无线动力胶囊在疑似胃轻瘫患者中的诊断和性能特征的验证。
Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis.
机构信息
Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan.
Division of Gastroenterology, Augusta University, Augusta, Georgia.
出版信息
Clin Gastroenterol Hepatol. 2019 Aug;17(9):1770-1779.e2. doi: 10.1016/j.cgh.2018.11.063. Epub 2018 Dec 14.
BACKGROUND & AIMS: It is a challenge to make a diagnosis of gastroparesis. There is good agreement in results from wireless motility capsule (WMC) analysis and gastric emptying scintigraphy (GES), but the diagnostic yield of WMC is unclear and the accuracy of this method has not been validated. We compared the performance characteristics of WMC vs GES in assessing gastric emptying in patients with suspected gastroparesis.
METHODS
We performed a prospective study of 167 subjects with gastroparesis (53 with diabetes and 114 without) at 10 centers, from 2013 through 2016. Subjects were assessed simultaneously by GES and with a WMC to measure gastric emptying and regional transit. Delayed gastric emptying by GES was defined as more than 10% meal retention at 4 hrs whereas delayed gastric emptying by WMC was defined as more than 5 hrs for passage of the capsule into the duodenum; a severe delay in gastric emptying was defined as a gastric emptying time of more than 12 hrs by WMC or more than 35% retention at 4 hrs by GES. Rapid gastric emptying was defined as less than 38% meal retention at 1 hr based on by GES or gastric emptying times less than 1:45 hrs by WMC. We compared diagnostic and performance characteristics of GES vs WMC.
RESULTS
Delayed gastric emptying was detected in a higher proportion of subjects by WMC (34.6%) than by GES (24.5%) (P=.009). Overall agreement in results between methods was 75.7% (kappa=0.42). In subjects without diabetes, the WMC detected a higher proportion of subjects with delayed gastric emptying (33.3%) than GES (17.1%) (P < .001). A higher proportion of subjects with diabetes had delayed gastric emptying detected by GES (41.7%) compared with non-diabetic subjects (17.1%) (P=.002). Severe delays in gastric emptying were observed in a higher proportion of subjects by WMC (13.8%) than by GES (6.9%) (P = .02). Rapid gastric emptying was detected in a higher proportion of subjects by GES (13.8%) than by WMC (3.3%) (P < .001). Regional and generalized transit abnormalities were observed in 61.8% subjects and only detected by WMC.
CONCLUSION
Although there is agreement in analysis of gastric emptying by GES vs WMC, WMC provides higher diagnostic yield than GES. WMC detects delayed gastric emptying more frequently than GES and identifies extra-gastric transit abnormalities. Diabetic vs non-diabetic subjects have different results from GES vs WMC. These findings could affect management of patients with suspected gastroparesis. ClinicalTrials.gov no: NCT02022826.
背景与目的
胃轻瘫的诊断具有挑战性。无线动力胶囊（WMC）分析和胃排空闪烁显像（GES）的结果有很好的一致性，但 WMC 的诊断效果尚不清楚，其准确性也尚未得到验证。我们比较了 WMC 与 GES 在评估疑似胃轻瘫患者胃排空方面的性能特征。
方法
我们在 2013 年至 2016 年期间在 10 个中心进行了一项对 167 例胃轻瘫患者（53 例糖尿病患者和 114 例非糖尿病患者）的前瞻性研究。同时通过 GES 和 WMC 对患者进行评估，以测量胃排空和区域转运。GES 定义延迟性胃排空为 4 小时时超过 10%的餐食残留；WMC 定义延迟性胃排空为胶囊进入十二指肠超过 5 小时；WMC 定义严重胃排空延迟为胃排空时间超过 12 小时，GES 定义为 4 小时时超过 35%的餐食残留。GES 定义快速胃排空为 1 小时时餐食残留少于 38%，WMC 定义为胃排空时间少于 1:45 小时。我们比较了 GES 与 WMC 的诊断和性能特征。
结果
WMC 检测到更多的延迟性胃排空患者（34.6%），而 GES 检测到更多的延迟性胃排空患者（24.5%）（P=.009）。两种方法的结果总体一致性为 75.7%（kappa=0.42）。在非糖尿病患者中，WMC 检测到更多的延迟性胃排空患者（33.3%），而 GES 检测到更多的延迟性胃排空患者（17.1%）（P <.001）。糖尿病患者中，GES 检测到更多的延迟性胃排空患者（41.7%），而非糖尿病患者中，GES 检测到更多的延迟性胃排空患者（17.1%）（P=.002）。WMC 检测到更多的严重胃排空延迟患者（13.8%），而 GES 检测到更多的严重胃排空延迟患者（6.9%）（P =.02）。GES 检测到更多的快速胃排空患者（13.8%），而 WMC 检测到更多的快速胃排空患者（3.3%）（P <.001）。61.8%的患者出现区域和全身转运异常，仅通过 WMC 检测到。
结论
尽管 GES 与 WMC 对胃排空的分析结果一致，但 WMC 的诊断效果优于 GES。WMC 比 GES 更频繁地检测到延迟性胃排空，并识别出胃外转运异常。糖尿病患者与非糖尿病患者在 GES 与 WMC 之间的结果不同。这些发现可能会影响疑似胃轻瘫患者的治疗。ClinicalTrials.gov 编号：NCT02022826。
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