Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial

NCT03192098 | Unknown DMC

• 1 other identifier: NL.60222.901.16
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Esophageal Stricture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Dysphagia free patients

  6 months

• Timeframe first dilation session

  1 month

• Dysphagia free time period

  6 months

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

  7 months

• Quality of Life

  6 months

Study Arms (2)

Progressive

EXPERIMENTAL

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

Device: Savary bougie dilation

Conservative (rule-of-3)

ACTIVE COMPARATOR

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

Device: Savary bougie dilation

Interventions

Savary bougie dilation DEVICE

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

Conservative (rule-of-3); Progressive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

RECRUITING

Central Study Contacts

Bram Vermeulen, Drs.

CONTACT

0611079557; bram.vermeulen@radboudumc.nl

Peter Siersema, Dr.

CONTACT

06 547 84 967; peter.siersema@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded for dilation strategy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled patient groups

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 19, 2017
• Study Start: May 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: May 1, 2019
• Last Updated: June 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)