Impact of Pringle Maneuver on Postoperative Gallbladder Diseases After Hepatectomy

NCT07452848 | Recruiting

• 1 other identifier: JHuang20236
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Gallbladder Diseases; Cholelithiasis

Keywords

Pringle maneuver; Hepatectomy; Hepatic inflow occlusion

Outcome Measures

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.

  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

  Up to 14 years (From the date of surgery to the follow-up cutoff date in January 2026)

Study Arms (2)

Pringle Maneuver Group

Patients who underwent elective hepatectomy with gallbladder preservation and received Pringle maneuver during the surgery.

Procedure: Pringle maneuver

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.

Interventions

Pringle maneuver PROCEDURE

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

Also known as: Hepatic inflow occlusion

Pringle Maneuver Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 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
• West China Hospital: lead
• First Affiliated Hospital of Harbin Medical University: collaborator
• Southern Medical University, China: collaborator
• Tongji Hospital: collaborator

Study Sites (8)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

RECRUITING

Xinqiao Hospital of Army Medical Universit

Chongqing, Chongqing Municipality, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Gallbladder Diseases; Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Jiwei Huang

CONTACT

+86 18980606725; huangjiwei@wchscu.cn

Jun Ji

CONTACT

+86 18752433889; jijun0317@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CN (8)