Gallbladder DiseasesNCT07452848
Impact of Pringle Maneuver on Postoperative Gallbladder Diseases After Hepatectomy
An observational study of Gallbladder Diseases and Cholelithiasis, run by West China Hospital at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gallbladder Diseases, Cholelithiasis
- What is being tested?
- Pringle maneuver
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 8 sitesChina
- Study dates
- 1 Mar 2026to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Xinqiao Hospital of Army Medical Universit
Chongqing, Chongqing Municipality
Lu Zheng, +86 15736202516, huangjiwei@wchscu.cn
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Dandan Hu, +86 13417108300, huangjiwei@wchscu.cn
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Jian Yang, +86 18349178834, huangjiwei@wchscu.cn
- Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Yong Ma, +86 13199452330, huangjiwei@wchscu.cn
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Dalong Yin, +86 18110984879, huangjiwei@wchscu.cn
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Decai Yu, +86 18036198729, huangjiwei@wchscu.cn
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Tianqiang Song, +86 18622221077, huangjiwei@wchscu.cn
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Peng Zhu, +86 18875435288, huangjiwei@wchscu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Gallbladder Diseases, Cholelithiasis
- Being tested
- Pringle maneuver
- Keywords
- Pringle maneuver, Hepatectomy, Hepatic inflow occlusion
- Medical subject headings
- Gallbladder Diseases, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pringle maneuverProcedure or surgery
Also called Hepatic inflow occlusion
A surgical technique utilized during hepatectomy that involves the temporary clamping of the hepatic hilum to control and reduce intraoperative blood loss.
| Study group | Role | What they receive |
|---|---|---|
| Pringle Maneuver Group | Patients who underwent elective hepatectomy with gallbladder preservation and received Pringle maneuver during the surgery. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 14 years (From the date of surgery to the follow-up cutoff date in January 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder DiseasesStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University, Southern Medical University, China, Tongji Hospital, Sun Yat-Sen University Cancer Center, Tianjin Medical University Cancer Institute and Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of University of Science and Technology of China, Army Medical University, China
- Responsible party
- Principal investigator, Jiwei Huang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452848
- Sponsor's protocol ID
- JHuang20236
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) has not yet been made. Because this is a multicenter study involving patient records from various institutions, data sharing requires consensus, formal data-sharing agreements, and institutional ethical approvals from all participating centers. A final decision will be made prior to the publication of the study results.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pringle Maneuver on the Occurrence of Postoperative Gallbladder Diseases After Hepatectomy: A Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07452848
- Acronym / sponsor ID
- JHuang20236
- Conditions
- Gallbladder Diseases, Cholelithiasis
- Keywords
- Pringle maneuver, Hepatectomy, Hepatic inflow occlusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University, Southern Medical University, China, Tongji Hospital, Sun Yat-Sen University Cancer Center, Tianjin Medical University Cancer Institute and Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of University of Science and Technology of China, Army Medical University, China
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pringle Maneuver Group | – | Procedure: Pringle maneuverPatients who underwent elective hepatectomy with gallbladder preservation and received Pringle maneuver during the surgery. |
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pringle maneuverAlso: Hepatic inflow occlusionA surgical technique utilized during hepatectomy that involves the temporary clamping of the hepatic hilum to control and reduce intraoperative blood loss. | Procedure or surgery | Pringle Maneuver Group |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) has not yet been made. Because this is a multicenter study involving patient records from various institutions, data sharing requires consensus, formal data-sharing agreements, and institutional ethical approvals from all participating centers. A final decision will be made prior to the publication of the study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallbladder Diseases and Cholelithiasis, run by West China Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiwei Huang (+86 18980606725, huangjiwei@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.