IEIK13/TDM-623/NxPURAは、ただの別製品ではなかった。PuraStatの機能改善版だった。 PuraStatは、抗凝固薬服用患者などESD後遅延性出血リスクが高い症例で、明確な優位性を示しきれていません。不安になられる方も多いと思います。 そのため、第2世代のTDM-623/IEIK13はどうなんだろうかと考えました。もう安心です。それに関する研究がありました。よかったよかった。 5年前に大阪大学から出ていたTDM-623論文です。 pmc.ncbi.nlm.nih.gov/article… 問題提起で以下のように明記していました： 第一世代RADA16/TDM-621/PuraStatの課題として、 ・ゲル形成がやや遅い ・組織表面への保持力が低い そこで検討されたのが、TDM-623/IEIK13です。 ブタ上部消化管出血モデルでは、ヘパリン化条件下でも 胃：74%で完全止血 十二指腸：80%で完全止血 「ゲル脱落ほぼなし。」これが知りたかったのだ！ 無処置の自然止血、他の止血材のデータはありませんが、ヘパリン条件下(ACT ≥200)でゲル脱落ほぼなしで、この止血率は好成績です。 さらに同グループの別論文では、TDM-623の人工胃液・人工膵液下での48時間安定性を確認。胃液での溶出は最大10.3%、膵液では有意な溶出なしでした。tandfonline.com/doi/10.1080/… 抗凝固薬服用患者では、二次止血が弱いからこそ、術後創面に残り続けるゲルのレオロジー、保持性、耐消化液性が重要になります。 これでIEIK13/TDM-623がRADA16の次に来るSAPとして他社製品を凌駕すると(ほぼ)確信しました。 TDM-623/IEIK13によるハイリスクESD後出血予防で、RCTをやるべきです。 PuraStatが開いた道を、TDM-623/IEIK13/NxPURAが超えていきます。 #3Dマトリックス #3Dmatrix #IEIK13 #TDM623 #NxPura #PuraStat #DelayedBleeding

In a large multicentre colorectal ESD study, #RADA16 use was associated with significantly lower rates of #haematochezia and #delayedbleeding. 👉 Explore the findings: hubs.li/Q03ZQm400 hubs.li/Q03ZQm400 #3dmatrix #PeptideTechnology #ColorectalESD #GIEndoscopy

When good haemostatic tools fail: lessons from delayed bleeding after EMR and ESD (2/2) Conclusion Taken together, the collective evidence from these four studies converges on a consistent conclusion: delayed bleeding after advanced colorectal resection is unlikely to be reliably prevented by any single local measure, including complete mechanical closure. Accordingly, negative or unfavourable outcomes observed when self-assembling peptide gels are used in isolation (as in the PURPLE trial or selected high-risk retrospective EMR cohorts) should not be extrapolated to dismiss their potential utility when integrated into a multimodal haemostatic strategy. Future research should therefore prioritise risk-stratified, prospective comparative studies that evaluate adjunctive PuraStat use within predefined haemostatic protocols, reflecting contemporary endoscopic practice and the multifactorial nature of delayed bleeding. ⸻ References (all four) 1.De Cristofaro E, Jacques J, Montori S, et al.; FECCo Working Group. Impact of prophylactic clipping on delayed bleeding after colorectal endoscopic submucosal dissection: a multicenter propensity score-matched study. Endoscopy. 2026. doi: 10.1055/a-2723-5162. 2.Drews J, Zachäus M, Kleemann T, et al. Multicentre randomised controlled trial of a self-assembling haemostatic gel to prevent delayed bleeding following endoscopic mucosal resection (PURPLE trial). Gut. 2025;74:1103–1111. 3.Barone VR, Ma M, Inamdar S, et al. Use of a novel self-assembling peptide gel for prevention of bleeding after endoscopic mucosal resection of large non-pedunculated sessile colorectal polyps: a case-control study. Journal Pre-proof. 4.Htet HMT, Subramaniam S, Parra-Blanco A, et al.; POPS Trial Investigators. Effectiveness and safety of a haemostatic gel in the treatment of intraprocedural bleeding and prevention of delayed bleeding after advanced endoscopic resection of large and complex gastrointestinal neoplasia : a multicentre prospective observational PuraStat study(POPS trial). Frontline Gastroenterology. 2025. doi: 10.1136/flgastro-2025-103153. #3Dmatrix #Endoscopy #GIbleeding #DelayedBleeding #PURPLEtrial #POPStrial #PuraStat #EMR #ESD #MultimodalHaemostasis #EvidenceBasedMedicine

