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A Fully Covered Irradiation Stent for the Palliation of Malignant Dysphagia

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ClinicalTrials.gov Identifier: NCT03186014
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Gao-jun Teng, Zhongda Hospital

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.

Condition or disease Intervention/treatment Phase
Malignant Dysphagia Device: Fully covered irradiation stent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Fully Covered Segmented Irradiation Stent Loaded With 125I Seeds for the Palliation of Malignant Dysphagia:a Prospective Pilot Study
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fully covered irradiation stent
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




Primary Outcome Measures :
  1. Recurrent dysphagia [ Time Frame: Participants will be followed till die or lost to follow-up, an expected average of 6 months. ]
    The rate of occurrence of tissue ingrowth or overgrowth, stent migration, and food obstruction.


Secondary Outcome Measures :
  1. Dysphagia score [ Time Frame: Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months ]
    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.

  2. ECOG performance status [ Time Frame: Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months ]
    Utilizing ECOG performance status score to assess the functional status.

  3. EORTC QLQ-C30 [ Time Frame: Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months ]
    Utilizing EORTC QLQ-C30 to assess the health-related quility of life.

  4. EORTC QLQ-OG25 [ Time Frame: Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months ]
    Utilizing EORTC QLQ-OG25 to assess the health-related quility of life in patients with cancer of the oesophagus and the oesophago-gastric junction.

  5. Technical success [ Time Frame: During operation ]
    The rate of adequate placement of the stent in the target position and good passage of contrast medium through the stent into the stomach.

  6. Clinical success [ Time Frame: 3 days after stent placement ]
    The rate of relief of dysphagia with a decrease of at least one point in the dysphagia score.

  7. Overall survival [ Time Frame: Participants will be followed till die or lost to follow-up, an expected average of 6 months. ]
    Time from initial stenting to the day when the patients died or lost to follow-up.

  8. Stent patency [ Time Frame: Participants will be followed till die or lost to follow-up, an expected average of 6 months. ]
    Time from initial stenting to the day when recurrent dysphagia occured or patients died.

  9. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Participants will be followed till die or lost to follow-up, an expected average of 6 months. ]
    Adverse events including hemorrhage, perforation, fistula, severe chest pain, and pneumonia.



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186014


Contacts
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Contact: Chao Wang, Ph.D +86 151 9585 3100 wangchaoseu@126.com

Locations
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China, Jiangsu
Zhongda Hospital,Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Chao Wang       wangchaoseu@126.com   
Sponsors and Collaborators
Zhongda Hospital
Investigators
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Principal Investigator: Gao-jun Teng, Ph.D,MD Zhongda Hospital Southeast University

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Responsible Party: Gao-jun Teng, Director of Department of Interventional Radiology & Vascular Surgery, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT03186014     History of Changes
Other Study ID Numbers: 2017ZDSYLL027
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gao-jun Teng, Zhongda Hospital:
Malignant dysphagia
Stent
Esophageal neoplasms
Brachytherapy

Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases