Endoscopic Classification of Fundoplication Integrity Predicts Pathologic Reflux

NCT07722663 | Completed

• 1 other identifier: EndoARS
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Gastro Esophageal Reflux

Keywords

endoscopy; pH study; anti-reflux surgery

Outcome Measures

Primary Outcomes (1)

• acid exposure time

  time of pH\<4 during the pH monitoring test

  during pH impedance monitoring

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent anti-reflux surgery and a complete manometric, reflux monitoring and endoscopic assessment

You may qualify if:

• 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)

You may not qualify if:

• Other foregut operations (Dor, Collis, magnetic sphincter augmentation, bariatric surgery)
• Insufficient quality of endoscopic videoclips
• Missing HRM or reflux monitoring

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MEDICAL DOCTOR

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start: April 1, 2018
• Primary Completion: April 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)