Common Bile Duct StoneNCT03442205
Treatment of Common Bile Duct Stones
A study testing LC + LCBDE + ENBD + primary closure of CBD, ERCP technique + LC and LC + LCBDE + primary closure of CBD in people with Common Bile Duct Stone, run by Tongji Hospital at 1 site in China.
Trial summary
ABSTRACT Introduction: Common bile duct (CBD) stone is a common clinical situation, especially in Asia area. Laparotomy and laparoscopic surgical procedure are often used for treatment. This study compares outcomes of different surgical procedures treating for the disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Common Bile Duct Stone
- What is being tested?
- LC + LCBDE + ENBD + primary closure of CBD, ERCP technique + LC and LC + LCBDE + primary closure of CBD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Mar 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age between 18 - 80 years.
- Patients diagnosed with gallstones.
- Patients diagnosed with common bile duct stone by one of the three exam (US、MRCP and CT).
- Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
- Patients understood the trial and accepted one of the three managements.
Who cannot join
- Combined with Mirizzi syndrome and intrahepatic bile duct stones
- Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)
- History of upper abdominal surgery.
- Serious heart, brain, lung, metabolic diseases history.
- Pregnant women.
- Unwillingness or inability to consent for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430000
Renyi Qin, pHD, +8602783665314, ryqin@tjh.tjmu.edu.cn
About this study
Official title: Randomized Clinical Trial Investigating the Best Method of Treatment of Common Bile Duct Stones
ABSTRACT Introduction: Common bile duct (CBD) stone is a common clinical situation, especially in Asia area. Laparotomy and laparoscopic surgical procedure are often used for treatment. This study compares outcomes of different surgical procedures treating for the disease.
Methods/design: This is a prospective, randomized, controlled multicenter trial with three treatment arms. One group underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + intraoperative endoscopic nasobiliary drainage ENBD + primary closure of CBD. The other underwent preoperative endoscopic retrograde cholangiopancreatography (ERCP) and subsequent LC and the third arm underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + primary closure of CBD. The duration of the entire trial is two years including prearrangement, follow-up and analyses.
Discussion: Despite the fact plenty evidences provided by meta-analyses suggests that these approaches would appear comparable. It is hopeful to fully address which would be the better approach with this RCT design.
- Conditions
- Common Bile Duct Stone
- Being tested
- LC + LCBDE + ENBD + primary closure of CBD, ERCP technique + LC, LC + LCBDE + primary closure of CBD
- Keywords
- Common Bile Duct Stone;, Laparoscopic Common Bile Duct Exploration;, ERCP;
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC + LCBDE + ENBD + primary closure of CBDProcedure or surgery
LC + LCBDE + ENBD + primary closure of CBD
ERCP technique + LCProcedure or surgery
ERCP technique + LC
LC + LCBDE + primary closure of CBDProcedure or surgery
LC + LCBDE + primary closure of CBD
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Procedure: LC + LCBDE + ENBD + primary closure of CBD |
| Group B | Experimental | Not described Receives: Procedure: ERCP technique + LC |
| Group C | Experimental | Not described Receives: Procedure: LC + LCBDE + primary closure of CBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Adverse outcomes
The patients developing complications/ the total patients
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct StoneStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renyi Qin, Tongji Hospital
- Investigators
- Renyi Qin, pHD, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442205
- Sponsor's protocol ID
- TJDBPS03
- Status last verified
- Feb 2018
- First submitted
- 17 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Investigating the Best Method of Treatment of Common Bile Duct Stones
- ClinicalTrials.gov ID
- NCT03442205
- Acronym / sponsor ID
- TJDBPS03
- Conditions
- Common Bile Duct Stone
- Keywords
- Common Bile Duct Stone;, Laparoscopic Common Bile Duct Exploration;, ERCP;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 22 Feb 2018 (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.
ABSTRACT Introduction: Common bile duct (CBD) stone is a common clinical situation, especially in Asia area. Laparotomy and laparoscopic surgical procedure are often used for treatment. This study compares outcomes of different surgical procedures treating for the disease.
Methods/design: This is a prospective, randomized, controlled multicenter trial with three treatment arms. One group underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + intraoperative endoscopic nasobiliary drainage ENBD + primary closure of CBD. The other underwent preoperative endoscopic retrograde cholangiopancreatography (ERCP) and subsequent LC and the third arm underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + primary closure of CBD. The duration of the entire trial is two years including prearrangement, follow-up and analyses.
Discussion: Despite the fact plenty evidences provided by meta-analyses suggests that these approaches would appear comparable. It is hopeful to fully address which would be the better approach with this RCT design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: LC + LCBDE + ENBD + primary closure of CBD |
| Group B | Experimental | Procedure: ERCP technique + LC |
| Group C | Experimental | Procedure: LC + LCBDE + primary closure of CBD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with age between 18 - 80 years.
- Patients diagnosed with gallstones.
- Patients diagnosed with common bile duct stone by one of the three exam (US、MRCP and CT).
- Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
- Patients understood the trial and accepted one of the three managements.
Key exclusion criteria (6 listed)
- Combined with Mirizzi syndrome and intrahepatic bile duct stones
- Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)
- History of upper abdominal surgery.
- Serious heart, brain, lung, metabolic diseases history.
- Pregnant women.
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 |
|---|---|---|
| LC + LCBDE + ENBD + primary closure of CBDLC + LCBDE + ENBD + primary closure of CBD | Procedure or surgery | Group A |
| ERCP technique + LCERCP technique + LC | Procedure or surgery | Group B |
| LC + LCBDE + primary closure of CBDLC + LCBDE + primary closure of CBD | Procedure or surgery | Group C |
Primary outcome
Rate of Adverse outcomes
Time frame: 24 months
The patients developing complications/ the total patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: Yes
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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.
Renyi Qin, pHD study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LC + LCBDE + ENBD + primary closure of CBD, ERCP technique + LC and LC + LCBDE + primary closure of CBD in people with Common Bile Duct Stone, run by Tongji Hospital 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 5 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 1 Mar 2018. 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 Hang Zhang, doctor (+8602783665314, okashiiyo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Adverse outcomes (time frame: 24 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 1 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.