Malignant Obstructive JaundiceNCT07381439
Comparison of Two Seed Strand Implantation Techniques for Biliary Cancer
A study testing Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strand and Percutaneous transhepatic biliary stenting with novel spiral ^125^I seeds strand in people with Malignant Obstructive Jaundice, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
This study aimed to compare the safety and effectiveness of two different methods for fabricating and implanting Iodine-125 (^125^I) radioactive seed strands combined with a metal stent for treating malignant obstructive jaundice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Obstructive Jaundice
- What is being tested?
- Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strand and Percutaneous transhepatic biliary stenting with novel spiral ^125^I seeds strand
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Obstructive jaundice attributable to benign etiology.
- Presence of any absolute contraindication listed in the inclusion criteria.
- Life expectancy estimated to be less than three months.
- Unwillingness to participate in the study or provide informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
About this study
Official title: A Prospective, Randomized Controlled Trial Comparing Conventional Linear Versus Novel Spiral Iodine-125 Seed Strand Implantation Combined With Metallic Stent for Malignant Obstructive Jaundice
This study aimed to compare the safety and effectiveness of two different methods for fabricating and implanting Iodine-125 (^125^I) radioactive seed strands combined with a metal stent for treating malignant obstructive jaundice. The conventional method uses a straight seed strand placed between the stent and the bile duct wall. A novel technique was developed that uses a spiral-shaped seed strand placed inside the stent lumen.
Between January 2018 and February 2024, 105 patients were randomly assigned to two groups. Group A (59 patients) received the conventional straight strand, while Group B (46 patients) received the novel spiral strand. The study compared therapeutic efficacy, the incidence of intraoperative and postoperative complications, stent patency duration, and patient survival.
Read more
Both methods successfully improved liver function. However, the novel spiral technique (Group B) caused significantly fewer complications, such as bile leakage and peritonitis, compared to the conventional method (Group A). Importantly, patients in Group B also had longer stent patency (305 days vs. 277 days) and longer overall survival (345 days vs. 300 days).
In conclusion, the novel spiral seed strand implantation technique is a safer and more effective treatment option for malignant obstructive jaundice.
Read the detailed description
Malignant obstructive jaundice often requires palliative drainage with self-expanding metallic stents. Combining stents with brachytherapy using Iodine-125 (^125^I) seed strands has been shown to prolong stent patency and patient survival compared to stenting alone. The conventional technique implants a linear seed strand between the stent and the bile duct wall, which is associated with risks of hemobilia, biliary fistula, and peritonitis due to the need for a larger puncture tract. This prospective, randomized controlled trial aimed to evaluate a novel, refined method involving a spiral-configured ^125^I seed strand implanted within the stent lumen, hypothesizing that it would reduce procedure-related complications while maintaining or improving therapeutic efficacy.
Study Design and Methods:
This was a single-center, prospective, randomized controlled trial. From January 2018 to February 2024, 105 patients with inoperable malignant obstructive jaundice were enrolled and randomly allocated into two groups.
Group A (Conventional, n=59): Received a straight ^125^I seed strand implanted between the metallic stent and the bile duct wall.
Group B (Novel, n=46): Received a spiral ^125^I seed strand implanted within the lumen of the metallic stent.
All patients first underwent percutaneous transhepatic biliary drainage (PTBD) for decompression, followed by the combined stent and seed strand (PTBSIS) procedure 3-7 days later.
Primary and Secondary Outcomes:
The primary endpoints were procedure-related complications (intraoperative and postoperative) and stent patency time. Secondary endpoints included technical success rate, improvement in liver function tests at one month, and overall patient survival. Complications assessed included nausea/vomiting, abdominal pain, hemobilia, vagal reflex, fever, biliary fistula, and biliary peritonitis.
Statistical Analysis:
Continuous data are presented as mean ± standard deviation or median (interquartile range). Categorical variables were compared using the Chi-square or Fisher's exact test. Stent patency and overall survival were analyzed using the Kaplan-Meier method with the log-rank test. A two-sided P-value < 0.05 was considered statistically significant. Analyses were performed using SPSS version 22.0.
