PROGRESSIVE ESOPHAGEAL DILATION FOR BENIGN STRICTURES: A RANDOMIZED CONTROLLED TRIA

Phase 3

Completed

• Conditions: benign esophageal narrowing; benign esophageal stricture; 10018008

• Registration Number: NL-OMON43360
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Dysphagia due benign esophageal stricture requiring esophageal dilation (e.g. surgery, radiation therapy, caustic ingestion, peptic injury, photodynamic therapy)
- 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 coagulopathy
- Patients with a benign stricture due to a previous performed laryngectomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to prospectively evaluate the efficacy of esophageal<br /><br>dilation according to the rule of 3 compared with the rule of > 3 in patients<br /><br>with severe benign esophageal strictures.<br /><br>Efficacy:<br /><br>- Total number of dilation sessions during dilation to 16-18mm and within 6<br /><br>months of follow-up</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Number of patients remaining dysphagia free within 6 months after dilation to<br /><br>16-18mm (measured with dysphagia diary)<br /><br>- Time from first dilation session to dilation of 16-18mm<br /><br>- Time to dilation of recurrent stricture after initial dilation to 16-18mm<br /><br>- Safety: mortality, serious adverse event and adverse events<br /><br>- Quality of Life (measured with EQ5D questionnaire)<br /><br>- Direct medicals costs: procedures, secondary interventions<br /><br>- Technical success<br /><br>* Definition: defined as ease of dilation with multiple Savary bougie<br /><br>implantations of different sizes at the required location of stenosis.</p><br>