NCT07150624RecruitingPhase 4
The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine
Polyene Phosphatidylcholine Injection for the Treatment of Perioperative Liver Injury With Laparoscopic Hepatectomy in Hepatocellular Carcinoma: a Multicenter Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
A multicenter, open-label, randomized, controlled study. It is proposed to evaluate the treatment plan of receiving 930mg polyene phosphatidylcholine injection one day before the operation, twice a day, and 930mg polyene phosphatidylcholine injection twice a day,combined with 100mg of magnesium isoglycyrrhizinate injection once a day,from the 1st to the 5th day after the operation. Compared with the monotherapy regimen of no liver protection treatment before the operation and receiving magnesium isoglycyrrhizinate injection 100mg once a day from the 1st to the 5th day after the operation.The efficacy and safety of treating postoperative liver function injury in patients undergoing laparoscopic hepatectomy for hepatocellular carcinoma were compared.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 21 Aug 2025
- Start date
- 10 Nov 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Anhui Provincial Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07150624
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 96
- From 10 Nov 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Non-anatomic liver resection, where the remaining liver contains large areas of ischemic/edematous regions
- Diseases that have previously received systemic treatment with glucocorticoids, such as chronic kidney disease, inflammatory diseases, or other immune system-related disorders
- Participated in other clinical trials within the previous 3 months before enrollment
Other illness
- Reserve liver vascular damage, including: reconstruction after severance, ligation, embolization, thrombosis, etc
- Combining obstructive jaundice, severe heart disease, severe kidney disease and other serious illnesses
- During the operation, an extra-hepatic disease was discovered. Other organs except the gallbladder needed to be removed simultaneously
- Allergy or intolerance to benzoic acid, or to the study drug
Other
- Combined with abnormal coagulation function (prothrombin time prolonged by more than 3 seconds)
- During the operation, microwave treatment or a combination of microwave treatment was adopted
- More than 4 times of blocking at the first hepatic hilum, or a single blocking duration longer than 15 minutes
- More than 1000ml of blood transfusion during the operation
- During the operation, other intrahepatic lesions were discovered, which required combination with other surgeries, such as ablation or choledochojejunostomy
- Psychosis, severe neurosis, those who cannot cooperate with this experiment
- Pregnant and lactating women
- The researchers believe that any participants who have any other factors that would make them unsuitable for this trial should not be included
Who the study is looking for
- Diagnosed as HCC through imaging and laboratory tests, and capable of undergoing laparoscopic anatomical resection.
- 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.
- 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.
- Age: 18 - 80 years old. Gender: Open to both male and female. Body Mass Index (BMI): 18.5 - 28 kg/m².
- Child-Pugh grade A or B, with a score of ≤ 7; ASA grades I to III.
- Preoperative ICG R15 \< 10%, and the residual liver volume/standard liver volume \> 40%.
- A single HCC (hepatocellular carcinoma), with a tumor diameter of less than 10 cm, without distant metastasis or invasion of the portal vein system.
- Preoperative ALT \< 2x ULN (upper limit of normal).
- 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.
- No liver-damaging treatment drugs were used within two weeks prior to enrollment.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.