NCT07150624Toboroz4. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 11.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 4. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 96 (tervezett)
- Első benyújtás
- 2025. aug. 21.
- Kezdés
- 2025. nov. 10.
- Elsődleges befejezés
- 2026. dec. 31.
- Fő szponzor
- Anhui Provincial Hospital
- Betegségek
- Máj- és epeúti rák
- NCT-szám
- NCT07150624
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 4. fázis
- Tervezett résztvevők: 96
- 2025. nov. 10. és az elsődleges befejezés (2026. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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
Más betegség
- 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
Egyéb
- 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
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Kína | Toboroz |
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