Gastrostomy Tube vs Stent for Esophageal Cancer

Overseen By Deb Lewis, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Disqualifiers: Under 18, Prior stent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

33 Participants Needed

Trial Summary

What is the purpose of this trial?

The main goal of this trial is to assess whether it's feasible to conduct a larger, full-scale study comparing the use of gastrostomy (g-tubes) and stents in patients with unresectable cancer of the stomach and/or esophagus, and to evaluate their impact on patients' quality of life. Additional objectives include examining the rates of complications, the need for additional treatments, and the total number of hospital days over a three-month period.

Research Team

Rahul Nayak, MD MSc

Principal Investigator

London Health Sciences Centre

Eligibility Criteria

This trial is for patients with inoperable esophageal or stomach cancer, specifically at the gastroesophageal junction (GEJ). It's focused on those who haven't had previous treatments that would interfere with the study. Details about specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am 18 or older with advanced cancer in my stomach or esophagus that cannot be surgically removed.

Exclusion Criteria

Prior Esophageal Stent or gastrostomy tube

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a gastrostomy tube or esophageal stent for palliation

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Gastrostomy Tube
• Self Expanding Metal Esophageal Stent

Trial Overview The trial is testing two methods to help manage symptoms: a gastrostomy tube (g-tube) which provides nutrition directly to the stomach, and a self-expanding metal stent that keeps the esophagus open. The goal is to see which method improves quality of life and requires fewer hospital visits over three months.

Participant Groups

Group I: Gastrostomy Tube Active Control 1 Intervention

Gastrostomy Tube insertion for palliation

Group II: Esophageal Stent Active Control 1 Intervention

Self Expanding Esophageal stent insertion for palliation

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+