CholangiojejunostomyNCT02915770
Clinical Application of Cholangiojejunostomy in the Surgical Treatment of Cholelithiasis With Moderate Dilatation of Common Bile Duct
A study testing cholangiojejunostomy, hepatectomy and T-tube in people with Cholangiojejunostomy and Cholelithiasis, run by Southwest Hospital, China at 1 site in China.
Trial summary
This study evaluates the clinical application of cholangiojejunostomy in the surgical treatment of cholelithiasis with Moderate dilatation of common bile duct. Half of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage, while the other half will receive hepatectomy and T-tube Drainage. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholangiojejunostomy, Cholelithiasis
- What is being tested?
- cholangiojejunostomy, hepatectomy and T-tube
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to May 2017
- 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
- Hepatic bile duct stone disease, need surgery
- No residual stones in the operation
- Extrahepatic bile duct dilatation, 15-30 mm in diam.
- No relaxation or stenosis of the sphincter of Oddi
Who cannot join
- Patient involuntary
- Surgical treatment can not be performed because of various reasons.
- Intrahepatic and extrahepatic bile duct stones can not be taken away
- with other biliary tract diseases, such as bile duct cancer
- Oddi sphincter relaxation or stenosis
- loss to follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hepatobiliary Surgery Institute, Southwest Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400038
xin 1 zhao, doctor, 86-23-68765805 ext. 1, zhaoxinxnyy@sina.com
About this study
This study evaluates the clinical application of cholangiojejunostomy in the surgical treatment of cholelithiasis with Moderate dilatation of common bile duct. Half of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage, while the other half will receive hepatectomy and T-tube Drainage.
- Conditions
- Cholangiojejunostomy, Cholelithiasis
- Being tested
- cholangiojejunostomy, hepatectomy, T-tube
- Keywords
- Moderate dilatation of common bile duct
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholangiojejunostomyProcedure or surgery
Half of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage,while the other half will receive hepatectomy and T-tube Drainage
hepatectomyProcedure or surgery
T-tubeDevice
T-tube Drainage
| Study group | Role | What they receive |
|---|---|---|
| participants receive cholangiojejunostomy | Experimental | participants will receive hepatectomy、cholangiojejunostomy and T-tube Drainage Receives: Procedure: cholangiojejunostomy; Procedure: hepatectomy; Device: T-tube |
| participants receive no cholangiojejunostomy | Active comparator | participants will receive hepatectomy and T-tube Drainage Receives: Procedure: hepatectomy; Device: T-tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of bile duct stones
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startDec 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiojejunostomyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dajiang li, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915770
- Sponsor's protocol ID
- 2014（18）
- Status last verified
- Sep 2016
- First submitted
- 6 Jul 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Cholangiojejunostomy in the Surgical Treatment of Cholelithiasis With Moderate Dilatation of Common Bile Duct
- ClinicalTrials.gov ID
- NCT02915770
- Acronym / sponsor ID
- 2014（18）
- Conditions
- Cholangiojejunostomy, Cholelithiasis
- Keywords
- Moderate dilatation of common bile duct
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 27 Sep 2016 (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.
This study evaluates the clinical application of cholangiojejunostomy in the surgical treatment of cholelithiasis with Moderate dilatation of common bile duct. Half of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage, while the other half will receive hepatectomy and T-tube Drainage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| participants receive cholangiojejunostomy | Experimental | Procedure: cholangiojejunostomy, Procedure: hepatectomy, Device: T-tubeparticipants will receive hepatectomy、cholangiojejunostomy and T-tube Drainage |
| participants receive no cholangiojejunostomy | Active comparator | Procedure: hepatectomy, Device: T-tubeparticipants will receive hepatectomy and T-tube Drainage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hepatic bile duct stone disease, need surgery
- No residual stones in the operation
- Extrahepatic bile duct dilatation, 15-30 mm in diam.
- No relaxation or stenosis of the sphincter of Oddi
Key exclusion criteria (6 listed)
- Patient involuntary
- Surgical treatment can not be performed because of various reasons.
- Intrahepatic and extrahepatic bile duct stones can not be taken away
- with other biliary tract diseases, such as bile duct cancer
- Oddi sphincter relaxation or stenosis
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 |
|---|---|---|
| cholangiojejunostomyHalf of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage,while the other half will receive hepatectomy and T-tube Drainage | Procedure or surgery | participants receive cholangiojejunostomy |
| hepatectomy | Procedure or surgery | participants receive cholangiojejunostomy, participants receive no cholangiojejunostomy |
| T-tubeT-tube Drainage | Device | participants receive cholangiojejunostomy, participants receive no cholangiojejunostomy |
Primary outcome
Recurrence of bile duct stones
Time frame: 2-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Individual participant dataSharing planned: Undecided
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.
Hepatobiliary Surgery Institute, Southwest Hospital, Third Military Medical University
Chongqing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholangiojejunostomy, hepatectomy and T-tube in people with Cholangiojejunostomy and Cholelithiasis, run by Southwest Hospital, China 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 6 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 27 Sep 2016. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of bile duct stones (time frame: 2-3 years). 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 27 Sep 2016.