Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopy in Patients With Upper Gastrointestinal Bleeding
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|ClinicalTrials.gov Identifier: NCT01716572|
Recruitment Status : Unknown
Verified October 2015 by Dr Antonio Soriano Izquierdo, Hospital Universitari de Bellvitge.
Recruitment status was: Active, not recruiting
First Posted : October 30, 2012
Last Update Posted : October 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Hemorrhage Hematemesis||Drug: Erythromycin Procedure: gastric lavage||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopic Examination in Patients With Upper Gastrointestinal Bleeding. A Prospective Randomized Trial.|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||December 2015|
Active Comparator: gastric lavage
gastric lavage by nasogastric tube with 1 liter saline before the endoscopy
Procedure: gastric lavage
gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy
Active Comparator: erythromycin
administration of 250mgr of erythromycin before the endoscopy
Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy
Other Name: Pantomicina Intravenosa
- Visual quality of endoscopy [ Time Frame: 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.
- need for a second-look endoscopy [ Time Frame: within the first 30 days after endoscopy ]To assess the need of a second-look endoscopy due to a full stomach during the first endoscopy or due to rebleeding
- need of blood transfusion [ Time Frame: within 30 days after endoscopy ]
- number of adverse events as a measure of safety and tolerability [ Time Frame: within the first 30 days after endoscopy ]
- length of hospitalisation [ Time Frame: within the first 30 days after endoscopy ]
- length of endoscopic procedure [ Time Frame: within the first 30 days after endoscopy ]
- need for arteriography or surgery [ Time Frame: within the first 30 days after endoscopy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716572
|Hospital Universitari de Bellvitge|
|L'Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Principal Investigator:||Antonio Soriano, M D, Ph D||Hospital Universitari de Bellvitge|