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Spiral seed strand boosts survival and cuts complications in bile duct cancer jaundice

NCT ID NCT07381439

Disease control Sponsor: The First Affiliated Hospital of Anhui Medical University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two methods of placing radioactive iodine seeds alongside a metal stent to treat jaundice from bile duct cancer. 105 patients were randomly assigned to get either a straight seed strand or a new spiral-shaped strand. Both methods improved liver function, but the spiral strand caused fewer complications like bile leaks and kept the stent open longer (305 vs. 277 days), leading to longer overall survival (345 vs. 300 days). The spiral technique appears safer and more effective for managing this condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

105 people

The number who actually took part.

Started

Jan 2018

Finished

Feb 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. Patients with a definitive diagnosis of Malignant Obstructive Jaundice (MOJ) confirmed by imaging (enhanced CT/MRCP), laboratory tests, and/or pathology. 2\. Assessed by a multidisciplinary team as not a candidate for curative surgical resection. 3\. No absolute contraindications for the combined implantation of a biliary metallic stent and an \^125\^I seeds strand (e.g., severe coagulation dysfunction, significant renal impairment, or uncontrolled serious cardiovascular/cerebrovascular diseases). 4\. Willing and able to provide written informed consent. Exclusion Criteria: 1. Obstructive jaundice attributable to benign etiology. 2. Presence of any absolute contraindication listed in the inclusion criteria. 3. Life expectancy estimated to be less than three months. 4. Unwillingness to participate in the study or provide informed consent.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant obstructive jaundice

Contacts and locations

Locations

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000, China

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