- Conditions
- Malignant Obstructive Jaundice
- Being tested
- Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strand, Percutaneous transhepatic biliary stenting with novel spiral ^125^I seeds strand
- Keywords
- Malignant obstructive jaundice, 125I seeds strand, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strandRadiation
Also called PTBSIS
This is a combined interventional radiology procedure for malignant obstructive jaundice. Under local anesthesia and fluoroscopic guidance, a self-expanding metallic biliary stent is percutaneously placed across the malignant stricture. Subsequently, a linear strand of Iodine-125 (^125^I) seeds, fabricated by sealing the prescribed number of seeds within a catheter, is implanted and fixed in the space between the outer wall of the stent and the bile duct wall. The ^125^I seeds provide continuous low-dose-rate brachytherapy to inhibit tumor ingrowth and prolong stent patency.
Percutaneous transhepatic biliary stenting with novel spiral ^125^I seeds strandRadiation
Also called PTBSIS (novel)
This is a combined interventional radiology procedure for malignant obstructive jaundice. Under local anesthesia and fluoroscopic guidance, a self-expanding metallic biliary stent is percutaneously placed across the malignant stricture. Subsequently, a spiral-configured strand of Iodine-125 (^125^I) seeds, fabricated by shaping a linear catheter strand with boiling water (using a slightly higher seed count to compensate for foreshortening), is implanted and secured within the inner lumen of the stent. The ^125^I seeds provide continuous low-dose-rate brachytherapy to inhibit tumor ingrowth and prolong stent patency. This method is designed to reduce tract-related injury by minimizing bile duct wall manipulation.
| Study group | Role | What they receive |
|---|---|---|
| Conventional linear implantation | Experimental | In this group, participants received percutaneous transhepatic biliary stenting combined with a straight-configured ^125^I seed strand. The strand was fabricated by loading the prescribed number of ^125^I seeds into a 4F catheter, the ends of which were subsequently heat-sealed. During the procedure, after the deployment of a self-expanding metallic stent across the malignant stricture, the straight seed strand was implanted and fixed in the space between the outer wall of the stent and the bile duct wall to deliver localized brachytherapy. Receives: Radiation: Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strand |
| Novel spiral implantation | Experimental | In this group, participants received percutaneous transhepatic biliary stenting combined with a spiral-configured ^125^I seed strand. The strand was fabricated by first preparing a linear catheter strand and then shaping it into a spiral configuration using boiling water. A slightly higher number of seeds were used to compensate for foreshortening. During the procedure, after stent deployment, the spiral seed strand was implanted and secured within the inner lumen of the metallic stent. This method was designed to reduce tract-related injury by utilizing a single, smaller working sheath and minimizing manipulation of the bile duct wall. Receives: Radiation: Percutaneous transhepatic biliary stenting with novel spiral ^125^I seeds strand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent Patency Time
The duration from the date of stent placement to the date of first documented stent re-obstruction (confirmed by imaging evidence of restenosis or occlusion). For patients who die without prior evidence of recurrent jaundice, the data will be censored at the date of death.
Measured: From the date of randomization/stent placement until the date of documented stent re-obstruction or death from any cause, whichever occurs first, assessed up to 24 months.
Overall Survival
The time from the date of the stent placement procedure until the date of death from any cause. For patients who are alive at the end of the study, survival data will be censored at the date of the last follow-up contact.
Measured: From the date of randomization/stent placement until the date of death from any cause, assessed up to 24 months.
Secondary outcomes (5)
Incidence of Procedure-Related Complications
The composite rate of intraoperative and postoperative adverse events. Assessed complications include nausea/vomiting, abdominal pain, hemobilia, vagus reflex, fever, biliary fistula, and biliary peritonitis. Each complication will be documented as present or absent based on clinical and diagnostic criteria.
Measured: Intraoperative period and up to 30 days after the procedure.
