Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

10,000

participants targeted

Target at P75+ for all trials

Timeline

179mo left

Started Mar 2026

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

15 years study duration

Study Progress2%

Mar 2026Mar 2041

First Submitted

Initial submission to the registry

March 9, 2026

Completed

Same day until next milestone

Study Start

First participant enrolled

March 9, 2026

Completed

24 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2031

Expected

10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2041

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

March 9, 2026

Last Update Submit

March 28, 2026

Conditions

Esophageal Diseases Achalasia Eosinophilic Esophagitis Motility Disorder GERD

Keywords

Esophageal disease; manometry; FLIP, pH-impedance

Outcome Measures

Primary Outcomes (2)

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
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
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
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
2026-2031

Secondary Outcomes (12)

To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital
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
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
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
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
2026-2031
+7 more secondary outcomes

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with reflux (typical or atypical) or obstructive esophageal symptoms on or off therapy, Barrett Esophagus patients, pts with eosinophilic esophagitis, gastroparesis, patients with primary motility esophageal disorders, patients undergone to foregut GI surgery procedures (esophageal myotomies, anti-reflux surgeries, bariatric procedures, gastroparesis surgery), Age \> 18 years

You may qualify if:

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

You may not qualify if:

Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

IRCCS San Raffaelelead

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, Lombardy, 20132, Italy

RECRUITING

Related Publications (3)

Carlson DA, Kahrilas PJ, Lin Z, Hirano I, Gonsalves N, Listernick Z, Ritter K, Tye M, Ponds FA, Wong I, Pandolfino JE. Evaluation of Esophageal Motility Utilizing the Functional Lumen Imaging Probe. Am J Gastroenterol. 2016 Dec;111(12):1726-1735. doi: 10.1038/ajg.2016.454. Epub 2016 Oct 11.
PMID: 27725650BACKGROUND
Salvador R, Pandolfino JE, Costantini M, Gyawali CP, Keller J, Mittal S, Roman S, Savarino EV, Tatum R, Tolone S, Zerbib F, Capovilla G, Jain A, Kathpalia P, Provenzano L, Yadlapati R; HRM & Foregut Surgery International Working Group. The Role of High-Resolution Manometry Before and Following Antireflux Surgery: The Padova Consensus. Ann Surg. 2025 Jan 1;281(1):124-135. doi: 10.1097/SLA.0000000000006297. Epub 2024 Apr 12.
PMID: 38606560BACKGROUND
Yadlapati R, Kahrilas PJ, Fox MR, Bredenoord AJ, Prakash Gyawali C, Roman S, Babaei A, Mittal RK, Rommel N, Savarino E, Sifrim D, Smout A, Vaezi MF, Zerbib F, Akiyama J, Bhatia S, Bor S, Carlson DA, Chen JW, Cisternas D, Cock C, Coss-Adame E, de Bortoli N, Defilippi C, Fass R, Ghoshal UC, Gonlachanvit S, Hani A, Hebbard GS, Wook Jung K, Katz P, Katzka DA, Khan A, Kohn GP, Lazarescu A, Lengliner J, Mittal SK, Omari T, Park MI, Penagini R, Pohl D, Richter JE, Serra J, Sweis R, Tack J, Tatum RP, Tutuian R, Vela MF, Wong RK, Wu JC, Xiao Y, Pandolfino JE. Esophageal motility disorders on high-resolution manometry: Chicago classification version 4.0(c). Neurogastroenterol Motil. 2021 Jan;33(1):e14058. doi: 10.1111/nmo.14058.
PMID: 33373111RESULT

MeSH Terms

Conditions

Esophageal DiseasesEsophageal AchalasiaEosinophilic EsophagitisGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesEsophageal Motility DisordersDeglutition DisordersEsophagitisGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Alberto Barchi, MD

CONTACT

+390226432643 barchi.alberto@hsr.it

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 10 Years
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Medical Doctor

Study Record Dates

First Submitted

March 9, 2026

First Posted

April 2, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2041

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing: Will not share

Locations

IT(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (12)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations