San Diego, CA, May 23, 2016—After undergoing Doppler endoscopic probe (DEP)-assisted treatment of severe variceal or portal hypertensive lesion upper gastrointestinal (UGI) bleeding, patients with cirrhosis and bleeding varices, post-rubber band ligation (RBL) ulcers, or Mallory Weiss tears (MWT) had significantly lower 30-day re-bleed rates, fewer red blood cell (RBC) or fresh frozen plasma (FFP) transfusions, and fewer days spent in the hospital compared with patients treated with standard, visually guided treatment without blood flow monitoring, according to data presented here at Digestive Disease Week 2016. In addition, researchers added, DEP was quick, safe, and very easy to use.
“We’ve used DEP for several years in a variety of studies, in cohort studies of ulcerative and nonvariceal bleeding, and varices, and we found out that in addition to visual guidelines for risk stratification and completion of treatment, that this helped us,” said lead researcher Dennis M. Jensen, MD, of the CURE Digestive Diseases Research Center, David Geffen School of Medicine at UCLA, and West Los Angeles Veterans Administration Medical Centers, Los Angeles, CA.
“For 40 years, gastroenterologists have only relied on vision. This adds another sense; it gives you an auditory signal, a ‘swish’ for an artery, or a hum for venous flow. It’s another dimension, something we didn’t have,” he said. “What determines whether a lesion re-bleeds or not is not what it looks like, but what the vasculature underneath that is feeding it--whether that is patent or not. We’ve known this from surgery, we’ve known it from radiology. We’ve never had the opportunity, in an easy way at the bedside to do this.”
Dr. Jensen and colleagues conducted this randomized, controlled trial of DEP-assisted treatment compared with standard hemostasis of severe variceal or portal hypertensive lesion UGI bleeding.
They included 86 patients with severe UGI bleeding, including clinical signs, a hemoglobin drop of > 2 g, and RBC transfusions, 79% of whom had esophageal varices (EVs) and 21% had other lesions. Patients were randomized during esophagogastroduodenoscopy (EGD) for EVs with or without stigmata of hemorrhage (SRH), active bleed, platelet plug, clot, or spot; gastric varices (GVs); post-RBL ulcers; or MWT with SRH.
Airways were protected, and patients underwent antibiotic and octreotide (OCT) infusions, and RBL hemostasis, distally and on SRH and for varices or MWT, with a minimum of two bands per column. To control severe active bleeding, sclerotherapy was used first and for bleeding varices and post-RBL ulcers, as well as during follow-up for those varices that were too small to band.
For DEP patients, varices and other lesions were interrogated near SRH and distally, and interrogated again after hemostasis using a DEP depth setting less than 4 mm with disposable probes. For residual lesion blood flow by DEP after standard treatment, more RBL and/or sclerotherapy was used to stop flow. For 72 hours, OCT infusions were administered to all patients (50 µ/h). For severe UGI re-bleeding or varix surveillance, EGD was repeated in 7 to 14 days and at 30 days. For continued bleeding, patients underwent TIPS.
Dr. Jensen and colleagues found a significant 23.4% difference in the 30-day re-bleed rate for standard (17 of 47) versus DEP patients (5/39)(OR: 3.85; 95% CI: 1.27, 11.71; P=0.024). The number needed to treat was 4.3. Finally, 30-day surgery rates (OLT: 3 vs 1, respectively), TIPS (3 vs 4), or deaths (2 vs 1) were not significantly different, but RBC and FFP transfusions and hospital days were.
“For high-risk patients who have nonvariceal bleeding ulcers, RBL ulcers, or MWT, or who have varices—esophageal varices, gastric varices or other lesions related to portal hypertension, [DEP-assisted treatment] substantially reduces re-bleeding rates and in some cases, surgery rates, transfusion requirements, and hospital stay. It’s a real advantage, particularly in this day and age where, in the United States, we’re supposed to get the job done with one treatment, and anything after 30 days, you are responsible for,” concluded Dr. Jensen.