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Safety and Ethics in Endoscopic Studies in Children: Evidence From the BEECH Study in Zambia
Kanta Chandwe1, Beatrice Amadi1, Miyoba Chipunza1
1Tropical Gastroenterology & Nutrition group, University of Zambia School of Medicine, 10101 Lusaka, Zambia.
Insights
Endoscopic biopsy is a safe and valuable procedure for diagnosing environmental enteropathy in children with stunting. This study in Zambia found minimal adverse events and potential clinical benefits, supporting its ethical use in pediatric research.
Area of Science:
- Pediatric Gastroenterology
- Global Health
- Intestinal Diseases
Background:
- Environmental enteropathy (EE) is a significant cause of malabsorption and stunting in children globally.
- While non-invasive diagnostic methods are sought, endoscopic biopsy remains crucial for detailed intestinal analysis (histology, RNA sequencing).
- Limited data exists on the safety of endoscopic biopsy in young, vulnerable children, particularly in resource-limited settings.
Purpose of the Study:
- To evaluate the safety and feasibility of upper gastrointestinal endoscopy with biopsy in children suffering from stunting in Zambia.
- To assess the ethical considerations surrounding endoscopic procedures for research in pediatric populations.
- To explore the potential clinical utility of endoscopy in diagnosing conditions like environmental enteropathy.
Main Methods:
- The study involved 119 children with stunting (length-for-age z-score ≤ -2) undergoing upper gastrointestinal endoscopy.
- Procedures were conducted in Lusaka, Zambia, with conscious sedation administered by anesthetists.
- Safety outcomes, adverse events, and clinical information derived from endoscopy were meticulously recorded.
Main Results:
- A total of 119 children underwent endoscopic biopsy, with only 5 (4%) experiencing transient desaturation; no serious adverse events were reported.
- No specific clinical, demographic, or anesthetic factors predicted desaturation.
- Endoscopy provided clinically useful information in two children, including one life-saving diagnosis. Lactase deficiency was identified in 54% of tested children.
Conclusions:
- Endoscopic biopsy is a safe procedure for children with stunting in resource-limited settings.
- The study met ethical preconditions for research, demonstrating safety and potential clinical benefit.
- Findings support the continued use of endoscopic biopsy for investigating environmental enteropathy and related conditions in pediatric populations.
Background:
Environmental enteropathy is an example of a poorly-understood intestinal disorder affecting millions of children worldwide, characterized by malabsorption and stunting. Although there is increasing interest in non-invasive means of assessing intestinal structure and function, the potential value of intestinal biopsy for histology, immunostaining, RNA sequencing and epigenetic work means that endoscopic biopsy remains extremely valuable. We here report our experience in the BEECH (Biomarkers of Environmental Enteropathy in CHildren) study of stunting in Zambia, in the belief that it may help address the knowledge gap regarding the safety of endoscopic biopsy in vulnerable young children.
Methods:
We report our experience of safety in 119 children undergoing endoscopic biopsy in the BEECH study in Lusaka Children's Hospital, Lusaka, and discuss ethical considerations in this light.
Results:
Upper gastrointestinal endoscopy was performed on children with stunting (length-for-age z score -2 or less) not responsive to nutritional interventions. Conscious sedation was provided by anaesthetists. Of 119 children, 5 (4%) developed transient desaturation, but no serious adverse events were experienced; no clinical, demographic or anaesthetic characteristics were identified as predictive of desaturation. Two children derived clinically useful information from the endoscopy, one life-saving. Of 105 lactase tests, 59 (54%) showed hypolactasia.
Discussion:
Children with stunting underwent endoscopy safely, and some derived clinical benefit. Safety and the possibility of clinical benefit are usually felt to be preconditions for the ethical justification for endoscopy for research in children, and we believe that these conditions were met in this study.
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