An interventional study of Brachytherapy and Stent insertion in Malignant Dysphagia and Esophageal Cancer, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Supportive care
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.
1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.
This study's enrollment of 3 is below the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 420 studies on the registry; 106 are open to participants now.
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Exclusion Criteria:
All patients in Arm A will receive self-expanding stent alone
Procedure: Stent insertion
Radiation: Brachytherapy
Patients in arm B will receive a single dose of brachytherapy (10Gy) via a 10 or 13 mm catheter within 10days of stent insertion. Patients on the study will not be given preferential treatment, and will not be prioritized over patients treated with brachytherapy not on the study.
After placement of clips to mark the proximal and distal extent of the tumor, an endoscopically placed self-expanding metallic stent (WallFlex™ Partially Covered Esophageal Stent by Boston Scientific) will be inserted within 10 days of recruitment. This will be the only intervention in Arm A patients.
To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks
Time frame: 2 years
The record gives a start of Jun 2011, a primary completion of Mar 2017 and a completion of Mar 2017. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre →