GallstonesPhase 4NCT01822262
Contrastive Study for Minimally Invasive Cholecystolithotomy With Gallbladder Reservation and Laparoscopic Cholecystectomy
A Phase 4 study testing minimally invasive cholecystolithotomy with gallbladder reservation and laparoscopic cholecystectomy in people with Gallstones, run by Chengyi Sun at 1 site in China.
Trial summary
To explore the therapeutic effects for treatment of cholecystolithiasis by minimally invasive cholecystolithotomy with gallbladder reservation and laparoscopic cholecystectomy. Method： patients with cholecystolithiasis who received minimally invasive Cholecystolithotomy with gallbladder reservation and patients with… Read more about this study
- Who is it for?
- Ages 12 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gallstones
- What is being tested?
- minimally invasive cholecystolithotomy with gallbladder reservation and laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2020
- Phase
- Phase 4
- 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 12 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of calculous cholecystitis.
Who cannot join
- Gallbladder's wall >3mm, atrophied gallbladder,gallstone obstruct the Hartmann's pouch.
- Abdominal ultrasound display the contractibility of gallbladder is poor.
- The aged patients with bad heart and lung function.
- Patients who has acute cholecystitis,pancreatitis,pancreaticobiliary diseases, especially choledocholithiasis.
- Pregnant or lactational women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou, 550004
Chengyi Sun, M.D, +86-0851-6771326, chengyisun@medmail.com.cn
About this study
Official title: All the Phases Study Will be Operated by the Department of Hepatobiliary Surgery, The Affiliated Hospital of Guiyang Medical College
To explore the therapeutic effects for treatment of cholecystolithiasis by minimally invasive cholecystolithotomy with gallbladder reservation and laparoscopic cholecystectomy. Method： patients with cholecystolithiasis who received minimally invasive Cholecystolithotomy with gallbladder reservation and patients with cholecystolithiasis who received laparoscopic cholecystectomy(LC) in The Affiliated Hospital of Guiyang Medical College from May 2011 to December 2013. Patients who received minimally invasive cholecystolithotomy with gallbladder reservation as trial group, patients who received LC as control group.the overall follow-up period is 1 year. Then the investigators statistically analyze improvement of cholecystolithiasis symptoms in every group, thickness of gall bladder wall, the gallbladder function and the rate of the recurrence of cholesterol gallstone in trial group.
Read the detailed description
The investigators Prospect： Minimally invasive cholecystolithotomy with gallbladder reservation is meaningful for recovering the function of gallbladder.
- Conditions
- Gallstones
- Being tested
- minimally invasive cholecystolithotomy with gallbladder reservation, laparoscopic cholecystectomy
- Keywords
- Cholecystolithotomy with gallbladder reservation, cholecystolithiasis
- Medical subject headings
- Gallstones, Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive cholecystolithotomy with gallbladder reservationProcedure or surgery
laparoscopic cholecystectomyProcedure or surgery
Also called LC
| Study group | Role | What they receive |
|---|---|---|
| gallbladder reservation | Experimental | Patients in trial group all took minimally invasive cholecystolithotomy with gallbladder reservation Receives: Procedure: minimally invasive cholecystolithotomy with gallbladder reservation |
| laparoscopiccholecystectomy | Experimental | Patients in control group all received LC. Receives: Procedure: laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The contraction function of the gallbladder
Measure the participants' contraction function of gallbladder by the trial for contraction function of gallbladder
Measured: Participants will be followed for overall 1 year after surgery
Secondary outcomes (1)
The thickness of gallbladder wall
Measure the participants' thickness of gallbladder wall by abdominal ultrasonography after surgery
Measured: Participants will be followed for overall 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstonesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengyi Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chengyi Sun, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Chengyi Sun, M.D, Study chair, The Affiliated Hospital of Guiyang Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822262
- Sponsor's protocol ID
- GYGDWK-01
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2013
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All the Phases Study Will be Operated by the Department of Hepatobiliary Surgery, The Affiliated Hospital of Guiyang Medical College
- ClinicalTrials.gov ID
- NCT01822262
- Acronym / sponsor ID
- GYGDWK-01
- Conditions
- Gallstones
- Keywords
- Cholecystolithotomy with gallbladder reservation, cholecystolithiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chengyi SunUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Apr 2013 (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.
To explore the therapeutic effects for treatment of cholecystolithiasis by minimally invasive cholecystolithotomy with gallbladder reservation and laparoscopic cholecystectomy. Method： patients with cholecystolithiasis who received minimally invasive Cholecystolithotomy with gallbladder reservation and patients with cholecystolithiasis who received laparoscopic cholecystectomy(LC) in The Affiliated Hospital of Guiyang Medical College from May 2011 to December 2013. Patients who received minimally invasive cholecystolithotomy with gallbladder reservation as trial group, patients who received LC as control group.the overall follow-up period is 1 year. Then the investigators statistically analyze improvement of cholecystolithiasis symptoms in every group, thickness of gall bladder wall, the gallbladder function and the rate of the recurrence of cholesterol gallstone in trial group.
Detailed description
The investigators Prospect： Minimally invasive cholecystolithotomy with gallbladder reservation is meaningful for recovering the function of gallbladder.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gallbladder reservation | Experimental | Procedure: minimally invasive cholecystolithotomy with gallbladder reservationPatients in trial group all took minimally invasive cholecystolithotomy with gallbladder reservation |
| laparoscopiccholecystectomy | Experimental | Procedure: laparoscopic cholecystectomyPatients in control group all received LC. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of calculous cholecystitis.
Key exclusion criteria (5 listed)
- Gallbladder's wall >3mm, atrophied gallbladder,gallstone obstruct the Hartmann's pouch.
- Abdominal ultrasound display the contractibility of gallbladder is poor.
- The aged patients with bad heart and lung function.
- Patients who has acute cholecystitis,pancreatitis,pancreaticobiliary diseases, especially choledocholithiasis.
- Pregnant or lactational 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 |
|---|---|---|
| minimally invasive cholecystolithotomy with gallbladder reservation | Procedure or surgery | gallbladder reservation |
| laparoscopic cholecystectomyAlso: LC | Procedure or surgery | laparoscopiccholecystectomy |
Primary outcome
The contraction function of the gallbladder
Time frame: Participants will be followed for overall 1 year after surgery
Measure the participants' contraction function of gallbladder by the trial for contraction function of gallbladder
1 secondary outcome
The thickness of gallbladder wall
Time frame: Participants will be followed for overall 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
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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.
The Affiliated Hospital of Guiyang Medical College
Guiyang, China
Chengyi Sun, M.D study chair
The Affiliated Hospital of Guiyang Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing minimally invasive cholecystolithotomy with gallbladder reservation and laparoscopic cholecystectomy in people with Gallstones, run by Chengyi Sun 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 5 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 13 Feb 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The contraction function of the gallbladder (time frame: Participants will be followed for overall 1 year after surgery). 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 13 Feb 2018.