Status:
UNKNOWN
Evaluating Acid Reflux After Oesophageal Stenting Using Anti-reflux Stents
Lead Sponsor:
University of Cape Town
Conditions:
Esophageal Cancer
Reflux, Gastroesophageal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Oesophageal cancer is an aggressive condition, resulting in the vast majority of patients having evidence of locally invasive, irresectable disease or distant metastases at the time of presentation. O...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05303298
Start Date
October 1 2022
End Date
December 1 2025
Last Update
November 7 2022
Active Locations (1)
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1
University of Cape Town
Cape Town, Western Cape, South Africa, 7925