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NCT Number: NCT06876454

Optimal Nutritional Palliation of Obstructed GEJ Cancer

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location contact

Rahul Nayak, MD MSc

CONTACT

[email protected]

15196858500 ext. 56927

Rahul Nayak, MD MSc

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastrostomy Tube

Procedure

Feeding gastrostomy tube insertion

Self Expanding Metal esophageal Stent

Device

Fully covered SEMS in the esophagus

Primary outcomes

  1. FACT-E

    Time frame: 3 months

    • Change in FACT-E scores

Secondary outcomes

  1. Complications

    Time frame: 3 months

    • The rates of grade 1 to 5 complications as per the TSQIC

  2. Crossover

    Time frame: 3 months

    Rate of crossover from initial intervention to comparator arm

Study contacts

Contact information is provided by the study sponsor or research team.

Deb Lewis, BSc

CONTACT

[email protected]

Samantha So, MSc

CONTACT

[email protected]

15196858500

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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