Change in Serum Total Bilirubin (TBIL) Level
The absolute change in serum total bilirubin concentration (measured in μmol/L) from the pre-procedure baseline (after initial PTBD drainage) to 1 month after the combined stent and seed strand implantation procedure.
Measured: Baseline (pre-PTBSIS, after initial PTBD) and 1 month after the PTBSIS procedure.
Change in Serum Alanine Aminotransferase (ALT) Level
The absolute change in serum alanine aminotransferase activity (measured in U/L) from the pre-procedure baseline (after initial PTBD drainage) to 1 month after the combined stent and seed strand implantation procedure.
Measured: Baseline (pre-PTBSIS, after initial PTBD) and 1 month after the PTBSIS procedure.
Change in Serum Aspartate Aminotransferase (AST) Level
The absolute change in serum aspartate aminotransferase activity (measured in U/L) from the pre-procedure baseline (after initial PTBD drainage) to 1 month after the combined stent and seed strand implantation procedure.
Measured: Baseline (pre-PTBSIS, after initial PTBD) and 1 month after the PTBSIS procedure.
Technical Success Rate
The proportion of procedures in which both the biliary metallic stent and the ^125^I seeds strand are successfully and precisely deployed at the intended target lesion site, as confirmed by immediate post-procedure fluoroscopy demonstrating unobstructed flow of contrast medium through the stent lumen into the duodenum.
Measured: Assessed immediately upon completion of the stent and seed strand implantation procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Jan 2018
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malignant Obstructive JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group, randomized controlled trial comparing a novel spiral seed strand implantation technique with the conventional linear technique.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng, Zhaohong, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381439
- Sponsor's protocol ID
- LLSC20221301
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang W, Shen J, Wang C, Ren B, Zhu X, Ni C. Safety and Feasibility of Helical I-125 Seed Implants Combined with Transcatheter Arterial Chemoembolization in Hepatocellular Carcinomas with Main Portal Vein Tumor Thrombus. Cardiovasc Intervent Radiol. 2019 Oct;42(10):1420-1428. doi: 10.1007/s00270-019-02256-z. Epub 2019 Jun 11.
PubMed 31187228Jang S, Stevens T, Parsi MA, Bhatt A, Kichler A, Vargo JJ. Superiority of Self-Expandable Metallic Stents Over Plastic Stents in Treatment of Malignant Distal Biliary Strictures. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e182-e195. doi: 10.1016/j.cgh.2020.12.020. Epub 2020 Dec 18.
PubMed 33346140Larghi A, Tringali A, Lecca PG, Giordano M, Costamagna G. Management of hilar biliary strictures. Am J Gastroenterol. 2008 Feb;103(2):458-73. doi: 10.1111/j.1572-0241.2007.01645.x. Epub 2007 Nov 19.
PubMed 18028506
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial Comparing Conventional Linear Versus Novel Spiral Iodine-125 Seed Strand Implantation Combined With Metallic Stent for Malignant Obstructive Jaundice
- ClinicalTrials.gov ID
- NCT07381439
- Acronym / sponsor ID
- LLSC20221301
- Conditions
- Malignant Obstructive Jaundice
- Keywords
- Malignant obstructive jaundice, 125I seeds strand, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to compare the safety and effectiveness of two different methods for fabricating and implanting Iodine-125 (^125^I) radioactive seed strands combined with a metal stent for treating malignant obstructive jaundice. The conventional method uses a straight seed strand placed between the stent and the bile duct wall. A novel technique was developed that uses a spiral-shaped seed strand placed inside the stent lumen.
Between January 2018 and February 2024, 105 patients were randomly assigned to two groups. Group A (59 patients) received the conventional straight strand, while Group B (46 patients) received the novel spiral strand. The study compared therapeutic efficacy, the incidence of intraoperative and postoperative complications, stent patency duration, and patient survival.
Both methods successfully improved liver function. However, the novel spiral technique (Group B) caused significantly fewer complications, such as bile leakage and peritonitis, compared to the conventional method (Group A). Importantly, patients in Group B also had longer stent patency (305 days vs. 277 days) and longer overall survival (345 days vs. 300 days).
