Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial) (SMART-B)
Randomized Clinical Trial of Suprapapillary Drainage With Metal Stent vs. Routine Internal-External Transpapillary Drainage in Patients With Malignant Hilar Biliary Obstruction
Malignant hilar biliary obstruction is a condition in which the bile ducts near the liver become blocked due to cancer. This blockage can lead to jaundice (yellowing of the skin and eyes), itching, infection, and impaired liver function. To relieve the obstruction, doctors commonly perform procedures to drain bile and restore its flow.
There are different techniques available for biliary drainage. One common method is percutaneous transpapillary internal-external drainage, in which a catheter is placed through the liver and across the natural opening of the bile duct into the intestine. Another approach is percutaneous suprapapillary drainage using a self-expanding metal stent, which allows bile to drain without crossing into the intestine and may reduce the risk of contamination and infection.
Currently, there is no clear consensus on which of these two techniques is safer or more effective for patients with malignant proximal biliary obstruction. Some studies suggest that avoiding manipulation of the intestinal opening of the bile duct may reduce complications such as infection, but high-quality comparative evidence is lacking.
The purpose of this study is to compare percutaneous suprapapillary drainage with a self-expanding metal stent versus routine percutaneous transpapillary internal-external drainage in patients with malignant proximal biliary obstruction. The study aims to compare the rate of drainage-related complications between the two techniques, as well as to evaluate treatment success, stent patency, and the need for reintervention. In addition, in patients with potentially resectable disease undergoing preoperative biliary drainage, the study will assess and compare surgical outcomes between the two approaches. The results of this study may help determine the safest and most effective drainage strategy for these patients and improve future clinical decision-making.
Descripción general del estudio
Estado
Descripción detallada
Malignant hilar biliary obstruction is most commonly associated with perihilar cholangiocarcinoma and represents a complex clinical condition characterized by impaired bile flow at or above the hepatic duct confluence. The resulting cholestasis may lead to progressive hepatic dysfunction, increased risk of infectious complications, and reduced tolerance to systemic or surgical therapies. In selected patients, preoperative biliary drainage is performed to optimize liver function and reduce perioperative risk prior to major hepatectomy.
Percutaneous biliary drainage is widely used in this setting due to its ability to selectively decompress specific hepatic segments, particularly in complex hilar strictures. The conventional approach consists of transpapillary internal-external drainage, in which a catheter is advanced across the obstruction and through the papilla into the duodenum. While effective in achieving biliary decompression, this technique may disrupt the function of the sphincter of Oddi and facilitate duodenobiliary reflux, which has been implicated as a potential mechanism for infectious complications.
Percutaneous suprapapillary drainage with placement of a self-expanding metal stent represents an alternative strategy. By avoiding transpapillary manipulation, this approach preserves sphincter function and may reduce bacterial contamination of the biliary tree. Early clinical data suggest a favorable safety profile, particularly regarding infectious outcomes; however, direct comparisons with conventional transpapillary drainage remain limited, and available studies are constrained by methodological limitations.
An additional area of uncertainty relates to patients with potentially resectable disease. In this subgroup, the choice of drainage technique may influence not only peri-procedural outcomes but also subsequent surgical management. Concerns have been raised regarding the potential impact of metallic stents on operative complexity and resectability, although robust data are lacking.
This randomized clinical trial is designed to compare two percutaneous drainage strategies within a standardized institutional framework. Patients with an indication for percutaneous biliary drainage will be allocated to receive either transpapillary internal-external drainage or suprapapillary drainage with a self-expanding metal stent. The study includes both patients with unresectable disease and those with potentially resectable malignancies, allowing for evaluation across different clinical scenarios.
All procedures will be performed by experienced interventional radiologists using uniform technical protocols, and patients will be managed according to institutional standards of care. Follow-up will include clinical, laboratory, and imaging assessment as appropriate to routine practice.
The study is designed to generate comparative evidence regarding the safety and performance of these two techniques. In addition, a prespecified subgroup analysis will focus on patients with potentially resectable cholangiocarcinoma undergoing preoperative biliary drainage, in order to explore the impact of drainage strategy on subsequent surgical outcomes.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cleber R. P. Kruel, Professor
- Número de teléfono: 8232 +55(51)3359-8232
- Correo electrónico: crkruel@hcpa.edu.br
Copia de seguridad de contactos de estudio
- Nombre: Gabriel L. da Silva, Attending Physician
- Número de teléfono: 8232 +55(51)3359-8232
- Correo electrónico: gablsilva@hcpa.edu.br
Ubicaciones de estudio
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
- Hospital de Clinicas de Porto Alegre
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Contacto:
- Cleber R. P. Kruel, Professor
- Número de teléfono: 8232 +55(51)3359-8232
- Correo electrónico: crkruel@hcpa.edu.br
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Contacto:
- Gabriel L. da Silva, Attending Physician
- Número de teléfono: 8232 +55(51)3359-8232
- Correo electrónico: gablsilva@hcpa.edu.br
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Sub-Investigador:
- Gabriel L. da Silva, Attending Physician
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Sub-Investigador:
- Leandro A. Scaffaro, Attending Physician
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Sub-Investigador:
- Mauricio Farenzena, Attending Physician
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Sub-Investigador:
- Flavia H. Feier, Professor
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Sub-Investigador:
- Pablo D. Rodrigues, Attending Physician
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Sub-Investigador:
- Tomaz J. M. Grezzana, Attending Physician
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Sub-Investigador:
- Marcio F. Chedid, Attending Physician
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Sub-Investigador:
- William F. Silvano, Attending Physician
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Sub-Investigador:
- Francisco C. B. Lemanski, General Surgery Resident
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Investigador principal:
- Cleber R. P. Kruel, Professor
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age >18 years.
- Malignant proximal biliary obstruction on imaging (magnetic resonance cholangiopancreatography or contrast-enhanced abdominal computed tomography) with histopathological confirmation or high clinical and radiological suspicion.
- Total bilirubin > 3 mg/dL.
- Patients not candidates for potentially curative surgical resection due to locally advanced disease, metastatic disease, or inadequate clinical condition.
- Patients with potentially resectable neoplasms, defined as the possibility of achieving complete resection (R0), who meet at least one of the following criteria:
5.1 Estimated future liver remnant <40%, in whom percutaneous portal vein embolization of the side to be resected will also be indicated after initial drainage.
5.2 Prolonged jaundice with total bilirubin >10 mg/dL for more than 14 days. 5.3 Malnutrition, defined as ≥10% unintentional weight loss or albumin <3 g/dL, presumably attributable to cholestasis.
5.4 Indication for neoadjuvant chemotherapy.
Exclusion Criteria:
- Tumor with distal extension to the duodenal papilla, precluding suprapapillary drainage.
- Prior biliary drainage procedure, either percutaneous (PTBD) or endoscopic (ERCP).
- Acute cholangitis, clinically defined as fever (axillary temperature >38°C) and leukocytosis (white blood cell count >10,000/mm³).
- Uncorrectable coagulopathy.
- Iodinated contrast allergy not amenable to desensitization.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Transpapillary internal-external drainage
Participants undergo percutaneous transpapillary internal-external biliary drainage with placement of a catheter across the obstruction and through the papilla into the duodenum, according to standard institutional practice.
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Percutaneous biliary drainage performed by advancing a catheter across the biliary obstruction and through the papilla into the duodenum, allowing internal and external bile drainage.
Otros nombres:
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Comparador activo: Suprapapillary Self-Expanding Metal Stent Drainage
Participants undergo percutaneous suprapapillary biliary drainage with placement of a self-expanding metal stent across the obstruction without crossing the papilla.
