Endoscopy 2025; 57(S 02): S225-S226
DOI: 10.1055/s-0045-1805552
Abstracts | ESGE Days 2025
Moderated poster
Controlling the procedure: principles, tricks and devices 04/04/2025, 10:00 – 11:00 Poster Dome 2 (P0)

Efficacy and Safety of a gel hemostatic powder (GHP) in Preventing Delayed Bleeding After Endoscopic Resection (ER) in High-Risk Patients: A Multicentric Prospective Study

J Chaves Rodriguez
1   Hospital Erasme HUB, Brussels, Belgium
,
P H Deprez
2   Cliniques universitaires Saint-Luc (UCLouvain), Bruxelles, Belgium
,
C Snauwaert
3   AZ Sint-Jan, Brugge, Belgium
,
R Bisschops
4   UZ Leuven Gasthuisberg Campus, Leuven, Belgium
,
P Leclercq
4   UZ Leuven Gasthuisberg Campus, Leuven, Belgium
,
D De Wulf
5   AZ Delta campus Rumbeke, Roeselare, Belgium
,
P Dewint
6   Maria Middelares, Gent, Belgium
,
M Figueiredo Ferreira
7   CHU Saint-Pierre, Brussels, Belgium
,
P Eisendrath
7   CHU Saint-Pierre, Brussels, Belgium
,
V Huberty
1   Hospital Erasme HUB, Brussels, Belgium
,
S Ouazzani
1   Hospital Erasme HUB, Brussels, Belgium
,
A M Bucalau
1   Hospital Erasme HUB, Brussels, Belgium
,
M Arvanitakis
1   Hospital Erasme HUB, Brussels, Belgium
,
J Deviere
1   Hospital Erasme HUB, Brussels, Belgium
,
A Lemmers
1   Hospital Erasme HUB, Brussels, Belgium
› Author Affiliations
› Further Information
Also available ateRef
 

Aims The study aimed to determine whether the application of the GHP at the end of ER can reduce the delayed bleeding (DB) rate in high-risk patients undergoing endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for lesions≥20 mm.

Methods A prospective, multicentric, open-label study was conducted at seven Belgian hospitals from September 2023 to June 2024. A sample size of 50 patients was computed based on the data provided from previously published cohorts to demonstrate a reduction from 16% to less than 5%. Patients with indications of ER for (1) upper or lower gastrointestinal lesions≥20 mm, either on anticoagulant or anti-P2Y12 therapy, or (2) undergoing duodenal EMR even without antithrombotic therapy, were enrolled prospectively in all participating centers. The GHP was applied at the end of the procedure to cover the entire resection field. The primary endpoint was the rate of DB within four weeks post procedure. DB was defined as clinical bleeding or haemoglobin drop of≥2 g/dL. Secondary endpoints included the safety profile of GHP, the duration of the endoscopic procedure and GHP spraying duration, the length of hospital stay, post-procedural pain, and the incidence of adverse events. Kaplan-Meier curves analyzed the probability of bleeding over time, and Cox regression identified factors influencing bleeding risk. Data were prospectively collected in an anonymized e-CRF. The study protocol was registered under the number NCT06096948.

Results Fifty patients (74% male, median age 73 (IQR 66-79) were enrolled and treated by endoscopic resection (46% by ESD, 54% by EMR) and GHP application at the end of the resection. 60% resumed anticoagulants and 8% anti-P2Y12 therapy after the ER procedure, with a median of 5 days for anticoagulants and 7 days for anti-P2Y12 therapy. Lesion location was distributed as follows: duodenum (40%), colon (20%), esophagus (18%), stomach (12%) and rectum (10%); with a median maximal size of 30mm (IQR 20-40mm). Among them, 22% (11/50) experienced DB. This complication was most frequently observed for rectal ESD (3/5, 60%) and duodenal EMR (6/19; 30%). DB typically occurred within the first 10 days post-procedure, with a median onset on day 7. The hypothesized reduction in DB from a mean 16% rate (extracted from the literature focussed on high-risk patients after ER) to below 5% was not achieved (p=0.2472). On univariate analysis, the only factor associated with DB risk was the lesion size (p=0.042). No adverse events related to the use of the GHP were reported [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] [21] [22] [23] [24] [25] [26] [27] [28] [29] [30] [31] [32] [33] [34] [35].

Conclusions In our prospective study involving high-risk patients, applying GHP following endoscopic resection did not significantly lower the rate of DB, with the observed rate reaching 22%. Lesion size was a key predictor of DB. Further studies are needed to find optimal preventive treatment after endoscopic resection.



Publication History

Article published online:
27 March 2025

© 2025. European Society of Gastrointestinal Endoscopy. All rights reserved.

