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Background Endoscopic sleeve gastroplasty (ESG) is a technique for managing mild to moderately obese patients. We aimed to evaluate the long-term outcomes, reproducibility, and predictors of weight response in a large multicenter cohort. Methods Patients who underwent ESG between January 2013 and December 2015 in three centers were retrospectively analyzed. All procedures were performed using the Apollo OverStitch device (Apollo Endosurgery, Austin, TX). We performed per protocol (PP) and intention-to-treat (ITT) analyses, where patients lost to follow-up were considered failures. Multivariable linear and logistic regression analyses were performed. Results We included 248 patients (mean age 44.5 ± 10 years, 73% female). Baseline BMI was 37.8 ± 5.6 kg/m 2 . At 6 and 24 months, 33 and 35 patients were lost to follow-up, respectively. At 6 and 24 months, %TBWL was 15.2 [95%CI 14.2–16.3] and 18.6 [15.7–21.5], respectively. Weight loss was similar between centers at both follow-up intervals. At 24 months, % of patients achieving ≥10% TBWL was 84.2 and 53% with PP and ITT analyses, respectively. On multivariable linear regression analysis, only %TBWL at 6 months strongly predicted %TBWL at 24 months (adjusted for age, gender, and baseline BMI, β  = 1.21, p  < 0.001). The odds of achieving ≥10%TBWL at 24 months if a patient achieved <10%TBWL at 6 months is 0.18 [0.034–0.84]. Five (2%) serious adverse events occurred. Conclusions ESG effectively induces weight loss up to 24 months in moderately obese patients. Failure to achieve adequate weight loss can be predicted early, and patients should be offered adjunctive therapies to augment it.

INTRODUCTION:The 2021 American College of Gastroenterology Guidelines suggested using of intravenous erythromycin before endoscopy in patients with upper gastrointestinal bleeding (UGIB) to enhance endoscopic view and reduce the need for repeat endoscopy. Evidence on intravenous metoclopramide, which is more accessible, is scant, especially in patients with active UGIB. This study aimed to evaluate the efficacy of metoclopramide for gastric visualization in patients with active UGIB.METHODS:Between April 10, 2021, and October 8, 2022, this double-blind, double-center randomized controlled trial enrolled patients with active UGIB (hematemesis or presence of fresh blood in the nasogastric tube). The eligible patients were randomly assigned in a concealed 1:1 allocation to metoclopramide or placebo. The primary outcome was adequate visualization by objective endoscopic visualized gastroduodenal scores (EVS). Secondary outcomes included mean difference in EVS, duration of esophagogastroduodenoscopy (EGD), immediate hemostasis, need for a second look EGD, units of blood transfusion, length of hospital stay, and 30-day rebleeding rate.RESULTS:Of the 68 eligible patients, 3 of each group were excluded by protocol violation. Finally, 62 patients (31 metoclopramide and 31 placebo) were analyzed. The percentage of patients with adequate visualization in metoclopramide and placebo group was 77.4% and 61.6% (odds ratio [OR] 2.16 [0.71-6.58], P = 0.16). The need for a second look EGD in the 72 hours was lower in the metoclopramide group (3.2% vs 22.6%, OR 0.11 [0.01-0.99], P = 0.02), whereas the other secondary outcomes were not different. However, in gastric lesions subgroup analysis, metoclopramide improved the adequate visualization rate (92.9% vs 50%, OR 13 [1.32-128.10], P = 0.03) and mean EVS at fundus (1.79 ± 0.42 vs 1.29 ± 0.72; P = 0.03).DISCUSSION:Metoclopramide did not improve endoscopic visualization but decreased the need for second look EGD in patients with overall active UGIB. It improved gastric visualization in those with UGIB due to gastric lesions, primarily by improving visualization in the fundus (ClinicalTrials.gov number NCT04771481).

AbstractObjectiveTo determine whether high flow nasal cannula (HFNC) oxygenation can reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in patients with obesity.DesignMulticentre, randomised, parallel group trial.SettingThree tertiary hospitals in Shanghai, China.Participants1000 adult patients with obesity (body mass index ≥28) who were scheduled for gastrointestinal endoscopy.InterventionsParticipants were randomly allocated to receive regular nasal cannula oxygenation or HFNC oxygenation during a sedated procedure with propofol and low dose sufentanil.Main outcome measuresThe primary outcome was the incidence of hypoxia (75%≤SpO2<90% for <60 s) during the procedure. Secondary outcomes included the incidences of subclinical respiratory depression (90%≤SpO2<95% for any duration) and severe hypoxia (SpO2<75% for any duration or 75%≤SPO2<90% for >60 s) during the procedure.ResultsFrom 6 May 2021 to 26 May 2023, 984 patients (mean age 49.2 years; 36.9% (n=363) female) completed the study and were analysed. Compared with regular nasal cannula oxygenation, HFNC oxygenation reduced the incidence of hypoxia from 21.2% (103/487) to 2.0% (10/497) (difference −19.14, 95% confidence interval −23.09 to −15.36; P<0.001), subclinical respiratory depression from 36.3% (177/487) to 5.6% (28/497) (difference −30.71, −35.40 to −25.92; P<0.001), and severe hypoxia from 4.1% (20/487) to 0% (0/497) (difference −4.11%, −6.26 to −2.48; P<0.001). Other sedation related adverse events did not differ between the two groups.ConclusionsIn patients with obesity, oxygenation via HFNC during sedated gastrointestinal endoscopy significantly reduced the incidences of hypoxia, subclinical respiratory depression, and severe hypoxia without increasing other adverse events.Trial registrationClinicalTrials.gov NCT04500392.

The objective was to assess the efficacy and safety of GED-0301, an antisense oligodeoxynucleotide to Smad7, in active Crohn's disease (CD). This phase 3, blinded study randomized patients (1:1:1:1) to placebo or 1 of 3 once-daily oral GED-0301 regimens: 160 mg for 12 weeks followed by 40 mg continuously or alternating placebo with 40 or 160 mg every 4 weeks through week 52. In all, 701 patients were randomized and received study medication before premature study termination; 78.6% (551/701) completed week 12, and 5.8% (41/701) completed week 52. The primary endpoint, clinical remission achievement (CD Activity Index score <150) at week 12, was attained in 22.8% of patients on GED-0301 vs 25% on placebo (P = 0.6210). At study termination, proportions of patients achieving clinical remission at week 52 were similar among individual GED-0301 groups and placebo. More placebo vs GED-0301 patients achieved endoscopic response (>50% decrease from baseline Simple Score for CD) at week 12 (18.1% vs 10.1%). Additional endoscopic endpoints were similar between groups at weeks 12 and 52. More placebo vs GED-0301 patients had clinical response (≥100-point decrease in the CD Activity Index score) at week 12 (44.4% vs 33.3%); at week 52, clinical response rates were similar. Adverse events were predominantly gastrointestinal and related to active CD, consistent with lack of clinical and endoscopic response to treatment. Two deaths occurred (GED-0301 total group) due to small intestinal obstruction and pneumonia; neither was suspected by the investigator to be treatment-related. GED-0301 did not demonstrate efficacy vs placebo in active CD.

BackgroundMost endoscopists believe that higher resolution improves lesion detection rates. However, existing studies primarily compared the detection rates of white light endoscopy (WLE) and other imaging modalities. Our previous study demonstrated the advantages of magnifying endoscopy from general endoscopy for lesion detection, prompting further investigation into the variations in lesion detection rates across endoscopes with different resolutions.MethodsEndoscopic and corresponding pathological data from our medical unit over the past 5 years were analyzed. We excluded specific-purpose endoscopic procedures to ensure the natural randomization of the data. Baseline adjustment and risk factor analyses used multi-group propensity score matching and logistic regression.ResultsThe overall lesion detection rate was significantly higher with high-quality endoscopy (Q-endoscopy) compared to high-definition endoscopy (H-endoscopy) and high definition and quality endoscopy (HQ-endoscopy) (34.4% vs. 30.2% vs. 29.6%, P = 0.001). Similar results were observed for elevated lesions (25.7% vs. 21.0% vs. 22.9%, P = 0.001) and depressed lesions (6.6% vs. 6.2% vs. 3.6%, P < 0.001). HQ-endoscopy had a superior detection rate for superficial lesions compared to both H- and Q-endoscopies (3.0% vs. 2.8% vs. 1.8%, P = 0.041). However, there were no significant differences in neoplastic detection rate or missed neoplastic lesion rate among the three groups.ConclusionQ-endoscopy is superior in detecting non-superficial lesions, while HQ-endoscopy is better at detecting superficial lesions. However, there were no statistically significant differences in detecting or omitting neoplastic lesions among the three endoscopic examinations.

The Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score for Crohn's Disease (SES-CD) are commonly used to assess Crohn's disease (CD) activity; however neither instrument is fully validated. We evaluated the responsiveness to change of the SES-CD and CDEIS using data from a trial of adalimumab, a drug therapy of known efficacy. Paired video recordings (N=112) of colonoscopies (baseline and week 8-12) obtained from patients with CD who participated in a trial of adalimumab therapy were reviewed in random order, in duplicate, by four central readers (56 pairs of videos by 2 groups of readers). Responsiveness of the SES-CD and the CDEIS was evaluated by comparing correlations between the observed and pre-specified predictions of change scores for these endoscopic indices with a global endoscopic evaluation of severity (GELS), a patient reported outcome (PRO2), and the Crohn's disease activity index (CDAI), and by calculation of the standardized effect size, and Guyatt's Responsiveness statistic (GRS) using 2 definitions of change; (1) treatment assignment and (2) an absolute change in total PRO2 of 50. The potential application of effect size estimates was demonstrated by calculating hypothetical sample sizes for comparing two independent groups. The impact of removing stenosis as an index item and adjusting for the number of segments observed was also assessed. Changes in both endoscopic instruments and the GELS were highly correlated. The SES-CD displayed numerically higher effect sizes for both definitions of change. The standardized effect size and GRS estimates (95% confidence interval) for the SES-CD based on treatment assignment were 0.84 (0.53, 1.15) and 0.79 (0.48, 1.09). Corresponding values for the CDEIS were 0.72 (0.42, 1.02) and 0.75 (0.45, 1.06). The standardized effect size and GRS estimates for the SES-CD based on an absolute change in total PRO2 of 50 points or greater were 0.76 (0.49, 1.02) and 0.93 (0.64, 1.21). Corresponding values for CDEIS were 0.70 (0.44, 0.97), 0.83 (0.55, 1.10). Removal of stenosis as an index item and adjusting for observed segments did not improve responsiveness estimates. Although both the SES-CD and CDEIS are valid measures of endoscopic disease activity that are moderately responsive to changes in endoscopic disease activity, the SES-CD displayed numerically greater responsiveness in this data set.

Abstract Introduction: Obesity is associated with reduced life expectancy and various comorbidities. Surgical interventions are effective but accompanied by the risk of serious complications. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liner (DJBL). A randomized, sham-controlled study comparing both procedures has not been undertaken so far. Methods: We performed a randomized, patient- and assessor-blinded, controlled trial comparing weight loss in IB versus DJBL versus a sham procedure (2:2:1 ratio). Patients with a BMI >35 kg/m2 or >30 with obesity-related comorbidities were included. The IB was removed after 6 months and the DJBL after 12 months. The main objective was successful weight loss (>10% from baseline) 12 months after explantation of the devices. Secondary outcomes were changes in comorbidities, quality of life, and complications. Results: Thirty-three patients were randomized. Recruitment has to be stopped suddenly in after the DJBL device lost its CE mark in Europe. In all, 11 patients received DJBL, 15 IB, and 7 were allocated to the sham group. Blinding was feasible in all patients. Weight decreased from baseline until explantation (DJBL: 129.4 ± 28.3 kg to 107.4 ± 16.7 kg; IB: 118.3 ± 22.8 kg to 107.4 ± 25.7 kg; sham: 134.6 ± 18.0 kg to 131.2 ± 14.3 kg), but patients regained weight almost to the baseline level 12 months after explantation. Only 1 patient in IB group reached the primary endpoint. Severe device-related complications were very rare. Conclusion: Endoscopic bariatric procedures failed to achieve effective weight loss 12 months after explantation of the devices. The results of this trial need to be interpreted with caution due to its early termination.

•This novel prospective randomized controlled study assesses the impact of dexmedetomidine as an adjunct to propofol sedation during gastrointestinal endoscopic ultrasound procedures.•Dexmedetomidine improved endoscopist satisfaction by reducing patient movement and cough reflexes, enhancing procedural smoothness.•Patients in the dexmedetomidine-propofol group experienced fewer respiratory adverse events and faster recovery compared to those receiving propofol alone.•This study lays the groundwork for evaluating this sedation approach in higher-risk patients who may benefit most from minimized respiratory compromise. Upper gastrointestinal endoscopic ultrasonography (EUS) necessitates well-balanced sedation to ensure patient safety while optimizing procedural conditions. This study evaluates the safety and efficacy of dexmedetomidine-propofol versus propofol-only sedation in terms of respiratory safety, sedation quality, and recovery outcomes. This prospective randomized controlled trial enrolled 145 patients undergoing lower esophageal or gastric EUS from January 2022 to May 2023. All participants received standardized premedication with midazolam and tetracaine gel for mucosal topicalization. Participants were randomized into two groups: dexmedetomidine-propofol (n = 72) and propofol-only (n = 73). Continuous variables were analyzed using independent t-tests, and categorical data were compared with chi-square tests, with statistical significance set at P < 0.05. No significant difference was observed in patient satisfaction (P = 0.717), but endoscopist satisfaction was significantly higher in the dexmedetomidine-propofol group (P < 0.05). This group also showed significantly fewer midazolam rescue doses, fewer respiratory adverse events, and reduced intra-procedural patient movement and cough reflexes (all P < 0.05). Furthermore, recovery outcomes were improved, with higher modified Aldrete scores and faster achievement of a post-anesthesia discharge score ≥9 (P < 0.05). However, induction time was longer and the incidence of hypotension and bradycardia was higher in the combination group (P < 0.05). Dexmedetomidine-propofol sedation enhances procedural conditions and recovery metrics in EUS but is associated with greater cardiovascular side effects. These findings suggest it is a valuable alternative to propofol alone, particularly when optimizing proceduralist satisfaction and minimizing respiratory complications.

