Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis

Официальное название

Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis (SupraBilS): a Randomized Controlled Trial

Обзор

This is a randomized controlled trial comparing patients with obstructive jaundice due to malignancies of the perihilar area of bile ducts and undergoing both preoperative and palliative biliary drainage. The comparison will focus on the technique:, on the one hand, an arm of patients undergoing standard-of-care ERCP with trans-papillary plastic protesis placement, and on the other hand, an experimental arm of patients undergoing suprapapillary plastic protesis placement with no sphincterotomy. The primary objective will be to compare the time-to-stent dysfunction in the two groups; secondary objectives will include a comparison of the safety, technical, and clinical success of the procedures.

Вмешательства

• Процедура ERCP with suprapapillary stent placement
  ERCP with no sphincterotomy and placement of plastic stents above the papilla of Vater.
• Процедура ERCP with transpapillary stent placement
  Standard ERCP with or without sphincterotomy with trans papillary stent placement

Первичные конечные точки

• Time-to-Stent disfunction [Срок оценки: From index procedure to a minimum of one year of follow up.]

Вторичные конечные точки (3)

• Safety of the procedure [Срок оценки: From the index procedure within 14 days.]
• Technical success [Срок оценки: At the moment of index procedure.]
• Clinical Success [Срок оценки: Between 14 and 30 days from the index procedure.]

Критерии участия

Критерии включения

• Radiological/ biochemical/pathological diagnosis of malignant OJ.
• Stenosis maximum extent may be 2 cm after biliary confluence.
• Documented obstructive jaundice (serum bilirubin > 3 mg/dL).
• Indication for biliary drainage (preoperative or palliative).
• Age ≥ 18 years.
• Signed informed consent.

Критерии исключения

• Contraindications to endoscopic approach (duodenal stenosis, surgically altered anatomy).
• Previous sphincterotomy or drainage.
• Involvement of the papilla of Vater by the tumour.
• Uncontrolled coagulopathy (INR > 1.5 uncorrectable or <50.000 PLTs).
• Ongoing uncontrolled cholangitis as defined according to the Tokyo 2018 Guidelines, or systemic sepsis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Naitoh I, Inoue T. Optimal endoscopic drainage strategy for unresectable malignant hilar biliary obstruction. Clin Endosc. 2023 Mar;56(2):135-142. doi: 10.5946/ce.2022.150. Epub 2023 Jan 5. PMID 36600654
• Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9. PMID 31078660
• Kiriyama S, Kozaka K, Takada T, Strasberg SM, Pitt HA, Gabata T, Hata J, Liau KH, Miura F, Horiguchi A, Liu KH, Su CH, Wada K, Jagannath P, Itoi T, Gouma DJ, Mori Y, Mukai S, Gimenez ME, Huang WS, Kim MH, Okamoto K, Belli G, Dervenis C, Chan ACW, Lau WY, Endo I, Gomi H, Yoshida M, Mayumi T, Baron TH, de Santibanes E, Teoh AYB, Hwang TL, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Higuchi R PMID 29032610
• Nass KJ, Zwager LW, van der Vlugt M, Dekker E, Bossuyt PMM, Ravindran S, Thomas-Gibson S, Fockens P. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc. 2022 Jun;95(6):1078-1085.e8. doi: 10.1016/j.gie.2021.11.038. Epub 2021 Dec 8. PMID 34890695
• Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available. PMID 20189503
• Kovacs N, Pecsi D, Sipos Z, Farkas N, Foldi M, Hegyi P, Bajor J, Eross B, Marta K, Miko A, Rakonczay Z Jr, Sarlos P, Abraham S, Vincze A. Suprapapillary Biliary Stents Have Longer Patency Times than Transpapillary Stents-A Systematic Review and Meta-Analysis. J Clin Med. 2023 Jan 23;12(3):898. doi: 10.3390/jcm12030898. PMID 36769545
• Okamoto T, Fujioka S, Yanagisawa S, Yanaga K, Kakutani H, Tajiri H, Urashima M. Placement of a metallic stent across the main duodenal papilla may predispose to cholangitis. Gastrointest Endosc. 2006 May;63(6):792-6. doi: 10.1016/j.gie.2005.05.015. PMID 16650540
• Keulen AV, Gaspersz MP, van Vugt JLA, Roos E, Olthof PB, Coelen RJS, Bruno MJ, van Driel LMJW, Voermans RP, van Eijck CHJ, van Hooft JE, van Lienden KP, de Jonge J, Polak WG, Poley JW, Pek CJ, Moelker A, Willemssen FEJA, van Gulik TM, Erdmann JI, Hol L, IJzermans JNM, Buttner S, Koerkamp BG. Success, complication, and mortality rates of initial biliary drainage in patients with unresectable perihi PMID 35989132

Идентификаторы

NCT: NCT07325877 · ID0001 · ID0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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