MedTrace Logo

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

NCT07558304 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-30

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Cleber R. P. Kruel, Professor · Hospital de Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07558304 on ClinicalTrials.gov