PRECISE ADMINISTRATION OF SUCRALFATE POWDER IN THE PREVENTION OF DELAYED POSTPOLYPECTOMY BLEEDING: AN INTERIM ANALYSIS OF THE RANDOMIZED CLINICAL TRIAL

INTRODUCTION: Delayed postpolypectomy bleeding is one of the colonoscopic polypectomy complications to be concerned, especially in high-risk patients. The general delayed post-polypectomy bleeding rate is approximately 1% - 2%, while the bleeding rate increases to 6% in larger colon polyps greater than 2 cm. Sucralfate, an aluminium salt of sucrose octa sulfate, tends to bind the exposed protein of damaged cells to provide a protective coating. It can also bind with growth factors and has angiogenic effects, promoting mucosal healing. Sucralfate has been used in gastrointestinal ulceration and radiation colitis. This study aimed to investigate whether sucralfate powder administration on polypectomy wounds can prevent the wound from delayed bleeding.
MATERIALS AND METHODS: This randomized clinical trial will recruit 160 patients. After randomization, 80 patients will be classified into the intervention group and 80 into the control group. The participants will receive an endoscopic survey as routine, and we will enroll all patients with polyp size > 0.5 cm after polyp excision. After that, 3 g of sucralfate powder will be sprayed through colonoscopy precisely on the polypectomy wound in the intervention group. All enrolled patients will be monitored for delayed bleeding for 28 days after the colonoscopy. Both standard criteria and extended criteria of delayed bleeding were recorded. The standard criteria of delayed bleeding indicate massive bloody stool in need of endoscopic hemostasis, transarterial embolization, or surgical intervention. The extended criteria of delayed bleeding indicate bloody stool is still noticed two days after the polypectomy either with or without spontaneous resolution,
RESULTS: From 2023/05 to 2023/10, 103 patients who accepted colonoscopic polypectomy were enrolled. Fifty-two patients were randomized in the sucralfate group, and fifty were in the control group. The baseline characteristics were balanced between the two groups (Figure 1). Under the standard criteria, no patient in the sucralfate group had delayed postpolypectomy bleeding, while 2 patients in the control group encountered delayed postpolypectomy bleeding (0% vs 4%, P-value = 0.238, Figure 1). Under the extended criteria, 1 patient in the sucralfate group had delayed bleeding, and 9 patients in the control group had minor delayed bleeding (1.9% vs 18%, P-value = 0.007, Figure 1). The time to delayed bleeding was longer in the sucralfate group using the extended criteria (P-value = 0.006, Figure 2). Besides, no patient had bowel perforation or constipation after the procedure.
CONCLUSION: Colonoscopic spray of sucralfate powder is a safe procedure. Delivery of the sucralfate powder on the polypectomy wound seems to have the potential to prevent delayed polypectomy bleeding. This clinical trial will be continued.