N/A
N=235
Doppler Ultrasound Probe for Blood Flow Detection in Severe Upper Gastrointestinal Hemorrhage
UGI Bleeding · Ulcer or Variceal Hemorrhage · Stigmata of Recent Hemorrhage · Endoscopy · Randomized Controlled Trials
Bottom Line
View on ClinicalTrials.gov: NCT00732212 ↗Enrolled (actual)
235
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: 30 Day Rebleeding Rate — 20; 8; 17; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Doppler endoscopic ultrasound probe for blood flow detection (Device); Standard endoscopic hemostasis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 30 Day Rebleeding Rate |
20; 8; 17; 6 | — |
| SECONDARY Rates of Surgery up to 30 Days After Randomization |
4; 0; 3; 1 | — |
| SECONDARY Rate of Complications |
4; 0; 2; 3 | — |
| SECONDARY Death |
3; 1; 2; 1 | — |
| SECONDARY Units of Red Blood Cells (RBC) Transfused for Rebleeding After Randomization |
1.09; 0.56; 2.00; 1.33 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 10 minutes.
- Contraindication to urgent endoscopy or follow-up procedures.
Data sourced from ClinicalTrials.gov (NCT00732212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.