Does removing more normal liver tissue raise the risk of liver failure after liver resection?
A Model Based on Resected Normal Liver Parenchymal Volume（RNLV）to Predict the Risk of Post-Hepatectomy Liver Failure (PHLF)
This study tests whether the amount of normal liver removed (RNLV) helps predict liver failure after surgery in people with hepatocellular carcinoma or intrahepatic cholangiocarcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Sex | All |
| Sponsor | National Natural Science Foundation of China Government |
| Locations | 3 sites (Fujian, Shanghai Municipality and 2 other locations) |
| Trial ID | NCT06366048 on ClinicalTrials.gov |
What this trial studies
Investigators performed a large retrospective review of over a thousand consecutive patients with hepatocellular carcinoma or intrahepatic cholangiocarcinoma who underwent selective hepatectomy at multiple Chinese centers. They calculated resected normal liver parenchymal volume (RNLV) from imaging and operative data and recorded post-hepatectomy liver failure (PHLF) according to 50-50 and ISGLS criteria. The team planned to build a predictive model combining RNLV with clinical variables and compare its performance to future liver remnant (FLR) metrics, with special attention to patients with large or multiple tumors. The goal was to see whether RNLV can be an informative variable for preoperative risk stratification and surgical safety planning.
Who should consider this trial
Good fit: Adults with histologically confirmed hepatocellular carcinoma or intrahepatic cholangiocarcinoma who underwent selective hepatectomy and have complete, accessible preoperative and operative data.
Not a fit: Patients with prior ALPPS, portal vein embolization, tumor rupture, emergency surgery, concurrent major organ resections, or diagnoses other than HCC/ICC were excluded and are unlikely to benefit from this specific model.
Why it matters
Potential benefit: If successful, the model could help surgeons better predict and reduce the risk of post-hepatectomy liver failure and guide safer surgical planning.
How similar studies have performed: Other research supports the use of future liver remnant to predict PHLF, but using resected normal parenchymal volume (RNLV) as a predictive variable is relatively novel and less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * selective hepatectomies; * histologically confirmed as HCC and ICC * complete and accessible data Exclusion criteria: * any history of Associated Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS) * any history of portal vein embolism (PVE) * any history of tumor rupture * emergency surgery * pathologically diagnosed with neither HCC nor ICC * concomitant resection of gastrointestinal organs, spleenectomy or other organs
Where this trial is running
Fujian, Shanghai Municipality and 2 other locations
- Mengchao Hepatobiliary Hospital of Fujian Medical University — Fujian, Shanghai Municipality, China (Recruiting)
- The Third Affiliated Hospital of Naval Medical University — Shanhai, Shanghai Municipality, China (Recruiting)
- Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen, Mengchao Hepatobiliary Hospital of Fujian Medical University — Shenzhencun, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yuan-yuan Wang
- Email: wangyuanyuan702@foxmail.com
- Phone: +8615800332525
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.