A randomized controlled trial presented at the American College of Gastroenterology (ACG) meeting shows the rebleeding rate after first-line OTSC treatment of NVUGIB to be 85 % lower than after standard treatment.
At this year’s ACG Annual Scientific Meeting, taking place on October 25-30 in San Antonio, TX, USA, Dr. D. Jensen UCLA School of Medicine, Los Angeles, CA, presented a RCT evaluating OTSC as first-line endoscopic treatment of severe non-variceal upper gastrointestinal bleeding (NVUGIB). The RCT was conducted at two academic medical centers. Patients with peptic ulcer bleeding or Dieulafoy’s lesions, who met emergency endoscopy criteria were included in the study and randomized in a 1:1 allocation to either standard treatment (conventional clips and/or multipolar electrical probe with epinephrine pre-injection) or OTSC. All patients received high dose PPIs after randomization and were followed for 30 days.
Overall 49 patients could be included in the study, 24 patients were allocated in the OTSC arm and 25 patients in the standard treatment arm. The two groups were well matched regarding demographics, risk factors, lesion type and stigmata of hemorrhage. During the 30 day follow up, rebleeding occurred in one patient in the OTSC group (1/24, 4.2 %) and 7 patients in the standard treatment group (7/25, 28 %; p=0.024). The rebleeding rate was 85 % lower in the OTSC group than in the Standard treatment group (relative risk 0.149, 95 % confidence intervals of 0.006 and 0.863). The number needed to treat (NNT) was 4.2. Severe complications did not occur in the OTSC group (0/24, 0 %), but did occur in 4 patients in the standard treatment group (4/25, 16 %, p=0.041). Angiographic embolization was not necessary in the OTSC group, but was necessary in 2 patients (8 %) of the standard treatment group (p=0.157). The mean number of red blood cell transfusions (± standard deviation) after randomization was 0.4 ± 0.2 in the OTSC group and 0.76 ± 1.64 in the standard treatment group, a Kruskal-Wallis test performed for statistical comparison.
In summary, patients with severe NVUGIB, who received primary endoscopic treatment with the OTSC, experienced significantly lower rates of rebleeding, significantly less severe complications, and needed fewer red blood cell transfusions than patients treated with standard endoscopic hemostasis. The authors concluded that the OTSC has a superior ability to obliterate arterial blood flow underneath stigmata of hemorrhage and thereby reduce lesion rebleeding.
Randomized Controlled Trial (RCT) of Over-the-Scope Clip (OTSC) as Initial Endoscopic Treatment of Severe Non-Variceal Upper Gastrointestinal Bleeding (NVUGIB).
Jensen DM, Kovacs TOG, Ghassemi KA, Kaneshiro M, Gornbein J. Los Angeles, CA, USA.
ACG 2019, Annual Scientific meeting & Postgraduate Course, Oct 25-30, 2019, San Antonio, TX, USA.