When good haemostatic tools fail: lessons from delayed bleeding after EMR and ESD (1/2) The prevention of delayed bleeding after advanced colorectal endoscopic resection represents a complex clinical challenge that appears resistant to single-modality prophylactic strategies. 1. The Limits of Mechanical Closure (De Cristofaro et al.) In the largest Western multicentre study to date, De Cristofaro et al. evaluated the impact of complete prophylactic clip closure after colorectal endoscopic submucosal dissection (ESD) using a robust propensity score–matched design based on validated Limoges Bleeding Score (LBS) risk factors. Despite analysing more than 3,000 ESD cases and 944 matched pairs, complete defect closure did not significantly reduce clinically significant delayed bleeding (CSDB), even among patients receiving antithrombotic therapy or those classified as high risk (LBS 5–8). Importantly, this lack of benefit persisted despite closure being a deep, mechanically intuitive intervention and despite meticulous adjustment for known bleeding predictors. 2. Reinterpreting the PURPLE Trial These findings have important implications for the interpretation of subsequent prophylactic haemostasis studies. In this context, the negative results of the PURPLE trial, which evaluated prophylactic application of a self-assembling peptide hydrogel (PuraStat) after EMR, should not be viewed as evidence of failure of the agent itself. Rather, when considered alongside De Cristofaro et al., PURPLE reinforces the concept that delayed bleeding is a multifactorial, time-dependent phenomenon that is unlikely to be prevented by a single local intervention, whether mechanical (clip closure) or topical (hydrogel application). The absence of benefit observed when PuraStat was applied as a stand-alone prophylactic measure after EMR is therefore pathophysiologically coherent, rather than contradictory, given that even complete closure of large ESD defects does not confer consistent protection. 3. Caution with Retrospective Data (Barone et al.) Similarly, the multicentre retrospective case-control study by Barone et al., which reported a higher rate of delayed bleeding associated with self-assembling peptide gel use after EMR of large non-pedunculated lesions not amenable to closure, must be interpreted with caution. This study inherently selected a highly enriched high-risk population in whom the decision to apply the gel likely reflected unmeasured intraprocedural factors such as extent of thermal injury, presence of high-risk exposed vessels, operator concern, or centre-specific haemostatic practice. In such a setting, confounding by indication is highly probable, and the observed association cannot be taken as proof of causality or harm, particularly in light of small event numbers and wide confidence intervals. 4. The Value of Multimodal Strategy (POPS Trial) In contrast, data from the POPS trial, a large multicentre prospective observational study evaluating PuraStat during high-risk tissue resection (HRTR) across both EMR and ESD, provide important real-world context. In POPS, PuraStat was frequently used as an adjunct to conventional haemostatic techniques, including targeted coagulation and focal clipping, rather than as an isolated prophylactic intervention. Within this multimodal haemostatic strategy, high intraprocedural haemostatic efficacy and a low overall delayed bleeding rate were observed. Although the absence of a control arm precludes causal inference, POPS supports the concept that the clinical value of self-assembling peptide hydrogels lies in their complementary role within layered haemostasis, rather than in replacement of deep vessel control. More thoughts in the next post. #3Dmatrix #Endoscopy #GIbleeding #DelayedBleeding #PURPLEtrial #POPStrial #PuraStat #EMR #ESD #MultimodalHaemostasis #EvidenceBasedMedicine

In this case video, Dr Noor Mohammed (Leeds Teaching Hospitals NHS Trust, UK) showcases the use of #PuraStat to manage #DelayedBleeding following #Rectal #ESD. 👉 See how PuraStat activates when in contact with blood: hubs.li/Q03VYH1M0 #GI #RADA16 #RectalBleeding

Our team is at the 46th Czech & Slovak Endoscopic Days 2025 with SuppMed & @FujifilmEMEA. Stop by to learn how #PuraStat supports #GI procedures! Don't miss tomorrow’s presentation on preventing #DelayedBleeding after advanced endoscopic therapy. hubs.li/Q03cL9Bl0

3DM 素晴らしい👍 「PuraStat を使用すると、高リスク患者の結腸 ESD 後の遅延出血が 50% 減少します。当社の臨床結果の詳細については、こちらをご覧ください: 」bit.ly/3LWtqMU #GI #Endoscopy #PuraStat #3dmatrix #bleedmanagement #clinicaldata #delayedbleeding

Achieve a 50% reduction in delayed bleeding following colonic ESD in high-risk patients with PuraStat. Discover more about our clinical results today: bit.ly/3LWtqMU #GI #Endoscopy #PuraStat #3dmatrix #bleedmanagement #clinicaldata #delayedbleeding

Did you know that PuraStat has been shown to help reduce #delayedbleeding after ESD, especially in the #colorectum? Take a look at the latest poster showcasing this, presented earlier this year at #ESGE. Read more: bit.ly/4cJwjMt #purastat #GI #3dmatrix #peptides #news

📞📧 Please get in touch for more information on @3dm_emea #PuraStat or pop over to see us @ACPGBI next week! #colorectal #lowerGI #delayedbleeding #ACPGBI2024 #GITwitter #ESD

As the festivities creep in and calendars fill up with joyous plans, time becomes even more precious. Avoid delays in endoscopic procedures and decrease the chances of #delayedbleeding for colonic ESD patients by using #PuraStat. bit.ly/48auerb #3dmatrix #patientoutcomes

Today we are are proud to be supporting the @kingslivelondon ESD and Suturing hands-on sessions with PuraStat alongside our partner @3dm_emea. #KingsLive2023 #PuraStat #ESD #haemostasis #delayedbleeding #GITwitter #morethanjustahaemostat #endoscopy

Dr ⁦⁦@vega_roser⁩ explaining during the Gastrointestinal Consequences of Cancer Treatments meeting how she uses⁩ #PuraStat in her practice to achieve #haemostasis following #EMR and #ESD, to significantly reduce the risk of #DelayedBleeding and to treat #RP

To learn more about how delayed bleeding following ESD was reduced by 50% in patients treated with #PuraStat in clinical study led by @gastro3570 please visit ueg.eu/library/minimising-th… #delayedbleeding #ESD #GIbleeds #GITwitter

A clinical study led by Prof. Pradeep Bhandari demonstrated that delayed bleeding after colonic ESD was reduced by 50% in patients treated with #PuraStat. Curious to know more about this study? Have a look here: hubs.li/Q01qJk0N0 #purastat #3dmatrix #ESD #delayedbleeding

We are back with more events. Check out the FUJIFILM France team who is ready to answer your PuraStat questions at the EUS ENDO 22 this week (15 - 17 Sept). #3dmatrix #Fujifilm #purastat #endoscopy #GI #France #bleedingmanagement #delayedbleeding #esd #emr

We are so excited about the launch of a new prospective observational registry (POPS) in Kuwait! Have you read the article on our news webpage? Check it here for more details: hubs.li/Q01hMDxX0 #3dmatrix #news #purastat #clinicalstudies #delayedbleeding #GI #RADA16

Delayed bleeding represents one of the most common complications after endoscopic resection of large gastrointestinal polyps. Learn more about the clinical trial here: hubs.li/Q01gXvTn0 #news #purastat #clinicalstudies #clinicaltrial #delayedbleeding #endoscopy

It's the last day of #ESGEDays2022 in Prague, don't miss speaking to our team about PuraStat on the #FUJIFILM booth! 💉 We look forward to speaking with you! #purastat #3dmatrix #fujijilm #esge #prague #endoscopy #GI #delayedbleeding #transparent #haemostat #medicaldevice

Did you know PuraStat is the first haemostat approved to reduce delayed bleeding following ESD in the colon? Please contact us to find out more! #notanotherhaemostat #ESD #endoscopy #aquilant #purastat #gibleeds #haemostasis #peptidesatwork #delayedbleeding #haemostat