A self-assembling matrix-forming gel can be easily and safely applied to prevent delayed bleeding after endoscopic resections
submitted 04. November 2015
accepted after revision 29. Januar 2016
30. März 2016 (online)
Background: Endoscopic resections have low morbidity and mortality. Delayed bleeding has been reported in approximately 1 – 15 % of cases, increasing with antiplatelet/anticoagulant therapy or portal hypertension. A self-assembling peptide (SAP) forming a gel could protect the mucosal defect during early healing. This retrospective trial aimed to assess the safety and efficacy of SAP in preventing delayed bleeding after endoscopic resections.
Methods: Consecutive patients with endoscopic resections were enrolled in two tertiary referral centers. Patients with a high risk of bleeding (antiplatelet agents, anticoagulation drugs with heparin bridge therapy, and cirrhosis with portal hypertension) were also included. The SAP gel was applied immediately after resection to cover the whole ulcer bed.
Results: In total, 56 patients were included with 65 lesions (esophagus [n = 8], stomach [n = 22], duodenum [n = 10], ampullary [n = 3], colon [n = 7], and rectum [n = 15]) in two centers. Among those 65 lesions, 29 were resected in high risk situations (9 uninterrupted aspirin therapy, 6 heparin bridge therapies, 5 cirrhosis and portal hypertension, 1 both cirrhosis and heparin bridge, 3 both cirrhosis and uninterrupted aspirin, 3 large duodenal lesions > 2 cm, and 2 early introduction of clopidogrel at day 1). The resection technique was endoscopic submucosal dissection (ESD) in 40 cases, en bloc endoscopic mucosal resection (EMR) in 16, piecemeal EMR in 6, and ampullectomy in 3. The mean lesion size was 37.9 mm (SD: 2.2 mm) with a mean area of 6.3 cm2 (SD: 3.5 cm2). No difficulty was noted during application. Four delayed overt bleedings occurred (6.2 %) (3 hematochezia, 1 hematemesis) requiring endoscopic hemostasis. The mean hemoglobin drop off was 0.6 g/dL (– 0.6 to 3.1 g/dL). No adverse events occurred.
Conclusion: The use of this novel extracellular matrix scaffold may help to reduce post-endoscopic resection bleedings including in high risk situations. Its use is easy and safe but further comparative studies are warranted to completely evaluate its effectiveness.
- 1 Tsujii Y, Nishida T, Nishiyama O et al. Clinical outcomes of endoscopic submucosal dissection for superficial esophageal neoplasms: a multicenter retrospective cohort study. Endoscopy 2015; 47: 775-783
- 2 Koh R, Hirasawa K, Yahara S et al. Antithrombotic drugs are risk factors for delayed postoperative bleeding after endoscopic submucosal dissection for gastric neoplasms. Gastrointest Endosc 2013; 78: 476-483
- 3 Lépilliez V, Chemaly M, Ponchon T et al. Endoscopic resection of sporadic duodenal adenomas: an efficient technique with a substantial risk of delayed bleeding. Endoscopy 2008; 40: 806-810
- 4 Takeuchi Y, Iishi H, Tanaka S et al. Factors associated with technical difficulties and adverse events of colorectal endoscopic submucosal dissection: retrospective exploratory factor analysis of a multicenter prospective cohort. Int J Colorectal Dis 2014; 29: 1275-1284
- 5 Tano S, Horiki N, Omata F et al. Second and third-look endoscopy for the prevention of post-ESD bleeding. Medicine (Baltimore) 2015; 94: e491
- 6 Repici A, Pagano N, Hassan C et al. Endoscopic submucosal dissection of gastric neoplastic lesions in patients with liver cirrhosis: a systematic review. J Gastrointest Liver Dis 2012; 21: 303-307
- 7 Ogura K, Okamoto M, Sugimoto T et al. Efficacy and safety of endoscopic submucosal dissection for gastric cancer in patients with liver cirrhosis. Endoscopy 2008; 40: 443-445
- 8 Basford PJ, George R, Nixon E et al. Endoscopic resection of sporadic duodenal adenomas: comparison of endoscopic mucosal resection (EMR) with hybrid endoscopic submucosal dissection (ESD) techniques and the risks of late delayed bleeding. Surg Endosc 2014; 28: 1594-1600
- 9 Choi KD, Jung H-Y, Lee GH et al. Application of metal hemoclips for closure of endoscopic mucosal resection-induced ulcers of the stomach to prevent delayed bleeding. Surg Endosc 2008; 22: 1882-1886
- 10 Liaquat H, Rohn E, Rex DK. Prophylactic clip closure reduced the risk of delayed postpolypectomy hemorrhage: experience in 277 clipped large sessile or flat colorectal lesions and 247 control lesions. Gastrointest Endosc 2013; 77: 401-407
- 11 Nieponice A, McGrath K, Qureshi I et al. An extracellular matrix scaffold for esophageal stricture prevention after circumferential EMR. Gastrointest Endosc 2009; 69: 289-296
- 12 Ono S, Fujishiro M, Yoshida N et al. Thienopyridine derivatives as risk factors for bleeding following high risk endoscopic treatments: Safe Treatment on Antiplatelets (STRAP) study. Endoscopy 2015; 47: 632-637
- 13 Masuhara H, Fujii T, Watanabe Y et al. Novel infectious agent-free hemostatic material (TDM-621) in cardiovascular surgery. Ann Thorac Cardiovasc Surg 2012; 18: 444-451
- 14 Yoshida M, Goto N, Kawaguchi M et al. Initial clinical trial of a novel hemostat, TDM-621, in the endoscopic treatments of the gastric tumors. J Gastroenterol Hepatol 2014; 29: 77-79
- 15 Tuthill DD, Bayer V, Gallagher AM et al. Assessment of topical hemostats in a renal hemorrhage model in heparinized rats. J Surg Res 2001; 95: 126-132
- 16 Wu M, Ye Z, Zhu H et al. Self-assembling peptide nanofibrous hydrogel on immediate hemostasis and accelerative osteosis. Biomacromolecules 2015; 16: 3112-3118
- 17 Ninomiya Y, Oka S, Tanaka S et al. Risk of bleeding after endoscopic submucosal dissection for colorectal tumors in patients with continued use of low-dose aspirin. J Gastroenterol 2015; 50: 1041-1046
- 18 Tsujii Y, Nishida T, Nishiyama O et al. Clinical outcomes of endoscopic submucosal dissection for superficial esophageal neoplasms: a multicenter retrospective cohort study. Endoscopy 2015; 47: 775-783