outcome was percent total body weight loss (%TBWL), and percent excess weight loss (%EWL) 7 months after initiation of liraglutide (12 months after ESG). The secondary outcome was change in percent body fat 12 months after ESG. ESG technique and postprocedure follow-up were identical at all 3 sites. RESULTS: Propensity score matching yielded 26 matched pairs. Adjusted comparisons between the 2 groups showed that patients who opted to take liraglutide had a superior mean %TBWL 7 months after initiation of liraglutide (ESG-L) compared with those who declined it (ESG) (24.72% ± 2.12% vs 20.51% ± 1.68%, respectively; P < .001). ESG-L had a statistically greater reduction in percent body fat compared with ESG (7.85% ± 1.26% vs 10.54% ± 1.88%, respectively; P < .001) at 12 months. CONCLUSIONS: Addition of liraglutide at 5 months results in superior weight loss and improved efficacy as demonstrated by decreased body fat 12 months after ESG. Further studies are imperative to determine optimal dose, timing, and duration of liraglutide.

Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis.

BACKGROUND & AIMS: Bariatric surgery is the most successful treatment for obesity. However, many patients avoid surgery due to its perceived invasive nature and fear of complications. Endoscopic sleeve gastroplasty (ESG) is a seemingly less invasive option for patients with obesity. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of ESG in adults. METHODS: We searched MEDLINE, Embase, Web of Science, and Cochrane Library through July 2019. Investigated outcomes included the percent total body weight loss (TBWL), body mass index reduction, percent excess weight loss (EWL), and adverse events. RESULTS: We extracted data from 8 original studies, published from 2016 through 2019, which included a total of 1772 patients. At 6 months, mean TBWL was 15.1% (95% CI, 14.3-16.0), mean decrease in body mass index was 5.65 kg/m2 (95% CI, 5.07-6.22), and mean excess weight loss was 57.7% (95% CI, 52.0-63.4). Weight loss was sustained at 12 months and 18-24 months with a TBWL of 16.5% (95% CI, 15.2-17.8) and 17.2% (95% CI, 14.6-19.7), respectively. The pooled post-ESG rate of severe adverse events was 2.2% (95% CI, 1.6%-3.1%), including pain or nausea requiring hospitalization (n = 18, 1.08%), upper gastrointestinal bleeding (n=9, 0.56%), and peri-gastric leak or fluid collection (n = 8, 0.48%). CONCLUSIONS: In a systematic review and meta-analysis, we found ESG to produce clinically significant weight loss that was reproducible among independent centers and to have a low rate of severe adverse events. ESG appears to be an effective intervention for patients with obesity, although comparative studies and randomized controlled trials are necessary. PROSPERO Identifier: CRD42019121921.

Role of endoscopic functional luminal imaging probe in predicting the outcome of gastric peroral endoscopic pyloromyotomy (with video).

BACKGROUND AND AIMS: Endoluminal functional luminal imaging probe (EndoFLIP) is an imaging tool that measures the physiologic characteristics of GI sphincters. In this study, we used EndoFLIP to evaluate the association between the pyloric physiologic measurements and the clinical outcomes of gastric peroral endoscopic myotomy (G-POEM) in patients with refractory gastroparesis. METHODS: Thirty-seven patients from 5 centers who underwent G-POEM for management of refractory gastroparesis and had EndoFLIP measurements were evaluated. Cross-sectional area (CSA), balloon pressure, and the distensibility index (DI) of the pylorus were evaluated by EndoFLIP at 40 mL and 50 mL balloon fills before and after G-POEM. One-year clinical success and change in gastric emptying study 3 months after the G-POEM procedure were compared with the EndoFLIP measurements. RESULTS: Clinical success was achieved in 26 (70%) patients. Post-G-POEM CSA and DI were significantly higher in the clinical success group with both 40-mL volume distension (CSA: 89.9 ± 64.8 vs 172.5 ± 71.9 mm2, P =.003; DI: 5.8 ± 4.4 vs 8.8 ± 6.1 mm2/mm Hg, P =.043) and 50-mL volume distention (CSA: 140.1 ± 89.9 vs 237.5 ± 80.3 mm2, P =.003; DI: 5.6 ± 3.3 vs 9.9 ± 6.6 mm2/mm Hg, P =.049). CSA using 40-mL volume distention with an area under the curve of 0.83 yielded a specificity of 91% and a sensitivity of 71% at a cutoff point of 154 mm2. CONCLUSIONS: Post-G-POEM CSA of the pylorus is associated with clinical success and improvement in a gastric emptying scan after G-POEM. EndoFLIP measurements of the pylorus have the potential to be used as a tool to predict the clinical outcome of G-POEM.

