The Role Of Empiric Dilation In Patients With Dysphagia With Normal Endoscopy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
C. Prakash Gyawali, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01444066
First received: September 28, 2011
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

The goal of our study is to determine if stretching the esophagus with a rubber dilator helps patients with swallowing difficulties who have a normal appearing esophagus on upper endoscopy. In order to do this we will perform a randomized controlled study, where patients will undergo esophageal dilation (stretching) with different diameter dilators. We will measure change in symptom severity between baseline (prior to dilation) and 1, 3, 6 and 12 months after the procedure


Condition Intervention
Dysphagia With Normal Endoscopy
Procedure: Dilation of the esophagus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Role Of Empiric Dilation In Patients With Dysphagia With Normal Endoscopy

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Improvement in dysphagia, quantified using 10 cm VAS scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the yield of esophageal biopsy in patients with dysphagia with normal endoscopy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Evaluate the yield of HRM and pH monitoring in patients with dysphagia and normal endoscopy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Identify predictors of response to empiric dilation in patients with dysphagia and normal endoscopy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: September 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: dilation to 27 French Procedure: Dilation of the esophagus
Esophagus will be dilated with a Savory dilator.
Experimental: Dilation of the esophagus to 54 French
Esophagus will be dilated with a Savory dilator
Procedure: Dilation of the esophagus
Esophagus will be dilated with a Savory dilator.

Detailed Description:

Dysphagia typically refers to the sensation of food being stuck in the throat or chest( esophageal dysphagia) as well as difficulty with the initiation of swallowing (oropharyngeal dysphagia). It is typically classified into oropharyngeal and esophageal dysphagia. Oropharyngeal dysphagia is typically the result of neuromuscular disease as well as head and neck malignancy and can be diagnosed on the basis of history and physical examination in most cases. Patients with esophageal dysphagia can further be sub-classified into two groups; those with obvious abnormality in the esophageal mucosa or motility on endoscopy and those with normal findings on endoscopic examination.

The diagnosis and treatment of patients with dysphagia and abnormal findings on endoscopy has been extensively studied and there are well-define practice guidelines availed on the subject. In contrast to this the management strategy for the group of patients with esophageal type dysphagia and a normal appearing esophagus on upper endoscopy (DNE) has been a topic of controversy for over a decade. Those patients with DNE are thought to fall into several categories, those with very subtle strictures and rings in the esophagus that are not seen during endoscopy, as well as patients with non-erosive reflux disease, eosinophilic esophagitis, primary motility disorders of the esophagus, and finally those with "functional" dysphagia (in whom no cause can be identified). Several approaches have been advocated for the evaluation and treatment of patients with DNE, including a trial of proton pump inhibitor therapy, obtaining random biopsies to exclude eosinophilic esophagitis and non-erosive reflux disease, referral for manometry and esophageal pH monitoring, as well as empiric esophageal dilation with a large caliber bougie. Of these options empiric esophageal dilation with a large diameter bougie has been the initial management approach recommended by the most recent AGA guidelines as well as many experts in the field of esophagology, for the treatment of DNE.

The initial evidence for empiric esophageal dilation in patients with DNE came from a retrospective study by Marshal et al, who found that 50% of patients experienced a sustained improvement in symptoms following dilation with a large diameter bougie. This was followed by a randomized controlled trial by Colon and coworkers, who again found a significant benefit to empiric esophageal bougie dilation. However, two randomized trials in the mid-2000's did not find any benefit to empiric esophageal dilation; although the dilation methods used in these studies differed from that used by Marshal and Colon et al. Despite these conflicting results empiric dilation continues to be popular by community gastroenterologists, and is perceived to be safe effective intervention for treating patients with DEN. A recent study by Olson et al found that empiric dilation for DNE was performed more commonly then dilation for dilation for esophageal strictures in the United States and is associated with a 0.65% complication rate. Additionally, in the current era of financial pressure on the medical community empiric dilation for DNE at the time of the first diagnostic upper endoscopy could lead to a significant savings if it is effective in relieving symptoms; by obviating the need for further diagnostic testing, medications and repeat endoscopy.

With this in mind, our goal is to conduct a randomized controlled trial evaluating the role of empiric dilation in patients with DNE, to help fill existing gaps in the medical literature. Specifically, prior studies are lacking with regard to three important points. First, esophageal manometry and pH monitoring were not uniformly performed on patients; this testing is crucial to excluding esophageal motility disorders and non-erosive reflux disease, which are thought to be causes of DNE. Second, esophageal biopsies were not performed in any of the studies; this has become a standard part of the evaluation of all patients with DNE over the past 5 years, as eosinophilic esophagitis and non-erosive reflux disease can lead to dysphagia and may be missed without microscopic examination of the esophageal mucosa. Finally, none of the studies used a standardized and validated dysphagia questionnaire, such as the Mayo Dysphagia Questionnaire (MDQ) to evaluate symptoms.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients age: > 18 years.
  2. Outpatients undergoing EGD for dysphagia.
  3. Ability to provide written informed consent.

Exclusion Criteria:

  • Abnormal endoscopy (stricture, abnormal motility or mucosa observed)
  • Oropharyngeal dysphagia suspected based on history and physical examination
  • History of CVA or other neurologic disorder
  • Known connective tissue disease (SLE, scleroderma, CREST, RA)
  • Known histopathology based esophageal motor disorder, e.g. achalasia
  • Prior thoracic or foregut surgery (excluding cholecystectomy)
  • Prior thoracic radiation therapy
  • Hiatus hernia >2 cm as judged during EGD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444066

Locations
United States, Missouri
Barnes Jewish Hospital
St Louis, Missouri, United States, 63112
Washington University
St Louis, Missouri, United States, 63112
Sponsors and Collaborators
Washington University School of Medicine
  More Information

No publications provided

Responsible Party: C. Prakash Gyawali, Professor of Medicine, Division of Gastroenterology, Principal Investigator, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01444066     History of Changes
Other Study ID Numbers: 201106053
Study First Received: September 28, 2011
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014