Endoscopic Classification of Fundoplication Integrity Predicts Pathologic Reflux

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.

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Key information

Conditions

Gastro Esophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

acid exposure time

Time frame: during pH impedance monitoring

time of pH<4 during the pH monitoring test

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Official study title

ENDOSCOPIC CLASSIFICATION OF FUNDOPLICATION INTEGRITY PREDICTS PATHOLOGIC REFLUX: DEVELOPMENT AND PROSPECTIVE VALIDATION

Important dates

Study start: 2018
Primary completion: 2026
Study completion: 2026
First posted: Jul 23, 2026
Registry last updated: Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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