Evaluating anti-reflux stents for patients with esophageal cancer
Evaluating Gastro-oesophageal Reflux After Palliative Stenting for Malignant Distal Oesophageal Obstruction Using Anti-Reflux Stents: a Randomised Controlled Trial
This study is testing whether special anti-reflux stents can help adults with advanced esophageal cancer who have trouble swallowing and deal with reflux after getting a stent.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cape Town Academic / other |
| Locations | 1 site (Cape Town, Western Cape) |
| Trial ID | NCT05303298 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of anti-reflux stents in patients with advanced esophageal cancer who experience dysphagia due to obstructive tumors. It aims to compare the outcomes of patients receiving anti-reflux stents versus conventional stents, focusing on the management of gastroesophageal reflux, a common complication following stent placement. The trial includes adult patients with histologically confirmed malignancy of the distal esophagus or esophagogastric junction, who are not candidates for curative treatment. Participants will be monitored for symptom relief and quality of life improvements post-stenting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with obstructive or irresectable esophageal cancer confirmed by histology.
Not a fit: Patients with benign esophageal conditions or those selected for curative treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients suffering from dysphagia due to esophageal cancer by reducing acid reflux symptoms.
How similar studies have performed: While there have been numerous trials on stenting for esophageal cancer, the evidence regarding the effectiveness of anti-reflux stents remains conflicting, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients - 18 years of age or older * Informed consent obtained from the patient after oral and written explanation of the trial * Histologically confirmed malignancy of the distal oesophagus or OGJ * Obstructive or irresectable malignancy due to metastases, local tumour infiltration or poor performance status * Once deployed, the distal end of the stent must have crossed the OGJ junction and be lying within the proximal stomach Exclusion Criteria: * Patient declining or unable to give informed consent, including inability to speak or understand either English, Afrikaans or isiXhosa (the three most commonly spoken local languages). * Patient unable to comply with the follow-up protocol of the trial (e.g. does not have a contactable telephone number) * Oesophageal cancers selected for curative treatment or irresectable oesophageal cancers selected for palliative chemoradiation, but not requiring oesophageal stenting * Benign oesophageal pathology or extrinsic compression of the oesophagus from another cause * Patients with oesophageal cancers where the stent does not cross the OGJ * Pregnant patients * Patient performance status precluding any intervention or sedation
Where this trial is running
Cape Town, Western Cape
- University of Cape Town — Cape Town, Western Cape, South Africa (Recruiting)
Study contacts
- Principal investigator: Matthias F Scriba, FCS (SA) — University of Cape Town
- Study coordinator: Matthias F Scriba, FCS (SA)
- Email: matthias.scriba@gmail.com
- Phone: +27 82 295 2611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.