Biliary Anastomotic StrictureNCT04170933
Magnetic Compression Anastomosis for Recanalization of Biliary Stricture
A study testing Magnetic recanalization in people with Biliary Anastomotic Stricture and Biliary Tract Diseases, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Biliary stricture is a common complication after end-to-end biliary anastomosis, especially after liver transplantation. This study is designed to investigate the safety and efficacy of magnetic recanalization technique, a newly clinical method, for treating biliary anastomotic stricture. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Biliary Anastomotic Stricture, Biliary Tract Diseases, Cholestasis, Extrahepatic
- What is being tested?
- Magnetic recanalization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥ 18 years old and ≤65 years old
- 2. patients with biliary stricture after end-to-end biliary anastomosis
Who cannot join
- 1. Pregnant woman
- 2.Have a history of cardiovascular disease, including coronary heart disease (angina pectoris, myocardial infarction, coronary angiogenesis or electrocardiographic abnormal Q wave (ECG)), stroke (ischemic or hemorrhagic, including transient ischemic attack)
- 3. Severe lung diseases such as COPD and asthma
- 4. Patients with acute infection or inflammation (i.e. pneumonia)
- 5. Any other medical condition considers the longest survival time to be less than 2 years
- 7. Immunodeficiency or HIV positive
- 8. No autonomy, inability to participate in follow-up
- 9. Illiterate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, 710061
Yi Lv, MD，PHD, 0086-13991200581, luyi169@126.com
About this study
Official title: A Prospective Study: Magnetic Compression Anastomosis for Recanalization of Biliary Stricture
Biliary stricture is a common complication after end-to-end biliary anastomosis, especially after liver transplantation. This study is designed to investigate the safety and efficacy of magnetic recanalization technique, a newly clinical method, for treating biliary anastomotic stricture.
Read the detailed description
Biliary anastomotic stricture is a common complication of after end-to-end biliary anastomosis. Magnetic recanalization is a promising way to establish connection of biliary tract after stenosis or completed obstruction. This study is designed to investigate the safety and efficacy of magnetic recanalization among patients with severe biliary stricture after biliary anastmosis. Patients who failed to undergo stent placement with endoscopic retrograde cholangiopancretography (ERCP) would be enrolled for magnetic recanalization treatment. Magnetic treatment will be implemented by several steps. Firstly, placement of one magnet through the sinus of percutaneous transhepatic cholangio drainage (PTCD) in upper part of the bile duct; Second, introduction of another magnet via ERCP into the distal part of the bile duct, and making them be mated together; Third, after necrosis of the tissue between the two magnets, the magnets will drop off and be taken out together through the thread connected with them out of the mouth. Last, a plastic stent should be placed in the bile duct for a lasting support. The time of recanalization (drop off of the magnets), and adverse events (e.g. fever, melena, nausea, vomiting, anorexia, hematemesis, abdominal pain, and gastrointestinal bleeding) will be recorded, and each patient will be followed up for long-term outcomes.
- Conditions
- Biliary Anastomotic Stricture, Biliary Tract Diseases, Cholestasis, Extrahepatic, Endotoxicosis
- Being tested
- Magnetic recanalization
- Keywords
- Magnetic recanalization, Biliary Anastomotic Stricture, Biliary Tract Diseases, Cholestasis, Extrahepatic
- Medical subject headings
- Biliary Tract Diseases, Cholestasis, Extrahepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic recanalizationProcedure or surgery
- Establish a percutaneous transhepatic cholangio drainage (PTCD) fistula.
- Perform endoscopic sphincterotomy (EST).
- Place one magnet above the stricture through the PTCD fistula.
- Introduce another magnet below the stricture through the common bile duct with ERCP.
- Place the magnets at the appropriate point to attract each other.
- The patient will be strictly followed, and the magnets will be taken out out of the mouth by the thread connected with the magnets.
- A plastic stent will be placed in the bile duct for lasting support.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic recanalization | Experimental | The subjects in this group will be treated by magnetic recanalization Receives: Procedure: Magnetic recanalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time duration of biliary recanalization, d (days)
Time period for recanalization of the bile duct
Measured: From date of treatment (two magnets mated together) until the date of drop-off or the two magnets from the biliary tract or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (1)
Incidence of stricture recurrence
Incidence of biliary stricture recurrence after magnetic recanalization treatment
Measured: From date of drop-off of the two magnets until the date of biliary stricture recurrence or end of the follow-up or date of death from any cause, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Apr 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Anastomotic StrictureStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective study of magnetic recanalization in treatment of biliary stricture
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Lv, MD,phD, Principal investigator, First Affiliated Hospital of Xian JiaotongUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170933
- Sponsor's protocol ID
- XJTU1AF-CRF-2015-001-4
- Status last verified
- Apr 2022
- First submitted
- 15 Nov 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study: Magnetic Compression Anastomosis for Recanalization of Biliary Stricture
- ClinicalTrials.gov ID
- NCT04170933
- Acronym / sponsor ID
- XJTU1AF-CRF-2015-001-4
- Conditions
- Biliary Anastomotic Stricture, Biliary Tract Diseases, Cholestasis, Extrahepatic, Endotoxicosis
- Keywords
- Magnetic recanalization, Biliary Anastomotic Stricture, Biliary Tract Diseases, Cholestasis, Extrahepatic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Nov 2019 (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.
