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Patients with obesity are more susceptible to hypoxemia. Anesthetic management for patients with obesity undergoing painless gastroscopy presents a severe challenge for anesthesiologists. Esketamine is a NMDA antagonist that has been proven to be beneficial for ameliorating respiratory depression owing to its sympathomimetic effect; however, there are no relevant reports on its use in patients with obesity. We designed a randomized controlled trial to evaluate whether esketamine can be the ideal adjuvant to propofol sedation in patients with obesity undergoing painless gastroscopy. A total of 104 patients with obesity undergoing painless gastroscopy were randomly divided into group C (propofol+saline) and group S (propofol+esketamine 0.25 mg/kg). Anesthesia was induced by 2 mg/kg propofol with saline or esketamine. The consumption of propofol, hemodynamic parameters, duration of procedure, induction time, postoperative awakening time, and orientation recovery time were recorded. Adverse events and satisfaction scores were also recorded. Propofol consumption was 274.4±22.6 mg and 201.3±16.6 mg in groups C and S, respectively. The induction time of groups C and S were 25.4±2.3 s and 17.8±1.9 s, respectively. The postoperative awakening times of groups C and S were 6.2±1.1 min and 4.8±1.3 min, respectively. Hemodynamic parameters were more stable in group S than in group C. The incidence of adverse events such as injection pain, hypoxemia, hypotension, bradycardia, choking, and body movement were significantly lower in group S. The satisfaction scores of the endoscopist and anesthesiologist were (4.58±0.49 vs 3.71±0.83) and (4.75±0.44 vs 3.33±0.92), respectively. The combination of propofol and esketamine (0.25 mg/kg) improves the safety and reduces the incidence of adverse events in patients with obesity during painless gastroscopy. Thus, this method is worthy of clinical application. ChiCTR 2200062547.

Objective To clarify the effectiveness of second-look endoscopy (SLE) at preventing bleeding after gastric endoscopic submucosal dissection (ESD). Design A multicentre prospective randomised controlled non-inferiority trial was conducted at five referral institutions across Japan. Patients with a solitary gastric neoplasm were enrolled. Exclusion criteria were previous oesophagogastric surgery or radiation therapy; perforation and the administration of antithrombotics, steroids or non-steroidal anti-inflammatory drugs. Patients were assigned to the SLE group or the non-SLE group by a computer-generated random sequence after ESD and were treated perioperatively with a proton pump inhibitor. SLE was performed one day after ESD. The primary endpoint was post-ESD bleeding, defined as an endoscopically proven haemorrhage. The trial had the power to detect a non-inferiority criterion of 7% between the groups. Results From February 2012 to February 2013, 130 and 132 patients were assigned to the SLE and the non-SLE groups, respectively. All patients were included in the intention-to-treat analysis of the primary endpoint. Post-ESD bleeding occurred in seven patients with (5.4%) SLE and five patients with (3.8%) non-SLE (risk difference −1.6% (95% CI −6.7 to 3.5); pnon-inferiority<0.001), meeting the non-inferiority criterion. All 12 patients with post-ESD bleeding and one patient with a delayed perforation were successfully managed with conservative treatment. Conclusions SLE after gastric ESD is not routinely recommended because it does not contribute to the prevention of post-ESD bleeding for patients with an average bleeding risk. Trial registration number UMIN-CTR000007170.

