Esophageal Dysmotility - Prospective Study Evaluating Methods for Esophageal Dilation

Effectiveness of Semi-rigid Savary Dilators vs. Balloon Dilators During Esophageal Dilation in the Treatment of Esophageal Dysmotility

The purpose of the study is to prospectively evaluate the most effective treatment of esophageal dysmotility that alleviates symptoms of dysphagia and improves quality of life.

Current practice uses either semi-rigid Savary dilators or balloon dilators for esophageal dilation to treat dysphagia due to esophageal dysmotility. The study aims to show which treatment method is more effective in alleviating symptoms, since there are no other treatments available. The null hypothesis is that there is no difference between the clinical benefits of each treatment.

Study Overview

• Status: Terminated
• Conditions: Esophageal Dysmotility
• Intervention / Treatment: Device: Dilation by Balloon; Device: Dilation by Semi-rigid Savary

Detailed Description

Both the Savary and balloon dilators are used as routine procedure at University of Massachusetts (UMass) Medical School's academic medical center UMass Memorial Health Care (UMMHC). Gastroenterologists are required as part of their training to be familiar with both types of procedures. This study aims to definitively determine which treatment method is more effective in alleviating the symptoms of esophageal dysmotility.

The primary clinical endpoint is to assess the therapeutic efficacy of different types of dilators in an esophageal dilation procedure in patients with esophageal dysmotility. This will be evaluated through the use of the dysphagia scale (Knyrim et al, 1993). The secondary aims are to assess time to relapse, diet improvement, as well as change in quality of life. Investigators will determine time to relapse by time between the dilation procedures. Participants are instructed to contact the GI office to schedule another dilation if they feel as though the therapeutic effect of the procedure has subsided and they are in need of additional relief. Diet will be assessed using the diet score (Cox et al, 1998) and quality of life will be assessed using the Short Form (SF) SF-12 Health Survey.

If patients fail the first procedure, they can be offered the alternative procedure at a later date. Both the patient and physician must agree that the treatment has not worked, and then the patient will be given the opportunity to cross over to the other procedure, still blinded to the device that will be used. Investigators will conduct an interim evaluation to assess the progress of the study and degree of crossover. This will ensure that all subjects are given the opportunity to have both devices used in the event that one is significantly superior to the other.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Umass Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• > 18 years old
• Dysphagia to liquids and/or solids
• Diagnosis of esophageal dysmotility
• Normal endoscopic exam

Exclusion Criteria:

• Diagnosis of achalasia
• Defined strictures or webs
• Vulnerable populations:
• Adults unable to consent (Individuals who are not yet adults (infants, children, teenagers), Pregnant women, Prisoners)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dilation by Balloon; Esophageal dilation by balloon device.	Device: Dilation by Balloon; Esophageal dilation by balloon device.
Active Comparator: Dilation by Semi-rigid Savary; Esophageal dilation by semi-rigid savary device.	Device: Dilation by Semi-rigid Savary; Esophageal dilation by semi-rigid savary device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic Efficacy as Measured by Change in Dysphagia Scale Score	Therapeutic efficacy of different types of dilators in an esophageal dilation procedure in patients with esophageal dysmotility. This will be evaluated through the use of the dysphagia scale (Knyrim 1993). Minimum score is 0. Maximum score is 4. Higher scores indicate a worse outcome. The data presented represent a change from baseline to 6 months calculated as the value at 6 months minus the value at baseline.	Baseline to 6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Relapse	Participants who required esophageal dilation within time frame	Baseline to 6 months
Time to Relapse	For the participants who relapsed, measure of time to relapse based on time from procedure to need for additional dilation due to subsidence of therapeutic effect of procedure.	Initial intervention to second dilation
Diet Dysphagia Score Change	Diet dysphagia score change based on change to Cox diet score, taken from Table 1 of publication Gut, 1988, 29, 1741-1747. The scores are determined based on the foods that cause dysphagia. The minimum value on the score is 0 (no dysphagia), followed by 1 (dysphagia with meat), 2 (dysphagia with bread), 3 (dysphagia with semi-solids), 4 (dysphagia with liquids), and the maximum score is 5 (total dysphagia). A higher score indicates a worse clinical outcome. The data presented represent a change from baseline to 6 months calculated as the value at 6 months minus the value at baseline	baseline to 6 months post procedure

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Principal Investigator: David Cave, MD, Professor of Medicine, UMass Medical School

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2014
• Primary Completion (Actual): November 26, 2016
• Study Completion (Actual): November 26, 2016

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Deglutition Disorders; Esophageal Diseases; Esophageal Motility Disorders; Esophageal Spasm, Diffuse
• Other Study ID Numbers: H00004174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes