GallstonesCREST CholesNCT02554097
Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis
An observational study of Gallstones and Cholelithiasis, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Patients with gallstone and confirmed common bile duct stones are registered in this study. The three managements for common bile duct stones are endoscopic sphincterotomy (EST), laparoscopic common bile duct exploration (LCBDE) and laparoscopic transcystic common bile duct exploration (LTCBDE). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gallstones, Cholelithiasis, Cholecystolithiasis
- What is being tested?
- endoscopic sphincterotomy, laparoscopic common bile duct exploration and laparoscopic transcystic common bile duct exploration
- Type of treatment
- Surgery or procedure
- How many people
- 2,700 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to 30 Dec 2018
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
Study population: Patients are diagnosed with gallstones and common bile duct stones.
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 (MRI、MRCP and CT).
- Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
- Patients accepted one of the three managements (EST+LC, LCBDE and LTCBDE).
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.
About this study
Official title: Optimization and Cost-effective Analysis of Secondary Biliary Stones' Managements - A Multicenter, Prospective and Retrospective Cohort Study Based on Case Register System
Patients with gallstone and confirmed common bile duct stones are registered in this study. The three managements for common bile duct stones are endoscopic sphincterotomy (EST), laparoscopic common bile duct exploration (LCBDE) and laparoscopic transcystic common bile duct exploration (LTCBDE). Patients will be assessed at baseline, preoperative investigations, operative method, operative time, conversion to open procedure, intraoperative and postoperative complications, and the presence of retained and recurrent stones. All patients were followed up for 3 years by telephone interview ang outpatient visits. Abdominal US and liver function tests were carried out whenever any abdominal symptom appeared during the follow-up period. If there were unusual findings, magnetic resonance cholangiopancreatography(MRCP) was carried out.
- Conditions
- Gallstones, Cholelithiasis, Cholecystolithiasis, Choledocholithiasis
- Being tested
- endoscopic sphincterotomy, laparoscopic common bile duct exploration, laparoscopic transcystic common bile duct exploration, laparoscopic cholecystectomy
- Keywords
- laparoscopic transcystic common bile duct exploration, laparoscopic common bile duct exploration, endoscopic sphincterotomy,, cost-effective analysis
- Medical subject headings
- Gallstones, Cholelithiasis, Cholecystolithiasis, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic sphincterotomyProcedure or surgery
Sphincterotomy (EST) is performed to remove the common bile duct stone.
laparoscopic common bile duct explorationProcedure or surgery
Transductal exploration was carried out to remove the common bile duct stone. Primary closure or a T tube drainage was performed according to the results of transductal surgery.
laparoscopic transcystic common bile duct explorationProcedure or surgery
A wide local dissection of Calot's triangle is performed and a 2.8mm, 3-mm or 5-mm flexible choledochoscope according to the diameter of the cystic duct is inserted through the cystic duct into the common bile duct. After the common bile duct stone is removed, the cystic duct was ligated with Hem-o-lok.
laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy is performed to remove the gallbladder.
| Study group | Role | What they receive |
|---|---|---|
| EST+LC group | Patients accept the management of endoscopic sphincterotomy and laparoscopic cholecystectomy. Receives: Procedure: endoscopic sphincterotomy; Procedure: laparoscopic cholecystectomy | |
| LCBDE+LC group | Patients accept the management of laparoscopic common bile duct exploration and laparoscopic cholecystectomy. Receives: Procedure: laparoscopic common bile duct exploration; Procedure: laparoscopic cholecystectomy | |
| LTCBDE+LC group | Patients accept the management of laparoscopic transcystic common bile duct exploration and laparoscopic cholecystectomy. Receives: Procedure: laparoscopic transcystic common bile duct exploration; Procedure: laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Adverse outcomes
The patients with complication / the total patients
Measured: 3 years
Secondary outcomes (10)
Incremental cost-effectiveness ratio
the average incremental cost associated with 1 additional unit of the measure of effect
Measured: 3 years
Hospital stay
The total days in hospital
Measured: 3 years
Acute cholangitis rate
The patients with acute cholangitis / the total patients
Measured: 30 days
Bile leakage rate
The patients with bile juice found in the abdominal cavity after procedures / the total patients
Measured: 30 days
Stricture of the bile duct rate rate
The patients with any stricture appeared after the procedures / the total patients
Measured: 3 years
Mortality
Number of death connected with the procedures and complications / total patients
Measured: 3 years
Perforation Rate
The patients with perforation after the procedures / the total patients
Measured: 30 days
Hemorrhage Rate
The patients with hemorrhage after the procedures / the total patients
Measured: 3 years
Operation time
The total time of all the procedures (min)
Measured: 3 years
Acute pancreatitis Rate
The patients with acute pancreatitis after the procedures / the total patients
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startAug 2015
- Primary completion15 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GallstonesStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,700 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Xuanwu Hospital, Beijing, Capital Medical University, Peking University Third Hospital, China-Japan Friendship Hospital, Beijing Tongren Hospital, LanZhou University, The First Affiliated Hospital of Dalian Medical University, Shanghai Zhongshan Hospital, Peking University, Peking Union Medical College Hospital
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
- Investigators
- Zhongtao Zhang, Doctor, Study chair, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554097
- Sponsor's protocol ID
- CR-CREST Choles
- Acronym
- CREST Choles
- Status last verified
- Nov 2018
- First submitted
- 15 Sep 2015
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhu JG, Wu S, Feng Q, Li F, Han W, Xiu D, Tan H, Fu J, Li X, Shang D, Liu H, Li B, Yang L, Kong Y, Zhan S, Guo W, Zhang ZT. Protocol for the CREST Choles (Chinese REgistry Study on Treatment of Cholecysto-Choledocholithiasis) study: an ambispective, multicenter, observational, open-cohort study. BMJ Open. 2019 Nov 24;9(11):e030293. doi: 10.1136/bmjopen-2019-030293.
