Diagnostic accuracy of magnetically guided capsule endoscopy with a detachable string for detecting oesophagogastric varices in adults with cirrhosis: prospective multicentre study
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SUBMITTER: Jiang X
PROVIDER: S-EPMC10912951 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundGastroesophageal varices is a serious complication of compensated advanced chronic liver disease (cACLD). Primary prophylaxis to reduce the risk of variceal hemorrhage is recommended if high-risk varices (HRV) are detected. We performed this study to compare the accuracy, patients' satisfaction and safety of detection of HRV by detachable string magnetically controlled capsule endoscopy (DS-MCCE) with esophagogastroduodenoscopy (EGD) as the reference.MethodsWe prospectively recruited participants with cACLD from 12 university hospitals (11 in China and one in the United Kingdom) between November 2018 and December 2019 (ClinicalTrials.gov, NCT03749954). All participants underwent DS-MCCE, followed by EGD within a week in a blinded fashion. Following endoscopy, and on the same day, participants were asked to fill in a satisfaction questionnaire regarding their experience.FindingsA total of 105 eligible participants were enrolled. With EGD as the reference standard, the concordance index, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of DS-MCCE in diagnosis of HRV were 0•90 (95% confidence interval [CI]: 0•83-0•95), 92% (95% CI: 78-98%), 88% (95% CI: 78-95%), 80% (95% CI: 70-92%), 95% (95% CI: 90-100%), 7•91 (95% CI: 4•10-15•30), and 0•09 (95% CI: 0•03-0•30), respectively. The kappa score of 0•78 (95% CI: 0•65-0•90) suggested substantial agreement between DS-MCCE and EGD. Moreover, in participants undergoing EGD without sedation, the satisfaction of DS-MCCE was significantly better than that of EGD (p < 0•0001, d = 1•15 [95%CI: 0•88-1•42]). All participants confirmed the excretion of the capsule, and no adverse events occurred.InterpretationDS-MCCE is an accurate alternative to EGD for detecting HRV in cACLD, which is safe and associated with better satisfaction.FundingA full list of funding can be found in the Funding Support section.
| S-EPMC8315440 | biostudies-literature
Project description:Delayed gastric emptying is a significant factor in incomplete small bowel capsule examinations. Gastric transit could be hastened by external magnetic control of the capsule. We studied the feasibility of this approach to improve capsule endoscopy completion rates.Prospective, single-center, randomized controlled trial involving 122 patients attending for small bowel capsule endoscopy using MiroCam Navi. Patients were randomized to either the control group (mobilisation for 30 minutes after capsule ingestion, followed by intramuscular metoclopramide 10 mg if the capsule failed to enter the small bowel) or the intervention group (1000 mL of water prior to capsule ingestion, followed by positional change and magnetic steering). Outcome measures were capsule endoscopy completion rate, gastric clarity and distention, relationship of body habitus to capsule endoscopy completion rate (CECR), and patient comfort scores.122 patients were recruited (61 each to the control and intervention groups: mean age 49 years [range 21 - 85], 61 females). There was no significant difference in CECR between the two groups (P = 0.39). Time to first pyloric image was significantly shorter in the intervention group (P = 0.03) but there was no difference in gastric transit times (P = 0.12), suggesting that magnetic control hastens capsular transit to the gastric antrum but does not influence duodenal passage. Gastric clarity and distention were significantly better in the intervention group (P < 0.0001 and P < 0.0001 respectively).Magnetic steering of a small bowel capsule is unable to overcome pyloric contractions to enhance gastric emptying and improve capsule endoscope completion rate. Excellent mucosal visualisation within the gastric cavity suggests this technique could be harnessed for capsule examination of the stomach.