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Percutaneous biliary drainage performed by placing a self-expanding metal stent across the biliary obstruction without crossing the papilla.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acute cholangitis
Periodo de tiempo: Within 90 days after intervention
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Defined by clinical criteria, including fever (axillary temperature >38°C) and leukocytosis (white blood cell count >10,000/mm³), in the absence of another infectious source on abdominal and chest imaging.
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Within 90 days after intervention
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Acute cholecystitis
Periodo de tiempo: Within 90 days after intervention
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Defined by radiological evidence of cholecystitis associated with fever (axillary temperature >38°C) and leukocytosis (white blood cell count >10,000/mm³).
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Within 90 days after intervention
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Acute pancreatitis
Periodo de tiempo: Within 90 days after intervention
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Defined by the presence of at least two of the following criteria: abdominal pain consistent with pancreatitis, elevation of amylase and/or lipase greater than three times the upper limit of normal, or characteristic imaging findings.
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Within 90 days after intervention
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Bile leak
Periodo de tiempo: Within 90 days after intervention
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Defined as intra-abdominal bile leakage due to biliary perforation or at the hepatic puncture site, confirmed by imaging.
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Within 90 days after intervention
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Hemorrhage
Periodo de tiempo: Within 90 days after intervention
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Defined as clinical or radiological evidence of bleeding requiring blood transfusion or reintervention.
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Within 90 days after intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Therapeutic success
Periodo de tiempo: Within 30 days after intervention
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Defined as a decrease in total bilirubin to <3 mg/dL or a reduction of more than 50% compared to pre-drainage levels
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Within 30 days after intervention
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Mortality
Periodo de tiempo: Within 90 days after intervention
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All-cause mortality following biliary drainage.
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Within 90 days after intervention
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Need for reintervention
Periodo de tiempo: Within 30 days after intervention
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Requirement for additional percutaneous or endoscopic procedures
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Within 30 days after intervention
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of curative surgery
Periodo de tiempo: Within 180 days of intervention
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Number of patients from group A (patients with potentially resectable neoplasms) who undergo potentially curative surgery
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Within 180 days of intervention
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90-day postoperative mortality
Periodo de tiempo: Within 90 days of curative surgery
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Surgical mortality in patients from Group A (patients with potentially ressectable neoplasms) who undergo potentially curative surgery
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Within 90 days of curative surgery
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90-day postoperative morbidity
Periodo de tiempo: Within 90 days of curative surgery
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Surgical morbidity in patients from Group A (patients with potentially ressectable neoplasms) who undergo potentially curative surgery according to Clavien-Dindo classification
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Within 90 days of curative surgery
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Incidence of postoperative liver failure
Periodo de tiempo: Within 90 days of curative surgery
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Incidence of postoperative liver failure in patients from Group A (patients with potentially ressectable neoplasms) who undergo potentially resectable surgery
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Within 90 days of curative surgery
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Stent patency duration
Periodo de tiempo: Within 180 days of intervention
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Duration of stent patency in patients from group B (patients not candidates for potentially curative resection)
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Within 180 days of intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Cleber R. P. Kruel, Professor, Hospital de Clinicas de Porto Alegre
Publicaciones y enlaces útiles
Publicaciones Generales
- Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Mullen JT, Ribero D, Reddy SK, Donadon M, Zorzi D, Gautam S, Abdalla EK, Curley SA, Capussotti L, Clary BM, Vauthey JN. Hepatic insufficiency and mortality in 1,059 noncirrhotic patients undergoing major hepatectomy. J Am Coll Surg. 2007 May;204(5):854-62; discussion 862-4. doi: 10.1016/j.jamcollsurg.2006.12.032. Epub 2007 Feb 15.
- Luman W, Cull A, Palmer KR. Quality of life in patients stented for malignant biliary obstructions. Eur J Gastroenterol Hepatol. 1997 May;9(5):481-4. doi: 10.1097/00042737-199705000-00013.
- Ferrucci JT Jr, Mueller PR, Harbin WP. Percutaneous transhepatic biliary drainage: technique, results, and applications. Radiology. 1980 Apr;135(1):1-13. doi: 10.1148/radiology.135.1.7360943.