Biliary stricture is a common complication after end-to-end biliary anastomosis, especially after liver transplantation. This study is designed to investigate the safety and efficacy of magnetic recanalization technique, a newly clinical method, for treating biliary anastomotic stricture.
Detailed description
Biliary anastomotic stricture is a common complication of after end-to-end biliary anastomosis. Magnetic recanalization is a promising way to establish connection of biliary tract after stenosis or completed obstruction. This study is designed to investigate the safety and efficacy of magnetic recanalization among patients with severe biliary stricture after biliary anastmosis. Patients who failed to undergo stent placement with endoscopic retrograde cholangiopancretography (ERCP) would be enrolled for magnetic recanalization treatment. Magnetic treatment will be implemented by several steps. Firstly, placement of one magnet through the sinus of percutaneous transhepatic cholangio drainage (PTCD) in upper part of the bile duct; Second, introduction of another magnet via ERCP into the distal part of the bile duct, and making them be mated together; Third, after necrosis of the tissue between the two magnets, the magnets will drop off and be taken out together through the thread connected with them out of the mouth. Last, a plastic stent should be placed in the bile duct for a lasting support. The time of recanalization (drop off of the magnets), and adverse events (e.g. fever, melena, nausea, vomiting, anorexia, hematemesis, abdominal pain, and gastrointestinal bleeding) will be recorded, and each patient will be followed up for long-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective study of magnetic recanalization in treatment of biliary stricture
| Arm | Type | Receives |
|---|---|---|
| Magnetic recanalization | Experimental | Procedure: Magnetic recanalizationThe subjects in this group will be treated by magnetic recanalization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Age ≥ 18 years old and ≤65 years old
- 2. patients with biliary stricture after end-to-end biliary anastomosis
Key exclusion criteria (8 listed)
- 1. Pregnant woman
- 2.Have a history of cardiovascular disease, including coronary heart disease (angina pectoris, myocardial infarction, coronary angiogenesis or electrocardiographic abnormal Q wave (ECG)), stroke (ischemic or hemorrhagic, including transient ischemic attack)
- 3. Severe lung diseases such as COPD and asthma
- 4. Patients with acute infection or inflammation (i.e. pneumonia)
- 5. Any other medical condition considers the longest survival time to be less than 2 years
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 |
|---|---|---|
| Magnetic recanalization1. Establish a percutaneous transhepatic cholangio drainage (PTCD) fistula. 2. Perform endoscopic sphincterotomy (EST). 3. Place one magnet above the stricture through the PTCD fistula. 4. Introduce another magnet below the stricture through the common bile duct with ERCP. 5. Place the magnets at the appropriate point to attract each other. 6. The patient will be strictly followed, and the magnets will be taken out out of the mouth by the thread connected with the magnets. 7. A plastic stent will be placed in the bile duct for lasting support. | Procedure or surgery | Magnetic recanalization |
Primary outcome
Time duration of biliary recanalization, d (days)
Time frame: From date of treatment (two magnets mated together) until the date of drop-off or the two magnets from the biliary tract or date of death from any cause, whichever came first, assessed up to 12 months
Time period for recanalization of the bile duct
1 secondary outcome
Incidence of stricture recurrence
Time frame: From date of drop-off of the two magnets until the date of biliary stricture recurrence or end of the follow-up or date of death from any cause, whichever came first, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Biliary Anastomotic Stricture
RecruitingObservational study
Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation.
Liver Transplant Disorder, Ischemic Cholangiopathy
Recruiting
Biodegradable Stents in Liver Transplant RecipIents for Treatment of Biliary Anastomotic Strictures
Liver Transplant, Complications, Biliary Anastomotic Stenosis
Recruiting
EBD RCT Trial in Living Donor Liver Transplantation
Liver Transplantation, Liver Transplant; Complications
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.
Yi Lv, MD,phD principal investigator
First Affiliated Hospital of Xian JiaotongUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic recanalization in people with Biliary Anastomotic Stricture and Biliary Tract Diseases, run by First Affiliated Hospital Xi'an Jiaotong 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Lv, MD,phD (86-29-85323900, luyi169@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time duration of biliary recanalization, d (days) (time frame: From date of treatment (two magnets mated together) until the date of drop-off or the two magnets from the biliary tract or date of death from any cause, whichever came first, assessed up to 12 months). 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 17 May 2022.