NCT01894763

Brief Summary

Esophageal cancer often causes difficulty swallowing (dysphagia) that can be relieved by placement of a stent (a flexible, expandable tube that props open the blockage caused by the cancer). Stents are effective but can cause complications. Stents come in different diameters. The purpose of this study is to learn if stents of different diameters are more or less effective for treatment of dysphagia caused by esophageal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2003

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

5.7 years

First QC Date

June 26, 2013

Last Update Submit

July 4, 2013

Conditions

Esophageal Cancer

Keywords

esophaguscancer

Outcome Measures

Primary Outcomes (3)

  • Relief of dysphagia

    Number of participants with improvement in dysphagia score to \<2

    1 month following stent placement

  • Complications

    Number of participants who experience stent-related symptoms (including chest pain, recurrent dysphagia, hematemesis, melena, palpitations) or complications (including gastrointestinal hemorrhage, esophago-respiratory fistula, stent migration, stent occlusion) from the time of stent placement until death or 5-year follow-up.

    from stent placement to death or 5 years of follow-up, whichever comes first

  • Mortality

    Time (in days) from stent placement to death, assessed by Kaplan-Meier analysis

    from stent placement to death or 5 years of follow-up, whichever comes first

Secondary Outcomes (2)

  • Endoscopic re-intervention

    from stent placement to death or 5 years of follow-up, whichever comes first

  • performance status

    from stent placement to death or 5 years of follow-up, whichever comes first

Study Arms (2)

Small-diameter stent

ACTIVE COMPARATOR

Placement of a 23 mm self-expandable metal stent

Device: Self-expandable metal stent

Large-diameter stent

ACTIVE COMPARATOR

Placement of a 28-mm self-expandable metal stent

Device: Self-expandable metal stent

Interventions

Self-expandable metal stentDEVICE

Placement of a self-expandable metal stent in the esophagus

Also known as: Ultraflex Esophageal Stents
Large-diameter stentSmall-diameter stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18 years
  • dysphagia due to unresectable esophageal cancer
  • participant resides within 50 km of Tenwek Hospital
  • tumor is ≤ 9 cm in length and \> 2 cm distal to the upper esophageal sphincter (UES)
  • no esophago-respiratory fistula (ERF) or suspected perforation is present

You may not qualify if:

  • unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tenwek Hospital

Bomet, Kenya

Location

Related Publications (1)

  • White RE, Chepkwony R, Mwachiro M, Burgert SL, Enders FT, Topazian M. Randomized Trial of Small-diameter Versus Large-diameter Esophageal Stents for Palliation of Malignant Esophageal Obstruction. J Clin Gastroenterol. 2015 Sep;49(8):660-5. doi: 10.1097/MCG.0000000000000333.

    PMID: 25992812DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsNeoplasms

Interventions

Self Expandable Metallic Stents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Russell White, M.D.

    Tenwek Hospital, Bomet, Kenya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 10, 2013

Study Start

September 1, 2003

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

July 10, 2013

Record last verified: 2013-07

Locations

KE(1)