Esophageal Cancer Clinical Trial
Official title:
Evaluating Gastro-oesophageal Reflux After Palliative Stenting for Malignant Distal Oesophageal Obstruction Using Anti-Reflux Stents: a Randomised Controlled Trial
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | December 1, 2025 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
South Africa | University of Cape Town | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
University of Cape Town |
South Africa,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective gastro-oesophageal reflux (GOR) - change in GOR over specified time periods | Self-reported symptomatic reflux using a validated reflux patient questionnaire - the GerdQ questionnaire. GerdQ: score ranges from 0 - 18 points with higher scores equating to higher GOR rates. | Will be assessed pre-intervention and then at 1, 2, 4, and 8 weeks post intervention | |
Primary | Objective gastro-oesophageal reflux (GOR) | Objective measure of GOR will be done using oesophageal scintigraphy | Will be performed as a once-off investigation on day 1 post stenting | |
Secondary | Dysphagia - change in dysphagia over specified time periods | Dysphagia will be assessed pre- and post intervention using a validated 5 part dysphagia score described by Knyrim et al - scores are reported as 0 - 5, with higher scores indicating more severe dysphagia. | Will be assessed pre-intervention and then at 1, 2, 4, and 8 weeks post intervention | |
Secondary | Pain - Change in pain over specified time periods | Pain will be assessed using a validated visual analog pain score using pictures of faces to signify pain. Pain will be rated from 0 - 5, with higher scores indicating more severe pain | Will be assessed pre-intervention and then at 1, 2, 4, and 8 weeks post intervention | |
Secondary | Cough - change in pain over specified time periods | Cough will be assessed using a validated cough score, the Simplified Cough Score assessing both daytime and night-time cough severity. Score will range from 0 - 6, with higher score indicating worse cough symptoms. | Will be assessed pre-intervention and then at 1, 2, 4, and 8 weeks post intervention | |
Secondary | Stent-related complications | All complications related to the stent insertion and later complications related to the stent will be documented | Documentation will occur at the time of stent insertion, day 1 post insertion and then at scheduled follow-ups at weeks 1, 2, 4 and 8 post-insertion or aat any time during the study period if a stent-related complication is reported | |
Secondary | Survival | Participant survival will be documented at the end of the study period | Documented at 8 weeks post stent insertion |
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