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Gastrointestinal HemorrhagePhase 3NCT01716572

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

A Phase 3 study testing Erythromycin and gastric lavage in people with Gastrointestinal Hemorrhage and Hematemesis, run by Hospital Universitari de Bellvitge at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Hemorrhage, Hematemesis
What is being tested?
Erythromycin and gastric lavage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteSpain
Study dates
Feb 2012to Dec 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • recent hematemesis (<12 hours)

Who cannot join

  • macrolides allergy
  • pregnancy or lactation
  • treatment with terfenadine, astemizole or cyclosporine
  • prior gastrectomy

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

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

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.

Read the detailed description

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

Being tested
Erythromycin, gastric lavage
Keywords
Upper gastrointestinal bleeding, Endoscopy, Erythromycin, Gastric lavage
Medical subject headings
Gastrointestinal Hemorrhage, Hematemesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErythromycinDrug

    Also called Pantomicina Intravenosa

    Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy

  • gastric lavageProcedure or surgery

    gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy

Study groups in NCT01716572
Study groupRoleWhat they receive
gastric lavageActive comparatorgastric lavage by nasogastric tube with 1 liter saline before the endoscopy
Receives: Procedure: gastric lavage
erythromycinActive comparatoradministration of 250mgr of erythromycin before the endoscopy
Receives: Drug: Erythromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual quality of 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.

    Measured: 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

Secondary outcomes (6)

  1. need for a second-look endoscopy

    To assess the need of a second-look endoscopy due to a full stomach during the first endoscopy or due to rebleeding

    Measured: within the first 30 days after endoscopy

  2. need of blood transfusion

    Measured: within 30 days after endoscopy

  3. number of adverse events as a measure of safety and tolerability

    Measured: within the first 30 days after endoscopy

  4. length of hospitalisation

    Measured: within the first 30 days after endoscopy

  5. length of endoscopic procedure

    Measured: within the first 30 days after endoscopy

  6. need for arteriography or surgery

    Measured: within the first 30 days after endoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionSep 2015
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01716572
Sponsor's protocol ID
ERITRO2011
Status last verified
Oct 2015
First submitted
28 Jun 2012
Last updated
8 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Frossard JL, Spahr L, Queneau PE, Giostra E, Burckhardt B, Ory G, De Saussure P, Armenian B, De Peyer R, Hadengue A. Erythromycin intravenous bolus infusion in acute upper gastrointestinal bleeding: a randomized, controlled, double-blind trial. Gastroenterology. 2002 Jul;123(1):17-23. doi: 10.1053/gast.2002.34230.

    PubMed 12105828

  • Coffin B, Pocard M, Panis Y, Riche F, Laine MJ, Bitoun A, Lemann M, Bouhnik Y, Valleur P; Groupe des endoscopistes de garde a l'AP-HP. Erythromycin improves the quality of EGD in patients with acute upper GI bleeding: a randomized controlled study. Gastrointest Endosc. 2002 Aug;56(2):174-9. doi: 10.1016/s0016-5107(02)70174-0.

    PubMed 12145593

  • Carbonell N, Pauwels A, Serfaty L, Boelle PY, Becquemont L, Poupon R. Erythromycin infusion prior to endoscopy for acute upper gastrointestinal bleeding: a randomized, controlled, double-blind trial. Am J Gastroenterol. 2006 Jun;101(6):1211-5. doi: 10.1111/j.1572-0241.2006.00582.x.

    PubMed 16771939

  • Pateron D, Vicaut E, Debuc E, Sahraoui K, Carbonell N, Bobbia X, Thabut D, Adnet F, Nahon P, Amathieu R, Aout M, Javaud N, Ray P, Trinchet JC; HDUPE Collaborative Study Group. Erythromycin infusion or gastric lavage for upper gastrointestinal bleeding: a multicenter randomized controlled trial. Ann Emerg Med. 2011 Jun;57(6):582-9. doi: 10.1016/j.annemergmed.2011.01.001. Epub 2011 Feb 17.

    PubMed 21333385

  • Barkun AN, Bardou M, Martel M, Gralnek IM, Sung JJ. Prokinetics in acute upper GI bleeding: a meta-analysis. Gastrointest Endosc. 2010 Dec;72(6):1138-45. doi: 10.1016/j.gie.2010.08.011.

    PubMed 20970794

  • Winstead NS, Wilcox CM. Erythromycin prior to endoscopy for acute upper gastrointestinal haemorrhage: a cost-effectiveness analysis. Aliment Pharmacol Ther. 2007 Nov 15;26(10):1371-7. doi: 10.1111/j.1365-2036.2007.03516.x. Epub 2007 Sep 10.

    PubMed 17848180

  • Barkun AN, Bardou M, Kuipers EJ, Sung J, Hunt RH, Martel M, Sinclair P; International Consensus Upper Gastrointestinal Bleeding Conference Group. International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2010 Jan 19;152(2):101-13. doi: 10.7326/0003-4819-152-2-201001190-00009.

    PubMed 20083829

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erythromycin and gastric lavage in people with Gastrointestinal Hemorrhage and Hematemesis, run by Hospital Universitari de Bellvitge at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01716572, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.

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