Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03192098
Recruitment Status : Unknown
Verified May 2017 by Radboud University.
Recruitment status was:  Recruiting
First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief 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.

Condition or disease Intervention/treatment Phase
Benign Esophageal Stricture Device: Savary bougie dilation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled patient groups
Masking: Single (Participant)
Masking Description: Participant will be blinded for dilation strategy.
Primary Purpose: Treatment
Official Title: Progressive Versus Conservative Dilation Strategy for Benign Esophageal Strictures: a Randomized Controlled Trial
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : May 1, 2019

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Dysphagia free patients [ Time Frame: 6 months ]
    Number of patients remaining dysphagia free within 6 months after dilation to 16-18mm

  2. Timeframe first dilation session [ Time Frame: 1 month ]
    Time from first dilation session to dilation of 16-18mm

  3. Dysphagia free time period [ Time Frame: 6 months ]
    Time to dilation of recurrent stricture after initial dilation to 16-18mm

  4. Incidence of treatment-related mortality (serious) adverse events (safety) [ Time Frame: 7 months ]
    Incidence of treatment-related mortality (serious) adverse events (safety)

  5. Quality of Life [ Time Frame: 6 months ]
    SF-36, disease specific questionnaire

  6. Medical costs [ Time Frame: 7 months ]
    Direct medicals costs: procedures, secondary interventions



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192098


Contacts
Layout table for location contacts
Contact: Bram Vermeulen, Drs. 0611079557 ext +31 bram.vermeulen@radboudumc.nl
Contact: Peter Siersema, Dr. 06 547 84 967 ext +31 peter.siersema@radboudumc.nl

Locations
Layout table for location information
Netherlands
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: Joost Drenth, Dr.    024 3613999 ext +31    Joost.Drenth@radboudumc.nl   
Sponsors and Collaborators
Radboud University

Layout table for additonal information
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03192098     History of Changes
Other Study ID Numbers: NL.60222.901.16
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases