{"id":19589,"date":"2024-11-26T07:30:00","date_gmt":"2024-11-26T07:30:00","guid":{"rendered":"https:\/\/endoscopiaterapeutica.net\/pt\/?p=19589"},"modified":"2024-11-24T19:57:34","modified_gmt":"2024-11-24T19:57:34","slug":"artigo-comentado-over-the-scope-clip-as-first-line-treatment-of-peptic-ulcer-bleeding-a-multicenter-randomized-controlled-trial-top-study","status":"publish","type":"post","link":"https:\/\/endoscopiaterapeutica.net\/pt\/artigoscomentados\/artigo-comentado-over-the-scope-clip-as-first-line-treatment-of-peptic-ulcer-bleeding-a-multicenter-randomized-controlled-trial-top-study\/","title":{"rendered":"Artigo comentado: Over-the-scope clip as first-line treatment of peptic ulcer bleeding: a multicenter randomized controlled trial (TOP Study)"},"content":{"rendered":"\n

Publicado por Soriani et al. na Endoscopy em maio de 2024 (1).<\/p>\n\n\n\n

Introdu\u00e7\u00e3o<\/strong><\/strong><\/h2>\n\n\n\n

As hemorragias digestivas altas (HDA) s\u00e3o frequentes na pr\u00e1tica cl\u00ednica e sua principal etiologia envolve as \u00falceras p\u00e9pticas. Recentemente, os \u201cover-the-scope clips\u201d (OTSC) v\u00eam sendo empregados para a hemostasia em \u00falceras p\u00e9pticas, inclusive como primeira linha. Estudos envolvendo diferentes etiologias demonstraram melhores resultados para o OTSC quando comparado ao tratamento padr\u00e3o com clipes convencionais (\u201cthrough-the-scope clips\u201d – TTSC) (2-4). Visando compreender melhor a efic\u00e1cia do OTSC, este estudo inclui apenas HDA por \u00falcera p\u00e9ptica, randomizando o tratamento para OTSC ou TTSC.<\/p>\n\n\n\n

M\u00e9todos<\/strong><\/h2>\n\n\n\n

O estudo foi conduzido em cinco centros europeus. Pacientes com HDA submetidos a EDA em at\u00e9 24h da admiss\u00e3o com classifica\u00e7\u00e3o de Forrest Ia, Ib e IIa (inclusive ap\u00f3s remo\u00e7\u00e3o de co\u00e1gulo) foram randomizados para OTSC ou TTSC. Nos casos de Forrest I submetidos a terapia com TTSC, associou-se rotineiramente o tratamento com solu\u00e7\u00e3o de adrenalina conforme recomenda\u00e7\u00e3o do Guideline da ESGE (5). Neste mesmo grupo, as \u00falceras Forrest IIa poderiam ter terapia associada com adrenalina ou n\u00e3o. N\u00e3o houve limite na quantidade de clipes empregada em ambos os grupos.<\/p>\n\n\n\n

O desfecho prim\u00e1rio foi ressangramento em 30 dias; os secund\u00e1rios correspondem a sucesso cl\u00ednico, necessidade de nova EDA, necessidade de transfus\u00e3o de concentrado de hem\u00e1cias, tempo de interna\u00e7\u00e3o, mortalidade em 30 dias e complica\u00e7\u00f5es associadas a terapia endosc\u00f3pica.<\/p>\n\n\n\n

Resultados<\/strong><\/h2>\n\n\n\n

Entre 2018 e 2022, foram inclu\u00eddos 112 pacientes (OTSC = 61 x TTSC = 51). Todos os pacientes foram classificados como Forrest I ou IIa (15 casos ap\u00f3s remo\u00e7\u00e3o de co\u00e1gulo) e receberam altas doses de IBP peri-procedimento (dose n\u00e3o especificada). Os grupos foram similares considerando as caracter\u00edsticas dos pacientes (uso de AINE, anticoagulantes, antiplaquet\u00e1rios, DAOC, altera\u00e7\u00f5es hemodin\u00e2micas, RNI, Hb, etc) e da \u00falcera (tamanho, topografia, Forrest, etc).<\/p>\n\n\n\n

Apenas um paciente no grupo do OTSC recebeu um segundo clipe. No grupo TTSC, a m\u00e9dia foi de 2 clipes (varia\u00e7\u00e3o de 1 a 8) e 28\/51 receberam inje\u00e7\u00e3o de solu\u00e7\u00e3o de adrenalina.<\/p>\n\n\n\n

Em rela\u00e7\u00e3o ao desfecho prim\u00e1rio, n\u00e3o houve diferen\u00e7a entre os grupos: OTSC 1\/61 paciente (1,6%) x TTSC 2\/51 (3,9%) apresentaram ressangramento dentro de 30 dias (RR = 0,42 (95%CI 0,04 \u2013 4,53, P = 0,47). Todos os casos foram tratados adequadamente em uma segunda endoscopia: o sangramento no grupo do OTSC foi resolvido com clipes convencionais e os dois casos do bra\u00e7o TTSC foram resolvidos, um com OTSC, e outro com m\u00e9todo t\u00e9rmico.<\/p>\n\n\n\n

No tocante aos desfechos secund\u00e1rios, a hemostasia inicial foi maior no grupo do OTSC: 98.4% (60\/61) x 78.4% (40\/51) (RR = 1,25, 95%CI 1,08 \u2013 1,45, P = 0,003). O caso de insucesso inicial do OTSC foi tratado com TTSC; dos 11 casos de insucesso inicial do TTSC, 10 foram resolvidos com OTSC e um precisou associar ainda, m\u00e9todo t\u00e9rmico e p\u00f3 hemost\u00e1tico. Vale ressaltar que dos 11 casos de falha do TTSC, 7 eram \u00falceras fibr\u00f3ticas e 3 localizadas na parede posterior do bulbo.<\/p>\n\n\n\n

N\u00e3o houve diferen\u00e7a em termos de transfus\u00e3o sangu\u00ednea (p = 0,66), tempo de interna\u00e7\u00e3o (p = 0,92) e mortalidade em 30 dias (p = 0,18).<\/p>\n\n\n\n

N\u00e3o houve eventos adversos relacionados \u00e0 terapia endosc\u00f3pica.<\/p>\n\n\n\n

Discuss\u00e3o<\/strong><\/h2>\n\n\n\n

Com o desenvolvimento de novas tecnologias, \u00e9 interessante compreender seu papel e vantagens em rela\u00e7\u00e3o a outros m\u00e9todos. Devemos considerar que os m\u00e9todos que temos atualmente para hemostasia das \u00falceras p\u00e9pticas, sendo os principais t\u00e9rmicos e TTSC associados ou n\u00e3o \u00e0 inje\u00e7\u00e3o de adrenalina, s\u00e3o altamente eficazes na grande maioria dos casos. De antem\u00e3o, reconhecemos limita\u00e7\u00f5es principalmente dos TTSC para \u00falceras fibr\u00f3ticas, de grandes dimens\u00f5es, e em posi\u00e7\u00f5es desfavor\u00e1veis, como parede posterior do bulbo e pequena curvatura g\u00e1strica. Neste contexto, e ainda em casos de falha de um m\u00e9todo pr\u00e9vio, ou seja, como terapia de resgate, percebe-se o maior benef\u00edcio potencial dos OTSC.<\/p>\n\n\n\n

O trabalho exposto mostra justamente este resultado, uma vez que o posicionamento\/estabiliza\u00e7\u00e3o do cap e maior abrang\u00eancia tecidual pelos OTSC favorecem este m\u00e9todo em casos previamente reconhecidos como de dif\u00edcil abordagem com os TTSC. A diferen\u00e7a em termos de resultados apresentou-se basicamente no crossover com uso de OTSC em casos de falha de TTSC (11 casos, sendo 7 \u00falceras fibr\u00f3ticas e 3 na parede posterior do bulbo). Nos demais casos, permanece a impress\u00e3o de uma alta efic\u00e1cia dos m\u00e9todos convencionais (como TTSC) que justifica seu uso, mesmo com os OTSC dispon\u00edveis. Por outro lado, tamb\u00e9m \u00e9 adequado optar pelos OTSC nestas ocasi\u00f5es, uma vez que esta recurso apresenta efic\u00e1cia e seguran\u00e7a similares. <\/p>\n\n\n\n

Em outras palavras, em situa\u00e7\u00f5es \u201ccomuns\u201d, podemos optar pelos TTSC ou pelos OTSC, por\u00e9m em situa\u00e7\u00f5es em que os TTSC apresentam pior desempenho (ex.: \u00falceras fibr\u00f3ticas, localiza\u00e7\u00e3o em parede posterior de bulbo e pequena curvatura de corpo g\u00e1strico), os OTSC devem ser empregados como primeira escolha.<\/p>\n\n\n\n

Esta colabora\u00e7\u00e3o foi muito importante em termos de conduta baseada em evid\u00eancias, pois foi o primeiro trabalho que randomizou OTSC e TTSC no contexto exclusivo de \u00falceras p\u00e9pticas. Se por um lado, poderia haver a impress\u00e3o de que existe uma superioridade em quase todas as situa\u00e7\u00f5es, do outro, poderia existir o receio de dificuldade t\u00e9cnica e eventos adversos associados. Como habitual, nenhum dos extremos foi demonstrado e cabe o reconhecimento dos benef\u00edcios e limita\u00e7\u00f5es de cada m\u00e9todo para o melhor emprego do arsenal terap\u00eautico dispon\u00edvel. Novos estudos, a experi\u00eancia pr\u00e1tica e o aprimoramento das tecnologias certamente poder\u00e3o elaborar ainda mais as discuss\u00f5es, bem como aumentar a efic\u00e1cia das terapias hemost\u00e1ticas endosc\u00f3picas.<\/p>\n\n\n\n

Para mais informa\u00e7\u00f5es sobre HDA clique: abordagem inicial<\/a>, plano de a\u00e7\u00e3o<\/a> e outras recomenda\u00e7\u00f5es<\/a>.<\/p>\n\n\n\n

Refer\u00eancias<\/strong><\/h2>\n\n\n\n
    \n
  1. Soriani P, Biancheri P, Bonura GF, et al. Over-the-scope clip as first-line treatment of peptic ulcer bleeding: a multicenter randomized controlled trial (TOP Study). Endoscopy. 2024;56(9):665-673. doi:10.1055\/a-2303-4824. 38599622.<\/li>\n\n\n\n
  2. Jensen DM, Kovacs T, Ghassemi KA, Kaneshiro M, Gornbein J. Randomized Controlled Trial of Over-the-Scope Clip as Initial Treatment of Severe Nonvariceal Upper Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2021;19(11):2315-2323.e2. doi:10.1016\/j.cgh.2020.08.046.<\/li>\n\n\n\n
  3. Meier B, Wannhoff A, Denzer U, et al. Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomized controlled trial (STING-2). Gut. 2022;71(7):1251-1258. doi:10.1136\/gutjnl-2021-325300.<\/li>\n\n\n\n
  4. Bapaye J, Chandan S, Naing LY et al. Safety and efficacy of over-the-scope clips versus standard therapy for high-risk nonvariceal upper GI bleeding: systematic review and meta-analysis. Gastrointest Endosc 2022; 96: 712\u2013720 doi:10.1016\/j.gie.2022.06.032.<\/li>\n\n\n\n
  5. Gralnek IM, Stanley AJ, Morris AJ, et al. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Update 2021. Endoscopy. 2021;53(3):300-332. doi:10.1055\/a-1369-5274.<\/li>\n<\/ol>\n\n\n\n

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    Publicado por Soriani et al. na Endoscopy em maio de 2024 (1). 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