Gastro Esophageal RefluxNCT07722663
Endoscopic Classification of Fundoplication Integrity Predicts Pathologic Reflux
An observational study of Gastro Esophageal Reflux, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
This single-center, two-phase cohort study aimed to develop and validate a simple endoscopic classification of fundoplication integrity after anti-reflux surgery (ARS - Nissen or Toupet fundoplication). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastro Esophageal Reflux
- How many people
- 153 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2018to 1 Jul 2026
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent anti-reflux surgery and a complete manometric, reflux monitoring and endoscopic assessment
Who may be able to join
- Adults (18-90 years)
- Previous Nissen or Toupet fundoplication for GERD or large hiatal hernia
- Completion of post-operative esophagogastroduodenoscopy (EGD)
- Adequate retroflexed endoscopic videoclip
- Post-operative High-resolution manometry (HRM) and reflux monitoring (MII-pH or wireless pH)
Who cannot join
- Other foregut operations (Dor, Collis, magnetic sphincter augmentation, bariatric surgery)
- Insufficient quality of endoscopic videoclips
- Missing HRM or reflux monitoring
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ENDOSCOPIC CLASSIFICATION OF FUNDOPLICATION INTEGRITY PREDICTS PATHOLOGIC REFLUX: DEVELOPMENT AND PROSPECTIVE VALIDATION
This single-center, two-phase cohort study aimed to develop and validate a simple endoscopic classification of fundoplication integrity after anti-reflux surgery (ARS - Nissen or Toupet fundoplication). Consecutive adult patients undergoing endoscopy, high-resolution manometry (HRM), and reflux monitoring after ARS were included. Retroflexed endoscopic videoclips were reviewed blinded to clinical and functional results. In the development cohort (2018-2024, n=73), individual endoscopic parameters were tested against pathologic GERD (Lyon 2.0 criteria). Three parameters significantly correlated with pathologic reflux: (1) intrathoracic valve location, (2) disrupted valve (deep anterior and/or posterior grooves), and (3) visible hiatal opening. Patients were stratified according to the number of impaired mechanisms (0-3). Symptom burden, manometric abnormalities, and reflux metrics worsened progressively with increasing impairment. The rate of pathologic GERD rose from 11.8% (0 mechanisms) to 37.5% (1-2 mechanisms) to 85.7% (3 mechanisms). The classification was then prospectively validated in an independent cohort (2024-2026, n=49), reproducing the same stepwise correlation. The number of impaired mechanisms showed excellent discriminatory capacity for pathologic GERD (AUC 0.860 in development, 0.870 in validation; overall AUC 0.869). This simple endoscopic classification, based on only three objective parameters, reliably identifies fundoplication failure and correlates with symptoms and objective pathophysiologic data. It has the potential to standardize endoscopic reporting after ARS.
Read the detailed description
This is a single-center observational cohort study designed to develop and prospectively validate a simple endoscopic classification of the fundoplication after anti-reflux surgery (ARS), using clinical symptoms and objective functional testing as the reference.
Consecutive adult patients undergoing follow-up esophagogastroduodenoscopy (EGD), high-resolution manometry (HRM) and ambulatory reflux monitoring after Nissen or Toupet fundoplication are studied. The protocol is carried out in two phases. In the development phase, retroflexed endoscopic videoclips are collected and de-identified by one investigator and independently reviewed by a senior foregut surgeon and endoscopist, blinded to the results of HRM and reflux monitoring. For each patient, the reconstructed gastro-esophageal valve is characterized by five parameters: valve location (intra-abdominal versus intrathoracic), degree of disruption (graded on the depth of the anterior and posterior grooves), visibility of the hiatal opening, valve lip thickness, and the presence of a para-esophageal hernia.
HRM is performed according to the Chicago Classification v4.0, including provocative maneuvers (multiple rapid swallows and straight leg raise), and interpreted using the Padova Consensus criteria for post-fundoplication manometry. Reflux monitoring is performed off acid-suppressive therapy using 24-hour pH-impedance or wireless pH monitoring, and interpreted according to the Lyon 2.0 criteria.
The endoscopic parameters found to be associated with pathologic reflux are combined into an ordinal score based on the number of impaired mechanisms (0 to 3), and its discriminative performance is quantified by the area under the ROC curve. In the second phase, the classification is applied to an independent, prospectively enrolled cohort assessed under the same protocol, and its performance is compared with that of the development phase. The study is reported in accordance with the TRIPOD statement.
