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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastrostomy Tube | Active Comparator | Gastrostomy Tube insertion for palliation |
|
| Esophageal Stent | Active Comparator | Self Expanding Esophageal stent insertion for palliation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastrostomy Tube | Procedure | Feeding gastrostomy tube insertion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| FACT-E | • Change in FACT-E scores | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | • The rates of grade 1 to 5 complications as per the TSQIC | 3 months |
| Crossover | Rate of crossover from initial intervention to comparator arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha So, MSc | Contact | 15196858500 | Samantha.so@lhsc.on.ca | |
| Deb Lewis, BSc | Contact | Deb.Lewis@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Rahul Nayak, MD MSc | London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre - Victoria Hospital | London | Ontario | N6A 5W9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32122974 | Background | 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. | |
| 30949884 | 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. |
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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.
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This study is a single centre, prospective, feasibility randomized controlled clinical trial.
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| Self Expanding Metal esophageal Stent |
| Device |
Fully covered SEMS in the esophagus |
|
| 3 months |
| 26095567 | 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. |
| 29225081 | 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. |
| 19473211 | 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. |
| 39131143 | 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. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |