PRospective Registry of Esophageal Motility

IRCCS San Raffaele10,000 enrolled

Overview

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). Primary objective of the study is to create a prospective/retrospective registry of all patients with \> 18 years of age referring to the Digestive Physiopathology division of San Raffaele Hospital, in order to register clinical, endoscopic, radiologic data of these patients integrating them with physiopatology outcomes in order to shape disease management and treatment work-up, also in long-term follow-up of these patients. Primary endpoints are the Integration and analysis of association/correlation of physiologic with endoscopic, radiologic and clinical data. PREM is a prospective registry recruiting patients retrospectively enrolled aiming\[RT1.1\] to include all clinical, endoscopic, radiological integrating them with physiopathology data of all patients referred to Digestive Physiopathology Division of San Raffaele Hospital, with the purpose of extracting data for prospective and retrospective analyses, in order to improve patients' management and clinical research and empower diagnostic and therapeutic work-up

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participant is willing and able to give informed consent for participation in the study. 2. The procedures are the standard of care for the patient or the participant is taking the medicinal product according to clinical practice 3. Aged \> 18 years. 4. 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. 5. Patients must be referred to the Digestive Physiopathology Unit of IRCCS San Raffaele Hospital for motility tests Exclusion Criteria: 1. Age \< 18 years 2. Not willing to provide informed consent to the inclusion in the registry

Outcomes

Primary Outcomes

To collect High Resolution Manometry (HRM) data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital

Time frame: 2026-2031

To collect pH-impedance data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital

Time frame: 2026-2031

Secondary Outcomes

To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital

Questionnaires of clinical activity will be collected using validated questionnaires: \- GERD-Q

Time frame: 2026-2031

To collect esophago-gastro-duodenoscopy (EGD) data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital

Time frame: 2026-2031

To collect radiological (TBE, barium esophagogram) data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital

Time frame: 2026-2031

To collect anamnestic, clinical data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital

Time frame: 2026-2031

To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital

Questionnaires of clinical activity will be collected using validated questionnaires: -GERD-HRQL

Time frame: 2026-2031

To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital

Questionnaires of clinical activity will be collected using validated questionnaires: \- RSI

Time frame: 2026-2031

To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital

Questionnaires of clinical activity will be collected using validated questionnaires: \- BEDQ

Time frame: 2026-2031

To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital

Questionnaires of clinical activity will be collected using validated questionnaires: \- Eckardt score

Time frame: 2026-2031

To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital

Questionnaires of clinical activity will be collected using validated questionnaires: \- DSQ

Time frame: 2026-2031

To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital

Questionnaires of clinical activity will be collected using validated questionnaires: \- DD

Time frame: 2026-2031

To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital

Questionnaires of clinical activity will be collected using validated questionnaires: \- EoE-QoL-A

Time frame: 2026-2031

To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital

Questionnaires of clinical activity will be collected using validated questionnaires: \- PiEAQ score

Time frame: 2026-2031

PRospective Registry of Esophageal Motility

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts