Evaluating anti-reflux stents for patients with esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.