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BackgroundColonoscopy is among the standard tests for colorectal cancer (CRC) screening. However, uptake varies, and alternatives such as colon capsule endoscopy (CCE) are available. The uptake and detection rate of clinically significant neoplasia with CCE, compared with colonoscopy, remain unclear in this setting.ObjectiveThe primary objective of this study was to compare the detection rates of advanced neoplasia between CCE and colonoscopy, using a pathway in which the study group could choose between the two procedures, while the control group was offered only colonoscopy.DesignA randomised, intention-to-treat trial was conducted among Danish CRC screening participants who tested positive with a faecal immunochemical test (FIT). The trial compared the detection rate of advanced neoplasia (primary outcome) and the uptake rate of both approaches between the two arms.ResultsA total of 473 684 invitations were sent to 396 676 individuals, with 62.6% returning the test. Among them, 11 075 tests were positive (4.5%), with no significant differences between the two study groups. Among FIT-positive cases, the uptake for colonoscopy was 91.1% in the control arm and 91.7% in the study arm, where participants had a choice of methods. In the study arm, 45.8% preferred CCE, 11.4% preferred colonoscopy and 42.8% had no preference and underwent colonoscopy. Ultimately, 69.9% of patients who initially opted for CCE were later referred for colonoscopy. The rate of advanced neoplasia detection was similar between the groups: 0.67% in the study arm versus 0.64% in the control arm.ConclusionOffering CCE as an alternative to colonoscopy did not significantly alter the detection rate of advanced neoplasia, nor did it increase uptake in a screening programme with high adherence to colonoscopy following a positive FIT test. Instead, it led to a very high rate of secondary colonoscopies. Therefore, CCE cannot be recommended in this setting.Trial registration number NCT04049357 (ClinicalTrials.gov)

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.

Background Colon capsule endoscopy (CCE) and CT colonography (CTC) are minimally invasive techniques for colorectal cancer (CRC) screening. Our objective is to compare CCE and CTC for the identification of patients with colorectal neoplasia among participants in a CRC screening programme with positive faecal immunochemical test (FIT). Primary outcome was to compare the performance of CCE and CTC in detecting patients with neoplastic lesions. Methods The VICOCA study is a prospective, single-centre, randomised trial conducted from March 2014 to May 2016; 662 individuals were invited and 349 were randomised to CCE or CTC before colonoscopy. Endoscopists were blinded to the results of CCE and CTC. Results Three hundred forty-nine individuals were included: 173 in the CCE group and 176 in the CTC group. Two hundred ninety individuals agreed to participate: 147 in the CCE group and 143 in the CTC group. In the intention-to-screen analysis, sensitivity, specificity and positive and negative predictive values for the identification of individuals with colorectal neoplasia were 98.1%, 76.6%, 93.7% and 92.0% in the CCE group and 64.9%, 95.7%, 96.8% and 57.7% in the CTC group. In terms of detecting significant neoplastic lesions, the sensitivity of CCE and CTC was 96.1% and 79.3%, respectively. Detection rate for advanced colorectal neoplasm was higher in the CCE group than in the CTC group (100% and 93.1%, respectively; RR = 1.07; p  = 0.08). Both CCE and CTC identified all patients with cancer. CCE detected more patients with any lesion than CTC (98.6% and 81.0%, respectively; RR = 1.22; p  = 0.002). Conclusion Although both techniques seem to be similar in detecting patients with advanced colorectal neoplasms, CCE is more sensitive for the detection of any neoplastic lesion. Trial registration ClinicalTrials.gov Identifier: NCT02081742 . Registered: September 16, 2013.

BackgroundCapsule endoscopy is currently available as a noninvasive and effective diagnostic modality to identify small bowel abnormalities, with a completion rate to the cecum between 75.1 and 95.6%. A novel magnetically controlled capsule endoscopy (MCE) system could facilitate passage of the capsule through the pylorus, thereby reducing the gastric transit time (GTT).ObjectiveWe performed this study to determine whether magnetic steering could improve the capsule endoscopy completion rate (CECR) compared to standard protocol.MethodsPatients referred for MCE in our center from June 2017 to November 2017 were prospectively enrolled. Magnetic steering of the capsule through the pylorus was performed after standard gastric examination. CECR, GTT, pyloric transit time (PTT), and rapid gastric transit (GTT ≤ 30 min) rate were compared with a historical control group enrolled from January 2017 to May 2017.ResultsCECR was significantly higher in the intervention group (n = 107) than control group (n = 120) (100% vs. 94.2%, P = 0.02), with a significantly shorter GTT (22.2 vs. 84.5 min, P < 0.001) and PTT (4.4 vs. 56.7 min, P < 0.001). Rapid gastric transit rate in the intervention group was significantly higher than the control group (58.9% vs. 15.0%, P < 0.001). There were no statistical differences in the diagnostic yields between the two groups.ConclusionsMagnetic steering of capsule endoscopy improves small bowel CECR by reducing GTT, adding further support to MCE as a practical tool for noninvasive examination of both the stomach and small bowel.Trial registration ClinicalTrials.gov, ID: NCT03482661.