PubMed 31767583
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization and Cost-effective Analysis of Secondary Biliary Stones' Managements - A Multicenter, Prospective and Retrospective Cohort Study Based on Case Register System
- ClinicalTrials.gov ID
- NCT02554097
- Acronym / sponsor ID
- CREST Choles / CR-CREST Choles
- Conditions
- Gallstones, Cholelithiasis, Cholecystolithiasis, Choledocholithiasis
- Keywords
- laparoscopic transcystic common bile duct exploration, laparoscopic common bile duct exploration, endoscopic sphincterotomy,, cost-effective analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Xuanwu Hospital, Beijing, Capital Medical University, Peking University Third Hospital, China-Japan Friendship Hospital, Beijing Tongren Hospital, LanZhou University, The First Affiliated Hospital of Dalian Medical University, Shanghai Zhongshan Hospital, Peking University, Peking Union Medical College Hospital
- Study start
- Aug 2015
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 18 Sep 2015 (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.
Patients with gallstone and confirmed common bile duct stones are registered in this study. The three managements for common bile duct stones are endoscopic sphincterotomy (EST), laparoscopic common bile duct exploration (LCBDE) and laparoscopic transcystic common bile duct exploration (LTCBDE). Patients will be assessed at baseline, preoperative investigations, operative method, operative time, conversion to open procedure, intraoperative and postoperative complications, and the presence of retained and recurrent stones. All patients were followed up for 3 years by telephone interview ang outpatient visits. Abdominal US and liver function tests were carried out whenever any abdominal symptom appeared during the follow-up period. If there were unusual findings, magnetic resonance cholangiopancreatography(MRCP) was carried out.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EST+LC group | – | Procedure: endoscopic sphincterotomy, Procedure: laparoscopic cholecystectomyPatients accept the management of endoscopic sphincterotomy and laparoscopic cholecystectomy. |
| LCBDE+LC group | – | Procedure: laparoscopic common bile duct exploration, Procedure: laparoscopic cholecystectomyPatients accept the management of laparoscopic common bile duct exploration and laparoscopic cholecystectomy. |
| LTCBDE+LC group | – | Procedure: laparoscopic transcystic common bile duct exploration, Procedure: laparoscopic cholecystectomyPatients accept the management of laparoscopic transcystic common bile duct exploration and laparoscopic cholecystectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are diagnosed with gallstones and common bile duct stones.
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 (MRI、MRCP and CT).
- Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
- Patients accepted one of the three managements (EST+LC, LCBDE and LTCBDE).
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 |
|---|---|---|
| endoscopic sphincterotomySphincterotomy (EST) is performed to remove the common bile duct stone. | Procedure or surgery | EST+LC group |
| laparoscopic common bile duct explorationTransductal exploration was carried out to remove the common bile duct stone. Primary closure or a T tube drainage was performed according to the results of transductal surgery. | Procedure or surgery | LCBDE+LC group |
| laparoscopic transcystic common bile duct explorationA wide local dissection of Calot's triangle is performed and a 2.8mm, 3-mm or 5-mm flexible choledochoscope according to the diameter of the cystic duct is inserted through the cystic duct into the common bile duct. After the common bile duct stone is removed, the cystic duct was ligated with Hem-o-lok. | Procedure or surgery | LTCBDE+LC group |
| laparoscopic cholecystectomyLaparoscopic cholecystectomy is performed to remove the gallbladder. | Procedure or surgery | EST+LC group, LCBDE+LC group, LTCBDE+LC group |
Primary outcome
Rate of Adverse outcomes
Time frame: 3 years
The patients with complication / the total patients
10 secondary outcomes
Incremental cost-effectiveness ratio
Time frame: 3 years
Hospital stay
Time frame: 3 years
Acute cholangitis rate
Time frame: 30 days
Bile leakage rate
Time frame: 30 days
Stricture of the bile duct rate rate
Time frame: 3 years
Mortality
Time frame: 3 years
Perforation Rate
Time frame: 30 days
Hemorrhage Rate
Time frame: 3 years
Operation time
Time frame: 3 years
Acute pancreatitis Rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Derived from this study: PubMed 31767583Zhu JG, Wu S, Feng Q, Li F, Han W, Xiu D, Tan H, Fu J, Li X, Shang D, Liu H, Li B, Yang L, Kong Y, Zhan S, Guo W, Zhang ZT. Protocol for the CREST Choles (Chinese REgistry Study on Treatment of Cholecysto-Choledocholithiasis) study: an ambispective, multicenter, observational, open-cohort study. BMJ Open. 2019 Nov 24;9(11):e030293. doi: 10.1136/bmjopen-2019-030293.
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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.
Zhongtao Zhang, Doctor study chair
Beijing Friendship Hospital
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 Gallstones and Cholelithiasis, run by Beijing Friendship 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 27 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Adverse outcomes (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02554097, which also lists 1 linked publication.
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 Nov 2018.