Detection of Minimal Change Esophagitis Using Confocal Laser Endomicroscopy

NCT00954070 | Terminated

• 1 other identifier: E/09/026
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational, prospective and pilot study to determine through confocal endomicroscopy diagnostic microscopic features detectable at the gastroesophageal junction of patients with non-erosive gastroesophageal reflux disease. The hypothesis is that minimal mucosal changes occur in non-erosive gastroesophageal reflux disease. Although these minimal changes are not always visible on white-light endoscopy, it is detectable using high-resolution confocal endomicroscopy and these confocal features are diagnostic of non-erosive reflux disease (NERD).

Conditions

Gastroesophageal Reflux Disease

Keywords

gastroesophageal reflux disease

Outcome Measures

Primary Outcomes (1)

• Specific microscopic changes in the esophageal mucosa as seen under the confocal endomicroscope

  After 4 weeks phamacological washout period

Study Arms (2)

Case (subjects with NERD)

The investigators cases are subjects with confirmed NERD and include male or female patients aged between 21 and 65 years, who present with typical clinical manifestations of gastroesophageal reflux and have no esophageal mucosal breaks upon conventional white-light endoscopy examination but show evidence of pathologic gastroesophageal reflux on 24-hr pH monitoring.

Device: Confocal endomicroscope (Pentax Model EC3870K)

Control

Healthy individuals aged between 21 and 65 years who are asymptomatic for GERD and other digestive diseases

Device: Confocal endomicroscope (Pentax Model EC3870K)

Interventions

Confocal endomicroscope (Pentax Model EC3870K) DEVICE

The intervention is an endoscopy procedure using a novel type of endoscope with a powerful confocal microscope attached to its tip. The endoscope (Pentax Model EC3870K) provides both white-light and confocal microscopic imaging.

Also known as: Pentax Model EC3870K, Pentax Corp, Tokyo, Japan

Case (subjects with NERD); Control

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hosipital patients with typical clinical manifestations of gastroesophageal reflux disease but no endoscopy evidence of esophagitis.

You may qualify if:

• Cases:
• male or female patients aged between 21 and 65 years with typical clinical manifestations of gastroesophageal reflux but endoscopy-negative for esophageal mucosal breaks
• by typical clinical manifestations of gastroesophageal reflux, we refer to the occurrence of heartburn and/or regurgitation more than twice a week, with a minimum duration of 8 consecutive weeks, and with symptoms severe enough to affect daily activities
• Controls:
• healthy male or female aged between 21 and 65 years who are asymptomatic for GERD and other digestive diseases

You may not qualify if:

• Endoscopic confirmed erosive esophagitis
• Complications such as Barrett's esophagus, gastric and/or duodenal peptic ulcer, stenosis
• Esophageal, gastric or duodenal cancer or other malignancy
• History of esophagus, stomach, or duodenum surgery
• Conditions that preclude safe biopsies (coagulopathy, haemophilia, esophageal varices, and patients on warfarin and antiplatelets)
• Scleroderma, diabetes mellitus, autonomic or peripheral neuropathy, myopathy or any underlying disease or medication that might affect the lower esophageal sphincter pressure or increase the acid clearance time
• A history of bronchial asthma, or known allergy to fluorescein
• Pregnant or breast-feeding (for females)
• Below 21 or above 65 years of age
• Severe co-morbidities (e.g., such as end-stage renal failure, congestive cardiac failure, liver cirrhosis, severe arthritis requiring long term non-steroidal anti-inflammatory drug therapy)
• Unable or unwilling to give informed consent

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (5)

• Barlow WJ, Orlando RC. The pathogenesis of heartburn in nonerosive reflux disease: a unifying hypothesis. Gastroenterology. 2005 Mar;128(3):771-8. doi: 10.1053/j.gastro.2004.08.014.

  PMID: 15765412 BACKGROUND

• Calabrese C, Fabbri A, Bortolotti M, Cenacchi G, Areni A, Scialpi C, Miglioli M, Di Febo G. Dilated intercellular spaces as a marker of oesophageal damage: comparative results in gastro-oesophageal reflux disease with or without bile reflux. Aliment Pharmacol Ther. 2003 Sep 1;18(5):525-32. doi: 10.1046/j.1365-2036.2003.01713.x.

  PMID: 12950425 BACKGROUND

• Ravelli AM, Villanacci V, Ruzzenenti N, Grigolato P, Tobanelli P, Klersy C, Rindi G. Dilated intercellular spaces: a major morphological feature of esophagitis. J Pediatr Gastroenterol Nutr. 2006 May;42(5):510-5. doi: 10.1097/01.mpg.0000215312.78664.b9.

  PMID: 16707972 BACKGROUND

• Caviglia R, Ribolsi M, Gentile M, Rabitti C, Emerenziani S, Guarino MP, Petitti T, Cicala M. Dilated intercellular spaces and acid reflux at the distal and proximal oesophagus in patients with non-erosive gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2007 Mar 1;25(5):629-36. doi: 10.1111/j.1365-2036.2006.03237.x.

  PMID: 17305764 BACKGROUND

• Caviglia R, Ribolsi M, Maggiano N, Gabbrielli AM, Emerenziani S, Guarino MP, Carotti S, Habib FI, Rabitti C, Cicala M. Dilated intercellular spaces of esophageal epithelium in nonerosive reflux disease patients with physiological esophageal acid exposure. Am J Gastroenterol. 2005 Mar;100(3):543-8. doi: 10.1111/j.1572-0241.2005.40978.x.

  PMID: 15743349 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Officials

• Khek Yu Ho, MD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Senior Consultant Gastroenterologist

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: August 6, 2009
• Study Start: August 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 28, 2012

Record last verified: 2012-12

Locations

SG (1)