NCT03186014

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

June 7, 2017

Last Update Submit

June 9, 2017

Conditions

Malignant Dysphagia

Keywords

Malignant dysphagiaStentEsophageal neoplasmsBrachytherapy

Outcome Measures

Primary Outcomes (1)

  • Recurrent dysphagia

    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 Outcomes (9)

  • Dysphagia score

    Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months

  • ECOG performance status

    Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months

  • EORTC QLQ-C30

    Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months

  • EORTC QLQ-OG25

    Baseline, post-op 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months

  • Technical success

    During operation

  • +4 more secondary outcomes

Study Arms (1)

Fully covered irradiation stent

EXPERIMENTAL

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

Device: Fully covered irradiation stent

Interventions

Fully covered irradiation stentDEVICE

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

Fully covered irradiation stent

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Gao-jun Teng, Ph.D,MD

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Wang, Ph.D

CONTACT

+86 151 9585 3100wangchaoseu@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Interventional Radiology & Vascular Surgery

Study Record Dates

First Submitted

June 7, 2017

First Posted

June 14, 2017

Study Start

June 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

CN(1)