BackgroundThe elderly assess higher incidence of gastric diseases and may meet challenges and contraindications when flexible esophagogastroduodenoscopy intubating. Magnetic-controlled capsule endoscopy (MCE) is declared as a promising alternative, but its applications in elderly population do not attach enough importance.AimsTo explore MCE’s efficiency and safety in the elderly.MethodsA single-center retrospective study has been conducted. Data from the elderly group (>65 year-old) who underwent MCE examination, including indications, MCE outcomes, gastric conditions, evaluations from MCE manipulators and endoscopists, subjective discomforts, adverse events, etc., had been collected, then analyzed, and compared with the ones from the middle-aged group (>40, ≤ 65 year-old).ResultsDuring April 2015 and September 2018, 98 elderly patients and 72 middle-aged patients underwent MCE examination. In the elderly, the indications included poor physical condition (28.6%), severe angiocardiopathy (39.8%), EGD rejection (13.3%), severe respiratory disorder (8.2%), craniocerebral injury (8.2%), and allergy to anesthetics (2.0%). Rate of complete gastric observation and positive finding were 98.0% and 72.4% (vs. middle-aged group, 94.4%, 56.9%, P = 0.220, 0.035), and gastric conditions showed relatively inferior. Gastric preparation and MCE procedure were generally tolerated, but three elderly patients (3.1%) experienced capsule blockage in stomach.ConclusionsOur preliminary data support that MCE offers considerable benefit and is general safe for the elderly. We hope such data promote greater awareness of innovative attempts for the specific elderly, and expect multi-center, large-scale trials with randomized controlled design bring optimized strategies for better gastric visibility, efficacy and lower potential risk.

Background and AimsGood gastric preparation is essential for magnetically controlled capsule gastroscopy (MCCG) examination. This study aims to determine if repetitive position change after dimethicone premedication could further improve gastric cleanliness for MCCG.MethodsConsecutive patients referred for MCCG in our center from May 7 to May 31, 2018 were prospectively enrolled and randomized to undergo repetitive position change for 15 min (position change group) or not (conventional group) after ingesting dimethicone. Primary outcome was gastric cleanliness score and secondary outcomes were detection rate of positive findings, number of lesions per patient, gastric examination time, and safety of MCCG.ResultsTotals of 43 and 40 were included in the position change and conventional groups, respectively. Gastric cleanliness score in the position change group was significantly higher than in the conventional group (21.2 ± 1.0 vs. 18.6 ± 2.0, P  < 0.001), as was the proportion of acceptable gastric cleanliness (gastric cleanliness score ≥ 18) (100% vs. 72.5%, P  < 0.001). There was no statistical difference in detection rate of positive findings between the two groups (27.9% vs. 27.5%, P  = 0.97). In the position change group, the gastric examination time was significantly reduced (13.2 ± 4.0 vs. 15.3 ± 5.1, P = 0.043). No adverse events were observed.ConclusionsRepetitive position change after dimethicone premedication significantly improves gastric cleanliness for MCCG examination.Clinical Trial Registration ClinicalTrials.gov, ID: NCT03514966.

Background Good gastric preparation is indispensable for Magnetic-controlled Capsule Endoscopy (MCE) examination, but there is no consensus yet. We aim to explore the clinical application value of positioning exercises in improving the quality of MCE examination. Methods Clinical data of 326 patients who underwent MCE examination from January 2020 to December 2023 were collected. The included patients were divided into two groups: the conventional medication preparation group (CMP group, accepted mucosal cleansing medication only) and the positioning exercises group (PE group, accepted mucosal cleansing medication plus positioning exercises). A comparison was made between the two groups in terms of gastric cavity cleanliness score, visibility score, and detection rate of positive lesions. Results The examination time was (21.29 ± 5.82) minutes in the PE group and (30.54 ± 6.37) minutes in the CMP group, showing a significant difference between the two groups ( P  < 0.001). The total cleanliness score and visibility score in the CMP group were 15.89 ± 2.82 and 10.93 ± 2.12, respectively. In contrast, the total cleanliness score and visibility score in the PE group were 19.52 ± 2.26 and 15.09 ± 2.31, respectively. The PE group showed significantly better cleanliness scores and visibility scores in all six anatomical regions compared to the CMP group (All P  < 0.001). However, there was no significant difference in the detection rate of positive lesions between the two groups (All P  > 0.05). Conclusion Positioning exercises before MCE examination can improve the quality of gastric mucosal images and reduce the duration of the examination for patients.

