Liver DiseasesNCT05556434
Predicting Complications of Hepatolithiasis After Hepatectomy
An observational study of Liver Diseases and Complication, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Postoperative complications seriously affect the recovery of patients undergoing hepatectomy. Identifying risk factors and develop predictive models of complications for patients with hepatolithiasis undergoing hepatectomy is important for clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Diseases, Complication
- What is being tested?
- radiological evaluation
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2011to 1 Jul 2024
- Phase
- Observational
- 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
Study population: Patients with hepatolithiasis who received liver resection for curative intent
Who may be able to join
- pathologically diagnosed hepatolithiasis
- without malignancies
- receiving liver resection
- Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2
- Child-Pugh score of ≤7
- complete clinical and follow-up information
- age between 18-80 years old
Who cannot join
- with malignancies
- receiving other treatments
- Eastern Cooperative Oncology Group performance status (ECOG-PS) >2
- Child-Pugh score of >7
- incomplete clinical data
- lost to follow up
- age <18 years old or >80 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Machine Learning Algorithms Based on Clinical Data to Predict Postoperative Complications of Patients With Hepatolithiasis Undergoing Hepatectomy
Postoperative complications seriously affect the recovery of patients undergoing hepatectomy. Identifying risk factors and develop predictive models of complications for patients with hepatolithiasis undergoing hepatectomy is important for clinical practice.
Read the detailed description
Along with the change of lifestyle and dietary habits, many people are diagnosed with hepatolithiasis that is especially prevalent in Asia. Liver resection remains the favorable curative therapy for hepatolithiasis with a relatively low recurrence rate. Although there have been great improvements in surgical techniques and perioperative management, postoperative complications remain commonplace and seriously threat the recovery of patients undergoing hepatectomy. Therefore, it is important to identify risk factors of complications to improve the overall prognosis of patients. We want to collect the clinical information of patients with hepatolithiasis undergoing hepatectomy, including demographic data , laboratory index, histological features and postoperative complications. Patients are followed up at a interval of 3 month after treatment, and the survival data and recurrence rate are recorded. Then the relationship between clinical data and short-term outcomes after surgery are explored. Then models based on clinical features are developed to predict short-term outcomes after hepatectomy.
- Conditions
- Liver Diseases, Complication
- Being tested
- radiological evaluation
- Keywords
- liver resection, complication, risk factor, machine learning, hepatolithiasis
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiological evaluationDiagnostic test
All patients undergoing hepatectomy receive imaging evaluation and laboratory test before and after surgery to define clinical parameters.
diseases
| Study group | Role | What they receive |
|---|---|---|
| patients with postoperative complications | Patients who experienced postoperative complications were divided into the first group. The complications were defined according to the Clavien-Dindo classification system. Receives: Diagnostic Test: radiological evaluation | |
| patients without postoperative complications | Patients who didn't experience postoperative complications were divided into the second group. Receives: Diagnostic Test: radiological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Postoperative complications and mortality are recorded according to the Clavien-Dindo classification system
Measured: 3 months
Secondary outcomes (1)
Recurrence of hepatolithiasis
Patients were followed-up at an interval of 3 months and recurrence of hepatolithiasis is evaluated by radiological methods.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Jul 2011
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Qilu Hospital of Shandong University
- Responsible party
- Principal investigator, Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University
- Investigators
- Gang Chen, MD,PhD, Principal investigator, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556434
- Sponsor's protocol ID
- prognosis of hepatolithiasis
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang T, Lau WY, Lai EC, Yang LQ, Zhang J, Yang GS, Lu JH, Wu MC. Hepatectomy for bilateral primary hepatolithiasis: a cohort study. Ann Surg. 2010 Jan;251(1):84-90. doi: 10.1097/SLA.0b013e3181b2f374.
PubMed 20032719Su CH, Shyr YM, Lui WY, P'Eng FK. Hepatolithiasis associated with cholangiocarcinoma. Br J Surg. 1997 Jul;84(7):969-73. doi: 10.1002/bjs.1800840717.
PubMed 9240138Tabrizian P, Jibara G, Shrager B, Schwartz ME, Roayaie S. Hepatic resection for primary hepatolithiasis: a single-center Western experience. J Am Coll Surg. 2012 Nov;215(5):622-6. doi: 10.1016/j.jamcollsurg.2012.07.005. Epub 2012 Aug 24.
PubMed 22921329Citterio D, Facciorusso A, Sposito C, Rota R, Bhoori S, Mazzaferro V. Hierarchic Interaction of Factors Associated With Liver Decompensation After Resection for Hepatocellular Carcinoma. JAMA Surg. 2016 Sep 1;151(9):846-53. doi: 10.1001/jamasurg.2016.1121.
PubMed 27248425Jarnagin WR, Gonen M, Fong Y, DeMatteo RP, Ben-Porat L, Little S, Corvera C, Weber S, Blumgart LH. Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade. Ann Surg. 2002 Oct;236(4):397-406; discussion 406-7. doi: 10.1097/01.SLA.0000029003.66466.B3.
PubMed 12368667
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning Algorithms Based on Clinical Data to Predict Postoperative Complications of Patients With Hepatolithiasis Undergoing Hepatectomy
- ClinicalTrials.gov ID
- NCT05556434
- Acronym / sponsor ID
- prognosis of hepatolithiasis
- Conditions
- Liver Diseases, Complication
- Keywords
- liver resection, complication, risk factor, machine learning, hepatolithiasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Qilu Hospital of Shandong University
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 27 Sep 2022 (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.
Postoperative complications seriously affect the recovery of patients undergoing hepatectomy. Identifying risk factors and develop predictive models of complications for patients with hepatolithiasis undergoing hepatectomy is important for clinical practice.
Detailed description
Along with the change of lifestyle and dietary habits, many people are diagnosed with hepatolithiasis that is especially prevalent in Asia. Liver resection remains the favorable curative therapy for hepatolithiasis with a relatively low recurrence rate. Although there have been great improvements in surgical techniques and perioperative management, postoperative complications remain commonplace and seriously threat the recovery of patients undergoing hepatectomy. Therefore, it is important to identify risk factors of complications to improve the overall prognosis of patients. We want to collect the clinical information of patients with hepatolithiasis undergoing hepatectomy, including demographic data , laboratory index, histological features and postoperative complications. Patients are followed up at a interval of 3 month after treatment, and the survival data and recurrence rate are recorded. Then the relationship between clinical data and short-term outcomes after surgery are explored. Then models based on clinical features are developed to predict short-term outcomes after hepatectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with postoperative complications | – | Diagnostic Test: radiological evaluationPatients who experienced postoperative complications were divided into the first group. The complications were defined according to the Clavien-Dindo classification system. |
| patients without postoperative complications | – | Diagnostic Test: radiological evaluationPatients who didn't experience postoperative complications were divided into the second group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatolithiasis who received liver resection for curative intent
Key inclusion criteria (7 listed)
- pathologically diagnosed hepatolithiasis
- without malignancies
- receiving liver resection
- Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2
- Child-Pugh score of ≤7
Key exclusion criteria (7 listed)
- with malignancies
- receiving other treatments
- Eastern Cooperative Oncology Group performance status (ECOG-PS) >2
- Child-Pugh score of >7
- incomplete clinical data
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 |
|---|---|---|
| radiological evaluationAll patients undergoing hepatectomy receive imaging evaluation and laboratory test before and after surgery to define clinical parameters. diseases | Diagnostic test | patients with postoperative complications, patients without postoperative complications |
Primary outcome
Complications
Time frame: 3 months
Postoperative complications and mortality are recorded according to the Clavien-Dindo classification system
1 secondary outcome
Recurrence of hepatolithiasis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 20032719Yang T, Lau WY, Lai EC, Yang LQ, Zhang J, Yang GS, Lu JH, Wu MC. Hepatectomy for bilateral primary hepatolithiasis: a cohort study. Ann Surg. 2010 Jan;251(1):84-90. doi: 10.1097/SLA.0b013e3181b2f374.
- Background: PubMed 9240138Su CH, Shyr YM, Lui WY, P'Eng FK. Hepatolithiasis associated with cholangiocarcinoma. Br J Surg. 1997 Jul;84(7):969-73. doi: 10.1002/bjs.1800840717.
- Background: PubMed 22921329Tabrizian P, Jibara G, Shrager B, Schwartz ME, Roayaie S. Hepatic resection for primary hepatolithiasis: a single-center Western experience. J Am Coll Surg. 2012 Nov;215(5):622-6. doi: 10.1016/j.jamcollsurg.2012.07.005. Epub 2012 Aug 24.
- Background: PubMed 27248425Citterio D, Facciorusso A, Sposito C, Rota R, Bhoori S, Mazzaferro V. Hierarchic Interaction of Factors Associated With Liver Decompensation After Resection for Hepatocellular Carcinoma. JAMA Surg. 2016 Sep 1;151(9):846-53. doi: 10.1001/jamasurg.2016.1121.
- Background: PubMed 12368667Jarnagin WR, Gonen M, Fong Y, DeMatteo RP, Ben-Porat L, Little S, Corvera C, Weber S, Blumgart LH. Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade. Ann Surg. 2002 Oct;236(4):397-406; discussion 406-7. doi: 10.1097/01.SLA.0000029003.66466.B3.
- Individual participant dataSharing planned: No
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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.
Gang Chen, MD,PhD principal investigator
First Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Complication, run by First Affiliated Hospital of Wenzhou 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 7 inclusion and 7 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 Sep 2023. 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?
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?
Complications (time frame: 3 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 NCT05556434, which also lists 5 linked publications.
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 Sep 2023.