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Evaluating Acid Reflux After Oesophageal Stenting Using Anti-reflux Stents

NCT05303298 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-11-07

No results posted yet for this study

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 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.

Conditions

  • Esophageal Cancer
  • Reflux, Gastroesophageal

Interventions

DEVICE

Anti-reflux oesophageal stent

Fully covered self-expanding metal stent with anti-reflux mechanism

DEVICE

Conventional oesophageal stent

Fully covered self-expanding metal stent without an anti-reflux mechanism

Sponsors & Collaborators

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Matthias F Scriba, FCS (SA) · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2025-10-01
Completion
2025-12-01

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05303298 on ClinicalTrials.gov