| S-EPMC4751924 | biostudies-other
Project description:Goals: To explore factors associated with inadequate gastric preparation for MCE. Background: Factors associated with inadequate gastric preparation for magnetically controlled capsule endoscopy (MCE) remains unclear. Study: Data of patients who underwent MCE from June 2021 to July 2022 were prospectively collected. The gastric cleanliness score (GCS) of the six stomach regions (gastric cardia, fundus, body, angulus, antrum, and pylorus) was recorded. Patients with GCS score ≥18 were defined as the adequate preparation. Factors related to inadequate gastric preparation were analyzed using a logistic regression model with estimated odds ratios (OR). Results: The mean GCS score of 211 patients was 17.01 ± 2.82. In the multivariable analysis, proton pump inhibitor (PPI) use (OR 3.57; 95% CI 1.69-7.95; p < 0.01) and premedication time after administering simethicone <30 min (OR 2.86; 95% CI 1.10-7.39; p = 0.03) were independent risk factors for inadequate gastric preparation. Comparing the gastric cleanliness of different locations, the median GCS of the lower stomach [10.00, IQR (9.50, 11.00)] was significantly higher than that of the upper stomach [7.00, IQR (6.00, 8.00)] (p <0.001). Conclusion: PPI use and inadequate premedication time (<30 min) may reduce the quality of gastric preparation for MCE. The type, dose, duration of medication, and discontinuation time of PPIs was well worth further exploration. Appropriate control of the type and time of premedication may be the key to improving overall gastric cleanliness.
| S-EPMC10493275 | biostudies-literature
Project description:AimTo compare feasibility and safety after gastrointestinal checkup by standing-type magnetically controlled capsule endoscopy (SMCE) and conventional gastroscopy.MethodsThis was a prospective multicenter, blinded study that compared SMCE with gastroscopy in patients from April 2018 to July 2018. All patients first underwent SMCE and then subsequently had gastroscopy with i.v. anesthesia. We calculated the compliance rates of gastric lesion detection by SMCE using gastroscopy as the standard. Capsule retention rate, incidence of adverse events, and patient satisfaction were documented throughout the study.ResultsOne hundred and sixty-one patients who completed SMCE and gastroscopy were included in the analysis. Positive compliance rate among SMCE and gastroscopy was 92.0% (95% CI: 80.77%-97.78%). Negative compliance rate was 95.5% (89.80%, 98.52%). Moreover, overall compliance rate was 94.41% (89.65%, 97.41%). Sixty-four pathological outcomes were identified. Of these 64 outcomes, 50 were detected by both procedures. The gastroscopy method neglected seven findings (such as five erosions, one polyp, and one ulcer). Furthermore, SMCE also overlooked seven lesions (i.e. one erosion, two polyps, one atrophy, and three submucosal tumors). Capsule retention or related adverse events were not reported.ConclusionStanding-type magnetically controlled capsule endoscopy provides equivalent agreement with gastroscopy and may be useful for screening of gastric illnesses without any anesthesia.
| S-EPMC7318584 | biostudies-literature
Project description:Background and aimsActual behaviors of drugs in the upper GI tract are not well elucidated. We assess the feasibility of magnetically controlled capsule endoscopy (MCE) in direct and real-time visualization of oral drug behaviors in the stomach.MethodsFrom November 2019 to December 2019, 9 patients with a recent history of upper GI symptoms and 10 healthy volunteers were enrolled in this study. Participants swallowed magnetically controlled capsules to examine the whole stomach. After baseline examination, participants ingested dyed sucralfate gel, and MCE recorded the adhesion time, retention time, and distribution area of sucralfate gel. Outcomes included behaviors of sucralfate gel, safety, and satisfaction assessment of the procedures.ResultsAdhesion time of sucralfate gel in the abdominal symptoms group was significantly shorter than in the healthy control group (23.76 ± 1.37 minutes vs 31.96 ± 3.09 minutes; P = .032), whereas retention time was longer (98.85 ± 13.94 minutes vs 63.93 ± 8.57 minutes; P = .043). The distribution area of sucralfate gel in the abdominal symptoms group was significantly larger than in healthy control group in cardia (24.29 ± 7.39 vs 9.18 ± 4.06; P < .0001), fundus (18.90 ± 7.08 vs 8.49 ± 4.10; P = .0015), and pylorus (4.64 ± 2.72 vs 0.94 ± 0.90; P = .0019). No adverse events were observed. All participants had a high degree of satisfaction.ConclusionsMCE is a feasible and noninvasive tool for direct and real-time visualization of drug behaviors (eg, sucralfate gel) in the stomach. (ClinicalTrials.gov. ID: NCT04327869.).
