Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopic Examination in Patients With Upper Gastrointestinal Bleeding. A Prospective Randomized Trial.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Visual quality of endoscopy
研究概览
简要总结
The researchers will investigate whether erythromycin infusion is better than gastric lavage prior to emergency endoscopy to improve the quality of examination in patients with upper gastrointestinal bleeding.
详细描述
The researchers will investigate whether erythromycin infusion is better than gastric lavage prior to emergency endoscopy to improve the quality of examination in patients with upper gastrointestinal bleeding.
One hundred and twenty-two patients admitted within 12 hours after hematemesis will be randomly assigned to receive erythromycin infusion or gastric lavage by nasogastric tube prior to emergency endoscopy. The endoscopic procedures will be recorded on Digital Video Disc (DVD). Two endoscopists blinded to the cleansing strategy will assess the quality of examination of the upper gastrointestinal tract by using scales designed by Frossard and Avgerinos .
Secondary endpoints will be the need for a second-look endoscopy, the mean number of blood units transfused, the need of surgery or arteriography, and the mean duration of hospitalization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recent hematemesis (<12 hours)
排除标准
- •macrolides allergy
- •pregnancy or lactation
- •treatment with terfenadine, astemizole or cyclosporine
- •prior gastrectomy
研究组 & 干预措施
gastric lavage
gastric lavage by nasogastric tube with 1 liter saline before the endoscopy
干预措施: gastric lavage (Procedure)
erythromycin
administration of 250mgr of erythromycin before the endoscopy
干预措施: Erythromycin (Drug)
结局指标
主要结局
Visual quality of endoscopy
时间窗: The endoscopy will be recorded and subsequently it will be evaluated by two endoscopists unaware of the cleaning strategy. The recording's evaluation will be made within the first 30 days after endoscopy
To assess the visual quality of endoscopy the investigators will use the Avgerinos' score modified by Frossard (Gastroenterology 2002;123:17-23). An score from 0 to 2(0 worst vision, where \< 25% of the surface was visible. 1, 25-75% visible and 2 \>75% visible) was derived from analysis of each area (fundus, body, antrum and bulbus). A score of 6 or greater is considered as a clear stomach, and a score of 5 or lower was considered as a full stomach.
次要结局
- length of endoscopic procedure(within the first 30 days after endoscopy)
- need for a second-look endoscopy(within the first 30 days after endoscopy)
- number of adverse events as a measure of safety and tolerability(within the first 30 days after endoscopy)
- length of hospitalisation(within the first 30 days after endoscopy)
- need for arteriography or surgery(within the first 30 days after endoscopy)
- need of blood transfusion(within 30 days after endoscopy)
研究者
Dr Antonio Soriano Izquierdo
Physician Doctor
Hospital Universitari de Bellvitge