Efficacy of a 7 Fr injection gold probe versus 10 Fr heater probe in treating patients with bleeding peptic ulcer: Preliminary results of a randomized trial

Background: It has been previously shown that large (10Fr) thermal probes are superior to 7Fr probes in the treatment of peptic ulcer bleeding. This is presumably due to the inability of the smaller probes to generate sufficient pressure for successful coaptive coagulation. We hypothesize that a newly developed 7Fr combination injection/coagulation probe with a stiff nitinol tip will have an efficacy comparable to that of larger probes. Aim: To compare the effectiveness of the 7FR injection gold probe (IGP) [Microvasive, MA] to that of the 10 Fr heater probe (HP) [Olympus, NY] for treating peptic ulcer hemorrhage. Methods: All patients seen by the GI Rapid Response Team for upper GI bleeding were eligible for the study. Patients with gastric (GU) and duodenal (DU) ulcers that were actively bleeding or which demonstrated a nonbleeding visible vessel were randomized. Active bleeding was treated with epinephrine injection followed by thermal therapy with either 10Fr HP or 7Fr IGP. Non-bleeding visible vessels were treated with thermal therapy only (10Fr HP or 7Fr IGP). Patients were then followed to determine success of initial hemostasis, rate of rebleeding, need for surgery, length of hospital stay and mortality. Results: Seventeen patients with bleeding ulcers have been randomized, 7 patients to IGP and 10 patients to HP. Patients were well matched with regards to age, comorbidity and ulcer location. Four patients in the IGP group (51%) and 6 patients in the HP group (60%) had non-bleeding visible vessels while 3 patients in the IGP group (43%) and 4 patients in the HP group (40%) had actively bleeding ulcers. The rate of initial hemostasis was 100% (7 of 7) with IGP and 90% (9 of 10) with HP. Rebleeding occurred in 29% (2 of 7) and 22% (2 of 9) with IGP and HP, respectively. Four patients required surgery, one in the IGP group and three in the HP group. There was no mortality in either group. Total length of stay (LOS) was a mean of 29 days (median =9days) with IGP and 15 days (median = 4.5 days) with HP. GI LOS was 5.4 days with IGP and 8.9 days with HP. None of these differences were statistically significant. Conclusion: Our preliminary data suggest that treatment of peptic ulcer hemorrhage with the 7Fr IGP is as effective as therapy with a 10Fr HP. The 7FrIGP should be useful in situations where only a 2.8mm channel endoscope is available.