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Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial) (SMART-B)

23. april 2026 opdateret af: Hospital de Clinicas de Porto Alegre

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

84

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Cleber R. P. Kruel, Professor
  • Telefonnummer: 8232 +55(51)3359-8232
  • E-mail: crkruel@hcpa.edu.br

Undersøgelse Kontakt Backup

  • Navn: Gabriel L. da Silva, Attending Physician
  • Telefonnummer: 8232 +55(51)3359-8232
  • E-mail: gablsilva@hcpa.edu.br

Studiesteder

  • Brasilien
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
        • Hospital De Clinicas De Porto Alegre
        • Kontakt:
          • Cleber R. P. Kruel, Professor
          • Telefonnummer: 8232 +55(51)3359-8232
          • E-mail: crkruel@hcpa.edu.br
        • Kontakt:
          • Gabriel L. da Silva, Attending Physician
          • Telefonnummer: 8232 +55(51)3359-8232
          • E-mail: gablsilva@hcpa.edu.br
        • Underforsker:
          • Gabriel L. da Silva, Attending Physician
        • Underforsker:
          • Leandro A. Scaffaro, Attending Physician
        • Underforsker:
          • Mauricio Farenzena, Attending Physician
        • Underforsker:
          • Flavia H. Feier, Professor
        • Underforsker:
          • Pablo D. Rodrigues, Attending Physician
        • Underforsker:
          • Tomaz J. M. Grezzana, Attending Physician
        • Underforsker:
          • Marcio F. Chedid, Attending Physician
        • Underforsker:
          • William F. Silvano, Attending Physician
        • Underforsker:
          • Francisco C. B. Lemanski, General Surgery Resident
        • Ledende efterforsker:
          • Cleber R. P. Kruel, Professor

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age >18 years.
  2. Malignant proximal biliary obstruction on imaging (magnetic resonance cholangiopancreatography or contrast-enhanced abdominal computed tomography) with histopathological confirmation or high clinical and radiological suspicion.
  3. Total bilirubin > 3 mg/dL.
  4. Patients not candidates for potentially curative surgical resection due to locally advanced disease, metastatic disease, or inadequate clinical condition.
  5. 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:

  1. Tumor with distal extension to the duodenal papilla, precluding suprapapillary drainage.
  2. Prior biliary drainage procedure, either percutaneous (PTBD) or endoscopic (ERCP).
  3. Acute cholangitis, clinically defined as fever (axillary temperature >38°C) and leukocytosis (white blood cell count >10,000/mm³).
  4. Uncorrectable coagulopathy.
  5. Iodinated contrast allergy not amenable to desensitization.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Procedure: Percutaneous transpapillary internal-external biliary drainage
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.
Andre navne:
  • Intervention 1
Aktiv komparator: 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.
Procedure: Percutaneous suprapapillary biliary drainage with self-expanding metal stent
Percutaneous biliary drainage performed by placing a self-expanding metal stent across the biliary obstruction without crossing the papilla.
Andre navne:
  • Intervention 2

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute cholangitis
Tidsramme: Within 90 days after intervention
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.
Within 90 days after intervention
Acute cholecystitis
Tidsramme: Within 90 days after intervention
Defined by radiological evidence of cholecystitis associated with fever (axillary temperature >38°C) and leukocytosis (white blood cell count >10,000/mm³).
Within 90 days after intervention
Acute pancreatitis
Tidsramme: Within 90 days after intervention
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.
Within 90 days after intervention
Bile leak
Tidsramme: Within 90 days after intervention
Defined as intra-abdominal bile leakage due to biliary perforation or at the hepatic puncture site, confirmed by imaging.
Within 90 days after intervention
Hemorrhage
Tidsramme: Within 90 days after intervention
Defined as clinical or radiological evidence of bleeding requiring blood transfusion or reintervention.
Within 90 days after intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Therapeutic success
Tidsramme: Within 30 days after intervention
Defined as a decrease in total bilirubin to <3 mg/dL or a reduction of more than 50% compared to pre-drainage levels
Within 30 days after intervention
Mortality
Tidsramme: Within 90 days after intervention
All-cause mortality following biliary drainage.
Within 90 days after intervention
Need for reintervention
Tidsramme: Within 30 days after intervention
Requirement for additional percutaneous or endoscopic procedures
Within 30 days after intervention

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of curative surgery
Tidsramme: Within 180 days of intervention
Number of patients from group A (patients with potentially resectable neoplasms) who undergo potentially curative surgery
Within 180 days of intervention
90-day postoperative mortality
Tidsramme: Within 90 days of curative surgery
Surgical mortality in patients from Group A (patients with potentially ressectable neoplasms) who undergo potentially curative surgery
Within 90 days of curative surgery
90-day postoperative morbidity
Tidsramme: Within 90 days of curative surgery
Surgical morbidity in patients from Group A (patients with potentially ressectable neoplasms) who undergo potentially curative surgery according to Clavien-Dindo classification
Within 90 days of curative surgery
Incidence of postoperative liver failure
Tidsramme: Within 90 days of curative surgery
Incidence of postoperative liver failure in patients from Group A (patients with potentially ressectable neoplasms) who undergo potentially resectable surgery
Within 90 days of curative surgery
Stent patency duration
Tidsramme: Within 180 days of intervention
Duration of stent patency in patients from group B (patients not candidates for potentially curative resection)
Within 180 days of intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital de Clinicas de Porto Alegre

Efterforskere

  • Studiestol: Cleber R. P. Kruel, Professor, Hospital De Clinicas De Porto Alegre

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

16. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-0661
  • 95412526.6.0000.5327 (Anden identifikator: Plataforma Brasil)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All IPD collected throughout the trial

IPD-delingstidsramme

Beginning 2 months and ending 2 years after the publication of results

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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