Optimal Nutritional Palliation of Obstructed GEJ Cancer

NCT ID: NCT06876454

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a single centre, prospective, feasibility randomized controlled clinical trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gastrostomy Tube

Gastrostomy Tube insertion for palliation

Group Type ACTIVE_COMPARATOR

Gastrostomy Tube

Intervention Type PROCEDURE

Feeding gastrostomy tube insertion

Esophageal Stent

Self Expanding Esophageal stent insertion for palliation

Group Type ACTIVE_COMPARATOR

Self Expanding Metal esophageal Stent

Intervention Type DEVICE

Fully covered SEMS in the esophagus

Interventions

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Gastrostomy Tube

Feeding gastrostomy tube insertion

Intervention Type PROCEDURE

Self Expanding Metal esophageal Stent

Fully covered SEMS in the esophagus

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Rahul Nayak

Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rahul Nayak, MD MSc

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

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London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Samantha So, MSc

Role: CONTACT

15196858500

Deb Lewis, BSc

Role: CONTACT

Facility Contacts

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Rahul Nayak, MD MSc

Role: primary

15196858500 ext. 56927

References

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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.

Reference Type BACKGROUND
PMID: 32122974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30949884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26095567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29225081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19473211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39131143 (View on PubMed)

Other Identifiers

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Nutrition Palliation of GEJ Ca

Identifier Type: -

Identifier Source: org_study_id

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