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

NCT07558304 | Not Yet Recruiting

• 2 other identifiers: 2025-066195412526.6.0000.5327
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholangiocarcinoma; Bile Duct Neoplasms; Malignant Biliary Obstruction

Keywords

Cholangiocarcinoma; Percutaneous biliary drainage; Self-expanding metal stent; Suprapapillary drainage; Malignant hilar biliary obstruction; Malignant Biliary Obstruction

Outcome Measures

Primary Outcomes (5)

• Acute cholangitis

  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

  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

  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

  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

  Defined as clinical or radiological evidence of bleeding requiring blood transfusion or reintervention.

  Within 90 days after intervention

Secondary Outcomes (3)

• Therapeutic success

  Within 30 days after intervention

• Mortality

  Within 90 days after intervention

• Need for reintervention

  Within 30 days after intervention

Other Outcomes (5)

• Rate of curative surgery

  Within 180 days of intervention

• 90-day postoperative mortality

  Within 90 days of curative surgery

• 90-day postoperative morbidity

  Within 90 days of curative surgery

Study Arms (2)

Transpapillary internal-external drainage

ACTIVE COMPARATOR

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

Suprapapillary Self-Expanding Metal Stent Drainage

ACTIVE COMPARATOR

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

Interventions

Percutaneous transpapillary internal-external biliary drainage PROCEDURE

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.

Also known as: Intervention 1

Transpapillary internal-external drainage

Percutaneous suprapapillary biliary drainage with self-expanding metal stent PROCEDURE

Percutaneous biliary drainage performed by placing a self-expanding metal stent across the biliary obstruction without crossing the papilla.

Also known as: Intervention 2

Suprapapillary Self-Expanding Metal Stent Drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Estimated future liver remnant \<40%, in whom percutaneous portal vein embolization of the side to be resected will also be indicated after initial drainage.
• 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.
• Indication for neoadjuvant chemotherapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (19)

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MeSH Terms

Conditions

Cholangiocarcinoma; Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Cleber R. P. Kruel, Professor

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

Central Study Contacts

Cleber R. P. Kruel, Professor

CONTACT

+55(51)3359-8232; crkruel@hcpa.edu.br

Gabriel L. da Silva, Attending Physician

CONTACT

+55(51)3359-8232; gablsilva@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who meet the inclusion criteria and do not meet any exclusion criteria will be divided into two clinical groups: Group A: Patients with potentially resectable neoplasms who meet criteria for biliary drainage as defined in the inclusion criteria. Group B: Patients who are not candidates for potentially curative surgical resection. Patients from both clinical groups will be randomized into two intervention groups: Intervention 1: Transpapillary internal-external drainage with a plastic catheter. Intervention 2: Suprapapillary drainage with a self-expanding metal stent.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 2 months and ending 2 years after the publication of results
• Access Criteria: 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.

Locations

BR (1)