Pringle maneuver and later gallbladder problems after liver resection
Impact of Pringle Maneuver on the Occurrence of Postoperative Gallbladder Diseases After Hepatectomy: A Multicenter Retrospective Cohort Study
This retrospective review will test whether temporarily clamping blood flow to the liver during hepatectomy raises the chance of gallstones or gallbladder inflammation in people whose gallbladder was preserved.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 8 sites (Hefei, Anhui and 7 other locations) |
| Trial ID | NCT07452848 on ClinicalTrials.gov |
What this trial studies
This multicenter retrospective cohort study will extract clinical records from patients who underwent elective hepatectomy with gallbladder preservation between January 2012 and January 2022. Patients meeting inclusion criteria (age 18–85, Child-Pugh A/B, ASA I–III) and without preexisting biliary disease will be grouped by whether the Pringle maneuver (hepatic inflow occlusion) was used. Investigators will compare the subsequent incidence of postoperative gallbladder diseases such as cholelithiasis and chronic cholecystitis between groups, adjusting for relevant clinical and operative covariates. The analysis aims to clarify whether ischemic insult from the maneuver is associated with increased gallbladder morbidity.
Who should consider this trial
Good fit: Ideal candidates for inclusion are adults aged 18–85 who had elective hepatectomy with the gallbladder preserved, had Child-Pugh A or B liver function, ASA I–III status, and no preexisting biliary tract disease.
Not a fit: People with preexisting biliary disease, prior upper abdominal surgery, use of alternative inflow occlusion techniques, or missing follow-up data would not benefit from the study's conclusions for their own past care and are excluded from analysis.
Why it matters
Potential benefit: If a clear link is found, surgeons could change intraoperative decisions or consider prophylactic gallbladder removal to lower patients' future risk of gallbladder disease.
How similar studies have performed: Robust evidence is limited and prior reports are inconsistent, so this large multicenter retrospective approach addresses a relatively underexamined clinical question rather than following an established successful model.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hefei, Anhui and 7 other locations
- 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)
Study contacts
- Study coordinator: Jiwei Huang
- Email: huangjiwei@wchscu.cn
- Phone: +86 18980606725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.