Haemocer Plus in the treatment and prevention of lower GI post-resectional bleeding: prospective multi center study

Aims GI bleeding associated to endoscopic procedure is defined as clinical evidence of bleeding and a drop in hemoglobin of≥2g/dL on the day of the procedure (early bleeding) or up to 14 days after the procedure (delayed bleeding). GI bleeding is a common complication of endoscopic procedures, such as endoscopic mucosal resection (EMR) and endoscopic sub mucosal dissection (ESD). New endoscopic hemostasis modaliBes (topical hemostatic agents) are emerging as possible alternative endotherapies for primary hemostasis when bleeding is refractory or not amenable to standard endoscopic hemostasis therapies.We aim to establish a multicenter, observational registry to collect data related to the use of HaemoCer PLUS for the primary prevention of delayed bleeding linked to endoscopic resectional procedures of the lower GI tract. Primary aim: prevention of delayed bleeding after colonic EMR or ESD larger than 30 mm. Secondary aim: evaluation of possible adverse events (AEs) related to the application of the powder.

Methods We enrolled all adults patients undergoing colorectal ESD or EMR for lesions bigger than 30 mm where HaemoCer PLUS has been used will be included.

Results Overall, 50 patients were collected; out of 50 patients, 31were male, and the mean patient age was 72.14 (SD 11.40). Lesions mean dimensions was 52.28 mm (SD: 18.29mm). The lesions were primarily located in the rectum (28 out of 50 cases), followed by the ascending colon, sigmoid colon, transverse colon, and cecum, with 10, 6, 4, and 2 cases, respectively. 43 out of the 50 lesions were classified as adenoma, 13 with low-grade dysplasia and 30 with high-grade dysplasia; 6 lesions were classified as invasive neoplasia (T1a) and 1 lesion was described as hyperplastic at the pathological report. Among the patients, 15 were undergoing antiplatelet therapy, and 8 were receiving anticoagulant treatment. Four of these patients were on both anticoagulant and antiplatelet therapies simultaneously. During the follow-up period, there were 3 bleeding events (6%). All cases of bleeding were diagnosed 24 hours after the procedure. One bleeding event occurred in the ESD group (1/20, 5%), and two occurred in the Hot-Snare resection group (2/17, 11.76%). Post-procedural bleeding events collected in the study occurred in patients with no record of intra-procedural bleeding. Bleeding occurred in two patients on single antiplatelet therapy with ticagrelor and also on anticoagulant therapy with LMW Heparin for permanent atrial fibrillation.

Conclusions Even if this is a preliminary results report, this hemostatic powder seems to be a valuable additional therapy to prevent bleeding in patients with large colonic endoscopic resection with ongoing antiplatelet therapy. Combined antiplatelet and anticoagulant therapy, conjunct to several comorbidities still remain a difficult to manage situation in daily practice.

Publication History

Article published online:
27 March 2025