Liver Transplant; ComplicationsNCT06048445
Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children
An observational study of Liver Transplant; Complications, run by Zhejiang University at 1 site in China.
Trial summary
Liver transplantation is an effective method for treating end-stage liver disease and metabolic diseases in children. With the advancement of surgical techniques and the improvement of perioperative management, the survival rates of patients and grafts after liver transplantation have significantly improved. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- intraoperative plancement of Biliary Drainage Stent
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients need liver transplantation
Who may be able to join
- The patient underwent liver transplantation surgery at the First Affiliated Hospital of Zhejiang University School of Medicine;
- Age ≤ 6 years old;
- First liver transplantation;
- Willing to sign an informed consent form.
Who cannot join
- Existence of mental illnesses that can affect cognition and coordination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Weili Wang, Doctor
About this study
Official title: Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children: A Prospective Study
Liver transplantation is an effective method for treating end-stage liver disease and metabolic diseases in children. With the advancement of surgical techniques and the improvement of perioperative management, the survival rates of patients and grafts after liver transplantation have significantly improved. However, the complication of biliary stenosis after transplantation is as high as 7.3% -33.3%, and in severe cases, it can even lead to graft failure and patient death. Therefore, the occurrence of biliary stenosis after liver transplantation seriously affects the quality of life of children, increases the economic burden on families, and urgently needs to find effective methods to reduce the occurrence of this complication.
Based on the clinical practice of our center, we believe that the placement of biliary external drainage stents has the following advantages: 1 Reduce intrahepatic biliary pressure and reduce the occurrence of postoperative biliary fistula; 2. The stent has a supporting effect and can maintain the open state of the bile duct; 3. By external drainage, the quality of bile secretion by the liver can be evaluated; 4. Provide a pathway for cholangiography. However, placing external biliary drainage may also pose certain risks, including increasing surgical procedures, stent detachment causing biliary fistula, and increasing the risk of infection.
This study aims to observe the effect of placing external biliary drainage stents on biliary stricture after liver transplantation in children. The aim is to evaluate the preventive effect of external biliary drainage stents on biliary intestinal anastomotic stenosis after liver transplantation in children, and to provide evidence-based evidence for reducing biliary complications in children.
- Conditions
- Liver Transplant; Complications
- Being tested
- intraoperative plancement of Biliary Drainage Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative plancement of Biliary Drainage StentDevice
plancement of Biliary Drainage Stent in liver transplantation of pediatric patients
| Study group | Role | What they receive |
|---|---|---|
| Biliary Drainage Stent group | placement of Biliary Drainage Stent in pediatric liver transplantation Receives: Device: intraoperative plancement of Biliary Drainage Stent | |
| no Biliary Drainage Stent group | no placement of Biliary Drainage Stent in pediatric liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
duct-jejunum anastomotic stoma stricture
number of participants with duct-jejunum anastomotic stoma stricture after liver transplantation
Measured: one year
Secondary outcomes (1)
biliary tract infection
number of participants with biliary tract infection after liver transplantation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start7 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weili Wang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048445
- Sponsor's protocol ID
- BDSPBIAP
- Status last verified
- Aug 2025
- First submitted
- 9 Sep 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children: A Prospective Study
- ClinicalTrials.gov ID
- NCT06048445
- Acronym / sponsor ID
- BDSPBIAP
- Conditions
- Liver Transplant; Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Sep 2023 (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.
Liver transplantation is an effective method for treating end-stage liver disease and metabolic diseases in children. With the advancement of surgical techniques and the improvement of perioperative management, the survival rates of patients and grafts after liver transplantation have significantly improved. However, the complication of biliary stenosis after transplantation is as high as 7.3% -33.3%, and in severe cases, it can even lead to graft failure and patient death. Therefore, the occurrence of biliary stenosis after liver transplantation seriously affects the quality of life of children, increases the economic burden on families, and urgently needs to find effective methods to reduce the occurrence of this complication.
Based on the clinical practice of our center, we believe that the placement of biliary external drainage stents has the following advantages: 1 Reduce intrahepatic biliary pressure and reduce the occurrence of postoperative biliary fistula; 2. The stent has a supporting effect and can maintain the open state of the bile duct; 3. By external drainage, the quality of bile secretion by the liver can be evaluated; 4. Provide a pathway for cholangiography. However, placing external biliary drainage may also pose certain risks, including increasing surgical procedures, stent detachment causing biliary fistula, and increasing the risk of infection.
This study aims to observe the effect of placing external biliary drainage stents on biliary stricture after liver transplantation in children. The aim is to evaluate the preventive effect of external biliary drainage stents on biliary intestinal anastomotic stenosis after liver transplantation in children, and to provide evidence-based evidence for reducing biliary complications in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biliary Drainage Stent group | – | Device: intraoperative plancement of Biliary Drainage Stentplacement of Biliary Drainage Stent in pediatric liver transplantation |
| no Biliary Drainage Stent group | – | –no placement of Biliary Drainage Stent in pediatric liver transplantation |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients need liver transplantation
Key inclusion criteria (4 listed)
- The patient underwent liver transplantation surgery at the First Affiliated Hospital of Zhejiang University School of Medicine;
- Age ≤ 6 years old;
- First liver transplantation;
- Willing to sign an informed consent form.
Key exclusion criteria (1 listed)
- Existence of mental illnesses that can affect cognition and coordination.
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 |
|---|---|---|
| intraoperative plancement of Biliary Drainage Stentplancement of Biliary Drainage Stent in liver transplantation of pediatric patients | Device | Biliary Drainage Stent group |
Primary outcome
duct-jejunum anastomotic stoma stricture
Time frame: one year
number of participants with duct-jejunum anastomotic stoma stricture after liver transplantation
1 secondary outcome
biliary tract infection
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications, run by Zhejiang 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 1 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: looking for participants now, as of the sponsor's last update on 11 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Wang, MD (19883132292 ext. +86, 1519185@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duct-jejunum anastomotic stoma stricture (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2025.