Optimal Management of Malignant Dysphagia

Not Applicable

Terminated

• Conditions: Malignant Dysphagia; Esophageal Cancer
• Interventions: Procedure: Stent insertion; Radiation: Brachytherapy

• Registration Number: NCT01366833
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

According to the Canadian Cancer Society there are approximately 1700 new cases of esophageal cancer per year in Canada. As most of these patients are diagnosed in advanced stages of the disease, 1800 deaths are estimated from this cancer annually . Progressive dysphagia is the most common presenting symptom and impacts not only the patient's quality of life but the ability to tolerate life prolonging treatments such as systemic chemotherapy.

Although there are several therapeutic modalities to alleviate malignant dysphagia including laser, photodynamic therapy and cryotherapy , the use of stents and radiotherapy are the most commonly employed. However, the optimal approach to effective, timely treatment of malignant dysphagia remains a challenge. The investigators conducted a preliminary retrospective review to investigate such palliation procedures and found that a multi-modality approach may yield the most favourable results .

Therefore, our clinical trial will examine the effectiveness of adding a single dose of brachytherapy to patients with severe dysphagia who have already been treated with a endoscopically placed self-expanding metallic stent.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-06
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Age ≥18 years
• Confirmed esophageal/gastroesophageal (GEJ) cancer (Siewert Type I and Type II only) of any histology on biopsy
• Dysphagia score ≥2
• Stage IV cancer/Metastatic disease

Exclusion Criteria

• Expected life expectancy < 3 months
• Inability to undergo stent insertion
• Siewert Type III gastroesophageal cancer
• Esophageal-Airway fistula

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self-expanding stent alone	Stent insertion	All patients in Arm A will receive self-expanding stent alone
Brachytherapy and Stent therapy	Brachytherapy	-

Primary Outcome Measures

Name	Time	Method
To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks	2 years

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada