HepatolithiasisNCT03098251
Effect of 3D Typing on Surgical Treatment of Hepatolithiasis
A study testing 3D typing and routine typing in people with Hepatolithiasis and Surgery, run by Southwest Hospital, China at 1 site in China.
Trial summary
According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatolithiasis, Surgery
- What is being tested?
- 3D typing and routine typing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2017to 31 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 65 years old
- Without gender restriction
- With a favorable liver function of Child-Pugh A to B
- No contraindications to surgery and anesthesia
- Diagnosed with Hepatolithiasis and Signed informed consent.
Who cannot join
- Diffused type of Hepatolithiasis
- Impairment in liver function
- Severe disorders in vital organ
- Accompanied with tumors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
xiaobin Feng, MD
About this study
Official title: Efficacy of 3D Typing and Routine Typing on Surgical Treatment of Hepatolithiasis
According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis.
Read the detailed description
According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis. In this cohort study, two group will be enrolled to compare the outcomes.
- Conditions
- Hepatolithiasis, Surgery
- Being tested
- 3D typing, routine typing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D typingProcedure or surgery
typing the patient with 3D typing system and give specific treatment
routine typingProcedure or surgery
typing the patient with routine typing system and give specific treatment
| Study group | Role | What they receive |
|---|---|---|
| 3D typing | Experimental | typing the patient with 3D typing system and give treatment according preestablished algorism in our center. Receives: Procedure: 3D typing |
| routine typing | Active comparator | typing the patient with routine typing system and give treatment according preestablished algorism in our center. Receives: Procedure: routine typing |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual ratio of biliary stone
residual ratio of biliary stone diagnosed within 3 months
Measured: 3 months
Secondary outcomes (4)
postoperative complications
postoperative complications diagnosed within 6 months
Measured: 6 months
residual lesions
residual lesions diagnosed within 6 months
Measured: 6 months
Health economics index
Health economics index within 3 months
Measured: 3 months
mortality
mortality occured within 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start11 Apr 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatolithiasisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Chinese PLA General Hospital
- Responsible party
- Principal investigator, feng xiaobin, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098251
- Sponsor's protocol ID
- SWHB017
- Status last verified
- Apr 2017
- First submitted
- 20 Mar 2017
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 3D Typing and Routine Typing on Surgical Treatment of Hepatolithiasis
- ClinicalTrials.gov ID
- NCT03098251
- Acronym / sponsor ID
- SWHB017
- Conditions
- Hepatolithiasis, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Chinese PLA General Hospital
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 31 Mar 2017 (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.
According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis.
Detailed description
According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis. In this cohort study, two group will be enrolled to compare the outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D typing | Experimental | Procedure: 3D typingtyping the patient with 3D typing system and give treatment according preestablished algorism in our center. |
| routine typing | Active comparator | Procedure: routine typingtyping the patient with routine typing system and give treatment according preestablished algorism in our center. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged from 18 to 65 years old
- Without gender restriction
- With a favorable liver function of Child-Pugh A to B
- No contraindications to surgery and anesthesia
- Diagnosed with Hepatolithiasis and Signed informed consent.
Key exclusion criteria (4 listed)
- Diffused type of Hepatolithiasis
- Impairment in liver function
- Severe disorders in vital organ
- Accompanied with tumors.
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 |
|---|---|---|
| 3D typingtyping the patient with 3D typing system and give specific treatment | Procedure or surgery | 3D typing |
| routine typingtyping the patient with routine typing system and give specific treatment | Procedure or surgery | routine typing |
Primary outcome
residual ratio of biliary stone
Time frame: 3 months
residual ratio of biliary stone diagnosed within 3 months
4 secondary outcomes
postoperative complications
Time frame: 6 months
residual lesions
Time frame: 6 months
Health economics index
Time frame: 3 months
mortality
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D typing and routine typing in people with Hepatolithiasis and Surgery, 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 5 inclusion and 4 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 12 Apr 2017. 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 Xiaobin Feng, MD (+86-2368765297, fengxiaobin200708@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
residual ratio of biliary stone (time frame: 3 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 12 Apr 2017.