Randomized Controlled Study of a New InScope Multi-Clip Applier, Olympus QuickClip2, MPEC, Injection and Combination Therapy Comparing Hemostasis and Healing of Bleeding Canine Acute Gastric Ulcers

Abstract

Purpose: There are no clinical and very few laboratory randomized studies comparing different hemoclips and other treatments for ulcer hemostasis. Our purposes were: 1) to compare deployment results of 3 clips/ulcer with InScope (INS) (Ethicon Endo-Surgery) vs. Olympus (OLY) QuickClip2's, 2) to evaluate long-term hemoclip retention rates, 3) to compare ulcer healing times after treatments and the influence of hemoclip retention on ulcer healing, and 4) to study safety of treatments. Methods: 6 adult mongrel dogs with prehepatic portal hypertension were heparinized. Gastric ulcers (GU's) were made with jumbo biopsy forceps (8 mm diameter, open) and randomized in pairs to 1 of 5 endoscopic treatments (INS, OLY, EPI, MPEC, EPI+MPEC) or control. Initial hemostasis was the 1° endpoint and closure of ulcers was a 2° endpoint for hemoclips. 3 hemoclips/ ulcer were placed. Animals were treated with oral PPI until ulcers healed. Failure of clip deployment on ulcers and time to initial hemostasis were recorded. At weekly F/U endoscopies, ulcer stigmata, size and healing; complications; and hemoclip retention were quantitated. Results: Initial failure of hemoclip deployment was 0% for INS and 7% for OLY. See Table 1 for initial results. The time required for 50% of ulcers to heal was significantly longer for MPEC (3 weeks) or EPI+MPEC (3.5 weeks) than EPI (2 weeks) or OLY, INS or control (1.5 weeks). There were no major complications.Table 1: Results to 4 wksConclusions: 1) Olympus and InScope hemoclips were similar in deployment times, success rates, and influence on ulcer healing. 2) More ulcer sites had InScope hemoclips retained after 1 month than OLY. 3) MPEC hemostasis was faster than either hemoclip. 4) Retained hemoclips across acute ulcers accelerated healing compared to MPEC, EPI, or combination. 5) No major complications resulted.Table 2: Ulcer Sites with ≥1 Hemoclips Retained in Long-Term F/U