Near Focus NBI-Driven Artificial Intelligence for the Diagnosis of Gastro-Oesophageal Reflux Disease

NCT04268719 | Completed DMC

• 1 other identifier: 227223
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Gastro-oesophageal reflux disease (GORD) is a chronic condition with symptoms arising secondary to the reflux of stomach contents (Vakil et al., 2006). It is divided into four phenotypes: Erosive Oesophagitis (EO), Non-Erosive Reflux Disease (NERD), Reflux Hypersensitivity (RH), Functional Heartburn (FH) (Nikaki, Woodland and Sifrim, 2016). The definition of these phenotype have evolved with the addition of diagnostic tests and methods of their interpretation, the most recent being the Lyon Consensus Statement (Gyawali et al., 2018). The majority of patients presenting with symptoms suggestive of GORD have no mucosal lesion seen at endoscopy (Nikaki, Woodland and Sifrim, 2016). Studies have shown a relation of increased IPCL numbers with GORD. This study aims to build a fully autmoated AI model using Near-Focus NBI images on patients with symptoms suggestive of GORD phenotyped in accordance with the Lyon Consensus.

Conditions

Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (2)

• To evaluate Intra-Papillary Capillary Loop (IPCL) changes secondary to oesophageal acid exposure.

  Parameters of IPCLs: IPCLs/region of interest, morphology: IPCL length, density correlated to oesophageal acid exposure

  6 weeks post completion of wireless capsule pH recording

• To develop an accurate and reliable artificial intelligence model for the diagnosis of Gastro-Oesophageal Reflux Disease (GORD)

  Patient data split into training/validation and test dataset for computer assisted and deep learning model training and testing

  3 months after completion of all data collection

Secondary Outcomes (1)

• To explore factors that may predict response to treatment.

  6 weeks to include data of response to antacid treatment

Study Arms (2)

Gastro-Esophageal Reflux Disease

Patients defined as having GERD as per Lyon Consensus

Diagnostic Test: wireless pH capsule recording

Non-acid Reflux

Patient excluded for GERD as per Lyon Consensus

Diagnostic Test: wireless pH capsule recording

Interventions

wireless pH capsule recording DIAGNOSTIC_TEST

wireless pH capsule recording for up to 96 hours

Gastro-Esophageal Reflux Disease; Non-acid Reflux

Eligibility Criteria

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

Study Population

Consecutive patients attending the Gastroenterology department for the investigation of symptoms suggestive of Gastro-Oesophageal Reflux Disease (GORD) were approached for recruitment. Patients had to have symptoms including heartburn, regurgitation or chest/epigastric pain for a minimum of 3 months.

You may qualify if:

• Retaining capacity and medically fit for gastroscopy
• Requiring gastroscopy by current BSG guidelines for the investigation of acid reflux/ dyspepsia

You may not qualify if:

• Unable to give informed consent
• History of oesophageal or gastric surgery
• Allergy to proton-pump inhibitor
• Known Barrett's Oesophagus/ oesophageal carcinoma/ oesophageal stricture/ known oesophageal dysmotility
• Portal Hypertension
• Pacemaker (BRAVO)

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

Shraddha Gulati

London, SE5 9RS, United Kingdom

Location

Related Publications (14)

• Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.

  PMID: 16928254 BACKGROUND

• Nikaki K, Woodland P, Sifrim D. Adult and paediatric GERD: diagnosis, phenotypes and avoidance of excess treatments. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):529-42. doi: 10.1038/nrgastro.2016.109. Epub 2016 Jul 27.

  PMID: 27485786 BACKGROUND

• Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362. doi: 10.1136/gutjnl-2017-314722. Epub 2018 Feb 3.

  PMID: 29437910 BACKGROUND

• Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999 Aug;45(2):172-80. doi: 10.1136/gut.45.2.172.

  PMID: 10403727 BACKGROUND

• Nozu T, Komiyama H. Clinical characteristics of asymptomatic esophagitis. J Gastroenterol. 2008;43(1):27-31. doi: 10.1007/s00535-007-2120-2. Epub 2008 Feb 24.

