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

Primary Purpose

Benign Esophageal Stricture

Status

Unknown status

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Savary bougie dilation

About this trial

This is an interventional treatment trial for Benign Esophageal Stricture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

RadboudumcRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Progressive

Conservative (rule-of-3)

Arm Description

Patients will be dilated > 3mm and can be dilated up to 6mm in diameter

Patients will be dilated according to the rule-of-3 (i.e. dilation of no more than 3mm in diameter)

Outcomes

Primary Outcome Measures

Total number of dilation procedures within 6 months of follow-up

Total number of dilation procedures during first dilation session to 16-18mm

Secondary Outcome Measures

Dysphagia free patients

Number of patients remaining dysphagia free within 6 months after dilation to 16-18mm

Timeframe first dilation session

Time from first dilation session to dilation of 16-18mm

Dysphagia free time period

Time to dilation of recurrent stricture after initial dilation to 16-18mm

Incidence of treatment-related mortality (serious) adverse events (safety)

Quality of Life

SF-36, disease specific questionnaire

Medical costs

Direct medicals costs: procedures, secondary interventions

Full Information

NCT ID

NCT03192098

First Posted

May 29, 2017

Last Updated

June 15, 2017

Sponsor

Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03192098

Brief Title

Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial

Acronym

DILATE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

November 1, 2018 (Anticipated)

Study Completion Date

May 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Esophageal Stricture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomized controlled patient groups

Masking

Participant

Masking Description

Participant will be blinded for dilation strategy.

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Progressive

Arm Type

Experimental

Arm Description

Patients will be dilated > 3mm and can be dilated up to 6mm in diameter

Arm Title

Conservative (rule-of-3)

Arm Type

Active Comparator

Arm Description

Patients will be dilated according to the rule-of-3 (i.e. dilation of no more than 3mm in diameter)

Intervention Type

Device

Intervention Name(s)

Savary bougie dilation

Intervention Description

Patients will be dilated with the use of the Savary bougienage device

Primary Outcome Measure Information:

Title

Total number of dilation procedures within 6 months of follow-up

Description

Total number of dilation procedures within 6 months of follow-up

Time Frame

6 months

Title

Total number of dilation procedures during first dilation session to 16-18mm

Description

Total number of dilation procedures during first dilation session to 16-18mm

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Dysphagia free patients

Description

Number of patients remaining dysphagia free within 6 months after dilation to 16-18mm

Time Frame

6 months

Title

Timeframe first dilation session

Description

Time from first dilation session to dilation of 16-18mm

Time Frame

1 month

Title

Dysphagia free time period

Description

Time to dilation of recurrent stricture after initial dilation to 16-18mm

Time Frame

6 months

Title

Incidence of treatment-related mortality (serious) adverse events (safety)

Description

Incidence of treatment-related mortality (serious) adverse events (safety)

Time Frame

7 months

Title

Quality of Life

Description

SF-36, disease specific questionnaire

Time Frame

6 months

Title

Medical costs

Description

Direct medicals costs: procedures, secondary interventions

Time Frame

7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bram Vermeulen, Drs.

Phone

0611079557

Ext

+31

bram.vermeulen@radboudumc.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Peter Siersema, Dr.

Phone

06 547 84 967

Ext

+31

peter.siersema@radboudumc.nl

Facility Information:

Facility Name

Radboudumc

City

Nijmegen

State/Province

Gelderland

ZIP/Postal Code

6500HB

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joost Drenth, Dr.

Phone

024 3613999

Ext

+31

Joost.Drenth@radboudumc.nl

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial

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