HepatolithiasisNCT03958825
Open Versus Laparoscopic Left Hepatic Sectionectomy
A study testing laparoscopic hepatic sectionectomy and open left hepatic sectionectomy in people with Hepatolithiasis and Laparoscopic Liver Resection, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial summary
Laparoscopic left sectionectomy has been associated with shorter hospital stay and reduced overall morbidity compared with open left sectionectomy. Strong evidence has not, however, been provided. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatolithiasis, Laparoscopic Liver Resection, Open Liver Resection
- What is being tested?
- laparoscopic hepatic sectionectomy and open left hepatic sectionectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2019to 1 Jun 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suitable for undergoing both laparoscopic left sectionectomy as well as open left sectionectomy of the liver
- Able to understand the nature of the study and what will be required of them
- Men and non-pregnant,non-lactating women between age 18-80
- BMI between 18-35
- Patients with ASA I-II-III
Who cannot join
- Inability to give written informed consent
- Patients undergoing liver resection other than left lateral hepatic sectionectomy
- Patients with ASA IV-V Underlying liver disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second hospital of Anhui Medical University,
Hefei, Anhui, 230061
shubo pan, +8615856943673 ext. +8615856943673, aydpanshubo@126.com
hui hou, +8615856943673 ext. +8615856943673, aydpanshubo@126.com
About this study
Official title: Randomized Clinical Trial of Open Versus Laparoscopic Left Hepatic Sectionectomy in Treatment of Hepatolithiasis Within an Enhanced Recovery After Surgery Programme
Laparoscopic left sectionectomy has been associated with shorter hospital stay and reduced overall morbidity compared with open left sectionectomy. Strong evidence has not, however, been provided.
Read the detailed description
The application of laparoscopic technology to liver surgery has been developing rapidly, yet very few studies have been conducted to compare the outcomes between open and laparoscopic liver resections. So little is known about their advantages and disadvantages. The aim of this prospective randomized study is to compare the outcomes between laparoscopic and open liver resection in treatment of hepatolithiasis within the left lobes within an enhanced recovery after surgery programme.
- Being tested
- laparoscopic hepatic sectionectomy, open left hepatic sectionectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic hepatic sectionectomyProcedure or surgery
Also called open left hepatic sectionectomy
patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme
open left hepatic sectionectomyProcedure or surgery
patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme
| Study group | Role | What they receive |
|---|---|---|
| open left hepatic sectionectomy | Active comparator | patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme Receives: Procedure: open left hepatic sectionectomy |
| laparoscopic hepatic sectionectomy | Experimental | patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme Receives: Procedure: laparoscopic hepatic sectionectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital duration after operation (days)
the length of hospital stay
Measured: up to 30 days after liver resection
Secondary outcomes (12)
Readmission percentage
Readmission percentage during one year follow-up
Measured: up to 30 days after liver resection
Total morbidity
According to The Clavien-Dindo Classification, https://www.assessurgery.com/clavien-dindo-classification/
Measured: up to 1 year after liver resection
Composite endpoint of liver surgery specific morbidity
Parameter composed of a combination of procedure-specific complications and considered as a single, dichotomous outcome: operative mortality, intra-abdominal haemorrhage, ascites, bile leakage, intra-abdominal abscess and postresectional liver failure. These components, which are all specific to liver surgery and have substantial clinical relevance, reflect Dindo grade 3-5 complications. A composite score of 1 (=failure) will reflect the occurrence of at least one of the above liver specific complications, consequently a score of 0 (=success) will be assigned if none occur.
Measured: up to 1 year after liver resection
Hospital and societal costs
The economic evaluation will include a cost-utility analysis from a Dutch societal perspective. The incremental costs per Quality Adjusted Life Year (QALY) gained will be based on utility scores from the EQ-5D. All hospital expenses (direct and indirect) related to both interventions will be monitored. In addition, a cost questionnaire offered at the regular follow-up consultation (3, 6 and 12 months) will help us to assess the societal and individual costs outside health care relating to patients' absence, impaired mobility, work or normal daily activities.
Measured: up to 1 year after liver resection
Incidence of incisional hernias
To assess the incidence of incisional hernias in laparoscopic and open left lateral hepatic sectionectomy patients will be contacted at a mean time of 1 year after resection to receive an ultrasound to diagnose incisional hernia.
Measured: up to 1 year after liver resection
Change of serum glutamic oxalacetic transaminase
Change of serum glutamic oxalacetic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.
Measured: up to 7 days after liver resection
Change of serum glutamic-pyruvic transaminase
Change of serum glutamic-pyruvic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.
