Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01444066 |
| Other study ID # |
201106053 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2011 |
| Est. completion date |
October 24, 2013 |
Study information
| Verified date |
June 2020 |
| Source |
Washington University School of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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
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.
