Doppler Ultrasound Probe for Blood Flow Detection in Severe Upper Gastrointestinal Hemorrhage

NCT00732212 | Completed Results DMC FDA Device

• 1 other identifier: CLIN-013-07F
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 2

Brief Summary

The main purposes of this study are to compare clinical outcomes of two groups of patients with similar medical conditions (one with non-variceal upper gastrointestinal (UGI) lesions such as ulcers and another group with varices or portal hypertensive lesions) who are treated either with current standard visually guided endoscopic treatment according to stigmata of hemorrhage or with endoscopic Doppler endoscopic ultrasound probe (DEP) monitoring of blood flow in the lesion.

Conditions

UGI Bleeding; Ulcer or Variceal Hemorrhage; Stigmata of Recent Hemorrhage; Endoscopy; Randomized Controlled Trials

Keywords

UGI Bleeding; Ulcer or variceal hemorrhage; Stigmata of recent hemorrhage; Endoscopy; Randomized Controlled Trial; Non-variceal UGI hemorrhage; Variceal hemorrhage

Outcome Measures

Primary Outcomes (1)

• 30 Day Rebleeding Rate

  The primary outcome is index lesion rebleeding rate up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.

  30 days

Secondary Outcomes (4)

• Rates of Surgery up to 30 Days After Randomization

  30 days

• Rate of Complications

  30 days

• Death

  30 days

• Units of Red Blood Cells (RBC) Transfused for Rebleeding After Randomization

  30 days

Other Outcomes (1)

• Hospital Days After Randomization

  30 days

Study Arms (2)

Doppler endoscopic probe hemostasis

EXPERIMENTAL

In addition to stigmata of hemorrhage and visual cues, Doppler endoscopic probe will be used for detection of blood flow before and after standard endoscopic hemostasis. If residual blood flow in the lesion is found after standard treatment, further endoscopic treatment will be applied as deemed safe by the investigator-endoscopist.

Device: Doppler endoscopic ultrasound probe for blood flow detection

Standard Endoscopic Hemostasis

ACTIVE COMPARATOR

Standard, visually guided endoscopic hemostasis based on visual cues of stigmata of hemorrhage and endoscopic control of bleeding or treatment of the stigmata according to current guidelines

Other: Standard endoscopic hemostasis

Interventions

Doppler endoscopic ultrasound probe for blood flow detection DEVICE

Used for blood flow detection

Doppler endoscopic probe hemostasis

Standard endoscopic hemostasis OTHER

Per current treatment guidelines for non-variceal UGI lesions - based upon stigmata of hemorrhage \& visual cues for risk stratification and completion of endoscopic treatment.

Standard Endoscopic Hemostasis

Eligibility Criteria

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

You may qualify if:

• Patients must have evidence of severe UGI bleeding by laboratory tests (Hgb less than or equal to 9 gms; with red blood cell (RBC) transfusions; or documented decrease in Hgb of greater than or equal to 2 gms relative to baseline) and by clinical parameters (melena; hematemesis or hematochezia; nasogastric tube (NG) evidence of UGI bleeding- fresh blood, clots, or old blood).
• The following non-variceal UGI lesions will be included if stigmata of hemorrhage are found on emergency endoscopy (active arterial bleeding, oozing, non-bleeding visible vessel (NBVV), adherent clot, or flat spot or a combination of these) for peptic ulcers (gastric, duodenal, esophageal, or anastomatic), Mallory-Weiss (MW) tears without portal hypertension (PHTN), or Dieulafoy's lesions.
• For other types of severe UGI bleeding related to PHTN, the investigators will include patients with esophageal or gastric varices (with or without stigmata, if no other UGI lesion is the source of the bleed); post-rubber band ligation (RBL) ulcers, and MW tears associated with PHTN and having some stigmata of recent hemorrhage.
• Life expectancy of at least 60 days based on lack of very severe or terminal comorbidity, as judged by the generalists or specialists caring for the patient.
• Written informed consent by patient or surrogate.

You may not qualify if:

• Patients who are uncooperative, unable to give written informed consent, who cannot return for 30 day follow-up, or refuse informed consent.
• Patients with UGI known malignancies or malignant appearing ulcers; diffuse bleeding from mucosal lesions or esophagitis; infectious UGI lesions; or other bleeding lesions (polyps, post-endoscopic mucosal resection (EMR), or post-sphincterotomy).
• End-stage, very severe, recurrent or ongoing co-morbid illness, e.g. severe liver, renal, cardiac, respiratory failure; peritonitis; or sepsis that preclude emergency procedures or clinical follow-up and limit survival.
• Persistent shock or hypotension (e.g. systolic blood pressure less than or equal to 99 mm mercury) that is unresponsive to less than or equal to 6 units of packed red blood cell (RBC) transfusions or requires continuous intravenous infusions of vasoactive drugs for blood pressure elevation.
• Severe coagulopathy unresponsive to blood transfusions e.g. international normalized ratio (INR) \> 2.0, platelet count \< 20,000, activated partial thromboplastin time (APTT) greater than 2.0 x normal, or bleeding time \> 10 minutes.
• Contraindication to urgent endoscopy or follow-up procedures.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of California, Los Angeles: collaborator
• Kaiser Permanente: collaborator

Study Sites (2)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

Related Publications (1)

• Jensen DM, Kovacs TOG, Ohning GV, Ghassemi K, Machicado GA, Dulai GS, Sedarat A, Jutabha R, Gornbein J. Doppler Endoscopic Probe Monitoring of Blood Flow Improves Risk Stratification and Outcomes of Patients With Severe Nonvariceal Upper Gastrointestinal Hemorrhage. Gastroenterology. 2017 May;152(6):1310-1318.e1. doi: 10.1053/j.gastro.2017.01.042. Epub 2017 Feb 4.

  PMID: 28167214 DERIVED

MeSH Terms

Conditions

Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Potential limitations of this study are expense of equipment, learning curve as new technology, and no other randomized controlled studies have been reported to confirm the results.

Results Point of Contact

• Title: Dennis M. Jensen, M.D.
• Organization: CURE Digestive Diseases Research Center

djensen@mednet.ucla.edu

310-268-3569

Study Officials

• Dennis M. Jensen, MD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2008
• First Posted: August 11, 2008
• Study Start: February 18, 2009
• Primary Completion: January 7, 2016
• Study Completion: January 7, 2016
• Last Updated: December 4, 2023
• Results First Posted: April 11, 2017

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)