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

NCT00689754 | Completed

• 1 other identifier: 102007-022
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Hemorrhage; Liver Cirrhosis

Keywords

gastrointestinal hemorrhage; gastrointestinal intubation; endoscopy

Outcome Measures

Primary Outcomes (1)

• The number of patients predicted accurately to have a treatable lesion

  24h

Secondary Outcomes (4)

• Complications of nasogastric aspiration and lavage

  24h

• Relationship between time to endoscopy and upper gastrointestinal hemorrhage

  24h

• Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused

  24h

• Complication of nasogastric tube placement and aspiration in cirrhotics

  24h

Study Arms (2)

NGA

ACTIVE COMPARATOR

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

Procedure: nasogastric tube placement

NO NGA

NO INTERVENTION

Patient presenting with Upper GI hemorrhage going straight to endoscopy.

Interventions

nasogastric tube placement PROCEDURE

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

NGA

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

Related Publications (12)

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

  PMID: 310892 RESULT

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

  PMID: 6976367 RESULT

• 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.

  PMID: 6971777 RESULT

• 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.

  PMID: 2196022 RESULT

• 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.

  PMID: 2369238 RESULT

• 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.

  PMID: 1556428 RESULT

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

  PMID: 9654567 RESULT

• 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.

  PMID: 14623622 RESULT

• 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.

  PMID: 14745388 RESULT

• 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.

  PMID: 15492601 RESULT

• 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.

  PMID: 16240216 RESULT

• 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.

  PMID: 28069629 DERIVED

Related Links

• UT Southwestern website

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Fibrosis

Study Officials

• Silvio W Melo, MD

  UT Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 4, 2008
• Study Start: January 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 18, 2011

Record last verified: 2011-11

Locations

US (1)