| S-EPMC8267953 | biostudies-literature
Project description:Background and aimsRemote endoscopy can improve diagnostic efficiency of gastrointestinal (GI) diseases for patients in remote areas. A novel remote magnetically controlled capsule endoscopy (MCE) system based on a 5G network was developed for real-time remote GI examinations. We aimed to evaluate the feasibility and safety of the 5G-based remote MCE for examination of the stomach and small bowel.MethodsThis was a prospective, nonrandomized, comparative study. Consecutive participants enrolled in the First People's Hospital of Yinchuan underwent remote MCE examinations performed by an endoscopist located in Changhai Hospital. Consecutive participants enrolled in Changhai Hospital underwent conventional MCE examinations performed by the same endoscopist. The main outcomes included the complete visualization rate of the stomach and small bowel, safety assessment and network latency time of remote MCE examinations.ResultsFrom March 2021 to June 2021, 20 participants in each group were enrolled. The complete visualization rate of the stomach and small bowel was 100% in both groups (p > 0.999) without any adverse event. The median network latency time of remote MCE group was 19.948 ms. Gastric examination time (8.96 vs. 8.92 min, p = 0.234), maneuverability (15.00 vs. 15.00, p = 0.317), image quality (1.00 vs. 1.00, p > 0.999) and diagnostic yields in the stomach and small bowel (55% vs. 30%, 5% vs. 0%, both p > 0.05) were comparable between remote and conventional MCE groups. All participants in remote MCE group considered remote MCE acceptable and necessary.Conclusions5G-based remote MCE was a feasible and safe method for viewing the stomach and small bowel.
| S-EPMC9892422 | biostudies-literature
Project description:BackgroundThe lesions of certain diseases are widely distributed in both stomach and small intestine, while the step-by-step strategy of gastroscopy followed by enteroscopy can be burdensome and costly. We aimed to determine if magnetically controlled capsule endoscopy (MCE) could be used in one-time gastro-small intestine (GSI) joint examination.MethodsIn this study, data of patients in Chinese PLA General Hospital and Changhai Hospital who underwent MCE GSI examination from January 2020 to August 2021 were retrospectively analysed. The primary outcome of this study was the success rate of one-time GSI joint examination, and secondary outcomes included visualization and cleanliness of gastrointestinal tract, gastrointestinal transit times, diagnostic yield and safety of MCE examination.ResultsA total of 768 patients were included. The success rate of one-time GSI joint examination was 92.58%. There were 94.92% MCEs observed > 90% gastric mucosa in the 6 anatomic landmarks. The rate of complete small bowel examination was 97.40%. The median gastric examination time, gastric transit time and small intestine transit time were 8.18 min, 63.89 min and 4.89 h, respectively. Magnetic steering of MCE significantly decreased gastric transit time (8.92 min vs. 79.68 min, P = 0.001) and increased duodenal lesion detection rate (13.47% vs. 6.26%, P = 0.001) when compared with non-magnetic steering group. Two capsules were retained and were removed by enteroscopy or spontaneously excreted.ConclusionsMCE is feasible to complete GSI joint examination and the detection of both gastric and small intestinal diseases can be achieved simultaneously. Trial registration Clinical Trial Registration ClinicalTrials.gov, ID: NCT05069233.
| S-EPMC9069740 | biostudies-literature
Project description:BackgroundWhile capsule endoscopy (CE) is the gold standard diagnostic method of detecting small bowel (SB) diseases and disorders, a novel magnetically controlled capsule endoscopy (MCCE) system provides non-invasive evaluation of the gastric mucosal surface, which can be performed without sedation or discomfort. During standard SBCE, passive movement of the CE may cause areas of the complex anatomy of the gastric mucosa to remain unexplored, whereas the precision of MCCE capsule movements inside the stomach promises better visualization of the entire mucosa.AimTo evaluate the Ankon MCCE system's feasibility, safety, and diagnostic yield in patients with gastric or SB disorders.MethodsOf outpatients who were referred for SBCE, 284 (male/female: 149/135) were prospectively enrolled and evaluated by MCCE. The stomach was examined in the supine, left, and right lateral decubitus positions without sedation. Next, all patients underwent a complete SBCE study protocol. The gastric mucosa was explored with the Ankon MCCE system with active magnetic control of the capsule endoscope in the stomach, applying three standardized pre-programmed computerized algorithms in combination with manual control of the magnetic movements.ResultsThe urea breath test revealed Helicobacter pylori positivity in 32.7% of patients. The mean gastric and SB transit times with MCCE were 0 h 47 min 40 s and 3 h 46 min 22 s, respectively. The average total time of upper gastrointestinal MCCE examination was 5 h 48 min 35 s. Active magnetic movement of the Ankon capsule through the pylorus was successful in 41.9% of patients. Overall diagnostic yield for detecting abnormalities in the stomach and SB was 81.9% (68.6% minor; 13.3% major pathologies); 25.8% of abnormalities were in the SB; 74.2% were in the stomach. The diagnostic yield for stomach/SB was 55.9%/12.7% for minor and 4.9%/8.4% for major pathologies.ConclusionMCCE is a feasible, safe diagnostic method for evaluating gastric mucosal lesions and is a promising non-invasive screening tool to decrease morbidity and mortality in upper gastro-intestinal diseases.
