Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial

NCT ID: NCT03192098

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-05-01

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.

Conditions

Benign Esophageal Stricture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Progressive

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

Group Type: EXPERIMENTAL

Savary bougie dilation

Intervention Type: DEVICE

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

Conservative (rule-of-3)

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

Group Type: ACTIVE_COMPARATOR

Savary bougie dilation

Intervention Type: DEVICE

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

Interventions

Savary bougie dilation

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

Intervention Type: DEVICE

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Bram Vermeulen, Drs.

Role: CONTACT

bram.vermeulen@radboudumc.nl

0611079557 ext. +31

Peter Siersema, Dr.

Role: CONTACT

peter.siersema@radboudumc.nl

06 547 84 967 ext. +31

Facility Contacts

Joost Drenth, Dr.

Role: primary

Joost.Drenth@radboudumc.nl

024 3613999 ext. +31

Other Identifiers

NL.60222.901.16

Identifier Type: -

Identifier Source: org_study_id