Measured: up to 7 days after liver resection
Mortality rates
the rate of postoperative death
Measured: up to 30 days after liver resection
Operation time(min)
the during of operation
Measured: intraoperative
Blood loss(ml)
the volume of blood loss
Measured: up to 30 days after liver resection
Blood transfusion (times and units)
intraoperative blood transfusion
Measured: intraoperative
C-reactive protein (mg/mL)
C-reactive protein levels on preoperative and postoperative day-1,3,5
Measured: up to 5 days after liver resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start10 Aug 2019
- Primary completion26 Dec 2022 (estimated)
- Study completion1 Jun 2023 (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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hui hou, The Second Hospital of Anhui Medical University
- Investigators
- hui hou, master, Study chair, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958825
- Sponsor's protocol ID
- 520
- Status last verified
- Sep 2020
- First submitted
- 20 May 2019
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan SB, Wu CL, Zhou DC, Xiong QR, Geng XP, Hou H. Total laparoscopic partial hepatectomy versus open partial hepatectomy for primary left-sided hepatolithiasis: study protocol for a randomized controlled trial. Trials. 2024 Feb 22;25(1):137. doi: 10.1186/s13063-023-07476-w.
PubMed 38383461
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Open Versus Laparoscopic Left Hepatic Sectionectomy in Treatment of Hepatolithiasis Within an Enhanced Recovery After Surgery Programme
- ClinicalTrials.gov ID
- NCT03958825
- Acronym / sponsor ID
- 520
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 26 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 22 May 2019 (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.
Laparoscopic left sectionectomy has been associated with shorter hospital stay and reduced overall morbidity compared with open left sectionectomy. Strong evidence has not, however, been provided.
Detailed description
The application of laparoscopic technology to liver surgery has been developing rapidly, yet very few studies have been conducted to compare the outcomes between open and laparoscopic liver resections. So little is known about their advantages and disadvantages. The aim of this prospective randomized study is to compare the outcomes between laparoscopic and open liver resection in treatment of hepatolithiasis within the left lobes within an enhanced recovery after surgery programme.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open left hepatic sectionectomy | Active comparator | Procedure: open left hepatic sectionectomypatients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme |
| laparoscopic hepatic sectionectomy | Experimental | Procedure: laparoscopic hepatic sectionectomypatients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suitable for undergoing both laparoscopic left sectionectomy as well as open left sectionectomy of the liver
- Able to understand the nature of the study and what will be required of them
- Men and non-pregnant,non-lactating women between age 18-80
- BMI between 18-35
- Patients with ASA I-II-III
Key exclusion criteria (3 listed)
- Inability to give written informed consent
- Patients undergoing liver resection other than left lateral hepatic sectionectomy
- Patients with ASA IV-V Underlying liver 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 |
|---|---|---|
| laparoscopic hepatic sectionectomyAlso: open left hepatic sectionectomypatients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme | Procedure or surgery | laparoscopic hepatic sectionectomy |
| open left hepatic sectionectomypatients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme | Procedure or surgery | open left hepatic sectionectomy |
Primary outcome
Hospital duration after operation (days)
Time frame: up to 30 days after liver resection
the length of hospital stay
12 secondary outcomes
Readmission percentage
Time frame: up to 30 days after liver resection
Total morbidity
Time frame: up to 1 year after liver resection
Composite endpoint of liver surgery specific morbidity
Time frame: up to 1 year after liver resection
Hospital and societal costs
Time frame: up to 1 year after liver resection
Incidence of incisional hernias
Time frame: up to 1 year after liver resection
Change of serum glutamic oxalacetic transaminase
Time frame: up to 7 days after liver resection
Change of serum glutamic-pyruvic transaminase
Time frame: up to 7 days after liver resection
Mortality rates
Time frame: up to 30 days after liver resection
Operation time(min)
Time frame: intraoperative
Blood loss(ml)
Time frame: up to 30 days after liver resection
Blood transfusion (times and units)
Time frame: intraoperative
C-reactive protein (mg/mL)
Time frame: up to 5 days after liver resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Derived from this study: PubMed 38383461Pan SB, Wu CL, Zhou DC, Xiong QR, Geng XP, Hou H. Total laparoscopic partial hepatectomy versus open partial hepatectomy for primary left-sided hepatolithiasis: study protocol for a randomized controlled trial. Trials. 2024 Feb 22;25(1):137. doi: 10.1186/s13063-023-07476-w.
- Individual participant dataSharing planned: No
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.
hui hou, master study chair
The Second Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic hepatic sectionectomy and open left hepatic sectionectomy in people with Hepatolithiasis and Laparoscopic Liver Resection, run by The Second Hospital of Anhui Medical University 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 3 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 18 Sep 2020. 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 hui s hou, master (+8615856943673 ext. +8615856943673, aydpanshubo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital duration after operation (days) (time frame: up to 30 days after liver resection). 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 NCT03958825, 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 18 Sep 2020.