| S-EPMC9157624 | biostudies-literature
Project description:Crohn's disease diagnosis and monitoring remains a great clinical challenge and often requires multiple testing modalities. Assessing Crohn's disease activity in the entire gastrointestinal (GI) tract using a panenteric capsule endoscopy (CE) system could be used as an alternative to colonoscopy and cross-sectional imaging. This study assessed the accuracy and safety of panenteric CE in Crohn's disease as compared with ileocolonoscopy (IC) and/or magnetic resonance enterography (MRE). A prospective, multicentre study was performed in subjects with established Crohn's disease. Individuals with proven small bowel patency underwent a standardised bowel preparation, followed by CE ingestion and IC either the same or following day. MRE, IC, and CE interpretations were performed by blinded central readers using validated scoring systems. The primary endpoint was the overall sensitivity of CE vs MRE and/or IC in Crohn's disease subjects. Study enrolment included 158 subjects from 21 sites in the USA, Austria, and Israel. Of those, 99 were included in the analysis. Imaging modality scores indicated none to mild inflammation in the proximal small bowel and colon, but discrepant levels of inflammation in the terminal ileum. Overall sensitivity for active enteric inflammation (CE vs MRE and/or IC) was 94% vs 100% (p=0.125) and specificity was 74% vs 22% (p=0.001). Sensitivity of CE was superior to MRE for enteric inflammation in the proximal small bowel (97% vs 71%, p=0.021), and similar to MRE and/or IC in the terminal ileum and colon (p=0.500-0.625). There were seven serious adverse advents of which three were related to the CE device. Panenteric CE is a reliable tool for assessing Crohn's disease mucosal activity and extent compared with more invasive methods. This study demonstrates high performance of the panenteric CE as compared to MRE and/or IC without the need for multiple tests in non-stricturing Crohn's disease. ClinicalTrials.gov NCT03241368.
| S-EPMC7282309 | biostudies-literature
Project description:BackgroundCapsule endoscopy (CE) is safe and widely accepted for small bowel (SB) investigation and an alternative to colonoscopy in specific clinical circumstances. As the capsule is orally ingested, the potential risk of aspiration is undoubtedly a constant concern among clinicians. However, it is a rare occurrence and often reported as isolated cases. Therefore, this review systematically compiles all the available data on capsule aspiration in the literature with an aim to provide an update on this complication of CE.MethodsA systematic literature search was performed on PubMed with the search terms 'capsule endoscopy' AND 'aspiration', searched as keywords and MeSH. All observational cohort studies that reported aspiration among complications/outcomes, case reports and series on capsule aspiration were included. Manual citation search was performed. Two extractors reviewed abstract and full-text and performed data extraction.ResultsWe found 95 relevant articles, and cross-checking references led to the inclusion of an additional 19 articles. We removed 57 and ended with 57 references-with 63 cases of aspirated capsules. One death was reported. The median age was 78, and there was male preponderance. The most common indication for CE was anaemia, and only aspiration of small bowel CE (SBCE) was reported. 61.9% of the aspirations were symptomatic; the most common symptom was coughing. 69.8% of capsules ended in the bronchus, but only 4 cases experienced desaturation. Thirty-two patients needed intervention for retrieval; the aspiration was self-resolved in the remaining. Only four patients had a history of dysphagia. Thirteen instances of aspiration were detected due to real-time viewing, and 24 cases from reviewing the capsule data afterwards.ConclusionsWith only 63 cases of aspirated capsules reported in the literature, this event remains rare, is safely managed, and should not discourage patients from the procedure. The importance of careful patient selection is crucial to minimize the likelihood of aspiration and capsule administration should be approached with precautions.
| S-EPMC10777238 | biostudies-literature