Optimal Nutritional Palliation of Obstructed GEJ Cancer

May 21, 2025 updated by: Rahul Nayak, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33

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 Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre - Victoria Hospital
        • Principal Investigator:
          • Rahul Nayak, MD MSc
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 years of age and older who present with an obstructing metastatic or unresectable gastroesophageal cancer.

Exclusion Criteria:

  • Patients under the age of 18 years.
  • Prior Esophageal Stent or gastrostomy tube

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gastrostomy Tube
Gastrostomy Tube insertion for palliation
Procedure: Gastrostomy Tube
Feeding gastrostomy tube insertion
Active Comparator: Esophageal Stent
Self Expanding Esophageal stent insertion for palliation
Device: Self Expanding Metal esophageal Stent
Fully covered SEMS in the esophagus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FACT-E
Time Frame: 3 months
• Change in FACT-E scores
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 3 months
• The rates of grade 1 to 5 complications as per the TSQIC
3 months
Crossover
Time Frame: 3 months
Rate of crossover from initial intervention to comparator arm
3 months

Collaborators and Investigators

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

Sponsor

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

Investigators

  • Principal Investigator: Rahul Nayak, MD MSc, London Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Actual)

May 25, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Nutrition Palliation of GEJ Ca

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

age, date of death, intervention received, complications from intervention, FACT-E score will be available as supplemental data in the final publication. A master list will be kept on site and can be shared if there are other collaborative projects and/or a data audit is required to validate final results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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