Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy

Trial Title: Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy

NCT ID: NCT06247293

Condition: Hyperthermic Intraperitoneal Chemotherapy
Hepatocellular Carcinoma
Ruptured Liver

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Hyperthermia
Fever

Conditions: Keywords:
ruptured and bleeding of Hepatocellular carcinoma
Hyperthermic intraperitoneal chemotherapy
recurrence-free survival

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Procedure
Intervention name: intraperitoneal hyperthermic perfusion chemotherapy
Description: （1）Partial hepatectomy: The reasonable resection method was selected according to the tumor location, residual liver volume and the operation process. The tumor margin should be more than 1 cm, the abdominal cavity was flushed with sterile warm distilled water. In the control group,1-2 abdominal drainage tubes were placed on the hepatic cross-section, in the exposed group,4 abdominal perfusion tubes were placed in the right hepatic apex, splenic fossa, left and right pelvic cavity to perform HIPEC postoperatively. (2) HIPEC: Temperature setting:43 °C perfusion time:60 min, perfusion speed:400-600 mL/min ,perfusion volume:3000 mL. （3）Hepatic artery embolization：Through the common femoral artery, the catheter passed through the abdominal aorta, celiac trunk, the common hepatic artery and the inherent hepatic artery to the blood supply target artery of liver cancer. The embolic agent Lipiodol was mixed and injected to embolize the bleeding artery to stop bleeding.
Arm group label: Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy
Arm group label: other
Arm group label: simple surgical resection

Other name: simple surgical resection

Other name: Hepatic artery embolization

Summary: Patients with ruptured liver cancer and bleeding after surgical resection were included according to the criteria of admission, and the patients were divided into experimental and control groups. the primary efficacy end point was RFS, and the secondary end point was the rate of abdominal implant metastases and OS.To analyze the efficacy of HIPEC.

Detailed description: Patients with ruptured liver cancer and bleeding after surgical resection were included according to the criteria of admission, and the patients were divided into groups: experimental group: surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy, and control group: simple surgical resection. At further follow-up, the primary efficacy end point was time to Recurrence free survival (RFS) ,the time from the patient's treatment until the discovery of abdominal metastases or until the follow-up period, and the secondary end point was the rate of abdominal implant metastases, that is, according to the postoperative follow-up test and imaging findings, the incidence of abdominal implantation and metastasis, until the end of abdominal recurrence or metastasis or observation period. Overall Survival OS and survival rate: the time from the time the patient underwent partial hepatectomy until death from tumor causes or the end of the observation period. To analyze the efficacy of HIPEC.

Criteria for eligibility:

Study pop:
From February 2017 to February 2023, patients with ruptured Southern Medical University of hepatocellular carcinoma diagnosed in the Department of Hepatobiliary Surgery of Pearl River Hospital or other hospitals.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: 1. according to the clinical diagnostic criteria of primary liver cancer (2022 edition) or confirmed by pathology/cytology; 2. preoperative diagnosis of rupture and hemorrhage of liver cancer by clinical manifestation, examination and imaging; 3. Age 18-80 years; 4. Child-pugh class A or class B after liver protection and albumin correction, without severe heart, lung or renal dysfunction, without absolute contraindication to surgery; 5. ECOG-PS score of 0-1; 6. without other neoplastic diseases; 7. Sign and perfect the informed consent form before operation; 8. without postoperative liver failure, without major complications such as massive hemorrhage, purulent infection and multiple organ failure, and without discharge from hospital. Exclusion Criteria: 1. having other active malignant tumor; 2. the expected survival time is less than 3 months; 3. Child-pugh class C, complicated with severe organic disease of important organs, complicated with severe cirrhosis.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Start date: February 1, 2024

Completion date: March 31, 2024

Lead sponsor:
Agency: Zhujiang Hospital
Agency class: Other

Source: Zhujiang Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06247293