Objective: Remimazolam is a novel benzodiazepine sedative that provides effective sedation, stable haemodynamics, and minimal adverse effects during intravenous general anaesthesia. The aim of this study was to determine the 50% effective dose (ED50) of remimazolam combined with different doses of esketamine for painless gastroscopy and to evaluate the efficacy and safety of this combination. Methods: This was a randomised, double-blind, up-and-down sequential allocation study. Patients undergoing painless gastroscopy who met all the inclusion criteria and did not meet any of the exclusion criteria were randomised in a 1:1:1 ratio into the ES0 group (0 mg/kg of esketamine), ES1 group (0.2 mg/kg of esketamine), and ES2 group (0.4 mg/kg of esketamine). The initial dose of remimazolam was 0.3 mg/kg in each group, with the dose increased or decreased by 0.05 mg/kg for the subsequent patient based on the success or failure of sedation in the previous patient. The trial was concluded when seven successful failure crossovers were achieved. The ED50 and 95% confidence intervals (CI) of remimazolam were calculated using Probit regression. Haemodynamic parameters, time to induction of anaesthesia, time to gastroscopy, time to awakening from anaesthesia, and adverse events were recorded. Results: A total of 59 patients were included in the final analysis: 19 in the ES0 group, 23 in the ES1 group, and 17 in the ES2 group. The ED50 (95% CI) of remimazolam in the ES0, ES1, and ES2 groups was 0.344 (0.302–0.389) mg/kg, 0.289 (0.249–0.328) mg/kg, and 0.193 (0.145–0.239) mg/kg, respectively. Additionally, the ES1 and ES2 groups exhibited more stable haemodynamics compared to the ES0 group. However, the ES1 and ES2 groups had significantly longer recovery times than the ES0 group. The incidence of hypotension was higher in the ES0 group compared to the ES1 and ES2 groups. Conclusion: The ED50 of remimazolam combined with 0 mg/kg, 0.2 mg/kg, and 0.4 mg/kg of esketamine for induction of anaesthesia during painless gastroscopy was 0.344 mg/kg, 0.289 mg/kg, and 0.193 mg/kg, respectively. Combining esketamine with remimazolam for induction of anaesthesia during painless gastroscopy offers advantages in terms of haemodynamic stability and reduced adverse effects.

INTRODUCTION:The early detection of gastric neoplasms (GNs) leads to favorable treatment outcomes. The latest endoscopic system, EVIS X1, includes third-generation narrow-band imaging (3G-NBI), texture and color enhancement imaging (TXI), and high-definition white-light imaging (WLI). Therefore, this randomized phase II trial aimed to identify the most promising imaging modality for GN detection using 3G-NBI and TXI.METHODS:Patients with scheduled surveillance endoscopy after a history of esophageal cancer or GN or preoperative endoscopy for known esophageal cancer or GN were randomly assigned to the 3G-NBI, TXI, or WLI groups. Endoscopic observations were performed to detect new GN lesions, and all suspected lesions were biopsied. The primary endpoint was the GN detection rate during primary observation. Secondary endpoints were the rate of missed GNs, early gastric cancer detection rate, and positive predictive value for a GN diagnosis. The decision rule had a higher GN detection rate between 3G-NBI and TXI, outperforming WLI by >1.0%.RESULTS:Finally, 901 patients were enrolled and assigned to the 3G-NBI, TXI, and WLI groups (300, 300, and 301 patients, respectively). GN detection rates in the 3G-NBI, TXI, and WLI groups were 7.3, 5.0, and 5.6%, respectively. The rates of missed GNs were 1.0, 0.7, and 1.0%, the detection rates of early gastric cancer were 5.7, 4.0, and 5.6%, and the positive predictive values for the diagnosis of GN were 36.5, 21.3, and 36.8% in the 3G-NBI, TXI, and WLI groups, respectively.DISCUSSION:Compared with TXI and WLI, 3G-NBI is a more promising modality for GN detection.

Background/objectives: This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention. Subjects/methods: In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30–40 kg m − 2 were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone. Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months. At 9 months, coprimary end points were two measures of weight loss. Results: At 6 months, weight loss was −3.3% of total body weight (−3.2 kg) in the lifestyle arm vs −10.2% (−9.9 kg) in the balloon plus lifestyle arm ( P <0.001); at 9 months (3 months postballoon removal), weight loss was −3.4% (−3.2 kg) vs −9.1% (−8.8 kg, P ⩽0.001); and at 12 months, −3.1% (−2.9 kg) vs −7.6% (−7.4 kg, P ⩽0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) ( P =0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group ( P <0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found. Conclusions and relevance: Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.

