Impact of Pringle Maneuver on the Occurrence of Postoperative Gallbladder Diseases After Hepatectomy: A Multicenter Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 8
- 主要终点
- Cumulative Incidence of Postoperative Gallbladder Diseases
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pringle Maneuver Group
Patients who underwent elective hepatectomy with gallbladder preservation and received Pringle maneuver during the surgery.
干预措施: Pringle maneuver (Procedure)
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.
结局指标
主要结局
Cumulative Incidence of Postoperative Gallbladder Diseases
时间窗: 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.
次要结局
- Risk Factors Associated with Postoperative Gallbladder Diseases(Up to 14 years (From the date of surgery to the follow-up cutoff date in January 2026))
研究者
Jiwei Huang
Professor
West China Hospital