Gastrostomy Tube vs Stent for Esophageal Cancer

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Overseen ByDeb Lewis, BSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to assist individuals with advanced stomach or esophageal cancer that cannot be surgically removed. It compares the use of a gastrostomy tube (a feeding tube placed directly into the stomach) with a self-expanding metal esophageal stent (a tube that keeps the esophagus open) to determine which one better improves quality of life. Researchers aim to assess the potential for expanding this study on a larger scale, while also monitoring for complications and hospital time required. Suitable candidates have cancer obstructing their stomach or esophagus and have not previously received a feeding tube or stent. As an unphased trial, this study provides a unique opportunity to contribute to research that could influence future treatment options.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using a feeding tube for patients with esophageal cancer is generally safe. Studies indicate that these tubes do not increase the risk of cancer recurrence or cause additional complications. They effectively ease symptoms caused by blockages.

Similarly, self-expanding metal stents for the esophagus are safe and effective. Most patients find swallowing easier after stent placement. The procedure to place these stents typically proceeds smoothly without major issues.

Both treatments are well-tolerated and have strong safety records for patients with esophageal cancer.12345

Why are researchers excited about this trial?

Unlike the standard of care for esophageal cancer, which often involves chemotherapy, radiation, or surgery, the gastroenteral options being explored, such as the gastrostomy tube and the self-expanding metal esophageal stent, focus on palliation—providing relief from symptoms. The gastrostomy tube is unique because it allows direct feeding into the stomach, bypassing the esophagus, which can be crucial when swallowing is difficult. On the other hand, the esophageal stent is designed to keep the esophagus open, making swallowing easier and improving the patient's quality of life. Researchers are excited about these options because they offer non-invasive ways to ease symptoms and potentially improve nutritional intake and comfort for patients dealing with advanced esophageal cancer.

What evidence suggests that this trial's treatments could be effective for esophageal cancer?

This trial will compare gastrostomy tubes (g-tubes) and self-expanding metal esophageal stents for patients with esophageal cancer. Studies have shown that g-tubes safely and effectively provide nutrition, managing severe swallowing problems with good safety outcomes. In this trial, some participants will receive a gastrostomy tube. Others will receive a self-expanding metal esophageal stent, which research indicates can quickly relieve swallowing difficulties in about 87% of patients. These stents have been found to maintain esophageal openness for extended periods, with some types lasting up to eight months. Both treatments aim to improve the quality of life for patients with advanced esophageal cancer.678910

Who Is on the Research Team?

RN

Rahul Nayak, MD MSc

Principal Investigator

London Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for patients with inoperable esophageal or stomach cancer, specifically at the gastroesophageal junction (GEJ). It's focused on those who haven't had previous treatments that would interfere with the study. Details about specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am 18 or older with advanced cancer in my stomach or esophagus that cannot be surgically removed.

Exclusion Criteria

Prior Esophageal Stent or gastrostomy tube
I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a gastrostomy tube or esophageal stent for palliation

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Gastrostomy Tube
  • Self Expanding Metal Esophageal Stent
Trial Overview The trial is testing two methods to help manage symptoms: a gastrostomy tube (g-tube) which provides nutrition directly to the stomach, and a self-expanding metal stent that keeps the esophagus open. The goal is to see which method improves quality of life and requires fewer hospital visits over three months.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Gastrostomy TubeActive Control1 Intervention
Group II: Esophageal StentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
678
Recruited
421,000+

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

Lead Sponsor

Trials
668
Recruited
424,000+

Citations

Impact of Percutaneous Endoscopic Gastrostomy Tube ...Weight loss, hospital admissions, surgical complications, and mortality were identical in oesophageal cancer patients referred for CRT, ...
Efficacy of Percutaneous Endoscopic Gastrostomy for ...Conclusion: PEG has less adverse effects on gastric tube production in esophagectomy and may be considered in highly selective patients during preoperative ...
The impact of percutaneous endoscopic gastrostomy on ...The median survival for the PEG group was 38.0 months (range, 6.0–60.3), and for the Non-PEG group, it was 43.5 months (range, 21.5–162.8).
Use of prophylactic and reactive feeding tubes in patients ...In this single-centre cohort study, severe dysphagia and undergoing chemotherapy were identified as risk factors for requiring a feeding tube later on.
Molecular and Clinical OncologyMethods, such as NG, gastrostomy and PEG feeding tubes have been proven to be safe and effective options.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/31397638/
Is Preoperative G-Tube Use Safe for Esophageal Cancer ...Conclusions: G-tube usage was not associated with increased tumor recurrence, anastomotic leak rates, or overall complication rates in this study. Our data ...
S2217 Comparative Outcomes of Gastrostomy Tube ...This study compares short-term outcomes of GI vs IR G-tube placement using real-world data from a large, multi-institutional electronic health record (EMR) ...
Pre-operative percutaneous endoscopic gastrostomy tube ...Our results confirm that PEG tubes are safe prior to neo-adjuvant treatment. Gastric conduit formation was possible in all our patients and the post-operative ...
American Society for Gastrointestinal Endoscopy guideline ...Palliative venting percutaneous endoscopic gastrostomy tube is safe and effective in patients with malignant obstruction.
Risk factors contributing to morbidity associated with ...We aim to determine factors associated with adverse outcomes after feeding tube placement to guide appropriate use of feeding tubes in esophageal carcinoma ...
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