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

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: Unknown
• Conditions: Benign Esophageal Stricture
• Intervention / Treatment: Device: Savary bougie dilation

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: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bram Vermeulen, Drs.; Phone Number: +31 0611079557; Email: bram.vermeulen@radboudumc.nl
• Study Contact Backup: Name: Peter Siersema, Dr.; Phone Number: +31 06 547 84 967; Email: peter.siersema@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500HB
      • Recruiting
      • Radboudumc
      • Contact: Joost Drenth, Dr.; Phone Number: +31 024 3613999; Email: Joost.Drenth@radboudumc.nl

Participation Criteria

Eligibility Criteria

• 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

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
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

Outcome Measure	Measure Description	Time Frame
Total number of dilation procedures within 6 months of follow-up	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	Total number of dilation procedures during first dilation session to 16-18mm	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysphagia free patients	Number of patients remaining dysphagia free within 6 months after dilation to 16-18mm	6 months
Timeframe first dilation session	Time from first dilation session to dilation of 16-18mm	1 month
Dysphagia free time period	Time to dilation of recurrent stricture after initial dilation to 16-18mm	6 months
Incidence of treatment-related mortality (serious) adverse events (safety)	Incidence of treatment-related mortality (serious) adverse events (safety)	7 months
Quality of Life	SF-36, disease specific questionnaire	6 months
Medical costs	Direct medicals costs: procedures, secondary interventions	7 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Constriction, Pathologic; Esophageal Stenosis
• Other Study ID 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