Benign Esophageal StrictureDILATENCT03192098
Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial
A study testing Savary bougie dilation in people with Benign Esophageal Stricture, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Esophageal Stricture
- What is being tested?
- Savary bougie dilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2017to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6500HB
Joost Drenth, Dr., 024 3613999 ext. +31, Joost.Drenth@radboudumc.nl
About this study
Official title: 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.
Read the 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.
- Conditions
- Benign Esophageal Stricture
- Being tested
- Savary bougie dilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Savary bougie dilationDevice
Patients will be dilated with the use of the Savary bougienage device
| Study group | Role | What they receive |
|---|---|---|
| Progressive | Experimental | Patients will be dilated > 3mm and can be dilated up to 6mm in diameter Receives: Device: Savary bougie dilation |
| Conservative (rule-of-3) | Active comparator | Patients will be dilated according to the rule-of-3 (i.e. dilation of no more than 3mm in diameter) Receives: Device: Savary bougie dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of dilation procedures within 6 months of follow-up
Total number of dilation procedures within 6 months of follow-up
Measured: 6 months
Total number of dilation procedures during first dilation session to 16-18mm
Total number of dilation procedures during first dilation session to 16-18mm
Measured: 1 month
Secondary outcomes (6)
Dysphagia free patients
Number of patients remaining dysphagia free within 6 months after dilation to 16-18mm
Measured: 6 months
Timeframe first dilation session
Time from first dilation session to dilation of 16-18mm
Measured: 1 month
Dysphagia free time period
Time to dilation of recurrent stricture after initial dilation to 16-18mm
Measured: 6 months
Incidence of treatment-related mortality (serious) adverse events (safety)
Incidence of treatment-related mortality (serious) adverse events (safety)
Measured: 7 months
Quality of Life
SF-36, disease specific questionnaire
Measured: 6 months
Medical costs
Direct medicals costs: procedures, secondary interventions
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 May 2017
- Primary completion1 Nov 2018 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Esophageal StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled patient groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192098
- Sponsor's protocol ID
- NL.60222.901.16
- Acronym
- DILATE
- Status last verified
- May 2017
- First submitted
- 29 May 2017
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Versus Conservative Dilation Strategy for Benign Esophageal Strictures: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03192098
- Acronym / sponsor ID
- DILATE / NL.60222.901.16
- Conditions
- Benign Esophageal Stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled patient groups
| Arm | Type | Receives |
|---|---|---|
| Progressive | Experimental | Device: Savary bougie dilationPatients will be dilated > 3mm and can be dilated up to 6mm in diameter |
| Conservative (rule-of-3) | Active comparator | Device: Savary bougie dilationPatients will be dilated according to the rule-of-3 (i.e. dilation of no more than 3mm in diameter) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Savary bougie dilationPatients will be dilated with the use of the Savary bougienage device | Device | Conservative (rule-of-3), Progressive |
Primary outcome
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
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
6 secondary outcomes
Dysphagia free patients
Time frame: 6 months
Timeframe first dilation session
Time frame: 1 month
Dysphagia free time period
Time frame: 6 months
Incidence of treatment-related mortality (serious) adverse events (safety)
Time frame: 7 months
Quality of Life
Time frame: 6 months
Medical costs
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Savary bougie dilation in people with Benign Esophageal Stricture, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bram Vermeulen, Drs. (0611079557 ext. +31, bram.vermeulen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of dilation procedures within 6 months of follow-up (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2017.