A Fully Covered Irradiation Stent for the Palliation of Malignant Dysphagia

June 9, 2017 updated by: Gao-jun Teng, Zhongda Hospital

A Novel Fully Covered Segmented Irradiation Stent Loaded With 125I Seeds for the Palliation of Malignant Dysphagia:a Prospective Pilot Study

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital,Southeast University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
A esophageal fully covered segmented irradiation stent loaded with 125I seeds is placed in Patients with malignant dysphagia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will be followed till die or lost to follow-up, an expected average of 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
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.
Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
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.
Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
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.
Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
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.
During operation
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.
3 days after stent placement
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.
Participants will be followed till die or lost to follow-up, an expected average of 6 months.
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.
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
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.
Participants will be followed till die or lost to follow-up, an expected average of 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

June 7, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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