Using polyene phosphatidylcholine to protect the liver after hepatectomy

Polyene Phosphatidylcholine Injection for the Treatment of Perioperative Liver Injury With Laparoscopic Hepatectomy in Hepatocellular Carcinoma: a Multicenter Randomized Controlled Study

This test checks whether giving polyene phosphatidylcholine before surgery plus magnesium isoglycyrrhizinate after surgery better prevents liver injury in people having laparoscopic liver resection for hepatocellular carcinoma.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (other gov)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT07150624 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, randomized, controlled Phase 4 trial compares a combination protocol of polyene phosphatidylcholine given the day before surgery and continued after surgery together with postoperative magnesium isoglycyrrhizinate, versus a regimen with no preoperative liver protection and postoperative magnesium isoglycyrrhizinate alone. Patients scheduled for laparoscopic anatomical hepatectomy for hepatocellular carcinoma are stratified by extent of resection (major versus minor hepatectomy) and undergo Pringle maneuver with specified clamping intervals. The study measures postoperative liver function injury and safety outcomes to determine whether the combination approach reduces liver damage after surgery. Sites are hospitals in Anhui province, and standard perioperative care is otherwise maintained across groups.

Who should consider this trial

Good fit: Adults aged 18–80 with hepatocellular carcinoma who are candidates for laparoscopic anatomical hepatectomy, have Child-Pugh A or B (≤7), BMI 18.5–28 kg/m², and meet preoperative ICG and residual liver volume requirements are ideal candidates.

Not a fit: Patients with more severe liver dysfunction (Child-Pugh C), ICG R15 ≥10%, those not undergoing the specified laparoscopic procedures, or who fall outside the age or BMI ranges are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the regimen could reduce postoperative liver function injury and speed biochemical recovery after laparoscopic hepatectomy for HCC.

How similar studies have performed: Other studies of liver-protective agents have shown some benefits for postoperative liver function, but the specific preoperative plus postoperative combination tested here has been less extensively studied.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed as HCC through imaging and laboratory tests, and capable of undergoing laparoscopic anatomical resection.
2. Surgical scope (defined by randomization stratification):Stratum 1: Major hepatectomy, involving the resection of at least 3 Couinaud liver segments, including right hemihepatectomy and extended right hemihepatectomy, etc.Stratum 2: Minor hepatectomy, involving the resection of no more than 2 Couinaud liver segments. This includes right posterior sectorectomy, right anterior sectorectomy, left lateral sectionectomy, single segmentectomy, etc.
3. During the operation, the Pringle method is used to block the first hepatic portal. Each block lasts ≤ 15 minutes, and the blocking procedure is performed 2 to 4 times.
4. Age: 18 - 80 years old. Gender: Open to both male and female. Body Mass Index (BMI): 18.5 - 28 kg/m².
5. Child-Pugh grade A or B, with a score of ≤ 7; ASA grades I to III.
6. Preoperative ICG R15 \< 10%, and the residual liver volume/standard liver volume \> 40%.
7. A single HCC (hepatocellular carcinoma), with a tumor diameter of less than 10 cm, without distant metastasis or invasion of the portal vein system.
8. Preoperative ALT \< 2x ULN (upper limit of normal).
9. No history of portal vein embolization prior to enrollment. If TACE treatment was previously received, it must have been completed \> 6 months ago; if systemic anti-tumor drug therapy was previously received, it must have been completed \> 4 weeks ago.
10. No liver-damaging treatment drugs were used within two weeks prior to enrollment.

Exclusion Criteria:

1. Reserve liver vascular damage, including: reconstruction after severance, ligation, embolization, thrombosis, etc
2. Combined with abnormal coagulation function (prothrombin time prolonged by more than 3 seconds)
3. Combining obstructive jaundice, severe heart disease, severe kidney disease and other serious illnesses
4. During the operation, microwave treatment or a combination of microwave treatment was adopted
5. More than 4 times of blocking at the first hepatic hilum, or a single blocking duration longer than 15 minutes
6. Non-anatomic liver resection, where the remaining liver contains large areas of ischemic/edematous regions
7. More than 1000ml of blood transfusion during the operation
8. During the operation, an extra-hepatic disease was discovered. Other organs except the gallbladder needed to be removed simultaneously
9. During the operation, other intrahepatic lesions were discovered, which required combination with other surgeries, such as ablation or choledochojejunostomy
10. Diseases that have previously received systemic treatment with glucocorticoids, such as chronic kidney disease, inflammatory diseases, or other immune system-related disorders
11. Psychosis, severe neurosis, those who cannot cooperate with this experiment
12. Participated in other clinical trials within the previous 3 months before enrollment
13. Allergy or intolerance to benzoic acid, or to the study drug
14. Pregnant and lactating women
15. The researchers believe that any participants who have any other factors that would make them unsuitable for this trial should not be included

Where this trial is running

Hefei, Anhui

• Anhui Provincial Hospital — Hefei, Anhui, China (RECRUITING)

Study contacts

• Study coordinator: Lianxin Liu

Conditions: Hepatocellular Carcinoma, Liver Diseases