Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial (DILATE)

June 15, 2017 updated by: Radboud University Medical Center

Progressive Versus Conservative Dilation Strategy for Benign Esophageal Strictures: a Randomized Controlled Trial

A randomized controlled prospective clinical trial assessing the efficacy and safety of progressive esophageal dilation compared to conservative esophageal dilation in patients with severe benign esophageal strictures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A randomized controlled prospective clinical trial assessing the efficacy and safety of progressive esophageal dilation (up to 6mm) compared to esophageal dilation according to the rule-of-3 in patients with severe benign esophageal strictures. Patients will be followed up for 6 months. When recurrent dysphagia occurs within 6 months the patients will be dilated according to the previously allocated strategy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dysphagia due to benign esophageal stricture (e.g. surgery, radiation therapy, caustic ingestion, peptic injury, photodynamic therapy) requiring esophageal dilation
  • Requiring first esophageal dilation for dysphagia due to a severe benign esophageal stricture with no patency for standard upper endoscope (9-10mm diameter)
  • No history of esophageal endoscopic dilations for benign strictures the past 6 months
  • Dysphagia for solid, semisolid or liquid food (dysphagia score ≥ 2 [Ogilvie]16, and dysphagia score ≤ 21 [Dakkak and Bennett]19, see appendix)
  • Written informed consent

Exclusion Criteria:

  • Patient < 18 years old
  • Patient is unwilling or unable to sign and date the informed consent
  • Patient is unwilling or unable to comply with the follow-up schedule
  • Patient is unable to understand informed consent and fill in the questionnaires due to a language barrier
  • Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 month
  • Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study
  • Previous esophageal dilation for benign stricture within the past 6 months
  • Patient with a life expectancy < 12 months
  • Patient with a known eosinophilic esophagitis or motility disorder (such as achalasia)
  • Patients with a known malignant esophageal stricture
  • Patients with a benign stricture due to a previous performed laryngectomy

Endoscopic exclusion criteria:

  • Benign strictures in the upper part of the esophagus too close to the cricopharyngeal muscle (for the purpose of this protocol, within 1½ cm of the upper esophageal sphincter)
  • Patients with stricture ≥ 10 cm in length
  • Patients with an active esophageal perforation, leak, fistula, or varices
  • Stricture within necrotic chronically bleeding tumors
  • Highly suspected esophageal malignancy
  • Stricture within polypoid lesions
  • Known or strongly suspected dysmotility esophageal disorder
  • Patient with high suspicion for an esophageal web, Schatzki ring, eosinophilic esophagitis, or motility disorder (such as achalasia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Progressive
Patients will be dilated > 3mm and can be dilated up to 6mm in diameter
Device: Savary bougie dilation
Patients will be dilated with the use of the Savary bougienage device
Active Comparator: Conservative (rule-of-3)
Patients will be dilated according to the rule-of-3 (i.e. dilation of no more than 3mm in diameter)
Device: Savary bougie dilation
Patients will be dilated with the use of the Savary bougienage device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total number of dilation procedures within 6 months of follow-up
Time Frame: 6 months
Total number of dilation procedures within 6 months of follow-up
6 months
Total number of dilation procedures during first dilation session to 16-18mm
Time Frame: 1 month
Total number of dilation procedures during first dilation session to 16-18mm
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dysphagia free patients
Time Frame: 6 months
Number of patients remaining dysphagia free within 6 months after dilation to 16-18mm
6 months
Timeframe first dilation session
Time Frame: 1 month
Time from first dilation session to dilation of 16-18mm
1 month
Dysphagia free time period
Time Frame: 6 months
Time to dilation of recurrent stricture after initial dilation to 16-18mm
6 months
Incidence of treatment-related mortality (serious) adverse events (safety)
Time Frame: 7 months
Incidence of treatment-related mortality (serious) adverse events (safety)
7 months
Quality of Life
Time Frame: 6 months
SF-36, disease specific questionnaire
6 months
Medical costs
Time Frame: 7 months
Direct medicals costs: procedures, secondary interventions
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL.60222.901.16

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

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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