Background and aimsWeight regain after RYGB is multifactorial including dilatation of the gastro-jejunal anastomosis. Transoral outlet reduction (TORe) procedure is a minimally invasive alternative to surgical anastomotic revision.MethodsWe conducted a prospective, multicenter, simple blind, randomized study in patients with weight regain following RYGB, comparing the efficacy of conventional nutritional and behavioral management associated with a TORe procedure (TORe group) with conventional management alone and a Sham procedure (Sham group). The main objective of this study was to evaluate the percentage of excess weight loss (%EWL) at 12 months after endoscopy.ResultsFrom January 2015 to January 2019, 73 subjects were randomized in four French Bariatric centers. The final analysis involved 50 subjects, 25 in each group, 44 women, 6 men, with an average BMI of 40.6 kg/m2.At 12 months, the average %EWL was significantly higher in the TORe group than in the Sham group (13.5 ± 14.1 vs. − 0.77 ± 17.1; p = 0.002). Cohen’s d was 0.91, indicating a large effect size of the procedure on the %EWL.There was no significant difference between groups concerning the improvement of obesity-related comorbidities (diabetes and dyslipidemia) and quality of life at 12 months. We report frequent adverse events in the TORe group (20% had adverse events related to the procedure). Three adverse events were serious, including two perforations of the gastro-jejunal anastomosis after TORe group that led to the premature termination of the study.ConclusionsAfter RYGBP failure linked to the dilatation of the gastro-jejunal anastomosis, TORe procedure with nutritional management results in significantly higher %EWL at 12 months compared to patients with nutritional management alone. As surgery, this minimally invasive endoscopic procedure can be associated with severe adverse events.

Background and Aim Diagnostic performance of esophagogastroduodenoscopy (EGD) may be compromized due to adherent mucus and foam. In this study, we aimed at assessing the impact of premedication on mucosal visibility during endoscopy. Methods This is a double-blinded (patient and investigator), randomized trial conducted at a tertiary care centre. Patients were randomized into four groups: A (water), B (simethicone [S]), C (N-acetyl cysteine [NAC]), D (S + NAC). Premedication solutions were administered 10-30 minutes before endoscopy and mucosal visibility graded from 1 (best) to 4 (worst) (1 best, 4 worst). Total mucosal visibility scores (TMVS) from six sites ranged from 6 (best) to 24 (worst) points. The primary outcome of study was comparison of TMVS between simethicone and combination (S + NAC) premedication groups. Secondary outcomes were adverse events and impact of endoscopy timing on TMVS. Results Total 800 patients (39 years, 68.8% males) were randomized into four groups. Median TMVS were significantly lower in groups B (7 [6-8]) and D (8 [6-9]) as compared to A (11 [9-13]) and C (10 [8-12]). Proportion of cases with adequate gastric mucosal visibility (score < 7) was 26% in group A, 71% in group B, 36% in group C and 79% in group D. There was no difference in TMVS in groups A and C ( p  = 0.137). TMVS were significantly lower in late (> 20-30 minutes) vs. early (10–20 minutes) endoscopy sub-group (8 [7–11] vs, 9 ([7–11], p  = 0.001). However, TMVS were similar between group B and group D in early endoscopy group ( p  = 0.451). There was no significant difference in the lesion detection rate among the different premedication drugs ( p  > 0.05). Conclusions Premedication with simethicone or combination (simethicone and NAC) significantly improves mucosal visibility during EGD. If early endoscopy is indicated, simethicone provides similar mucosal visibility and may be an effective alternative to combined premedication. Trial registration NCT05951712. Graphical abstract