Endoscopic sleeve gastroplasty versus high-intensity diet and lifestyle therapy: a case-matched study.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is a safe and effective minimally invasive bariatric procedure. This study compared weight loss in patients undergoing ESG with that of matched patients undergoing high-intensity diet and lifestyle therapy (HIDLT). METHODS: In this case-matched study, patients were matched 2/3:1 (HIDLT/ESG) by age, sex, and body mass index (BMI). One hundred five patients (30 men) who underwent ESG + low-intensity diet and lifestyle therapy (LIDLT) between 2016 and 2018 were compared with 281 patients (92 men) who underwent HIDLT at the Johns Hopkins Medical Institutions from 2013 to 2014. Weight was evaluated 1, 3, 6, and 12 months after beginning HIDLT or post-ESG to determine the mean percent total body weight loss (%TBWL). RESULTS: Mean age across both cohorts was 48.0 ± 12.1, and baseline BMI was 40.0 ± 7.7 kg/m2. In multivariable analysis controlling for age, sex, and baseline BMI, the mean %TBWL at 1, 3, 6, and 12 months was significantly higher in patients undergoing ESG than matched patients undergoing HIDLT. Specifically, at 3 months, the mean %TBWL in the ESG cohort was 14.0% compared with 11.3% in the HIDLT cohort (P <.011), and at 12 months the mean %TBWL in the ESG cohort was 20.6% versus 14.3% in the HIDLT cohort (P < .001). ESG patients with baseline BMI ≤40 kg/m2 continued to show significantly greater %TBWL than those of the same BMI group in the HIDLT group at 1, 3, 6, and 12 months after intervention (3 months, coefficient = 3.43 [P < .001]; 12 months, coefficient = 8.14 [P < .001]). CONCLUSIONS: Through 12 months of follow-up, patients who underwent ESG achieved significantly greater weight loss than patients enrolled in HIDLT. ESG appears to be a valuable alternative for patients who experience difficulty complying with HIDLT.

Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) has become the mainstay for the treatment of achalasia at many institutions around the world since its inception in 2008. POEM can be performed using either the anterior or posterior approach. The primary aim of this study was to compare the efficacy of the anterior and posterior approaches at 1 year after POEM. METHODS: This is a single-blinded, randomized, noninferiority international clinical trial. Eligible participants were adult patients with a confirmed diagnosis of achalasia via high-resolution esophageal manometry. Patients were randomly allocated with a 1:1 ratio to receive POEM with anterior or posterior approach. The primary aim was to compare the rate of clinical success (Eckardt score <3) of anterior and posterior approaches at 1 year. RESULTS: One hundred fifty patients were randomized to receive either anterior (n = 73) or posterior (n = 77) POEM. One hundred forty-eight patients received the POEM treatment, and 138 patients completed the 1-year follow-up and were included in the primary efficacy analysis. Technical success was achieved in 71 patients (97.3%) in the anterior group versus 77 patients (100%) in the posterior group (P = .23). The median (interquartile range) length of hospital stay after the procedure was 2 (1-3) days for both groups. Adverse events occurred in 15 patients (10%), 8 patients (11%) in the anterior group and 7 patients (9%) in the posterior group (P = .703). Clinical success was achieved in 90% of patients in the anterior group and 89% of patients in the posterior group. Abnormal esophageal acid exposure was detected in 29 of 59 patients (49%) and 25 of 60 patients (42%) in the anterior and posterior groups, respectively (P = .67). GERD questionnaire scores were also not significantly different between the study groups. In both groups, quality of life improved after POEM for all 36-Item Short-Form Health Survey measures and was similar between both groups. CONCLUSIONS: Posterior myotomy during POEM was not inferior to anterior myotomy in terms of efficacy and safety in the treatment of patients with achalasia. (Clinical trial registration number: NCT02454335.).

Cryoballoon ablation for gastric pouch and/or outlet reduction in patients with weight regain post Roux-en-Y gastric bypass.