Gastrointestinal injury is a common complication in patients treated with antiplatelet agents after percutaneous coronary intervention (PCI). However, the effects of different antiplatelet regimens on the incidence and severity of gastrointestinal injury have not been well studied, principally due to the lack of a low-risk sensitive and accurate detection system. OPT-PEACE is a multicenter, randomized, double-blind, placebo-controlled trial. Gastrointestinal injury will be evaluated with the ANKON magnetically controlled capsule endoscopy system (AMCE), a minimally invasive approach for detecting mucosal lesions in the stomach, duodenum and small intestine. Patients without AMCE-detected gastrointestinal erosions, ulceration or bleeding after drug-eluting stent implantation are enrolled and treated with open-label aspirin (100 mg/d) plus clopidogrel (75 mg/d) for 6 months. Thereafter, 480 event-free patients will undergo repeat AMCE and are randomly assigned in a 1:1:1 ratio to receive aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo for an additional 6 months. A final AMCE is performed at 12 months. The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment. OPT-PEACE is the first study to investigate the incidence and severity of gastrointestinal injury in patients receiving different antiplatelet therapy regimens after stent implantation. This trial will inform clinical decision-making for personalized antiplatelet therapy post-PCI.

Background: An effective bowel cleanse can improve the imaging quality of video capsule endoscopy (VCE). We aimed to further investigate the optimal small bowel cleanse method by comparing the efficacy of 4 L of clear liquids, 2 L of polyethylene glycol (PEG), and 4 L of PEG on the image quality of VCE. Methods: A randomized controlled, non-inferiority trial was performed comparing 4 L of clear liquids (Group A), 2 L of PEG (Group B), and 4 L of PEG (Group C). The primary endpoint was image quality between the groups. The secondary endpoints included patient tolerability and side effects. Results: Eighty-one patients were analyzed in group A, 84 patients were analyzed in group B, and 80 patients were analyzed in group C. Image quality scores revealed 4 L of clear liquids to be non-inferior to 2 L of PEG, and 2 L of PEG to be non-inferior to 4 L of PEG (p < 0.0167). Group A had a lower difficulty of completion rate than Group B and Group C and a lower rate of side effects when compared to Group C (p < 0.0167). Conclusion: Four liters of clear liquids should be considered a routine method for small bowel preparation prior to VCE.

Background and Study Aims To obtain an adequate view of the whole small intestine during capsule endoscopy (CE) a clear liquid diet and overnight fasting is recommended. However, intestinal content can hamper vision in spite of these measures. Our aim was to evaluate tolerance and degree of intestinal cleanliness during CE following three types of bowel preparation. Patients and Methods This was a prospective, multicenter, randomized, controlled study. Two-hundred ninety-one patients underwent one of the following preparations: 4 L of clear liquids (CL) (group A; 92 patients); 90 mL of aqueous sodium phosphate (group B; 89 patients); or 4 L of a polyethylene glycol electrolyte solution (group C; 92 patients). The degree of cleanliness of the small bowel was classified by blinded examiners according to four categories (excellent, good, fair or poor). The degree of patient satisfaction, gastric and small bowel transit times, and diagnostic yield were measured. Results The degree of cleanliness did not differ significantly between the groups ( P  = 0.496). Interobserver concordance was fair ( k  = 0.38). No significant differences were detected between the diagnostic yields of the CE ( P  = 0.601). Gastric transit time was 35.7 ± 3.7 min (group A), 46.1 ± 8.6 min (group B) and 34.6 ± 5.0 min (group C) ( P  = 0.417). Small-intestinal transit time was 276.9 ± 10.7 min (group A), 249.7 ± 13.1 min (group B) and 245.6 ± 11.6 min (group C) ( P  = 0.120). CL was the best tolerated preparation. Compliance with the bowel preparation regimen was lowest in group C ( P  = 0.008). Conclusions A clear liquid diet and overnight fasting is sufficient to achieve an adequate level of cleanliness and is better tolerated by patients than other forms of preparation.