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

Sponsor
Hospital de Clinicas de Porto Alegre
Study ID
NCT07558304
Status
Not Yet Recruiting

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Conditions

  • Bile Duct Neoplasms
  • Cholangiocarcinoma
  • Malignant Biliary Obstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Apr 30, 2026
Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Acute cholangitis [ Time Frame: Within 90 days after intervention ]

Central Contacts

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