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1.
BMJ ; 384: e078581, 2024 03 05.
Article in English | MEDLINE | ID: mdl-38443074

ABSTRACT

OBJECTIVE: To evaluate the diagnostic accuracy and safety of using magnetically guided capsule endoscopy with a detachable string (ds-MCE) for detecting and grading oesophagogastric varices in adults with cirrhosis. DESIGN: Prospective multicentre diagnostic accuracy study. SETTING: 14 medical centres in China. PARTICIPANTS: 607 adults (>18 years) with cirrhosis recruited between 7 January 2021 and 25 August 2022. Participants underwent ds-MCE (index test), followed by oesophagogastroduodenoscopy (OGD, reference test) within 48 hours. The participants were divided into development and validation cohorts in a ratio of 2:1. MAIN OUTCOME MEASURES: The primary outcomes were the sensitivity and specificity of ds-MCE in detecting oesophagogastric varices compared with OGD. Secondary outcomes included the sensitivity and specificity of ds-MCE for detecting high risk oesophageal varices and the diagnostic accuracy of ds-MCE for detecting high risk oesophagogastric varices, oesophageal varices, and gastric varices. RESULTS: ds-MCE and OGD examinations were completed in 582 (95.9%) of the 607 participants. Using OGD as the reference standard, ds-MCE had a sensitivity of 97.5% (95% confidence interval 95.5% to 98.7%) and specificity of 97.8% (94.4% to 99.1%) for detecting oesophagogastric varices (both P<0.001 compared with a prespecified 85% threshold). When using the optimal 18% threshold for luminal circumference of the oesophagus derived from the development cohort (n=393), the sensitivity and specificity of ds-MCE for detecting high risk oesophageal varices in the validation cohort (n=189) were 95.8% (89.7% to 98.4%) and 94.7% (88.2% to 97.7%), respectively. The diagnostic accuracy of ds-MCE for detecting high risk oesophagogastric varices, oesophageal varices, and gastric varices was 96.3% (92.6% to 98.2%), 96.9% (95.2% to 98.0%), and 96.7% (95.0% to 97.9%), respectively. Two serious adverse events occurred with OGD but none with ds-MCE. CONCLUSION: The findings of this study suggest that ds-MCE is a highly accurate and safe diagnostic tool for detecting and grading oesophagogastric varices and is a promising alternative to OGD for screening and surveillance of oesophagogastric varices in patients with cirrhosis. TRIAL REGISTRATION: ClinicalTrials.gov NCT03748563.


Subject(s)
Capsule Endoscopy , Esophageal and Gastric Varices , Varicose Veins , Adult , Humans , Esophageal and Gastric Varices/diagnosis , Esophageal and Gastric Varices/etiology , Liver Cirrhosis/complications , Prospective Studies
2.
Front Pharmacol ; 13: 1002381, 2022.
Article in English | MEDLINE | ID: mdl-36532761

ABSTRACT

Objectives: To evaluate the effectiveness and safety of a newly designed self-assembling gel in treating ESD-induced gastric ulcers in patients. Methods: This open-label, multicenter, randomized controlled trial enrolled patients who underwent ESD between September 2020 and May 2021. Patients were randomized (1:1) to receive the gel (applied to cover the entire ulcer bed under endoscopic guidance immediately after ESD; gel group) or not (control group). The primary outcome was the ulcer healing rate at 28 days. And the secondary outcomes were the delayed bleeding, changes in the ulcer stage, and adverse events. Results: Finally, 125 patients (mean age, 63.7 years; 70 [56.0%] males) were enrolled. The ulcer healing rate was higher in the gel group than in the control group at 28 days (96.9 ± 4.1% vs. 94.7 ± 5.0%; p = 0.001). The ulcer reduction rate at 28 days differed significantly (p < 0.001) between ulcers with majority gel coverage (99.8%), ulcers with minority gel coverage (96.2%), and ulcers with no gel coverage (98.0%). Delayed bleeding was found in 1/63 gel-treated patients (1.6%) versus 5/62 controls (8.1%). A1-stage ulcers were found in 16/63 patients in the gel group versus 44/62 patients in the control group (25.4% vs. 71.0%, p < 0.001) at 3-5 days. Conclusion: The newly developed self-assembling gel was safe and effective in accelerating gastric ulcer healing in patients after ESD. Clinical Trial Registration: UMIN Clinical Trials Registry System (registration number, ChiCTR2100052935).

