Bile Duct Obstruction, ExtrahepaticNCT03030573
Reconstruction of the Bile Duct With the Round Ligament
A study testing Reconstruction of the bile duct with the round ligament in people with Bile Duct Obstruction, Extrahepatic, run by Beaujon Hospital at 1 site in France.
Trial summary
The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bile Duct Obstruction, Extrahepatic
- What is being tested?
- Reconstruction of the bile duct with the round ligament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Nov 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Radiological or operative diagnosis of bile duct Injury or defect
- Can underwent surgical procedure
Who cannot join
- 1) The absence of the round ligament
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Departement HPB surgery, Beaujon Hospital
Clichy, Hauts de seine, 92110
Safi Dokmak, MD, 0033140875797, safi.dokmak@bjn.aphp.fr
Safi Dokmak, MD
About this study
Official title: Reconstruction of Postcholecystectomy Bile Duct Injury and Bile Duct Defects With the Round Ligament
The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament
Read the detailed description
Classically, the bile duct defect after bile duct injury or resection is achieved by bilioenteric reconstruction. However bilioenteric anastomosis is associated with long term complications including intrahepatic bile ducts infection, specific complications related to the Roux en Y jejunal loop and eliminate the endoscopic access to intrahepatic bile ducts. The investigators had recently developed a new surgical technique to reconstruct the veins with the parietal peritoneum with excellent results. Accordingly the investigators decided to develop a new surgical technique in order to reconstruct the bile duct defects with the vascularized round ligament.
- Conditions
- Bile Duct Obstruction, Extrahepatic
- Being tested
- Reconstruction of the bile duct with the round ligament
- Keywords
- Bile duct injury, Bile duct defect, Round ligament, Reconstruction
- Medical subject headings
- Cholestasis, Extrahepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstruction of the bile duct with the round ligamentProcedure or surgery
In patients who had bile duct defect by injury or resection, the Round ligament will be used to reconstruct the defect. Surgical technique, the early and long term postoperative measures are detailed in the investigators protocol.
| Study group | Role | What they receive |
|---|---|---|
| Device: Round ligament and the bile duct | Other | The investigators describe the safety and efficacy of the reconstruction of the bile duct with the Round ligament. Receives: Procedure: Reconstruction of the bile duct with the round ligament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - absence of any severe complication or mortality related to the new procedure
Safety is defined by the absence of any severe complication (necrosis or biliary fistula) or mortality related to the new procedure.
Measured: at 1 year
Secondary outcomes (1)
Bile buct patency
Secondary outcome include mainly the patency of the reconstructed bile duct.
Measured: at 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct Obstruction, ExtrahepaticStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beaujon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safi Dokmak, Beaujon Hospital
- Investigators
- Safi Dokmak, MD, Principal investigator, HBP department, Beaujon hospital, Clichy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030573
- Sponsor's protocol ID
- Beaujon Hospital
- Status last verified
- Feb 2017
- First submitted
- 19 Nov 2016
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Postcholecystectomy Bile Duct Injury and Bile Duct Defects With the Round Ligament
- ClinicalTrials.gov ID
- NCT03030573
- Acronym / sponsor ID
- Beaujon Hospital
- Conditions
- Bile Duct Obstruction, Extrahepatic
- Keywords
- Bile duct injury, Bile duct defect, Round ligament, Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beaujon HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 25 Jan 2017 (estimated)
- 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.
The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament
Detailed description
Classically, the bile duct defect after bile duct injury or resection is achieved by bilioenteric reconstruction. However bilioenteric anastomosis is associated with long term complications including intrahepatic bile ducts infection, specific complications related to the Roux en Y jejunal loop and eliminate the endoscopic access to intrahepatic bile ducts. The investigators had recently developed a new surgical technique to reconstruct the veins with the parietal peritoneum with excellent results. Accordingly the investigators decided to develop a new surgical technique in order to reconstruct the bile duct defects with the vascularized round ligament.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: Round ligament and the bile duct | Other | Procedure: Reconstruction of the bile duct with the round ligamentThe investigators describe the safety and efficacy of the reconstruction of the bile duct with the Round ligament. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Radiological or operative diagnosis of bile duct Injury or defect
- Can underwent surgical procedure
Key exclusion criteria (1 listed)
- 1) The absence of the round ligament
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 |
|---|---|---|
| Reconstruction of the bile duct with the round ligamentIn patients who had bile duct defect by injury or resection, the Round ligament will be used to reconstruct the defect. Surgical technique, the early and long term postoperative measures are detailed in the investigators protocol. | Procedure or surgery | Device: Round ligament and the bile duct |
Primary outcome
Safety - absence of any severe complication or mortality related to the new procedure
Time frame: at 1 year
Safety is defined by the absence of any severe complication (necrosis or biliary fistula) or mortality related to the new procedure.
1 secondary outcome
Bile buct patency
Time frame: at 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Safi Dokmak, MD principal investigator
HBP department, Beaujon hospital, Clichy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconstruction of the bile duct with the round ligament in people with Bile Duct Obstruction, Extrahepatic, run by Beaujon Hospital at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 7 Feb 2017. 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 France. 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 Safi Dokmak, MD (0033140875797, safi.dokmak@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - absence of any severe complication or mortality related to the new procedure (time frame: at 1 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 7 Feb 2017.