Clinical Trials
Search for actively enrolling clinical trials
Examining Lamina Propria Procurement with Various Combinations of Endoscopic Biopsy Sampling Techniques in Pediatric Eosinophilic Esophagitis Patients
Study ID: STU-2018-0272
Summary
This study focuses on eoe, a chronic inflammatory disease that can lead to fibrotic remodeling of the esophagus. in order to evaluate for early fibrosis, an esophageal biopsy that procures adequate subepithelium, or LP, is needed. The goal of this study is to evaluate the LP procurement rate of various combinations of standard endoscopic esophageal biopsy sampling techniques. This study will be divided into 4 parts. in Part i, we will determine the superiority of the combination of Perpendicular-Suction-Single Pinch techniques over the Tangential-no Suction-Double Pinch techniques. For each subject, the Study endoscopist will collect half of the clinical biopsies using one combination and half of the clinical biopsies using the other. in Part ii, we will determine the non-inferiority of the combination of Tangential-Suction-Single Pinch techniques from the Perpendicular-Suction-Single Pinch techniques. For each subject, the Study endoscopist will collect half of the clinical biopsies using one combination and half of the clinical biopsies using the other. in Part iii, we will determine the non-inferiority of the combination of Perpendicular-Suction-Double Pinch techniques from the Perpendicular-Suction-Single Pinch techniques. For each subject, the Study endoscopist will collect half of the clinical biopsies using one combination and half of the clinical biopsies using the other. in Part iV, we will determine the non-inferiority of the combination of Perpendicular-no Suction-Single Pinch techniques from the Perpendicular-Suction-Single Pinch techniques. For each subject, the Study endoscopist will collect half of the clinical biopsies using one combination and half of the clinical biopsies using the other. Study Pathologists blinded to the techniques will grade the quality of the biopsy samples on the following: fragmentation of the samples, presence or absence of adequate LP, the presence or absence of fibrosis, and the peak intraepithelial eosinophil count.
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- EDAIRE CHENG
UNIVERSITY OF TEXAS SOUTHWESTERN
Esophagus
eosinophilic esophagitis is an antigen-mediated chronic inflammatory disorder of the esophagus, often detected in childhood. eoe can lead to tissue remodeling of the esophagus. evidence of tissue remodeling include fibrostenotic features such as rings, stricture, and narrowing that can be detected by endoscopy. However, children may lack gross fibrostenotic features, making evaluation of early esophageal remodeling challenging. Detection of subepithelial or lamina propria fibrosis by evaluation of esophageal mucosal biopsies also indicates tissue remodeling. However, the detection of LP fibrosis is limited by the quality of the biopsies. We speculate that the endoscopic biopsy sampling technique is a factor that impacts the successful procurement of adequate LP in esophageal biopsies. in this study, we will analyze the LP procurement rate of standard endoscopic esophageal biopsy sampling techniques in order to identify a superior combination of endoscopic esophageal biopsy techniques that has the highest LP procurement rate for early fibrosis diagnosis. First, we will determine the superiority of the Perpendicular-Suction-Single Pinch technique over Tangential-no Suction-Double Pinch technique. Secondly, we will determine the non-inferiority of Tangential-Suction-Single Pinch from Perpendicular-Suction-Single Pinch. Thirdly, we will determine the non-inferiority of Perpendicular-Suction-Double Pinch from Perpendicular-Suction-Single Pinch. Lastly, we will determine the non-inferiority of Perpendicular-no Suction-Single Pinch from Perpendicular-Suction-Single Pinch. We hypothesize that the combination of Perpendicular-Suction-Single Pinch techniques will be superior. The identification of a superior combination of biopsy sampling techniques will improve our ability to evaluate eoe patients for early signs of fibrosis and may allow for earlier clinical intervention. in addition, it will reduce the need to re-biopsy a patient and re-analyze tissue specimens.