An interventional study of Fully covered irradiation stent in Malignant Dysphagia, sponsored by Zhongda Hospital. Status unknown at 1 site in China. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-06-14.
Sponsored by Zhongda Hospital · Not applicable, Interventional, and Treatment
Dysphagia is the major symptom of patients with malignant esophageal stricture caused predominantly by advanced esophageal cancer. Stent placement is the most commonly used strategies for relieving the dysphagia and a novel irradiation stent loaded with 125I seeds has recently been developed. A multicentre randomized clinical trial demonstrated this irradiation stent can relieve the dysphagia rapidly and prolong the survival of patients with advanced esophageal cancer, but the total stent stenosis rate cannot be ruduced. A novel fully covered segmented retrievable irradiation stent was developed in our institute. The purpose of this study is to evaluate the safety and clinical efficacy of this newly developed irradiation stent in patients with unresectable malignant dysphagia.
Esophageal cancer is the eighth most common cancer and the sixth leading cause of cancer related mortality worldwide. Most patients have lost chance of surgical resection when they are initially diagnosed, because of late stage cancer or metastasis. Dysphagia is the major symptom of patients with advanced esophageal cancer. The two most commonly used strategies for relieving the dysphagia are stent placement and intraluminal brachytherapy. Stent placement provides a fast improvement of dysphagia, while intraluminal brachytherapy provides a more durable effect on dysphagia. To combine the advantages of the immediate relief of esophageal dysphagia with stent placement and long-term benefit with brachytherapy, a novel irradiation stent loaded with 125I seeds has been developed in the authors' institute. Recently, a multicentre randomized clinical trial demonstrated this novel irradiation stent can relieve the dysphagia rapidly and prolong the survival of patients with advanced esophageal cancer. However, this irradiation stent only provides a slightly longer relief of dysphagia and cannot reduce the total stent stenosis rate, because partly covered stent with uncoated flanges on both ends for anchoring the stent are used. In the past few years, fully covered retrievable stents which allow less tissue overgrowth have been used in patients with longer life expectancy, especially if they are receiving additional palliative therapy like brachytherapy. In order to provide a further longer relief of dysphagia and prevent stent migration caused by tumor regresses with brachytherapy, a fully covered segmented retrievable irradiation stent has been developed. The aim of the current study is to evaluate the clinical efficacy, particularly focus on stent stenosis and stent migration, and safety of this newly developed irradiation stent in patients with unresectable malignant dysphagia.
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Exclusion Criteria:
A esophageal fully covered segmented irradiation stent loaded with 125I seeds is placed in Patients with malignant dysphagia
Device: Fully covered irradiation stent
A esophageal fully covered segmented irradiation stent loaded with 125I seeds is placed in Patients with malignant dysphagia
Recurrent dysphagia
The rate of occurrence of tissue ingrowth or overgrowth, stent migration, and food obstruction.
Time frame: Participants will be followed till die or lost to follow-up, an expected average of 6 months.
Dysphagia score
Investigated with the Ogilvie score: 0 for nil, 1 for normal diet avoiding certain foods such as raw apple and steak, 2 for semi-solid diet, 3 for fluids only, and 4 for complete dysphagia, even for liquids.
Time frame: Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
ECOG performance status
Utilizing ECOG performance status score to assess the functional status.
Time frame: Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
EORTC QLQ-C30
Utilizing EORTC QLQ-C30 to assess the health-related quility of life.
Time frame: Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
EORTC QLQ-OG25
Utilizing EORTC QLQ-OG25 to assess the health-related quility of life in patients with cancer of the oesophagus and the oesophago-gastric junction.
Time frame: Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Technical success
The rate of adequate placement of the stent in the target position and good passage of contrast medium through the stent into the stomach.
Time frame: During operation
Clinical success
The rate of relief of dysphagia with a decrease of at least one point in the dysphagia score.
Time frame: 3 days after stent placement
Overall survival
Time from initial stenting to the day when the patients died or lost to follow-up.
Time frame: Participants will be followed till die or lost to follow-up, an expected average of 6 months.
Stent patency
Time from initial stenting to the day when recurrent dysphagia occured or patients died.
Time frame: Participants will be followed till die or lost to follow-up, an expected average of 6 months.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse events including hemorrhage, perforation, fistula, severe chest pain, and pneumonia.
Time frame: Participants will be followed till die or lost to follow-up, an expected average of 6 months.
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Zhongda Hospital