- 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.
- Qumseya BJ, Jamil LH, Elmunzer BJ, Riaz A, Ceppa EP, Thosani NC, Buxbaum JL, Storm AC, Sawhney MS, Pawa S, Naveed M, Lee JK, Law JK, Kwon RS, Jue TL, Fujii-Lau LL, Fishman DS, Calderwood AH, Amateau SK, Al-Haddad M, Wani S. ASGE guideline on the role of endoscopy in the management of malignant hilar obstruction. Gastrointest Endosc. 2021 Aug;94(2):222-234.e22. doi: 10.1016/j.gie.2020.12.035. Epub 2021 May 20.
- Hameed A, Pang T, Chiou J, Pleass H, Lam V, Hollands M, Johnston E, Richardson A, Yuen L. Percutaneous vs. endoscopic pre-operative biliary drainage in hilar cholangiocarcinoma - a systematic review and meta-analysis. HPB (Oxford). 2016 May;18(5):400-10. doi: 10.1016/j.hpb.2016.03.002. Epub 2016 Apr 4.
- Pavlidis ET, Pavlidis TE. Pathophysiological consequences of obstructive jaundice and perioperative management. Hepatobiliary Pancreat Dis Int. 2018 Feb;17(1):17-21. doi: 10.1016/j.hbpd.2018.01.008. Epub 2018 Jan 31.
- Coelen RJS, Roos E, Wiggers JK, Besselink MG, Buis CI, Busch ORC, Dejong CHC, van Delden OM, van Eijck CHJ, Fockens P, Gouma DJ, Koerkamp BG, de Haan MW, van Hooft JE, IJzermans JNM, Kater GM, Koornstra JJ, van Lienden KP, Moelker A, Damink SWMO, Poley JW, Porte RJ, de Ridder RJ, Verheij J, van Woerden V, Rauws EAJ, Dijkgraaf MGW, van Gulik TM. Endoscopic versus percutaneous biliary drainage in patients with resectable perihilar cholangiocarcinoma: a multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):681-690. doi: 10.1016/S2468-1253(18)30234-6. Epub 2018 Aug 17.
- Zhao XQ, Dong JH, Jiang K, Huang XQ, Zhang WZ. Comparison of percutaneous transhepatic biliary drainage and endoscopic biliary drainage in the management of malignant biliary tract obstruction: a meta-analysis. Dig Endosc. 2015 Jan;27(1):137-45. doi: 10.1111/den.12320. Epub 2014 Sep 24.
- Wiggers JK, Groot Koerkamp B, Cieslak KP, Doussot A, van Klaveren D, Allen PJ, Besselink MG, Busch OR, D'Angelica MI, DeMatteo RP, Gouma DJ, Kingham TP, van Gulik TM, Jarnagin WR. Postoperative Mortality after Liver Resection for Perihilar Cholangiocarcinoma: Development of a Risk Score and Importance of Biliary Drainage of the Future Liver Remnant. J Am Coll Surg. 2016 Aug;223(2):321-331.e1. doi: 10.1016/j.jamcollsurg.2016.03.035. Epub 2016 Apr 5.
- Shim DJ, Gwon DI, Han K, Kim Y, Ko GY, Shin JH, Ko HK, Kim JH, Kim JW, Yoon HK, Sung KB. Percutaneous Metallic Stent Placement for Palliative Management of Malignant Biliary Hilar Obstruction. Korean J Radiol. 2018 Jul-Aug;19(4):597-605. doi: 10.3348/kjr.2018.19.4.597. Epub 2018 Jun 14.
- Ribero D, Zimmitti G, Aloia TA, Shindoh J, Fabio F, Amisano M, Passot G, Ferrero A, Vauthey JN. Preoperative Cholangitis and Future Liver Remnant Volume Determine the Risk of Liver Failure in Patients Undergoing Resection for Hilar Cholangiocarcinoma. J Am Coll Surg. 2016 Jul;223(1):87-97. doi: 10.1016/j.jamcollsurg.2016.01.060. Epub 2016 Feb 13.
