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Efficacy and Safety Study on Nasogastric (NG) Tube in Patients With Upper Gastrointestinal Bleed

NCT ID: NCT00689754

Last Updated: 2011-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-08-31

Brief Summary

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Upper gastrointestinal tract hemorrhage (UGIH) remains a major cause of morbidity and mortality . Nasogastric aspiration (NGA) is routinely performed in patients with UGIH to obtain important clinical data and make therapeutic decisions. But routine use of NGA remains controversial with studies reporting its usefulness and its redundant clinical information. Early esophagogastroduodenoscopy (EGD) is recommended by most gastrointestinal societies to allow for risk stratification and to perform endoscopic treatments. The results of the NGA may assist to differentiate between high-risk versus low-risk lesions. Our hypothesis is that presence of NGA can identify lesions that require endoscopic treatment and provides important clinical information to guide the treating physician. In addition, we hypothesized that the results of the NGA influence the clinical decision of the treating physician regarding the prediction of the need for endoscopic therapy. This observational randomized cross-sectional study will enroll consecutive patients with presumed UGIH and randomized them to NGA and no NGA recording its results. All patients will receive an EGD and its results will also be recorded. Subsequently, we will evaluate if the NGA is important in identifying endoscopically significant lesions. The information gained will help guide clinicians evaluating patient with UGIH.

Detailed Description

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Conditions

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Gastrointestinal Hemorrhage Liver Cirrhosis

Keywords

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gastrointestinal hemorrhage gastrointestinal intubation endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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NGA

Patients will receive the standard of care to proceed with nasogastric tube placement, aspiration and lavage up to 1L of normal saline

Group Type ACTIVE_COMPARATOR

nasogastric tube placement

Intervention Type PROCEDURE

standard nasogastric tube placement, aspiration and lavage up to 1L of normal saline

NO NGA

Patient presenting with Upper GI hemorrhage going straight to endoscopy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nasogastric tube placement

standard nasogastric tube placement, aspiration and lavage up to 1L of normal saline

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients older then 21 years-old presenting with actual or reported: Hematemesis, Melena, or Hematemesis and Melena

Exclusion Criteria

* Refusal to participate
* Severe comorbid conditions making EGD hazardous for the patient, such as myocardial infarction \< 3 months with the exception if the myocardial infarction was caused by the UGIH, hemorrhagic or ischemic stroke \< 3 months, decompensated congestive heart failure, severe respiratory failure unless the patient is already intubated
* Survival expected to be less than 72h as judged by treating clinician
* Prisoners
* Patient with severe mental illness precluding the ability to obtain informed consent
* Ongoing anticoagulation which can not be reversed secondary to patient safety
* Strongly suspected gastrointestinal perforation
* Recent endoscopy (less than 30 days)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Silvio Melo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Silvio W Melo, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center at Dallas

Locations

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Parkland Memorial Hospital

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Luk GD, Bynum TE, Hendrix TR. Gastric aspiration in localization of gastrointestinal hemorrhage. JAMA. 1979 Feb 9;241(6):576-8.

Reference Type RESULT
PMID: 310892 (View on PubMed)

Peterson WL. Evaluation and initial management of patients with upper gastrointestinal bleeding. J Clin Gastroenterol. 1981;3(Suppl 2):79-84.

Reference Type RESULT
PMID: 6976367 (View on PubMed)

Gilbert DA, Silverstein FE, Tedesco FJ, Buenger NK, Persing J. The national ASGE survey on upper gastrointestinal bleeding. III. Endoscopy in upper gastrointestinal bleeding. Gastrointest Endosc. 1981 May;27(2):94-102. doi: 10.1016/s0016-5107(81)73157-2. No abstract available.

Reference Type RESULT
PMID: 6971777 (View on PubMed)

Cuellar RE, Gavaler JS, Alexander JA, Brouillette DE, Chien MC, Yoo YK, Rabinovitz M, Stone BG, Van Thiel DH. Gastrointestinal tract hemorrhage. The value of a nasogastric aspirate. Arch Intern Med. 1990 Jul;150(7):1381-4. doi: 10.1001/archinte.150.7.1381.

Reference Type RESULT
PMID: 2196022 (View on PubMed)

Basuk PM, Isenberg JI. Gastric lavage in patients with gastrointestinal hemorrhage. Yea or nay? Arch Intern Med. 1990 Jul;150(7):1379-80. No abstract available.

Reference Type RESULT
PMID: 2369238 (View on PubMed)

Cappell MS, Scarpa PJ, Nadler S, Miller SH. Complications of nasoenteral tubes. Intragastric tube knotting and intragastric tube breakage. J Clin Gastroenterol. 1992 Mar;14(2):144-7. doi: 10.1097/00004836-199203000-00015.

Reference Type RESULT
PMID: 1556428 (View on PubMed)

Levy H. Nasogastric and nasoenteric feeding tubes. Gastrointest Endosc Clin N Am. 1998 Jul;8(3):529-49.

Reference Type RESULT
PMID: 9654567 (View on PubMed)

Barkun A, Bardou M, Marshall JK; Nonvariceal Upper GI Bleeding Consensus Conference Group. Consensus recommendations for managing patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2003 Nov 18;139(10):843-57. doi: 10.7326/0003-4819-139-10-200311180-00012.

Reference Type RESULT
PMID: 14623622 (View on PubMed)

Aljebreen AM, Fallone CA, Barkun AN. Nasogastric aspirate predicts high-risk endoscopic lesions in patients with acute upper-GI bleeding. Gastrointest Endosc. 2004 Feb;59(2):172-8. doi: 10.1016/s0016-5107(03)02543-4.

Reference Type RESULT
PMID: 14745388 (View on PubMed)

Lee SD, Kearney DJ. A randomized controlled trial of gastric lavage prior to endoscopy for acute upper gastrointestinal bleeding. J Clin Gastroenterol. 2004 Nov-Dec;38(10):861-5. doi: 10.1097/00004836-200411000-00005.

Reference Type RESULT
PMID: 15492601 (View on PubMed)

Cappell MS. Safety and efficacy of nasogastric intubation for gastrointestinal bleeding after myocardial infarction: an analysis of 125 patients at two tertiary cardiac referral hospitals. Dig Dis Sci. 2005 Nov;50(11):2063-70. doi: 10.1007/s10620-005-3008-8.

Reference Type RESULT
PMID: 16240216 (View on PubMed)

Rockey DC, Ahn C, de Melo SW Jr. Randomized pragmatic trial of nasogastric tube placement in patients with upper gastrointestinal tract bleeding. J Investig Med. 2017 Apr;65(4):759-764. doi: 10.1136/jim-2016-000375. Epub 2017 Jan 9.

Reference Type DERIVED
PMID: 28069629 (View on PubMed)

Related Links

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http://www.utsouthwestern.edu

UT Southwestern website

Other Identifiers

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102007-022

Identifier Type: -

Identifier Source: org_study_id