Optimal Nutritional Palliation of Obstructed GEJ Cancer

NCT06876454 | Not Yet Recruiting

• 1 other identifier: Nutrition Palliation of GEJ Ca
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer

Keywords

metastatic; obstructing

Outcome Measures

Primary Outcomes (1)

• FACT-E

  • Change in FACT-E scores

  3 months

Secondary Outcomes (2)

• Complications

  3 months

• Crossover

  3 months

Study Arms (2)

Gastrostomy Tube

ACTIVE COMPARATOR

Gastrostomy Tube insertion for palliation

Procedure: Gastrostomy Tube

Esophageal Stent

ACTIVE COMPARATOR

Self Expanding Esophageal stent insertion for palliation

Device: Self Expanding Metal esophageal Stent

Interventions

Gastrostomy Tube PROCEDURE

Feeding gastrostomy tube insertion

Gastrostomy Tube

Self Expanding Metal esophageal Stent DEVICE

Fully covered SEMS in the esophagus

Esophageal Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Related Publications (6)

• Brenner DR, Weir HK, Demers AA, Ellison LF, Louzado C, Shaw A, Turner D, Woods RR, Smith LM; Canadian Cancer Statistics Advisory Committee. Projected estimates of cancer in Canada in 2020. CMAJ. 2020 Mar 2;192(9):E199-E205. doi: 10.1503/cmaj.191292. Epub 2020 Mar 2.

  PMID: 32122974 BACKGROUND

• Kakuta T, Kosugi SI, Ichikawa H, Hanyu T, Ishikawa T, Kanda T, Wakai T. Palliative interventions for patients with incurable locally advanced or metastatic thoracic esophageal carcinoma. Esophagus. 2019 Jul;16(3):278-284. doi: 10.1007/s10388-019-00665-0. Epub 2019 Apr 4.

  PMID: 30949884 BACKGROUND

• Philips P, North DA, Scoggins C, Schlegel M, Martin RC. Gastric-Esophageal Stenting for Malignant Dysphagia: Results of Prospective Clinical Trial Evaluation of Long-Term Gastroesophageal Reflux and Quality of Life-Related Symptoms. J Am Coll Surg. 2015 Jul;221(1):165-73. doi: 10.1016/j.jamcollsurg.2015.01.062. Epub 2015 Feb 28.

  PMID: 26095567 BACKGROUND

• Yu FJ, Shih HY, Wu CY, Chuang YS, Lee JY, Li HP, Fang PT, Tsai DL, Chou SH, Wu IC. Enteral nutrition and quality of life in patients undergoing chemoradiotherapy for esophageal carcinoma: a comparison of nasogastric tube, esophageal stent, and ostomy tube feeding. Gastrointest Endosc. 2018 Jul;88(1):21-31.e4. doi: 10.1016/j.gie.2017.11.030. Epub 2017 Dec 7.

  PMID: 29225081 BACKGROUND

• Madhusudhan C, Saluja SS, Pal S, Ahuja V, Saran P, Dash NR, Sahni P, Chattopadhyay TK. Palliative stenting for relief of dysphagia in patients with inoperable esophageal cancer: impact on quality of life. Dis Esophagus. 2009;22(4):331-6. doi: 10.1111/j.1442-2050.2008.00906.x.

  PMID: 19473211 BACKGROUND

• Amin S, Lin C. Immunotherapy Plus Chemoradiation Improves Overall Survival in Stage IV Esophageal Cancer: A Cohort Study. Gastro Hep Adv. 2023 Dec 12;3(3):302-310. doi: 10.1016/j.gastha.2023.12.004. eCollection 2024.

  PMID: 39131143 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Rahul Nayak, MD MSc

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha So, MSc

CONTACT

15196858500; Samantha.so@lhsc.on.ca

Deb Lewis, BSc

CONTACT

Deb.Lewis@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: This study is a single centre, prospective, feasibility randomized controlled clinical trial.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CA (1)