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Randomized Controlled Trial
. 2017 May;152(6):1310-1318.e1.
doi: 10.1053/j.gastro.2017.01.042. Epub 2017 Feb 4.

Doppler Endoscopic Probe Monitoring of Blood Flow Improves Risk Stratification and Outcomes of Patients With Severe Nonvariceal Upper Gastrointestinal Hemorrhage

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Randomized Controlled Trial

Doppler Endoscopic Probe Monitoring of Blood Flow Improves Risk Stratification and Outcomes of Patients With Severe Nonvariceal Upper Gastrointestinal Hemorrhage

Dennis M Jensen et al. Gastroenterology. 2017 May.

Abstract

Background & aims: For 4 decades, stigmata of recent hemorrhage in patients with nonvariceal lesions have been used for risk stratification and endoscopic hemostasis. The arterial blood flow that underlies the stigmata rarely is monitored, but can be used to determine risk for rebleeding. We performed a randomized controlled trial to determine whether Doppler endoscopic probe monitoring of blood flow improves risk stratification and outcomes in patients with severe nonvariceal upper gastrointestinal hemorrhage.

Methods: In a single-blind study performed at 2 referral centers we assigned 148 patients with severe nonvariceal upper gastrointestinal bleeding (125 with ulcers, 19 with Dieulafoy's lesions, and 4 with Mallory Weiss tears) to groups that underwent standard, visually guided endoscopic hemostasis (control, n = 76), or endoscopic hemostasis assisted by Doppler monitoring of blood flow under the stigmata (n = 72). The primary outcome was the rate of rebleeding after 30 days; secondary outcomes were complications, death, and need for transfusions, surgery, or angiography.

Results: There was a significant difference in the rates of lesion rebleeding within 30 days of endoscopic hemostasis in the control group (26.3%) vs the Doppler group (11.1%) (P = .0214). The odds ratio for rebleeding with Doppler monitoring was 0.35 (95% confidence interval, 0.143-0.8565) and the number needed to treat was 7.

Conclusions: In a randomized controlled trial of patients with severe upper gastrointestinal hemorrhage from ulcers or other lesions, Doppler probe guided endoscopic hemostasis significantly reduced 30-day rates of rebleeding compared with standard, visually guided hemostasis. Guidelines for nonvariceal gastrointestinal bleeding should incorporate these results. ClinicalTrials.gov no: NCT00732212 (CLIN-013-07F).

Keywords: Clinical Trial; Endoscopy; Stigmata of Hemorrhage; UGI Bleeding.

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Figures

Figure 1
Figure 1
CONSORT diagram of Doppler Endoscopic Probe Randomized Controlled Trial. * The specific reasons were ASA 5 or very poor prognosis – 30 day survival not expected including those without organ transplantation (176 patients), no consent for study including surrogate (110 patients), uncooperative, non-compliant, or unable to return for study follow-up (45 patients), refused to consent (32 patients), UGI malignancy (26 patients), hypotensive on pressors (17 patients), not severe enough hemorrhage (13 patients), did not meet entry criteria.
Figure 2
Figure 2
Proportion of patients without rebleeding (Rebleed free) during 30 days after randomization. Top curve is Doppler patients and lower curve is standard treated patients. Product limit plots, compared by Log-rank test. p = 0.0174. ** These included esophageal varices or portal hypertensive lesions (87 patients) and no SRH or UGI lesions that did not meet endoscopic inclusion criteria (288 patients).

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