Development and validation of hydroxy ethyl starch kits for instant use in gastroesophageal reflux and gastric...

A reduction method based on stannous chloride is described to prepare hydroxy ethyl starch kits for gastrointestinal reflux and gastric motility studies. Following verification of the consistency of radiolabelling, in vitro experiments were carried out to validate 99mTc hydroxy ethyl starch as a liquid phase and solid phase gastric motility imaging radiotracer. Gastroesophageal reflux, liquid phase and solid phase studies were then conducted in 13 adult volunteers to examine the in vivo stability of the radiotracer. High labelling efficiency (>95% when prepared at neutral pH) was consistently achieved, which remained stable in conditions simulating gastric environment. Twelve of the 13 volunteers did not show absorption of any radioactivity from the gastro-intestinal tract. 99mTc hydroxy ethyl starch is a new agent suitable for gastroesophageal reflux and gastric motility studies. It is available in kit form and is a more 'physiological' agent than 99mTc sulphur colloid for preparing a solid radioactive meal. 99mTc hydroxy ethyl starch represents a true carbohydrate meal, and unlike 99mTc sulphur colloid, is easy to prepare and can easily be standardized to produce a standard vegetarian meal.