NCT07506746

PRospective Registry of Esophageal Motility

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed description

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

Conditions

• Esophageal Diseases
• Achalasia
• Eosinophilic Esophagitis
• Motility Disorder
• GERD

Interventions

Type	Name	Description
OTHER	No intervention	No intervention

Timeline

• Start date: 2026-03-09
• Primary completion: 2031-03-01
• Completion: 2041-03-01
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: Italy