Clinical trial NCT06878586: Diagnostic Evaluation of Esophageal Motility Disorders Using the Chicago IV Protocol in Egypt
Official title: Diagnostic Evaluation of Esophageal Motility Disorders Using the Chicago IV Protocol in Egypt
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Esophageal Motility Disorders
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (age ≥ 18 years) at Ain Shams University presenting symptoms such as dysphagia, chest pain, regurgitation, or heartburn.

Brief summary: Esophageal motility disorders (EMDs) encompass a spectrum of conditions characterized by abnormal movement and coordination of the esophagus, leading to symptoms such as dysphagia, chest pain, regurgitation, and heartburn . These symptoms can severely impact quality of life, often requiring detailed diagnostic evaluations for appropriate management . High-resolution esophageal manometry (HRM) has emerged as a critical diagnostic tool, providing comprehensive assessments of esophageal motility and improving our understanding of the pathophysiology behind EMDs . The advancements in HRM technology have significantly enhanced diagnostic accuracy, leading to more effective treatment strategies.

The Chicago Classification (CC) was introduced to standardize the interpretation of HRM findings and facilitate communication among clinicians. Since its inception in 2009, the classification has undergone several updates to reflect ongoing advancements. The most recent update, Chicago Classification version 4.0 (CC v4.0), resulted from two years of collaboration by an international working group of motility experts . This version places a greater emphasis on clinical relevance, refining diagnostic criteria to include standardized assessments in both the supine and upright positions, as well as the use of provocative maneuvers to provide a more thorough evaluation of esophageal function

. These enhancements aim to improve the understanding and diagnosis of complex motility disorders Although CC version 3.0 (CC v3.0) has been widely utilized, it has limitations that CC v4.0 effectively addresses to enhance esophageal motility testing. By requiring assessments in both supine and upright positions, CC v4.0 captures motility abnormalities in more physiologically relevant conditions, The inclusion of provocative testing methods, such as multiple rapid swallows (MRS) and solid swallows, further increases sensitivity for detecting disorders under stress. Moreover, CC v4.0 offers a comprehensive analysis of esophagogastric junction (EGJ) function, introducing criteria for EGJ outflow obstruction and EGJ typing, which clarify interactions with the lower esophageal sphincter . This updated framework also emphasizes bolus transit and metrics for fragmented peristalsis, facilitating the identification of subtle motility issues that may impact bolus clearance In Egypt, the majority of manometric devices are configured to automatically interpret results using CC v3.0, limiting the integration of newer diagnostic criteria. By manually applying CC v4.0 in this study, we seek to determine whether its updated metrics offer enhanced diagnostic precision and a better correlation with clinical symptoms.


Eligibility criteria: Inclusion Criteria:

* Adult patients (age ≥ 18 years) at Ain Shams University presenting symptoms such as dysphagia, chest pain, regurgitation, or heartburn.

Exclusion Criteria:

* Patients with prior esophageal surgeries, significant structural abnormalities, or those unable to provide informed consent will be excluded.

Primary outcomes:
measure: Chicago Classification version 4 for esophageal motility disorders (EMDs) in the Egyptian population
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: