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Clinical Trials in China / NCT07452848
Recruiting Observational

Impact of Pringle Maneuver on Postoperative Gallbladder Diseases After Hepatectomy

NCT07452848 · tracked via the Priya Life Science China tracker
Sponsor
West China Hospital
Phase
Observational
Started
2026-03-01
Last updated
2026-03-05

Condition(s) studied

Gallbladder DiseasesCholelithiasis

Investigational drug(s) / intervention(s)

Pringle maneuver

Pringle maneuver: A surgical technique utilized during hepatectomy that involves the temporary clamping of the hepatic hilum to control and reduce intraoperative blood loss.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Cumulative Incidence of Postoperative Gallbladder Diseases — 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.

Trial sites (8)

FacilityCityRegionStatus
The First Affiliated Hospital of University of Science and Technology of China Hefei Anhui Recruiting
Xinqiao Hospital of Army Medical Universit Chongqing Chongqing Municipality Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong Recruiting
The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Recruiting
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality Recruiting

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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy Active, not recruiting
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Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation Starting soon
Endoscopic vs Non-endoscopic Drainage for Benign Gallbladder Diseases in High-risk Patients or Patients Desiring Gallbladder Preservation Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07452848 on ClinicalTrials.gov ↗ ← All trials in China