In conclusion, the novel spiral seed strand implantation technique is a safer and more effective treatment option for malignant obstructive jaundice.
Detailed description
Malignant obstructive jaundice often requires palliative drainage with self-expanding metallic stents. Combining stents with brachytherapy using Iodine-125 (^125^I) seed strands has been shown to prolong stent patency and patient survival compared to stenting alone. The conventional technique implants a linear seed strand between the stent and the bile duct wall, which is associated with risks of hemobilia, biliary fistula, and peritonitis due to the need for a larger puncture tract. This prospective, randomized controlled trial aimed to evaluate a novel, refined method involving a spiral-configured ^125^I seed strand implanted within the stent lumen, hypothesizing that it would reduce procedure-related complications while maintaining or improving therapeutic efficacy.
Study Design and Methods:
This was a single-center, prospective, randomized controlled trial. From January 2018 to February 2024, 105 patients with inoperable malignant obstructive jaundice were enrolled and randomly allocated into two groups.
Group A (Conventional, n=59): Received a straight ^125^I seed strand implanted between the metallic stent and the bile duct wall.
Group B (Novel, n=46): Received a spiral ^125^I seed strand implanted within the lumen of the metallic stent.
All patients first underwent percutaneous transhepatic biliary drainage (PTBD) for decompression, followed by the combined stent and seed strand (PTBSIS) procedure 3-7 days later.
Primary and Secondary Outcomes:
The primary endpoints were procedure-related complications (intraoperative and postoperative) and stent patency time. Secondary endpoints included technical success rate, improvement in liver function tests at one month, and overall patient survival. Complications assessed included nausea/vomiting, abdominal pain, hemobilia, vagal reflex, fever, biliary fistula, and biliary peritonitis.
Statistical Analysis:
Continuous data are presented as mean ± standard deviation or median (interquartile range). Categorical variables were compared using the Chi-square or Fisher's exact test. Stent patency and overall survival were analyzed using the Kaplan-Meier method with the log-rank test. A two-sided P-value < 0.05 was considered statistically significant. Analyses were performed using SPSS version 22.0.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group, randomized controlled trial comparing a novel spiral seed strand implantation technique with the conventional linear technique.
| Arm | Type | Receives |
|---|---|---|
| Conventional linear implantation | Experimental | Radiation: Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strandIn this group, participants received percutaneous transhepatic biliary stenting combined with a straight-configured ^125^I seed strand. The strand was fabricated by loading the prescribed number of ^125^I seeds into a 4F catheter, the ends of which were subsequently heat-sealed. During the procedure, after the deployment of a self-expanding metallic stent across the malignant stricture, the straight seed strand was implanted and fixed in the space between the outer wall of the stent and the bile duct wall to deliver localized brachytherapy. |
| Novel spiral implantation | Experimental | Radiation: Percutaneous transhepatic biliary stenting with novel spiral ^125^I seeds strandIn this group, participants received percutaneous transhepatic biliary stenting combined with a spiral-configured ^125^I seed strand. The strand was fabricated by first preparing a linear catheter strand and then shaping it into a spiral configuration using boiling water. A slightly higher number of seeds were used to compensate for foreshortening. During the procedure, after stent deployment, the spiral seed strand was implanted and secured within the inner lumen of the metallic stent. This method was designed to reduce tract-related injury by utilizing a single, smaller working sheath and minimizing manipulation of the bile duct wall. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Obstructive jaundice attributable to benign etiology.
- Presence of any absolute contraindication listed in the inclusion criteria.
- Life expectancy estimated to be less than three months.
