Clinical trial NCT03186014: A Fully Covered Irradiation Stent for the Palliation of Malignant Dysphagia
Official title: A Novel Fully Covered Segmented Irradiation Stent Loaded With 125I Seeds for the Palliation of Malignant Dysphagia：a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Dysphagia
Keywords: Malignant dysphagia
Stent
Esophageal neoplasms
Brachytherapy
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Endoscopically and histologically confirmed malignant obstruction of the esophagus or the gastroesophageal junction
* Progressive dysphagia with a dysphagia score of 2-4
* Unresectable tumours due to extensive lesions, metastases, or poor medical condition
* Patients with clear consciousness, cooperation
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3
* Informed consent: authorization and signature

Exclusion Criteria:

* The superior border of the lesion extending beyond the level of the seventh cervical vertebrae
* Previous treatment with a stent or surgical resection for the same condition
* Ulcerative esophageal cancer
* Esophageal fistula
* Severe hepatic inadequacy or renal inadequacy

Primary outcomes:
measure: Recurrent dysphagia
timeFrame: Participants will be followed till die or lost to follow-up, an expected average of 6 months.
Secondary outcomes:
measure: Dysphagia score
timeFrame: Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
measure: ECOG performance status
timeFrame: Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
measure: EORTC QLQ-C30
timeFrame: Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
measure: EORTC QLQ-OG25
timeFrame: Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
measure: Technical success
timeFrame: During operation
measure: Clinical success
timeFrame: 3 days after stent placement
measure: Overall survival
timeFrame: Participants will be followed till die or lost to follow-up, an expected average of 6 months.
measure: Stent patency
timeFrame: Participants will be followed till die or lost to follow-up, an expected average of 6 months.
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Participants will be followed till die or lost to follow-up, an expected average of 6 months.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital,Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-jun Teng, Ph.D,MD
role: PRINCIPAL_INVESTIGATOR
References: