Clinical trial NCT02397616: Effects of Position and a Test Meal on Esophago-gastric Junction Morphology and Function Assessed by High-resolution Impedance Manometry (HRM)
Official title: Effects of Position and a Test Meal on Esophago-gastric Junction Morphology and Function Assessed by High-resolution Impedance Manometry (HRM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiatus Hernia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to hour unit for high resolution manometry (patients with dysphagia, reflux or other complaints)

Brief summary: Retrospective analysis for HRM measurements using liquid swallows and a test meal for the presence of hiatal hernia. The investigators will correlate hernia descriptions with presence of acidic reflux and clinical complaints.

Detailed description: We will retrospectively analyze all patients referred to hour unit for high-resolution esophageal manometry. These patients have been tested using liquid swallows and a test meal. We will analyze the HRM measurements for presence of manometric signs of hiatal hernia and determine predictive factors for hernia presence. We will correlate hernia description versus presence of acid reflux, clinical complaints and HRM measurements.

Eligibility criteria: Inclusion Criteria:

* All patients referred to our functional lab for esophageal high-resolution manometry from January 2013 - December 20165
* Lack of documentation of patient preferences against usage of medical data for biomedical research
* Male and female patients ≥18 years of age

Exclusion Criteria:

* Age under 18 years
* Patient's wishes against scientific use of their clinical data

Primary outcomes:
measure: Effects of hernia type (consistent hernia, transient hernia and no hernia, as specified bellow) on reflux symptoms
timeFrame: 1 months
Secondary outcomes:
measure: Differences in hernia size between sitting and recumbent position as well as between liquid swallows, free drinking and test meal.
timeFrame: 1 hour
measure: Diagnostic accuracy for hernia diagnosis by HRM for sitting, and recumbent position, free drinking and test meal.
timeFrame: 1 hour
measure: Correlation of pH-impedance measurements (if available) with manometric and clinical data.
timeFrame: 1 hour
measure: Correlation of various measurements describing esophageal motility according to Chicago classification with type of hernia, clinical symptoms and pH-impedance measurements
timeFrame: 1 hour
measure: Correlation of hernia diagnosis and hernia size according to imaging exams (if available: CT scan, fluoroscopy) and endoscopy (if available) with hernia diagnosis by HRM
timeFrame: 1 hour
measure: Correlation of body measurements (body mass index, BMI, waist circumference) of patients with type of hernia, clinical symptoms and pH-impedance measurements
timeFrame: 1 hour
measure: Correlation of visceral sensitivity (determined by balloon inflation) with reflux symptoms
timeFrame: 1 hour
measure: Prediction of reflux symptoms using a model including hernia and esophageal peristalsis characteristics, visceral sensitivity (balloon inflation) and anthropometric measurements
timeFrame: 1 hour
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Division of Gastroenterology, University Hospital Zurich
Study officials:
References:
citation: Ang D, Misselwitz B, Hollenstein M, Knowles K, Wright J, Tucker E, Sweis R, Fox M. Diagnostic yield of high-resolution manometry with a solid test meal for clinically relevant, symptomatic oesophageal motility disorders: serial diagnostic study. Lancet Gastroenterol Hepatol. 2017 Sep;2(9):654-661. doi: 10.1016/S2468-1253(17)30148-6. Epub 2017 Jul 3.
citation: Hollenstein M, Thwaites P, Butikofer S, Heinrich H, Sauter M, Ulmer I, Pohl D, Ang D, Eberli D, Schwizer W, Fried M, Distler O, Fox M, Misselwitz B. Pharyngeal swallowing and oesophageal motility during a solid meal test: a prospective study in healthy volunteers and patients with major motility disorders. Lancet Gastroenterol Hepatol. 2017 Sep;2(9):644-653. doi: 10.1016/S2468-1253(17)30151-6. Epub 2017 Jul 3.