HepatolithiasisNCT03098264
Safety and Efficacy of Simultaneous or Staged Surgery on Complicated Hepatolithiasis
A study testing Simultaneous surgery and staged surgery in people with Hepatolithiasis, run by Southwest Hospital, China at 1 site in China.
Trial summary
For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatolithiasis
- What is being tested?
- Simultaneous surgery and staged surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 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 portal hypertension
- 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: A Cohort Study on Safety and Efficacy of Simultaneous or Staged Surgery in Complicated Hepatolithiasis
For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed.
Read the detailed description
For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed. In this protocol, we will assign the eligible cases into two group. And then perform surgery as simultaneously or separately.By long-term follow-up,to examine the safety and advantages of each procedure.
- Conditions
- Hepatolithiasis
- Being tested
- Simultaneous surgery, staged surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous surgeryProcedure or surgery
Simultaneous surgery in complicated hepatolithiasis
staged surgeryProcedure or surgery
staged surgery in complicated hepatolithiasis
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous surgery | Experimental | to perform surgery both on biliary stone and portal hypertension Receives: Procedure: Simultaneous surgery |
| Staged surgery | Active comparator | to perform surgery on biliary stone and portal hypertension by staged surgery Receives: Procedure: staged surgery |
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
- 92 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, Eastern Hepatobiliary Surgery Hospital, First Affiliated Hospital of Zhongshan Medical University, Air Force Military Medical University, China, Huaxi Hospital, Tongji Hospital, Union hospital of Fujian Medical University
- Responsible party
- Principal investigator, feng xiaobin, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098264
- Sponsor's protocol ID
- SWHB018
- 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
- A Cohort Study on Safety and Efficacy of Simultaneous or Staged Surgery in Complicated Hepatolithiasis
- ClinicalTrials.gov ID
- NCT03098264
- Acronym / sponsor ID
- SWHB018
- Conditions
- Hepatolithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Chinese PLA General Hospital, Eastern Hepatobiliary Surgery Hospital, First Affiliated Hospital of Zhongshan Medical University, Air Force Military Medical University, China, Huaxi Hospital, Tongji Hospital, Union hospital of Fujian Medical University
- 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.
For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed.
Detailed description
For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed. In this protocol, we will assign the eligible cases into two group. And then perform surgery as simultaneously or separately.By long-term follow-up,to examine the safety and advantages of each procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous surgery | Experimental | Procedure: Simultaneous surgeryto perform surgery both on biliary stone and portal hypertension |
| Staged surgery | Active comparator | Procedure: staged surgeryto perform surgery on biliary stone and portal hypertension by staged surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 portal hypertension
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 |
|---|---|---|
| Simultaneous surgerySimultaneous surgery in complicated hepatolithiasis | Procedure or surgery | Simultaneous surgery |
| staged surgerystaged surgery in complicated hepatolithiasis | Procedure or surgery | Staged surgery |
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 Simultaneous surgery and staged surgery in people with Hepatolithiasis, 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 6 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.