- Pietrzak J, Przybylkowski A. Endoscopic Treatment of Malignant Hilar Biliary Obstruction. Cancers (Basel). 2023 Dec 13;15(24):5819. doi: 10.3390/cancers15245819.
- Elmunzer BJ, Smith ZL, Tarnasky P, Wang AY, Yachimski P, Banovac F, Buscaglia JM, Buxbaum J, Chak A, Chong B, Cote GA, Draganov PV, Dua K, Durkalski V, Geller BS, Jamil LH, Keswani RN, Khashab MA, Law R, Lo SK, McCarthy S, Selby JB, Singh VK, Taylor JR, Willingham FF, Spitzer RL, Foster LD; INTERCPT study group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE). An Unsuccessful Randomized Trial of Percutaneous vs Endoscopic Drainage of Suspected Malignant Hilar Obstruction. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1282-1284. doi: 10.1016/j.cgh.2020.05.035. Epub 2020 May 23.
- Liu JG, Wu J, Wang J, Shu GM, Wang YJ, Lou C, Zhang J, Du Z. Endoscopic Biliary Drainage Versus Percutaneous Transhepatic Biliary Drainage in Patients with Resectable Hilar Cholangiocarcinoma: A Systematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech A. 2018 Sep;28(9):1053-1060. doi: 10.1089/lap.2017.0744. Epub 2018 Mar 12.
- Franssen S, Rousian M, van Verschuer V, Bruno M, Doukas M, van Driel L, Homs M, Mohseny B, de Wilde R, de Jonge J, Polak W, Porte R, Bijdevaate D, Moelker A, Groot Koerkamp B. Primary percutaneous stenting for palliative biliary drainage of patients with malignant hilar biliary obstruction: TESLA trial. JHEP Rep. 2025 Sep 11;7(11):101541. doi: 10.1016/j.jhepr.2025.101541. eCollection 2025 Nov.
- Farges O, Regimbeau JM, Fuks D, Le Treut YP, Cherqui D, Bachellier P, Mabrut JY, Adham M, Pruvot FR, Gigot JF. Multicentre European study of preoperative biliary drainage for hilar cholangiocarcinoma. Br J Surg. 2013 Jan;100(2):274-83. doi: 10.1002/bjs.8950. Epub 2012 Nov 2.
- Benson AB, D'Angelica MI, Abbott DE, Anaya DA, Anders R, Are C, Bachini M, Borad M, Brown D, Burgoyne A, Chahal P, Chang DT, Cloyd J, Covey AM, Glazer ES, Goyal L, Hawkins WG, Iyer R, Jacob R, Kelley RK, Kim R, Levine M, Palta M, Park JO, Raman S, Reddy S, Sahai V, Schefter T, Singh G, Stein S, Vauthey JN, Venook AP, Yopp A, McMillian NR, Hochstetler C, Darlow SD. Hepatobiliary Cancers, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021 May 1;19(5):541-565. doi: 10.6004/jnccn.2021.0022.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades del Tracto Biliar
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Carcinoma
- Enfermedades de las vías biliares
- Neoplasias del Tracto Biliar
- Colangiocarcinoma
- Neoplasias de las vías biliares
Otros números de identificación del estudio
- 2025-0661
- 95412526.6.0000.5327 (Otro identificador: Plataforma Brasil)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Access to individual participant data (IPD) and supporting documents (including the study protocol and statistical analysis plan) will be granted to researchers who provide a methodologically sound research proposal. Requests must specify the intended use of the data and will be reviewed by the study investigators in accordance with institutional policies.
Data will be shared in a de-identified format to ensure participant confidentiality. Access will be provided upon reasonable request to the corresponding author, subject to approval by the investigators and applicable ethical and legal requirements. Data will be made available through secure data transfer methods.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
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