RecruitingNCT07506746

PRospective Registry of Esophageal Motility


Sponsor

IRCCS San Raffaele

Enrollment

10,000 participants

Start Date

Mar 9, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

Digestive physiopathology is a branch of gastroenterology aiming to study patients with upper GI symptoms, mainly gastro-esophageal, potentially indicating the presence of Gastroesophageal Reflux Disease (GERD)/Barrett Esophagus (BE) or obstructive esophageal motility disorders (achalasia being the most relevant), but including also other primary motility disorders such as Esophgago-Gastric Junction Outflow Obstruction (EGJOO), Hypercontractile Esophagus (HE), Distal Esophageal Spasm (DES) and other minor disorders. Physiopathological testing encompasses High-Resolution Manometry (HRM), 24-H esophageal pH-impedance testing, Functional Lumen Imaging Probe (FLIP) assessment. All these tests are designed to provide a clear phenotyping of esophago-gastric disorders related to reflux or obstructive esophageal symptoms, either in naïve patients, as well as after foregut surgery (particularly anti-reflux surgery, achalasia/primary motility disorders treatment).


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Participant is willing and able to give informed consent for participation in the study.
  • The procedures are the standard of care for the patient or the participant is taking the medicinal product according to clinical practice
  • Aged \> 18 years.
  • Any typical (heartburn or regurgitation) or atypical reflux symptom (Laryngeal Cough, laryngitis, sub-glottic stenosis, globus, laryngeal cancer, vocal cord granuloma, vocal cord irritation, vocal cord polyps and post-nasal drip; Oropharyngeal: Dental erosion, pharyngitis, sore or burning throat, gingivitis and halitosis; Ears and sinuses: Earaches, otitis media and sinusitis; Pulmonary: Chronic bronchitis, pneumonia, aspiration, bronchiectasis, asthma and idiopathic pulmonary fibrosis; Cardiac: Arrhythmia, angina and myocardial infarction; Sleep: Sleep apnoea, sleep deprivation, insomnia, snoring, nightmare and sleep disturbance), but also any obstructive esophageal symptom potentially reflecting a primary or secondary motility disorder (oropharyngeal or esophageal dysphagia, chest pain, bolus impaction). Every patient with a diagnosis of esophageal inflammatory disorder (including EoE and others) or systemic rheumatological condition (scleroderma, systemic sclerosis, lichen planus and others), every patient previously undergone to any anti-reflux surgery, bariatric surgery, endoscopic or surgical esophageal or gastric myotomy (also for gastroparesis) may be included.
  • Patients must be referred to the Digestive Physiopathology Unit of IRCCS San Raffaele Hospital for motility tests

Exclusion Criteria2

  • Age \< 18 years
  • Not willing to provide informed consent to the inclusion in the registry

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Interventions

OTHERNo intervention

No intervention


Locations(1)

IRCCS San Raffaele Hospital

Milan, Lombardy, Italy

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NCT07506746


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