Impact of Pringle Maneuver on Postoperative Gallbladder Diseases After Hepatectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population consists of consecutive patients who underwent elective hepatectomy for hepatic solid lesions with their gallbladder preserved at multiple participating clinical centers in China between January 2012 and January 2022.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Pringle maneuver
Procedure/SurgeryA surgical technique utilized during hepatectomy that involves the temporary clamping of the hepatic hilum to control and reduce intraoperative blood loss.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Pringle Maneuver Group1 intervention
Group B: Non-Pringle Maneuver Group0 interventions
Trial outcomes
Primary outcomes
1
Cumulative Incidence of Postoperative Gallbladder Diseases
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.
Time frame
Up to 14 years (From the date of surgery to the follow-up cutoff date in January 2026)Secondary outcomes
1
Risk Factors Associated with Postoperative Gallbladder Diseases
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.
Time frame
Up to 14 years (From the date of surgery to the follow-up cutoff date in January 2026)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
West China Hospital
Lead sponsor
First Affiliated Hospital of Harbin Medical University
Collaborator
Southern Medical University, China
Collaborator
Tongji Hospital
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
The First Affiliated Hospital of University of Science and Technology of China
Collaborator
Army Medical University, China
Collaborator
Source ClinicalTrials.gov