Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial

Benign Esophageal Stricture Clinical Trial

— DILATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03192098
• Other study ID #: NL.60222.901.16
• Status: Recruiting
• Phase: N/A
• First received: May 29, 2017
• Last updated: June 15, 2017
• Start date: May 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2017
• Source: Radboud University
• Contact: Bram Vermeulen, Drs.
• Phone: 0611079557
• Email: bram.vermeulen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Benign Esophageal Stricture
• Constriction, Pathologic
• Esophageal Stenosis

Intervention

Device:
• Savary bougie dilation
Patients will be dilated with the use of the Savary bougienage device

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

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