- Unwillingness to participate in the study or provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strandAlso: PTBSISThis is a combined interventional radiology procedure for malignant obstructive jaundice. Under local anesthesia and fluoroscopic guidance, a self-expanding metallic biliary stent is percutaneously placed across the malignant stricture. Subsequently, a linear strand of Iodine-125 (^125^I) seeds, fabricated by sealing the prescribed number of seeds within a catheter, is implanted and fixed in the space between the outer wall of the stent and the bile duct wall. The ^125^I seeds provide continuous low-dose-rate brachytherapy to inhibit tumor ingrowth and prolong stent patency. | Radiation | Conventional linear implantation |
| Percutaneous transhepatic biliary stenting with novel spiral ^125^I seeds strandAlso: PTBSIS (novel)This is a combined interventional radiology procedure for malignant obstructive jaundice. Under local anesthesia and fluoroscopic guidance, a self-expanding metallic biliary stent is percutaneously placed across the malignant stricture. Subsequently, a spiral-configured strand of Iodine-125 (^125^I) seeds, fabricated by shaping a linear catheter strand with boiling water (using a slightly higher seed count to compensate for foreshortening), is implanted and secured within the inner lumen of the stent. The ^125^I seeds provide continuous low-dose-rate brachytherapy to inhibit tumor ingrowth and prolong stent patency. This method is designed to reduce tract-related injury by minimizing bile duct wall manipulation. | Radiation | Novel spiral implantation |
Primary outcome
Stent Patency Time
Time frame: From the date of randomization/stent placement until the date of documented stent re-obstruction or death from any cause, whichever occurs first, assessed up to 24 months.
The duration from the date of stent placement to the date of first documented stent re-obstruction (confirmed by imaging evidence of restenosis or occlusion). For patients who die without prior evidence of recurrent jaundice, the data will be censored at the date of death.
Overall Survival
Time frame: From the date of randomization/stent placement until the date of death from any cause, assessed up to 24 months.
The time from the date of the stent placement procedure until the date of death from any cause. For patients who are alive at the end of the study, survival data will be censored at the date of the last follow-up contact.
5 secondary outcomes
Incidence of Procedure-Related Complications
Time frame: Intraoperative period and up to 30 days after the procedure.
Change in Serum Total Bilirubin (TBIL) Level
Time frame: Baseline (pre-PTBSIS, after initial PTBD) and 1 month after the PTBSIS procedure.
Change in Serum Alanine Aminotransferase (ALT) Level
Time frame: Baseline (pre-PTBSIS, after initial PTBD) and 1 month after the PTBSIS procedure.
Change in Serum Aspartate Aminotransferase (AST) Level
Time frame: Baseline (pre-PTBSIS, after initial PTBD) and 1 month after the PTBSIS procedure.
Technical Success Rate
Time frame: Assessed immediately upon completion of the stent and seed strand implantation procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Results publication: PubMed 31187228Wang W, Shen J, Wang C, Ren B, Zhu X, Ni C. Safety and Feasibility of Helical I-125 Seed Implants Combined with Transcatheter Arterial Chemoembolization in Hepatocellular Carcinomas with Main Portal Vein Tumor Thrombus. Cardiovasc Intervent Radiol. 2019 Oct;42(10):1420-1428. doi: 10.1007/s00270-019-02256-z. Epub 2019 Jun 11.
- Results publication: PubMed 33346140Jang S, Stevens T, Parsi MA, Bhatt A, Kichler A, Vargo JJ. Superiority of Self-Expandable Metallic Stents Over Plastic Stents in Treatment of Malignant Distal Biliary Strictures. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e182-e195. doi: 10.1016/j.cgh.2020.12.020. Epub 2020 Dec 18.
- Results publication: PubMed 18028506Larghi A, Tringali A, Lecca PG, Giordano M, Costamagna G. Management of hilar biliary strictures. Am J Gastroenterol. 2008 Feb;103(2):458-73. doi: 10.1111/j.1572-0241.2007.01645.x. Epub 2007 Nov 19.
- Individual participant dataSharing planned: No
Related trials for Malignant Obstructive Jaundice
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Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Biliary Tract Neoplasms, Biliary Drainage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strand and Percutaneous transhepatic biliary stenting with novel spiral ^125^I seeds strand in people with Malignant Obstructive Jaundice, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent Patency Time (time frame: From the date of randomization/stent placement until the date of documented stent re-obstruction or death from any cause, whichever occurs first, assessed up to 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07381439, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.