Evaluating Acid Reflux After Oesophageal Stenting Using Anti-reflux Stents

Incurable oesophageal cancer remains a global problem and in South Africa the vast majority of patients with oesophageal cancer have advanced disease at first presentation and are not curable. Likely the most distressing symptom of advanced cancer in the oesophagus is dysphagia, which is the inability to swallow solids and later also liquids. This is successfully addressed in most cases by the placement of a stent in the oesophagus which opens the area of obstruction. When placed in the lower oesophagus, one of the major drawbacks of these stents is that they disrupt the anti-reflux mechanism of the oesophago-gastric junction, which can result in severe acid reflux, severely impacting the quality of life of the patient. To address this problem, a range of approved anti-reflux stents have been developed and tested in numerous trials. To date, the evidence is conflicting and there is insufficient current evidence to support the routine use of these stents. However, the trials are not all similar in how the acid reflux was measured or what type of stent was used. Furthermore, the use of anti-reflux medication, such as proton pump inhibitors, which may help reduce reflux, are not standardised across the trials and make further conclusions about these stents difficult to interpret. No data from Sub-Saharan Africa on the use of anti-reflux stents in these patients is available. South Africa faces a large burden of incurable oesophageal cancer and improving the quality of life of these patients is of paramount importance. This randomised controlled trial aims to investigate whether anti-reflux stents do indeed reduce acid reflux in patients with incurable oesophageal cancer compared to conventional oesophageal stents that do not have such an anti-reflux mechanism. Reflux will be measured using patient questionnaires about reflux, and other quality of life parameters, and will also be objectively measured using oesophageal scintigraphy, which has not been used in previous similar trials.

Sex

All

Minimum age

18 Years

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

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