3.
Gastric Cancer ; 24(6): 1194-1202, 2021 11.
Article in English | MEDLINE | ID: mdl-34152518

ABSTRACT

OBJECTIVE: Early detection of gastric cancer (GC) is a critical step for decreasing mortality. The aim of this study was to evaluate the performance of four prediction models for risk stratification in the screening of GC and precancerous lesions among a large, high-risk population in China. DESIGN: This study was a retrospective analysis of data from the Provincial Gastric Cancer Screening Program (Zhejiang, China) spanning the period between October 2016 and April 2019, in which 97,541 individuals from the urban areas of 10 cities in Zhejiang province, China participated in this program. Demographic and clinical characteristics data were collected, and serum pepsinogens I and II, gastrin-17, and anti-H. pylori IgG antibody were detected. Participants were asked to voluntarily undergo gastroscopy. The performance of the ABC method, new ABC method, Tu's prediction model, and Li's prediction model, which stratified participants into low-, medium- and high-risk subgroups, were evaluated using the area under the receiver-operating characteristic (ROC) curve (AUC) and Youden index. RESULTS: Among the participants, 6005 (3447 males and 2558 females, mean age of 58.35 years), voluntarily underwent gastroscopy. Overall, 72 (1.20%) GC cases (30 early and 42 advanced) and 2006 cases with precancerous lesions (270 atrophic gastritis, 1634 intestinal metaplasia, and 102 dysplasia/intraepithelial neoplasia) were identified. Notably, Li's prediction model achieved the greatest AUC and Youden index values (0.708 and 0.319, respectively) for predicting GC, and exhibited the greatest ability to detect precancerous lesions, especially intestinal metaplasia. CONCLUSION: Li's prediction model performs the best for risk stratification in the screening, detection, and diagnosis of GC and precancerous lesions, whereas the overall performance of the other three models is similar ( www.chictr.org.cn , ChiCTR2100043363).


Subject(s)
Models, Theoretical , Stomach Neoplasms/epidemiology , Adult , Aged , Aged, 80 and over , Asian People , Biomarkers, Tumor/blood , China/epidemiology , Cities , Early Detection of Cancer , Female , Helicobacter pylori/immunology , Humans , Male , Middle Aged , Pepsinogens/blood , Predictive Value of Tests , Retrospective Studies , Risk , Stomach Neoplasms/blood , Stomach Neoplasms/diagnosis , Stomach Neoplasms/etiology , Urban Population
4.
Sci Rep ; 9(1): 14909, 2019 10 17.
Article in English | MEDLINE | ID: mdl-31624309

