Clinical Trial: Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopy in Patients With Upper Gastrointestinal Bleeding

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopic Examination in Patients With Upper Gastrointestinal Bleeding. A Prospective Randomized Trial.

Brief Summary: 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.

Detailed Summary:

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


Sponsor: Hospital Universitari de Bellvitge

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Hospital Universitari de Bellvitge

Dates:
Date Received: June 28, 2012
Date Started: February 2012
Date Completion: December 2015
Last Updated: October 7, 2015
Last Verified: October 2015