An interventional study of Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction in Biliary Strictures Caused by Malignant Neoplasms, sponsored by Olympus Corporation of the Americas. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Olympus Corporation of the Americas (part of Olympus Corporation) · Not applicable, Interventional, and Supportive care
The objective of this study is to demonstrate clinical safety and performance of the HANAROSTENT® Multi-Hole™ Biliary Stent for the palliative treatment of malignant biliary obstruction.
The HANAROSTENT® Multi-Hole™ Biliary Stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
456 studies on the registry are indexed under Constriction, Pathologic; 109 are open to participants now.
This study's planned enrollment of 66 is close to the median of 72 across 295 interventional studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →Olympus Corporation of the Americas is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical symptoms including (e.g., cholangitis, jaundice, pruritus, pale stools, and/or dark urine)
Biochemical evidence (Tbili > 3mg/dL)
High quality imaging (e.g., ultrasound, CT, MRCP, or ERCP)
≥ 18 years of age
Willing and able to provide
Exclusion Criteria:
Intrahepatic that extensively involve both lobes of the liver
Patients with a distal malignant biliary obstruction due to potential resectable disease
Strictures that could not be traversed by the delivery system
Perforation of any duct within the biliary tree
Presence of a biliary self-expanding metal stent (SEMS), esophageal stent, or duodenal stent
Active viral hepatitis
of \< 3 months
Patient has undergone (within 30 days prior to enrollment) or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources
Unwilling or unable to comply with the follow-up schedule
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Multi-hole anti-migration stent for biliary strictures produced by malignant neoplasms
Primary Endpoints
Primary Outcome Measures 1\. Clinical palliation of biliary obstruction maintenance of total bilirubin (Tbili) at 1-month follow-up \< 3 mg/dL OR Tbili reduction by \> 30% if the baseline value is \> 3 mg/dL and absence of acute cholangitis AND absence of stent-related re-intervention until death, surgery, completion of data collection at 6-month follow-up visit, or withdrawal, whichever occurs first.
Time frame: 6 Month
Stent Repositioning
Ability to successfully reposition or remove the stent, if required, at initial placement without clinically significant complications or technical difficulties
Time frame: During the procedure
Stent Deployment
Stent Deployment Ability to deploy the stent in satisfactory position \[During the procedure\]
Time frame: During the procedure
Symptoms
Symptoms of biliary obstruction (including jaundice, pruritus, right upper quadrant pain, fever, nausea, vomiting, and dark urine) at 1-, 3-, and 6-month follow-up visits and Tbili at 1-, 3-, and 6-month follow-up visits
Time frame: 6 months
Stent Patency
Stent patency rate at 1-, 3-, and 6-months post stent placement 6. Stent Occlusion or migration
Time frame: 6 months
6. Stent Occlusion or migration
Time to stent occlusion (days between stent placement and confirmation of stent obstruction), if applicable
Time frame: 6 Months
7. Occurrence and severity of device and procedure-related adverse events
Occurrence and severity of device and procedure-related adverse events
Time frame: 6 Months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Feb 2027, 3 months later.
Of 43 industry-sponsored interventional studies with no phase under Constriction, Pathologic, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 58. This study's planned 3 months is below that.
Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 18 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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