Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy

Zhujiang Hospital

Status: Not yet enrolling

Conditions: Ruptured Liver; Hyperthermic Intraperitoneal Chemotherapy; Hepatocellular Carcinoma

Treatments: Procedure: intraperitoneal hyperthermic perfusion chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06247293

2023-KY-078-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 3 patient groups

Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy

Description:

Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy

Treatment:

Procedure: intraperitoneal hyperthermic perfusion chemotherapy

simple surgical resection

Description:

Control group: simple surgical resection

Treatment:

Procedure: intraperitoneal hyperthermic perfusion chemotherapy

other

Description:

imple interventional hemostasis group

Treatment:

Procedure: intraperitoneal hyperthermic perfusion chemotherapy