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 

  • References

  • 1 Ogiyama H, Inoue T, Maekawa A, Yoshii S, Yamaguchi S, Nagai K. et al. Effect of anticoagulants on the risk of delayed bleeding after colorectal endoscopic submucosal dissection Endosc Int Open. 2020; 8 11.
    PubMed
  • 2 Harada H, Nakahara R, Murakami D, Suehiro S, Nagasaka T, Ujihara T. et al. The effect of anticoagulants on delayed bleeding after colorectal endoscopic submucosal dissection. Surg Endosc 2020; 34 (08): 3330-7
    CrossrefPubMedSearch in Google Scholar
  • 3 Hirai R, Kawano S, Inoo S, Kuraoka S, Okanoue S, Satomi T. et al. Postoperative Bleeding Risk after Gastric Endoscopic Submucosal Dissection in Patients Receiving a P2Y12 Receptor Antagonist. Gut Liver 2023; 17 (03): 404-11
    CrossrefPubMedSearch in Google Scholar
  • 4 Probst A, Freund S, Neuhaus L, Ebigbo A, Braun G, Goelder S. et al. Complication risk despite preventive endoscopic measures in patients undergoing endoscopic mucosal resection of large duodenal adenomas. Endoscopy 2020; 52 (10): 847-55
    Thieme ConnectPubMedSearch in Google Scholar
  • 5 Libânio D, Costa MN, Pimentel-Nunes P, Dinis-Ribeiro M.. Risk factors for bleeding after gastric endoscopic submucosal dissection: a systematic review and meta-analysis. Gastrointest Endosc 2016; 84 (04): 572-86
    CrossrefPubMedSearch in Google Scholar
  • 6 Yasuda R, Yoshida N, Murakami T, Hirose R, Inoue K, Dohi O. et al. Multicenter Study of the Hemorrhage Risk after Endoscopic Mucosal Resection Associated with Direct Oral Anticoagulants. Gastroenterol Res Pract 2019; 2019: 5743561
    CrossrefPubMedSearch in Google Scholar
  • 7 Feagins LA, Smith AD, Kim D, Halai A, Duttala S, Chebaa B. et al. Efficacy of Prophylactic Hemoclips in Prevention of Delayed Post-Polypectomy Bleeding in Patients With Large Colonic Polyps. Gastroenterology. 2019; 157 (04): 967-976.e1
    CrossrefPubMedSearch in Google Scholar
  • 8 Spadaccini M, Albéniz E, Pohl H, Maselli R, Thoguluva Chandrasekar V, Correale L. et al. Prophylactic Clipping After Colorectal Endoscopic Resection Prevents Bleeding of Large, Proximal Polyps: Meta-analysis of Randomized Trials. Gastroenterology 2020; 159 (01): 148-158.e11
    CrossrefPubMedSearch in Google Scholar
  • 9 Jiang SX, Chahal D, Ali-Mohamad N, Kastrup C, Donnellan F.. Hemostatic powders for gastrointestinal bleeding: a review of old, new, and emerging agents in a rapidly advancing field Endosc Int Open. 2022; 10 (08).
    PubMed
  • 10 Liu K, Gao L, Bai JW, Wang LL, Zhu SH, Zhao X, Han Y, Liu ZG.. Efficacy of new hemostatic techniques in nonvariceal gastrointestinal bleeding: A systematic review and network meta- analysis. J Dig Dis 2023; 24 (03): 181-93
    CrossrefPubMedSearch in Google Scholar
  • 11 Cha B, Lee D, Shin J, Park JS, Kwon GS, Kim H.. Hemostatic efficacy and safety of the hemostatic powder UI-EWD in patients with lower gastrointestinal bleeding. BMC Gastroenterol 2022; 22 (01): 170
    CrossrefPubMedSearch in Google Scholar
  • 12 Omori J, Goto O, Habu T, Ishikawa Y, Kirita K, Koizumi E. et al. Prophylactic clip closure for mucosal defects is associated with reduced adverse events after colorectal endoscopic submucosal dissection: a propensity-score matching analysis. BMC Gastroenterol 2022; 22 (01): 139
    CrossrefPubMedSearch in Google Scholar
  • 13 Nonaka S, Oda I, Tada K, Mori G, Sato Y, Abe S, Suzuki H, Yoshinaga S, Nakajima T, Matsuda T, Taniguchi H, Saito Y, Maetani I.. Clinical outcome of endoscopic resection for nonampullary duodenal tumors. Endoscopy. 2015; 47 (02): 129-35
    PubMedSearch in Google Scholar
  • 14 Binmoeller KF, Shah JN, Bhat YM, Kane SD.. ‘Underwater’ EMR of sporadic laterally spreading nonampullary duodenal adenomas (with video). Gastrointest Endosc 2013; 78 (03): 496-502
    CrossrefPubMedSearch in Google Scholar
  • 15 Bendall O, James J, Pawlak KM, Ishaq S, Tau JA, Suzuki N, Bollipo S, Siau K.. Delayed Bleeding After Endoscopic Resection of Colorectal Polyps: Identifying High-Risk Patients. Clin Exp Gastroenterol 2021; 14: 477-92
    CrossrefPubMedSearch in Google Scholar
  • 16 Yan Z, Gao F, Xie J, Zhang J.. Incidence and risk factors of colorectal delayed post- polypectomy bleeding in patients taking antithrombotics. J of Digest Diseases 2021; 22 (08): 481-7
    CrossrefPubMedSearch in Google Scholar
  • 17 Kono Y, Hirata I, Katayama T, Uemura H, Hirata T, Gotoda T, Miyahara K, Moritou Y, Nakagawa M.. Current evidence and issues of endoscopic submucosal dissection for gastric neoplasms during antithrombotic therapy. Clin J Gastroenterol 2020; 13 (05): 650-9
    CrossrefPubMedSearch in Google Scholar
  • 18 Lu X, Ma J.. Risk factors of delayed post-polypectomy bleeding after treatment of gastrointestinal polyps with snare-assisted endoscopic sub-mucosal dissection. J Minim Access Surg 2023; 19 (02): 272-7
    CrossrefPubMedSearch in Google Scholar
  • 19 Htet H, Longcroft-Wheaton G.. Prevention of delayed bleeding after resection of large colonic polyps. Best Pract Res Clin Gastroenterol 2024; 69: 101907
    CrossrefPubMedSearch in Google Scholar
  • 20 Klein A, Nayyar D, Bahin FF, Qi Z, Lee E, Williams SJ, Byth K, Bourke MJ.. Endoscopic mucosal resection of large and giant lateral spreading lesions of the duodenum: success, adverse events, and long-term outcomes. Gastrointest Endosc 2016; 84 (04): 688-96
    CrossrefPubMedSearch in Google Scholar
  • 21 Murata M, Sugimoto M, Ueshima S, Nagami Y, Ominami M, Sawaya M, Nakatani Y, Furumoto Y, Dohi O, Sumiyoshi T, Fukuzawa M, Tsuji S, Miyahara K, Takeuchi Y, Suzuki S, Tominaga N, Yagi N, Osawa S, Sakata Y, Yamada T, Yoshizawa Y, Yamauchi A, Yamamura T, Orihara S, Miyamoto S, Matsuda S, Hira D, Terada T, Katsura T, Gotoda T, Fujishiro M, Kawai T.. Association of direct oral anticoagulant and delayed bleeding with pharmacokinetics after endoscopic submucosal dissection. Gastrointest Endosc 2024; 99 (05): 721-731.e4
    CrossrefPubMedSearch in Google Scholar
  • 22 Jiang W, Cen L, Dong C, Zhu S, Shen Z, Li D.. Prophylactic Clipping to Prevent Delayed Bleeding and Perforation After Endoscopic Submucosal Dissection and Endoscopic Mucosal Resection: A Systematic Review and Meta-analysis. J Clin Gastroenterol 2022; 56 (08): 643-53
    CrossrefPubMedSearch in Google Scholar
  • 23 Park JS, Kim HK, Shin YW, Kwon KS, Lee DH.. Novel hemostatic adhesive powder for nonvariceal upper gastrointestinal bleeding. Endosc Int Open 2019; 7 (12): E1763-7
    Thieme ConnectPubMedSearch in Google Scholar
  • 24 Libânio D, Pimentel-Nunes P, Bastiaansen B, Bisschops R, Bourke MJ, Deprez PH, Esposito G, Lemmers A, Leclercq P, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, Fuccio L, Bhandari P, Dinis-Ribeiro M.. Endoscopic submucosal dissection techniques and technology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy 2023; 55 (04): 361-89
    Thieme ConnectPubMedSearch in Google Scholar
  • 25 Akimoto T, Goto O, Sasaki M, Mizutani M, Tsutsumi K, Kiguchi Y, Takatori Y, Nakayama A, Kato M, Fujimoto A, Ochiai Y, Maehata T, Kaise M, Iwakiri K, Yahagi N.. Endoscopic hand suturing for mucosal defect closure after gastric endoscopic submucosal dissection may reduce the risk of postoperative bleeding in patients receiving antithrombotic therapy. Dig Endosc 2022; 34 (01): 123-32
    CrossrefPubMedSearch in Google Scholar
  • 26 Kolb JM, Hammad H.. The Use of the Overstitch to Close Endoscopic Resection Defects. Gastrointest Endosc Clin N Am 2020; 30 (01): 163-71