BackgroundMagnetic capsule gastroscopy (MCG) is a non-invasive diagnostic method for the digestive tract. However, its efficiency in visualizing the gastric cardia is often compromised due to the capsule’s rapid passage. This study introduces a novel sugar-glued tether-assisted technique inspired by a traditional Chinese snack-making process to enhance cardia visualization and patient comfort during MCG.MethodsThis pilot, open-label, single-center, randomized controlled, non-inferiority study was conducted at Binzhou Medical University Hospital. Seventy-eight patients were enrolled and divided into three groups: conventional MCG, suction cup tether-assisted MCG, and sugar-glued tether-assisted MCG. The primary outcomes included safety, comfort level, and gastric cardia visualization quality. Secondary outcomes assessed technique-associated performance and clinical factors.ResultsThe sugar-glued tether-assisted MCG demonstrated comparable cardia visualization quality to the suction cup method, with significantly better results than conventional MCG. Comfort levels were significantly higher in the sugar-glued group compared to the suction cup group. The number of swallow attempts was significantly lower in the sugar-glued group, with no adverse events reported. Secondary outcomes showed no significant differences in MCG assembly time and ingestion-to-detachment period between the suction cup and sugar-glued groups.ConclusionThe sugar-glued tether-assisted MCG is a feasible and safe modification that enhances gastric cardia visualization while improving patient comfort. This technique provides a cost-effective alternative to the suction cup method, warranting further investigation in larger, multi-center studies.

Propofol infusion is a popular single drug of choice for sedation in the gastrointestinal endoscopy suite. Drug combinations are more beneficial than single-drug regimens in gastroscopy sedation. However, the cardiopulmonary complications of propofol sedation raise concern. Remimazolam is a novel, ultra-short-acting benzodiazepine sedative, and alfentanil is a weak opioid. During endoscopic procedures, remimazolam is an effective and safe sedative procedure. No synergistic effect has been reported when remimazolam was combined with alfentanil in gastroscopy sedation. Here, we evaluated the effective dose, sedative efficacy, and safety of the remimazolam-alfentanil combination in gastroscopy sedation and compared the results with those of the propofol-alfentanil combination. This study was conducted in two parts. In Part 1, Dixon's up-and-down method (sequential distribution) was adopted for determining the 95% effective dose (ED95) (95% CI) and 95% CI of remimazolam combined with 5 µg/kg alfentanil. In Part 2, after obtaining the predictive remimazolam ED95, 161 patients were randomized into the remimazolam group (remimazolam-alfentanil) and the propofol group (propofol-alfentanil). The effectiveness of the drug combinations was measured according to successful sedation parameters. Changes in vital signs and the appearance of adverse events were used to assess the safety of drug combinations. Evaluation of patient and physician satisfaction was included as quality indicators of treatment. Baseline demographic and clinical characteristics were comparable between the 2 parts of the study. The ED95 of remimazolam in inhibiting a positive response to gastroscopy placement into the pharyngeal cavity was 0.33 mg/kg (95% CI, 0.289 to 1.023). The procedure success rate was 97.53% in the remimazolam group and 97.50% in the propofol group. The difference in the success rate of the procedure between the remimazolam and propofol groups was 0.03% (95% CI, –2.5 to 2.4). However, the incidence of injection pain, hypotension, respiratory depression, and dizziness was lower in the remimazolam group compared with the propofol group (P < 0.05). Furthermore, patients from the propofol group were more likely to be drowsy, and their work efficiency was reduced the day after leaving the hospital, whereas patients in the remimazolam group were less affected (P < 0.05). The ED95 of remimazolam was 0.33 mg/kg when it was combined with alfentanil (5 µg/kg) for gastroscopy sedation. The sedation strategy of remimazolam-alfentanil has noninferior efficacy, fewer adverse effects, and a better postoperative recovery process than propofol-alfentanil for patients undergoing gastroscopy. Chinese Clinical Trials Registry identifier: ChiCTR2100051565.