BACKGROUND: Cryoballoon ablation could induce stricture formation to achieve outlet and pouch reduction in patients regaining weight after Roux-en-Y gastric bypass (RYGB). This pilot study aimed to assess technical feasibility and short-term efficacy. METHODS: A retrospective chart review (January - November 2018) at two academic centers identified patients with weight regain post-RYGB, treated with cryoablation if pouch > 4 cm and/or outlet > 15 mm. Patients were scheduled for surveillance endoscopies at 8 weeks. RESULTS: 22 patients presented 10.5 years (SD 4.42) post-RYGB with weight regain of 30.9 kg (SD 13.7). Technical success was 89.5 % for outlet ablation and 93.0 % for pouch ablation. From baseline to 8 weeks, the outlet was reduced from 24.1 mm (95 % confidence interval [CI] 19.8 to 28.5) to 17.1 mm (95 %CI 13.1 to 21.1; P < 0.001), and pouch from 5 cm (95 %CI 4.1 to 5.9) to 3.9 cm (95 %CI 2.6 to 5.1; P < 0.05). Total body weight loss at 8 weeks was 8.1 % (SD 12.8 %). CONCLUSION: Cryoablation appears technically feasible and effective for outlet and/or pouch reduction in the short term.

A Randomized Trial of Topical Epinephrine and Rectal Indomethacin for Preventing Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis in High-Risk Patients.

INTRODUCTION: Rectal indomethacin and topical spray of epinephrine have separately shown efficacy in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) in randomized controlled trials. We hypothesized that the combination of indomethacin and topical spray of epinephrine on the duodenal papillae would further reduce PEP than when indomethacin was used alone. METHODS: We conducted a comparative effectiveness, multicenter, double-blinded, randomized trial of rectal indomethacin alone vs a combination of rectal indomethacin and topical spray of epinephrine for the prevention of PEP in high-risk patients. The primary outcome was the incidence of PEP and the secondary outcome was the severity of PEP. A 2-tailed Fisher's exact test was used to analyze the difference in the proportion of patients with PEP in the indomethacin alone vs the combination group. RESULTS: A total of 960 patients (mean age 52.33 ± 14.96 years; 551 [57.4%] females) were randomized and 959 completed follow-up. The baseline demographic and clinical characteristics were similar between the 2 groups. Women <50 years of age (25.4%) and difficult cannulation (84.9%) were the most common PEP risk factors. The incidence of PEP was 6.4% in the indomethacin alone group (n = 482) compared to 6.7% in the combination group (n = 477; P = 0.87). Severe PEP was found in 5 (12%) and 7 (16%) patients in the indomethacin alone and combination groups, respectively (P = 0.88). The overall mortality was 0.6%, which was unrelated to the primary outcome. CONCLUSIONS: The combination of rectal indomethacin and topical spray of epinephrine does not reduce the incidence of PEP compared to rectal indomethacin alone in high-risk patients; https://clinicaltrials.gov/ct2/show/NCT02116309.

Endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy: a case-matched study.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) reduces the gastric lumen to a size comparable with that of laparoscopic sleeve gastrectomy (LSG). However, there is a paucity of research comparing outcomes between the 2 procedures. Our study compared the 6-month weight loss outcomes and adverse events of ESG with LSG in a case-matched cohort. METHODS: We retrospectively reviewed prospectively collected data for patients undergoing ESG or LSG at a single academic center. Weight was recorded at 1 and 6 months postprocedure, and percent total body weight loss (%TBWL) was calculated. Adverse events and new-onset Gastroesophageal Reflux Disease (GERD) were also recorded. RESULTS: A total of 54 ESG patients were matched with 83 LSG patients by age, sex, and body mass index. The proportion of patients with GERD at baseline was similar in the 2 groups (16.7% in ESG group vs 25.3% in LSG group, P = .27). At the 6-month follow-up, %TBWL (compared with baseline) was significantly lower in the ESG group compared with the LSG group (17.1% ± 6.5% vs 23.6% ± 7.6%, P < .01). ESG patients had significantly lower rates of adverse events compared with LSG patients (5.2% vs 16.9%, P < .05). New-onset GERD was also significantly lower in the ESG group compared with the LSG group (1.9% vs 14.5%, P < .05). CONCLUSIONS: ESG, a minimally invasive same-day procedure, achieved less weight loss at 6 months than LSG, with the caveat that LSG caused more adverse events and new-onset GERD than ESG.