  PMID: 18297432 BACKGROUND

• Zagari RM, Fuccio L, Wallander MA, Johansson S, Fiocca R, Casanova S, Farahmand BY, Winchester CC, Roda E, Bazzoli F. Gastro-oesophageal reflux symptoms, oesophagitis and Barrett's oesophagus in the general population: the Loiano-Monghidoro study. Gut. 2008 Oct;57(10):1354-9. doi: 10.1136/gut.2007.145177. Epub 2008 Apr 18.

  PMID: 18424568 BACKGROUND

• Lee YC, Lin JT, Chiu HM, Liao WC, Chen CC, Tu CH, Tai CM, Chiang TH, Chiu YH, Wu MS, Wang HP. Intraobserver and interobserver consistency for grading esophagitis with narrow-band imaging. Gastrointest Endosc. 2007 Aug;66(2):230-6. doi: 10.1016/j.gie.2006.10.056.

  PMID: 17643694 BACKGROUND

• Fock KM, Teo EK, Ang TL, Tan JY, Law NM. The utility of narrow band imaging in improving the endoscopic diagnosis of gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2009 Jan;7(1):54-9. doi: 10.1016/j.cgh.2008.08.030. Epub 2008 Sep 3.

  PMID: 18852068 BACKGROUND

• Inoue H, Kaga M, Ikeda H, Sato C, Sato H, Minami H, Santi EG, Hayee B, Eleftheriadis N. Magnification endoscopy in esophageal squamous cell carcinoma: a review of the intrapapillary capillary loop classification. Ann Gastroenterol. 2015 Jan-Mar;28(1):41-48.

  PMID: 25608626 BACKGROUND

• Kato M, Kaise M, Yonezawa J, Toyoizumi H, Yoshimura N, Yoshida Y, Kawamura M, Tajiri H. Magnifying endoscopy with narrow-band imaging achieves superior accuracy in the differential diagnosis of superficial gastric lesions identified with white-light endoscopy: a prospective study. Gastrointest Endosc. 2010 Sep;72(3):523-9. doi: 10.1016/j.gie.2010.04.041. Epub 2010 Jul 3.

  PMID: 20598685 BACKGROUND

• Sharma P, Wani S, Bansal A, Hall S, Puli S, Mathur S, Rastogi A. A feasibility trial of narrow band imaging endoscopy in patients with gastroesophageal reflux disease. Gastroenterology. 2007 Aug;133(2):454-64; quiz 674. doi: 10.1053/j.gastro.2007.06.006. Epub 2007 Jun 8.

  PMID: 17681166 BACKGROUND

• Lv J, Liu D, Ma SY, Zhang J. Investigation of relationships among gastroesophageal reflux disease subtypes using narrow band imaging magnifying endoscopy. World J Gastroenterol. 2013 Dec 7;19(45):8391-7. doi: 10.3748/wjg.v19.i45.8391.

  PMID: 24363532 BACKGROUND

• Pace F, Buscema M, Dominici P, Intraligi M, Baldi F, Cestari R, Passaretti S, Bianchi Porro G, Grossi E. Artificial neural networks are able to recognize gastro-oesophageal reflux disease patients solely on the basis of clinical data. Eur J Gastroenterol Hepatol. 2005 Jun;17(6):605-10. doi: 10.1097/00042737-200506000-00003.

  PMID: 15879721 BACKGROUND

• Zhao YY, Xue DX, Wang YL, Zhang R, Sun B, Cai YP, Feng H, Cai Y, Xu JM. Computer-assisted diagnosis of early esophageal squamous cell carcinoma using narrow-band imaging magnifying endoscopy. Endoscopy. 2019 Apr;51(4):333-341. doi: 10.1055/a-0756-8754. Epub 2018 Nov 23.

  PMID: 30469155 BACKGROUND

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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: November 23, 2017
• Primary Completion: July 26, 2018
• Study Completion: November 30, 2018
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)