Objective Patients with gastric atrophy and intestinal metaplasia (IM) were at risk for gastric cancer, necessitating an accurate risk assessment. We aimed to establish and validate a diagnostic approach for gastric biopsy specimens using deep learning and OLGA/OLGIM for individual gastric cancer risk classification. Methods In this study, we prospectively enrolled 545 patients suspected of atrophic gastritis during endoscopy from 13 tertiary hospitals between December 22, 2017, to September 25, 2020, with a total of 2725 whole-slide images (WSIs). Patients were randomly divided into a training set ( n  = 349), an internal validation set ( n  = 87), and an external validation set ( n  = 109). Sixty patients from the external validation set were randomly selected and divided into two groups for an observer study, one with the assistance of algorithm results and the other without. We proposed a semi-supervised deep learning algorithm to diagnose and grade IM and atrophy, and we compared it with the assessments of 10 pathologists. The model’s performance was evaluated based on the area under the curve (AUC), sensitivity, specificity, and weighted kappa value. Results The algorithm, named GasMIL, was established and demonstrated encouraging performance in diagnosing IM (AUC 0.884, 95% CI 0.862–0.902) and atrophy (AUC 0.877, 95% CI 0.855–0.897) in the external test set. In the observer study, GasMIL achieved an 80% sensitivity, 85% specificity, a weighted kappa value of 0.61, and an AUC of 0.953, surpassing the performance of all ten pathologists in diagnosing atrophy. Among the 10 pathologists, GasMIL’s AUC ranked second in OLGA (0.729, 95% CI 0.625–0.833) and fifth in OLGIM (0.792, 95% CI 0.688–0.896). With the assistance of GasMIL, pathologists demonstrated improved AUC ( p  = 0.013), sensitivity ( p  = 0.014), and weighted kappa ( p  = 0.016) in diagnosing IM, and improved specificity ( p  = 0.007) in diagnosing atrophy compared to pathologists working alone. Conclusion GasMIL shows the best overall performance in diagnosing IM and atrophy when compared to pathologists, significantly enhancing their diagnostic capabilities.

Background Transnasal humidified rapid-insufflation ventilatory exchange is a novel ventilation modality which can provide very high flow (up to 70 l/min) heated and humidified gas with adjustable temperatures (31–37 °C) and oxygen concentrations (21–100%). However its application in sedated gastroscopy in children has received little attention. Objective To observe transnasal humidified rapid-insufflation ventilatory exchange in sedated gastroscopy in children and its effect on the incidence of hypoxemia. Design A prospective randomized clinical trial. Setting Endoscopy Center in Shenzhen Children’s Hospital. Patients 120 children (ASA grade I–II), aged 6–12 years with a body mass index of 18–25 kg m-2, who underwent sedated gastroscopy at Shenzhen Children’s Hospital between June 2022 and November 2022. Interventions The participants were randomly assigned in a 1:1 ratio to receive transnasal humidified rapid-insufflation ventilatory exchange or nasal cannula oxygen therapy. Main outcome measures The primary outcome was hypoxemia incidence. The secondary outcomes included the lowest oxygen saturation index, duration of hypoxemia, incidence of adverse respiratory conditions, intervention rate, and endoscopist satisfaction. Results Five children (8.3%) in thetransnasal humidified rapid-insufflation ventilatory exchange group had hypoxemia compared with 17 (28.3%) in the nasal cannula group, with a significant difference (P<0.01). The lowest oxygen saturation index in two groups shows no significant difference [98 (95, 99) vs. 98 (90, 99), P=0.087]. However compared with the nasal cannula group, the duration of hypoxaemia was significantly shorter (9.00 ± 1.73 s vs. 13.18 ± 3.49 s, 95% CI -6.63 to -1.72; P<0.01), the intervention rate was significantly lower (n=7, 11% vs. n=18, 30%; P<0.05), the incidence of adverse breathing complications was significantly lower (n=8, 13.3% vs. n=18, 30%; P<0.05), and the satisfaction of endoscopists was significantly higher (88.3% vs. 68.3%, P<0.05) in the transnasal humidified rapid-insufflation ventilatory exchange group. Conclusion Transnasal humidified rapid-insufflation ventilatory exchange can promote oxygenation reducing the incidence of hypoxemia in sedated gastroscopy in children. Trial registration ChiCTR2200060799. Key points - THRIVE can reduce the work of breathing and improve oxygenation in children. - THRIVE can provide positive respiratory and continuous positive airway pressure, thereby promoting end-respiratory alveolar dilation. - THRIVE ensures oxygenation during short duration paediatric gastroscopy.

