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.
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.
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.
Parallel
Percutaneous transpapillary internal-external biliary drainage
Procedure/SurgeryPercutaneous 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/SurgeryPercutaneous biliary drainage performed by placing a self-expanding metal stent across the biliary obstruction without crossing the papilla.
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.
Acute cholecystitis
Defined by radiological evidence of cholecystitis associated with fever (axillary temperature \>38°C) and leukocytosis (white blood cell count \>10,000/mm³).
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.
Bile leak
Defined as intra-abdominal bile leakage due to biliary perforation or at the hepatic puncture site, confirmed by imaging.
Therapeutic success
Defined as a decrease in total bilirubin to \<3 mg/dL or a reduction of more than 50% compared to pre-drainage levels
Mortality
All-cause mortality following biliary drainage.
Need for reintervention
Requirement for additional percutaneous or endoscopic procedures
Rate of curative surgery
Number of patients from group A (patients with potentially resectable neoplasms) who undergo potentially curative surgery
90-day postoperative mortality
Surgical mortality in patients from Group A (patients with potentially ressectable neoplasms) who undergo potentially curative surgery
90-day postoperative morbidity
Surgical morbidity in patients from Group A (patients with potentially ressectable neoplasms) who undergo potentially curative surgery according to Clavien-Dindo classification
Incidence of postoperative liver failure
Incidence of postoperative liver failure in patients from Group A (patients with potentially ressectable neoplasms) who undergo potentially resectable surgery
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