Gallbladder StonesNCT03577873
RCT on Necessity of Cholecystectomy for Patients After Clearance of Bile Duct Stones
A study testing gallbladder preserved and cholecystectomy in people with Gallbladder Stones and Complication, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
To discuss necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallbladder Stones, Complication, Cholecystectomy
- What is being tested?
- gallbladder preserved and cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 1 Feb 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtention of a written informed consent; Clinical diagnosis of gallbladder stones and common bile duct stones; No absolute operation indications of cholecystectomy
Who cannot join
- Intrahepatic stones; Malignant tumor disease ;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial on Necessity of Cholecystectomy for Patients With Bile Duct Stones Combined With Gallbladder Stones After Clearance of Stones
To discuss necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.
Read the detailed description
Cholecystectomy was recommended for patients with stones in their bile ducts and gallbladders in European and American countries after clearance of bile duct stones with ERCP, which reduced the incidence of biliary events. However, some researches showed that the incidence of biliary events was not reduced but increased.The purpose of this study is to discuss the necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.
- Conditions
- Gallbladder Stones, Complication, Cholecystectomy
- Being tested
- gallbladder preserved, cholecystectomy
- Keywords
- gallbladder stones, common bile duct stones, Endoscopic retrograde cholangiopancreatography
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gallbladder preservedOther
Gallbladders will be remained after clearance of bile duct stones with ERCP and conventional therapy, such as fluid replacement and prophylactic anti infection, will be accepted.
cholecystectomyProcedure or surgery
Cholecystectomy will be done right now after clearance of bile duct stones with ERCP, and then conventional therapy will be accepted.
| Study group | Role | What they receive |
|---|---|---|
| gallbladder preserved | Placebo comparator | Patients with stones in their bile ducts and gallbladders will keep gallbladders in stay after clearance of bile duct stones with ERCP. Receives: Other: gallbladder preserved |
| cholecystectomy | Experimental | Patients with stones in their bile ducts and gallbladders will undergo cholecystectomy after clearance of bile duct stones with ERCP. Receives: Procedure: cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
biliary events
The incidence of biliary events will be compared in the two groups.
Measured: 12 months
Secondary outcomes (1)
adverse events
Number of participants with adverse events: type, frequency and intensity of adverse events.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Nov 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
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 Gallbladder StonesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Yang, First People's Hospital of Hangzhou
- Investigators
- Xiangfeng Zhang, M.S, Study director, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577873
- Sponsor's protocol ID
- 2018-107-01
- Status last verified
- Jun 2018
- First submitted
- 5 Jun 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Heo J, Jung MK, Cho CM. Should prophylactic cholecystectomy be performed in patients with concomitant gallstones after endoscopic sphincterotomy for bile duct stones? Surg Endosc. 2015 Jun;29(6):1574-9. doi: 10.1007/s00464-014-3844-8. Epub 2014 Oct 8.
PubMed 25294531
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Necessity of Cholecystectomy for Patients With Bile Duct Stones Combined With Gallbladder Stones After Clearance of Stones
- ClinicalTrials.gov ID
- NCT03577873
- Acronym / sponsor ID
- 2018-107-01
- Conditions
- Gallbladder Stones, Complication, Cholecystectomy
- Keywords
- gallbladder stones, common bile duct stones, Endoscopic retrograde cholangiopancreatography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 5 Jul 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.
To discuss necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.
Detailed description
Cholecystectomy was recommended for patients with stones in their bile ducts and gallbladders in European and American countries after clearance of bile duct stones with ERCP, which reduced the incidence of biliary events. However, some researches showed that the incidence of biliary events was not reduced but increased.The purpose of this study is to discuss the necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gallbladder preserved | Placebo comparator | Other: gallbladder preservedPatients with stones in their bile ducts and gallbladders will keep gallbladders in stay after clearance of bile duct stones with ERCP. |
| cholecystectomy | Experimental | Procedure: cholecystectomyPatients with stones in their bile ducts and gallbladders will undergo cholecystectomy after clearance of bile duct stones with ERCP. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obtention of a written informed consent; Clinical diagnosis of gallbladder stones and common bile duct stones; No absolute operation indications of cholecystectomy
Key exclusion criteria (1 listed)
- Intrahepatic stones; Malignant tumor disease ;
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 |
|---|---|---|
| gallbladder preservedGallbladders will be remained after clearance of bile duct stones with ERCP and conventional therapy, such as fluid replacement and prophylactic anti infection, will be accepted. | Other | gallbladder preserved |
| cholecystectomyCholecystectomy will be done right now after clearance of bile duct stones with ERCP, and then conventional therapy will be accepted. | Procedure or surgery | cholecystectomy |
Primary outcome
biliary events
Time frame: 12 months
The incidence of biliary events will be compared in the two groups.
1 secondary outcome
adverse events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Background: PubMed 25294531Heo J, Jung MK, Cho CM. Should prophylactic cholecystectomy be performed in patients with concomitant gallstones after endoscopic sphincterotomy for bile duct stones? Surg Endosc. 2015 Jun;29(6):1574-9. doi: 10.1007/s00464-014-3844-8. Epub 2014 Oct 8.
- Individual participant dataSharing planned: Undecided
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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.
Xiangfeng Zhang, M.S study director
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gallbladder preserved and cholecystectomy in people with Gallbladder Stones and Complication, run by First People's Hospital of Hangzhou 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 1 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: finished, as of the sponsor's last update on 5 Jul 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
biliary events (time frame: 12 months). 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 NCT03577873, 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 5 Jul 2018.