An international study on the use of peroral endoscopic myotomy (POEM) in the management of esophageal diverticula: the first multicenter D-POEM experience.

BACKGROUND: The aim of this study is to report a novel, multicenter experience with the diverticular peroral endoscopic myotomy (D-POEM) technique in the management of esophageal diverticula. METHODS: This is a multicenter, international, retrospective study involving three centers. D-POEM was performed using the principles of submucosal endoscopy. RESULTS: A total of 11 patients with an esophageal diverticulum (Zenker's 7, mid-esophagus 1, epiphrenic 3) were included. The mean size of the esophageal diverticula was 34.5 mm. The overall technical success rate of D-POEM was 90.9 %, with a mean procedure time of 63.2 minutes. There were no adverse events. Clinical success was achieved in 100 % (10 /10), with a decrease in mean dysphagia score from 2.7 to 0.1 (P < 0.001) during a median follow-up of 145 days (interquartile range 126 - 273). CONCLUSION: Endoscopic management of esophageal diverticula using the novel technique of D-POEM appears promising. This first case series on D-POEM suggests that the procedure is feasible, safe, and effective in the management of esophageal diverticula. D-POEM offers the distinct advantage of ensuring a complete septotomy. Larger studies are needed to confirm these intriguing results.

Endoscopic sleeve gastroplasty versus intragastric balloon insertion: efficacy, durability, and safety.

BACKGROUND: Intragastric balloon (IGB) placement and endoscopic sleeve gastroplasty (ESG) are reported to be safe and effective endoscopic bariatric therapies. This study aimed to compare the patient demographics and therapeutic outcomes between the IGB and ESG procedures. METHODS: This was a retrospective review of prospectively collected data from consecutive patients between December 2015 and October 2017 who underwent IGB or ESG at a single academic center. Fluid-filled IGBs implanted for a 6-month duration were used. IGB and ESG patients were subjected to identical post-procedure dietary instructions and follow-up protocols. Body weight was recorded at 1, 3, 6, and 12 months post-procedure. RESULTS: A total of 47 patients underwent IGB insertion and 58 underwent ESG. The IGB cohort had a lower baseline body mass index (BMI) than the ESG (34.5 vs. 41.5 kg/m2; P < 0.001) and a significantly lower proportion of men (2.1 % vs. 41.4 %; P < 0.001). IGB patients showed a mean (standard deviation [SD]) percentage total body weight loss (%TBWL) that was significantly lower than ESG patients at 1 month (6.6 % [2.6 %] vs. 9.9 % [2.4 %]; P < 0.001), 3 months (11.1 % [4.4 %] vs. 14.3 % [4.6 %]; P = 0.004), 6 months (15.0 % [7.6 %] vs. 19.5 % [5.7 %]; P = 0.01), and 12 months (13.9 % [9.0 %] vs. 21.3 % [6.6 %]; P = 0.005). The IGB cohort also experienced significantly more adverse events compared with the ESG (17 % vs. 5.2 %; P = 0.048). CONCLUSIONS: IGB placement and ESG result in clinically meaningful weight loss. However, ESG appears to provide clinically superior and more enduring weight loss with fewer adverse events compared with an IGB.

Real-World Safety and Efficacy of Fluid-Filled Dual Intragastric Balloon for Weight Loss.

BACKGROUND & AIMS: Reshape Duo is a saline-filled dual, integrated intragastric balloon (IGB) approved by the Food and Drug Administration for weight loss in patients with obesity. In a prospective, randomized trial, obese patients who received the balloon had significantly greater percent excess weight loss (%EWL) compared with patients treated with diet and exercise alone. However, there are limited data on the real-world efficacy of the Reshape balloon. METHODS: We performed a retrospective study of data collected from 2 academic centers and 5 private practices in which all patients paid for the IGB and follow-up visits out of pocket. The IGB was removed after 6 months. We collected data (demographic, medical, and laboratory) from 202 adults (mean age 47.8 ± 10.8 years; 83% female) with a baseline mean body mass index of 36.8 + 8.4 kg/m2 who had IGB insertion for weight loss therapy, along with counselling on lifestyle modifications focused on diet and exercise. Primary outcomes were percent total body weight loss (%TBWL) and %EWL at 1, 3, 6, 9, and 12 months after the procedure. RESULTS: Mean %TBWL at 1, 3, 6, 9 and 12 months was 4.8 ± 2.4%, 8.8 ± 4.3%, 11.4 ± 6.7%, 13.3 ± 7.8%, and 14.7 ± 11.8%, respectively. Data were available from 101 patients at 6 months and 12 patients at 12 months; 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL. Seventeen patients (8.4%) had esophageal tears during balloon insertion, with no intervention required. Thirteen patients (6.4%) had their IGB removed before the end of the 6-month treatment period. Nausea, vomiting, and abdominal pain were the most common adverse effects, occurring in 149 (73.8%), 99 (49%), and 51 (25.2%) patients. In one patient, the IGB migrated distally leading to small intestinal obstruction requiring surgical removal. CONCLUSION: In a retrospective analysis of real-world patients who received the Reshape Duo IGB, we found it to be a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at 6 months.

