Predicting Complications of Hepatolithiasis After Hepatectomy

NCT ID: NCT05556434

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-01

Study Completion Date

2024-07-01

Brief Summary

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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

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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

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Liver Diseases Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

radiological evaluation

Intervention Type DIAGNOSTIC_TEST

All patients undergoing hepatectomy receive imaging evaluation and laboratory test before and after surgery to define clinical parameters.

diseases

patients without postoperative complications

Patients who didn't experience postoperative complications were divided into the second group.

radiological evaluation

Intervention Type DIAGNOSTIC_TEST

All patients undergoing hepatectomy receive imaging evaluation and laboratory test before and after surgery to define clinical parameters.

diseases

Interventions

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radiological evaluation

All patients undergoing hepatectomy receive imaging evaluation and laboratory test before and after surgery to define clinical parameters.

diseases

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Gang Chen, MD

Clinical Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gang Chen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Wenzhou Medical University

Locations

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Gang Chen

Wenzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 20032719 (View on PubMed)

Su 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.

Reference Type BACKGROUND
PMID: 9240138 (View on PubMed)

Tabrizian 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.

Reference Type BACKGROUND
PMID: 22921329 (View on PubMed)

Citterio 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.

Reference Type BACKGROUND
PMID: 27248425 (View on PubMed)

Jarnagin 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.

Reference Type BACKGROUND
PMID: 12368667 (View on PubMed)

Other Identifiers

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prognosis of hepatolithiasis

Identifier Type: -

Identifier Source: org_study_id

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