    CrossrefPubMedSearch in Google Scholar
  • 27 Working group. Almario JA, Zhang LY, Cohen J, Haber GB, Ramberan H, Storm AC, Gordon S, Adler JM, Pohl H, Schlachterman A, Kumar A, Singh S, Qumseya B, Draganov PV, Kumta NA, Canakis A, Kim R, Aihara H, Shrigiriwar A, Ngamruengphong S, Khashab MA. Through-the-scope suture closure of nonampullary duodenal endoscopic mucosal resection defects: a retrospective multicenter cohort study. Endoscopy 2023; 55 (09): 865-70
    Thieme ConnectPubMedSearch in Google Scholar
  • 28 Subramaniam S, Kandiah K, Chedgy F, Fogg C, Thayalasekaran S, Alkandari A, Baker- Moffatt M, Dash J, Lyons-Amos M, Longcroft-Wheaton G, Brown J, Bhandari P.. A novel self- assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial. Endoscopy 2021; 53 (01): 27-35
    Thieme ConnectPubMedSearch in Google Scholar
  • 29 Ferlitsch M, Hassan C, Bisschops R, Bhandari P, Dinis-Ribeiro M, Risio M, Paspatis GA, Moss A, Libânio D, Lorenzo-Zúñiga V, Voiosu AM, Rutter MD, Pellisé M, Moons LMG, Probst A, Awadie H, Amato A, Takeuchi Y, Repici A, Rahmi G, Koecklin HU, Albéniz E, Rockenbauer LM, Waldmann E, Messmann H, Triantafyllou K, Jover R, Gralnek IM, Dekker E, Bourke MJ.. Colorectal polypectomy and endoscopic mucosal resection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Update 2024. Endoscopy 2024; 56 (07): 516-45
    Thieme ConnectPubMedSearch in Google Scholar
  • 30 Fanning SB, Bourke MJ, Williams SJ, Chung A, Kariyawasam VC.. Giant laterally spreading tumors of the duodenum: endoscopic resection outcomes, limitations, and caveats. Gastrointest Endosc 2012; 75 (04): 805-12
    CrossrefPubMedSearch in Google Scholar
  • 31 Lee HS, Jeon SW, Kwon YH, Nam SY, Shin S, Kim R, Ahn S.. Prophylactic endoscopic coagulation to prevent delayed post-EMR bleeding in the colorectum: a prospective randomized controlled trial (with videos). Gastrointest Endosc 2019; 90 (05): 813-22
    CrossrefPubMedSearch in Google Scholar
  • 32 Yoshida N, Hayashi Y, Togo D, Oka S, Takada K, Fukunaga S, Morita Y, Hayashi T, Kozuka K, Tsuji Y, Murakami T, Yamamura T, Komeda Y, Takeuchi Y, Shinmura K, Fukuda H, Yoshii S, Ono S, Katsuki S, Kawashima K, Nemoto D, Yamamoto H, Saito Y, Tamai N, Iwao A, Itoi Y, Tsuji S, Inagaki Y, Inada Y, Soga K, Hasegawa D, Murakami T, Yoriki H, Fukumoto K, Motoyoshi T, Nakatani Y, Sano Y, Iguchi M, Fujii S, Ban H, Harada K, Okamoto K, Nishiyama H, Sasaki F, Mizukami K, Shono T, Shimoda R, Miike T, Yamaguchi N.. An Analysis of Delayed Bleeding in Cases of Colorectal Endoscopic Submucosal Dissection Due to Types of Direct Oral Anticoagulants in Japan. Clin Gastroenterol Hepatol 2024; 22 (02): 271-282.e3
    CrossrefPubMedSearch in Google Scholar
  • 33 Mukai S, Cho S, Kotachi T, Shimizu A, Matuura G, Nonaka M, Hamada T, Hirata K, Nakanishi T.. Analysis of delayed bleeding after endoscopic submucosal dissection for gastric epithelial neoplasms. Gastroenterol Res Pract 2012; 2012: 875323
    CrossrefPubMedSearch in Google Scholar
  • 34 Harada H, Suehiro S, Murakami D, Nakahara R, Nagasaka T, Ujihara T, Sagami R, Katsuyama Y, Hayasaka K, Amano Y.. Feasibility of gastric endoscopic submucosal dissection with continuous low-dose aspirin for patients receiving dual antiplatelet therapy. World J Gastroenterol 2019; 25 (04): 457-68
    CrossrefPubMedSearch in Google Scholar
  • 35 Kono Y, Obayashi Y, Baba Y, Sakae H, Gotoda T, Miura K, Kanzaki H, Iwamuro M, Kawano S, Kawahara Y, Tanaka T, Okada H.. Postoperative bleeding risk after gastric endoscopic submucosal dissection during antithrombotic drug therapy. J Gastroenterol Hepatol 2018; 33 (02): 453-60
    CrossrefPubMedSearch in Google Scholar