Gastric mucosal devitalization reduces adiposity and improves lipid and glucose metabolism in obese rats.

BACKGROUND AND AIMS: The gastric mucosa is an endocrine organ that regulates satiation pathways by expression of orexigenic and anorexigenic hormones. Vertical sleeve gastrectomy (VSG) excludes gastric mucosa and reduces gastric volume. Our study aimed to investigate the independent effects of altering gastric mucosa on obesity and its related comorbidities. METHODS: Gastric mucosa devitalization (GMD) of 70% of the stomach was achieved by argon plasma coagulation in a high-fat diet rat model and was compared with VSG and sham surgery. In an 8-week follow-up study, we quantified body weight, visceral adiposity, insulin resistance index, cholesterol profiles, and free fatty acid profiles by enzyme-linked immunosorbent assay (ELISA). Following a 2-hour oral glucose tolerance test, the kinetics of ghrelin, glucagon-like peptide-1, peptide YY, and serum and liver bile acid levels were measured. Liver lipid content was quantified by ELISA. RESULTS: GMD resulted in significant reductions in body weight, visceral and subcutaneous adipose tissue, and hepatic steatosis as well as an improvement in lipid metabolism. GMD resulted in significant reductions in food intake and intestinal malabsorption of free fatty acids, both contributing to improved body composition and metabolic profile. Mechanistically, GMD resulted in a significant reduction in serum palmitate levels as well as an increase in serum and liver bile acid levels, known to alter glucose and lipid metabolism. Similar changes were noted when VSG rats were compared with sham surgery rats. CONCLUSIONS: Devitalization of gastric mucosa, independent of altering gastric volume, was able to reduce obesity-related comorbidities. The gastric mucosa may be a potential target for treating obesity and its associated comorbidities.

Gastric mucosal devitalization is safe and effective in reducing body weight and visceral adiposity in a porcine model.

BACKGROUND AND AIMS: The early improvement in metabolic profile after sleeve gastrectomy (SG) indicates that the significant benefits of metabolic surgery are gastric in origin. We have previously demonstrated that devitalization of the gastric mucosa (without a reduction in gastric volume) in metabolically disturbed obese rats results in an improvement of obesity and its associated comorbidities. The aims of this study were to assess the technical feasibility, efficacy, and safety of gastric mucosal devitalization (GMD) in a large animal (porcine) model. METHODS: A 3-arm (GMD versus SG versus sham [SH]) prospective randomized controlled trial with an 8-week follow-up period was performed. The primary endpoint was relative weight loss. Secondary endpoints were absolute body weight, abdominal visceral adiposity, abdominal subcutaneous adiposity, organ lipid content, and serum ghrelin level. RESULTS: GMD resulted in a significant relative weight loss of 36% over SH at 8 weeks (P < .05). There was no significant difference in relative weight loss between GMD and SG at 4 weeks; however, SG resulted in a 29% superior relative weight loss at 8 weeks (P < .05). With regard to visceral adiposity, there was a significant benefit of GMD over SH at 8 weeks. Despite differences in relative weight loss, there was no significant difference in visceral adiposity between SG and GMD at 8 weeks. Significant improvements in GMD over SH were noted with regard to skeletal and heart muscle lipid content. GMD pigs at 8 weeks demonstrated regeneration of the gastric mucosa without ulceration or significant scarring. Despite mucosal regeneration, the abundance of serum ghrelin was significantly lower in the GMD cohort compared with the SG and SH cohorts. CONCLUSIONS: GMD was technically feasible and resulted in relative weight loss and an improvement in visceral adiposity. The benefits noted were out of proportion to what would be expected with weight loss alone.