A post-marketing, parallel-controlled clinical trial (REST trial) was conducted to evaluate the safety and efficacy of cipepofol versus propofol for the induction of anesthesia/sedation in Chinese elderly patients undergoing gastroscopy. All enrolled patients aged ≥65 years were assigned randomly in a 1:1 ratio to be administered intravenous cipepofol-0.3 mg/kg or propofol-1.5 mg/kg. The primary endpoint was incidence of respiratory-related adverse events (AEs) including respiratory depression (respiratory rate < 8 breaths/min lasting for >30 s), apnea (loss of thoracic movement for >15 s) and hypoxemia (SpO2 < 93 % lasting for >15 s). Secondary endpoints included: success rates of the gastroscopy procedure and gastroscope insertion; gastroscopy-related duration (successful anesthesia/sedation induction duration; time to full alertness; time to leaving the post-anesthesia care unit; gastroscope insertion duration); satisfaction rate for the anesthesia/sedation process and anesthetics. Among 890 randomized patients, 871 were finally included in the full analysis set (FAS), with 431 receiving cipepofol and 440 receiving propofol. Patients treated with cipepofol had a significantly lower incidence of respiratory-related AEs compared to propofol treatment (FAS: 22.3 % vs. 33.9 %, per-protocol set: 20.6 % vs. 34.5 %, all P < 0.001), regardless of sex. Multivariable analysis revealed that the risk of patients experiencing respiratory-related AEs was 1.82 times higher in the propofol group compared to cipepofol group (P < 0.001). The success rates of the gastroscopy procedure and gastroscope insertion were both 100 % in the two groups. Gastroscopy procedure-related durations were shorter in propofol group compared to cipepofol group (all P < 0.05). Patients treated with cipepofol exhibited a significantly lower rate of treatment-emergent AEs (TEAEs) (55.0 % vs. 67.7 %, P < 0.001), TEAEs of special interest (53.4 % vs. 65.2 %, P < 0.001) and injection pain (2.6 % vs. 28.4 %, P < 0.001). Cipepofol-0.3 mg/kg is a safe and effective intravenous anesthetic for Chinese elderly patients undergoing gastroscopy, especially complimented by lower incidences of respiratory-related AEs and injection pain. Clinical trials registration: Chinese Clinical Trial Registry, ChiCTR2100052299, registered on October 24, 2021. [Display omitted] •Safety and the efficacy of cipepofol vs propofol for the induction of anesthesia/sedation during gastroscopy were evaluated.•Cipepofol group showed significantly lower incidences of respiratory-related adverse events and injection pain.•Success rates of the gastroscopy procedure and gastroscope insertion were both 100 % between groups.•Gastroscopy procedures-related durations were shorter in the propofol group compared to the cipepofol group.•Cipepofol-0.3 mg/kg is a safe and effective intravenous anesthetic for Chinese elderly patients undergoing gastroscopy.