ABSTRACT

Operative Link on Gastritis Assessment (OLGA) and Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) were adopted to evaluate gastric risk stratification in five biopsy samples. This study aimed to evaluate the degree of gastric atrophy (GA) and intestinal metaplasia (IM) in five locations to detect a more representative biopsy sample in gastric cancer (GC) screening. Our study enrolled 368 patients and 5 biopsy pieces were acquired from them. Gastric risk stratification was calculated by OLGA and OLGIM staging system. The results revealed that the IM score in the incisura angularis was higher than that in the larger and lesser curvature of corpus mucosa (p = 0.037 and p = 0.030, respectively) and the IM score in the lesser curvature of antrum mucosa was higher than that in the incisura angularis mucosa (p = 0.018). IM is more frequently observed in the angulus region than in the lesser curvature of corpus in the mild degree (p = 0.004) and mild IM lesions in the lesser curvature of antrum were more frequently observed than in the incisura angularis mucosa (p = 0.004), Four biopsy pieces protocol (larger curvature and lesser curvature of the antrum, lesser curvature of the corpus and angulus) demonstrated accurate consistency (97.83% and 98.37%, respectively) with a Kendall's tau-b of higher than 0.990, along with low misdiagnosis rates of OLGA and OLGIM (III + IV) (9.76% and 5.00%, respectively). Three biopsy pieces protocol (lesser curvature of the antrum and corpus, angulus biopsy) in OLGA and OLGIM staging system was close to the standard protocol (five biopsy specimens) with a consistency of 94.84% and 94.29% and has a Kendall's tau-b higher than 0.950 and diagnostic omission rates of 9.76% and 5.00%, respectively, which was exactly the same with the four biopsy pieces protocol. Furthermore, it had the second-highest Youden index (0.902 and 0.950, respectively) and area under the ROC curve (0.992 and 0.996, respectively) for the screening of high-risk GC by OLGA and OLGIM stages. Thus, we recommended the angulus and the lesser curvature of antrum as a conventional biopsy and three biopsy pieces for further GC risk screening.


Subject(s)
Early Detection of Cancer/methods , Gastric Mucosa/pathology , Mass Screening/methods , Precancerous Conditions/diagnosis , Stomach Neoplasms/diagnosis , Adult , Aged , Aged, 80 and over , Biopsy/methods , Biopsy/standards , Clinical Protocols , Early Detection of Cancer/standards , Female , Gastric Mucosa/diagnostic imaging , Gastritis, Atrophic/diagnosis , Gastritis, Atrophic/pathology , Gastroscopy/methods , Gastroscopy/standards , Humans , Male , Mass Screening/standards , Metaplasia/diagnosis , Metaplasia/pathology , Middle Aged , Practice Guidelines as Topic , Precancerous Conditions/pathology , Prospective Studies , ROC Curve , Risk Factors , Stomach Neoplasms/pathology , Stomach Neoplasms/prevention & control , Young Adult
5.
J Gastroenterol ; 51(5): 458-64, 2016 May.
Article in English | MEDLINE | ID: mdl-26498923

ABSTRACT

BACKGROUND: Peroral endoscopic myotomy (POEM) has been introduced as a novel endoscopic treatment for achalasia. The aim of this work is to assess the changes in esophageal motility caused by POEM in patients with achalasia. METHODS: Forty-one patients with achalasia underwent POEM from September 2012 to November 2014. Esophageal motility of all patients was evaluated preoperatively and 1 month after POEM utilizing high-resolution manometry, which was performed with ten water swallows, ten steamed bread swallows, and multiple rapid swallows (MRS). RESULTS: In single swallows, including liquid swallows and bread swallows, all the parameters of lower esophagus sphincter resting pressure (LESP), 4-s integrated relaxation pressure (4sIRP), and intra-bolus pressure (IBP) were decreased between pre- and post-POEM patients (all p < 0.05). Postoperatively, the trend of distal contractile integral (DCI) and distal esophageal peristaltic amplitude declined in subtype II and subtype III (subtype II: p < 0.05; subtype III: p > 0.05), but increased in subtype I (subtype I: p > 0.05). In liquid swallows, the Eckardt score of subtype II patients decreased with DCI, and distal esophageal peristaltic amplitude after POEM was significantly lower compared with those showing increased values of those two parameters (p < 0.05). In MRS, the rate of LES relaxation increased from 66.67 to 95.24%, but without normal response in all achalasia patients. CONCLUSIONS: POEM reduces LES pressure in achalasia, and partly restores esophageal motility. POEM displayed varying effect on esophageal motility in patients with different patterns of swallowing. In addition, the changes in parameters associated with esophageal peristalsis correlated with decreases in Eckardt score.


Subject(s)
Deglutition/physiology , Esophageal Achalasia/surgery , Esophagoscopy/methods , Gastrointestinal Motility/physiology , Adolescent , Adult , Aged , Female , Follow-Up Studies , Humans , Male , Manometry , Middle Aged , Peristalsis/physiology , Pressure , Prospective Studies , Young Adult
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