- Conditions
- Gastro Esophageal Reflux
- Keywords
- endoscopy, pH study, anti-reflux surgery
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal fundoplication | Patients with 0 impaired mechanisms of ARB restoration | |
| Partially impaired fundoplication | Patients with 1-2 impaired mechanisms of ARB restoration | |
| Fully impaired fundoplication | Patients with 3 impaired mechanisms of ARB restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
acid exposure time
time of pH<4 during the pH monitoring test
Measured: during pH impedance monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Apr 2018
- Primary completion1 Apr 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Siboni, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722663
- Sponsor's protocol ID
- EndoARS
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDOSCOPIC CLASSIFICATION OF FUNDOPLICATION INTEGRITY PREDICTS PATHOLOGIC REFLUX: DEVELOPMENT AND PROSPECTIVE VALIDATION
- ClinicalTrials.gov ID
- NCT07722663
- Acronym / sponsor ID
- EndoARS
- Conditions
- Gastro Esophageal Reflux
- Keywords
- endoscopy, pH study, anti-reflux surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, two-phase cohort study aimed to develop and validate a simple endoscopic classification of fundoplication integrity after anti-reflux surgery (ARS - Nissen or Toupet fundoplication). Consecutive adult patients undergoing endoscopy, high-resolution manometry (HRM), and reflux monitoring after ARS were included. Retroflexed endoscopic videoclips were reviewed blinded to clinical and functional results. In the development cohort (2018-2024, n=73), individual endoscopic parameters were tested against pathologic GERD (Lyon 2.0 criteria). Three parameters significantly correlated with pathologic reflux: (1) intrathoracic valve location, (2) disrupted valve (deep anterior and/or posterior grooves), and (3) visible hiatal opening. Patients were stratified according to the number of impaired mechanisms (0-3). Symptom burden, manometric abnormalities, and reflux metrics worsened progressively with increasing impairment. The rate of pathologic GERD rose from 11.8% (0 mechanisms) to 37.5% (1-2 mechanisms) to 85.7% (3 mechanisms). The classification was then prospectively validated in an independent cohort (2024-2026, n=49), reproducing the same stepwise correlation. The number of impaired mechanisms showed excellent discriminatory capacity for pathologic GERD (AUC 0.860 in development, 0.870 in validation; overall AUC 0.869). This simple endoscopic classification, based on only three objective parameters, reliably identifies fundoplication failure and correlates with symptoms and objective pathophysiologic data. It has the potential to standardize endoscopic reporting after ARS.
Detailed description
This is a single-center observational cohort study designed to develop and prospectively validate a simple endoscopic classification of the fundoplication after anti-reflux surgery (ARS), using clinical symptoms and objective functional testing as the reference.
Consecutive adult patients undergoing follow-up esophagogastroduodenoscopy (EGD), high-resolution manometry (HRM) and ambulatory reflux monitoring after Nissen or Toupet fundoplication are studied. The protocol is carried out in two phases. In the development phase, retroflexed endoscopic videoclips are collected and de-identified by one investigator and independently reviewed by a senior foregut surgeon and endoscopist, blinded to the results of HRM and reflux monitoring. For each patient, the reconstructed gastro-esophageal valve is characterized by five parameters: valve location (intra-abdominal versus intrathoracic), degree of disruption (graded on the depth of the anterior and posterior grooves), visibility of the hiatal opening, valve lip thickness, and the presence of a para-esophageal hernia.
HRM is performed according to the Chicago Classification v4.0, including provocative maneuvers (multiple rapid swallows and straight leg raise), and interpreted using the Padova Consensus criteria for post-fundoplication manometry. Reflux monitoring is performed off acid-suppressive therapy using 24-hour pH-impedance or wireless pH monitoring, and interpreted according to the Lyon 2.0 criteria.
The endoscopic parameters found to be associated with pathologic reflux are combined into an ordinal score based on the number of impaired mechanisms (0 to 3), and its discriminative performance is quantified by the area under the ROC curve. In the second phase, the classification is applied to an independent, prospectively enrolled cohort assessed under the same protocol, and its performance is compared with that of the development phase. The study is reported in accordance with the TRIPOD statement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal fundoplication | – | –Patients with 0 impaired mechanisms of ARB restoration |
| Partially impaired fundoplication | – | –Patients with 1-2 impaired mechanisms of ARB restoration |
| Fully impaired fundoplication | – | –Patients with 3 impaired mechanisms of ARB restoration |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent anti-reflux surgery and a complete manometric, reflux monitoring and endoscopic assessment
Key inclusion criteria (5 listed)
- Adults (18-90 years)
- Previous Nissen or Toupet fundoplication for GERD or large hiatal hernia
- Completion of post-operative esophagogastroduodenoscopy (EGD)
- Adequate retroflexed endoscopic videoclip
- Post-operative High-resolution manometry (HRM) and reflux monitoring (MII-pH or wireless pH)
Key exclusion criteria (3 listed)
- Other foregut operations (Dor, Collis, magnetic sphincter augmentation, bariatric surgery)
- Insufficient quality of endoscopic videoclips
- Missing HRM or reflux monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
acid exposure time
Time frame: during pH impedance monitoring
time of pH<4 during the pH monitoring test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro Esophageal Reflux, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acid exposure time (time frame: during pH impedance monitoring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.