Impact of Pringle Maneuver on Postoperative Gallbladder Diseases After Hepatectomy
Impact of Pringle Maneuver on the Occurrence of Postoperative Gallbladder Diseases After Hepatectomy: A Multicenter Retrospective Cohort Study
The liver is an organ with a rich blood supply. During liver surgery (hepatectomy), surgeons often temporarily clamp the blood vessels supplying the liver to maintain a clear surgical field and reduce bleeding. This common technique is known as the Pringle maneuver. However, this maneuver also temporarily cuts off the blood supply to the gallbladder. Currently, doctors debate whether to routinely remove a healthy gallbladder during liver surgery to prevent future gallbladder problems, or to preserve it.
The primary purpose of this multicenter retrospective cohort study is to evaluate whether using the Pringle maneuver during liver surgery increases the risk of patients developing gallbladder diseases (such as gallstones or inflammation) later on. Researchers will review the past medical records of patients who underwent liver surgery with their gallbladder preserved between January 2012 and January 2022. By comparing patients who had the Pringle maneuver with those who did not, the study aims to provide reliable clinical evidence to help surgeons make better decisions about whether to preserve or remove the gallbladder during liver surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hepatectomy is a primary curative treatment for various liver solid lesions. Given the liver's extensive vascular network, effective inflow occlusion is crucial during hepatectomy to minimize intraoperative blood loss and shorten operative time. The Pringle maneuver, which involves the temporary clamping of the hepatic artery and portal vein, is the most frequently utilized technique for this purpose. Despite its effectiveness in controlling hemorrhage, the Pringle maneuver inevitably induces ischemic-reperfusion injury to the hepatobiliary system and interrupts the blood supply to the gallbladder. This interruption may theoretically contribute to a higher risk of postoperative gallbladder diseases, including cholelithiasis and chronic cholecystitis.
In current clinical practice, the management of a disease-free gallbladder during hepatectomy remains controversial. Some surgeons advocate for simultaneous prophylactic cholecystectomy to prevent future gallbladder-related complications, whereas others prefer gallbladder preservation when no overt pathological changes are present. To date, robust evidence regarding the definitive impact of the Pringle maneuver on the incidence of postoperative gallbladder diseases is lacking.
This multicenter retrospective cohort study is designed to bridge this evidence gap. Clinical data will be retrospectively extracted for patients who underwent elective hepatectomy with gallbladder preservation across multiple major clinical centers in China from January 2012 to January 2022. The study will comprehensively evaluate and analyze baseline demographic profiles, preoperative laboratory indicators, tumor characteristics, intraoperative parameters (specifically the application and duration of the Pringle maneuver), and postoperative outcomes. The primary focus is to assess the occurrence of postoperative gallbladder diseases and identify potential risk factors associated with this complication. The findings are expected to provide high-quality, real-world evidence to guide surgical decision-making regarding gallbladder management during hepatectomy.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jiwei Huang
- Phone Number: +86 18980606725
- Email: huangjiwei@wchscu.cn
Study Contact Backup
- Name: Jun Ji
- Phone Number: +86 18752433889
- Email: jijun0317@163.com
Study Locations
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Anhui
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Hefei, Anhui, China
- Recruiting
- The First Affiliated Hospital of University of Science and Technology of China
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Contact:
- Dalong Yin
- Phone Number: +86 18110984879
- Email: huangjiwei@wchscu.cn
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China
- Recruiting
- Xinqiao Hospital of Army Medical Universit
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Contact:
- Lu Zheng
- Phone Number: +86 15736202516
- Email: huangjiwei@wchscu.cn
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Guangdong
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Guangzhou, Guangdong, China
- Recruiting
- Sun Yat-sen University Cancer Center
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Contact:
- Dandan Hu
- Phone Number: +86 13417108300
- Email: huangjiwei@wchscu.cn
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Guangzhou, Guangdong, China
- Recruiting
- ZhuJiang Hospital of Southern Medical University
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Contact:
- Jian Yang
- Phone Number: +86 18349178834
- Email: huangjiwei@wchscu.cn
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Heilongjiang
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Harbin, Heilongjiang, China
- Recruiting
- The First Affiliated Hospital of Harbin Medical University
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Contact:
- Yong Ma
- Phone Number: +86 13199452330
- Email: huangjiwei@wchscu.cn
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Hubei
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Wuhan, Hubei, China
- Recruiting
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Contact:
- Peng Zhu
- Phone Number: +86 18875435288
- Email: huangjiwei@wchscu.cn
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Jiangsu
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Nanjing, Jiangsu, China
- Recruiting
- Nanjing Drum Tower Hospital
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Contact:
- Decai Yu
- Phone Number: +86 18036198729
- Email: huangjiwei@wchscu.cn
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China
- Recruiting
- Tianjin Medical University Cancer Institute and Hospital
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Contact:
- Tianqiang Song
- Phone Number: +86 18622221077
- Email: huangjiwei@wchscu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18 to 85 years.
- Definitive diagnosis of hepatic solid lesions confirmed by imaging (such as CT, MRI, or ultrasound) and/or pathology.
- Underwent elective hepatectomy with gallbladder preservation.
- Preoperative liver function evaluated as Child-Pugh class A or B.
- Preoperative American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.
Exclusion Criteria:
- Preoperative evaluation indicating pre-existing biliary tract diseases (e.g., cholelithiasis, biliary inflammation, neoplastic lesions).
- History of previous upper abdominal surgery.
- Application of non-hepatic inflow occlusion methods during surgery (e.g., hemihepatic vascular occlusion, selective segmental vascular occlusion).
- Personal history of long-term use of hormone replacement therapy, somatostatin and its analogues, or oral contraceptives.
- Loss to follow-up or missing critical data postoperatively.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pringle Maneuver Group
Patients who underwent elective hepatectomy with gallbladder preservation and received Pringle maneuver during the surgery.
|
A surgical technique utilized during hepatectomy that involves the temporary clamping of the hepatic hilum to control and reduce intraoperative blood loss.
Other Names:
|
|
Non-Pringle Maneuver Group
Patients who underwent elective hepatectomy with gallbladder preservation but did not receive Pringle maneuver or any other specific vascular occlusion during the surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative Incidence of Postoperative Gallbladder Diseases
Time Frame: Up to 14 years (From the date of surgery to the follow-up cutoff date in January 2026)
|
The cumulative incidence of gallbladder diseases after hepatectomy.
Gallbladder diseases are defined as any of the following conditions confirmed by postoperative imaging or pathology: gallstones with or without cholecystitis (ICD-10: K80.0-K80.2);
acute or chronic cholecystitis (ICD-10: K81.0-K81.9);
other gallbladder diseases such as polyps, cholesterolosis, or adenomyomatosis (ICD-10: K82.0-K82.9);
and gallbladder malignancy (ICD-10: C23).
The cumulative incidence rate will be estimated using the Cumulative Incidence Function (CIF) to appropriately account for competing risks.
|
Up to 14 years (From the date of surgery to the follow-up cutoff date in January 2026)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk Factors Associated with Postoperative Gallbladder Diseases
Time Frame: Up to 14 years (From the date of surgery to the follow-up cutoff date in January 2026)
|
Identification of independent risk factors (including patient baseline demographics, tumor characteristics, and surgical parameters such as the application of the Pringle maneuver) associated with the development of postoperative gallbladder diseases.
To appropriately account for competing events (e.g., death prior to the onset of gallbladder disease), multivariable competing risk regression analysis, specifically the Fine-Gray subdistribution hazard model, will be utilized.
|
Up to 14 years (From the date of surgery to the follow-up cutoff date in January 2026)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JHuang20236
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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