Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy

NCT ID: NCT06247293

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-03-31

Brief 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.

Conditions

Hyperthermic Intraperitoneal Chemotherapy; Hepatocellular Carcinoma; Ruptured Liver

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy

Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy

intraperitoneal hyperthermic perfusion chemotherapy

Intervention Type: PROCEDURE

（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.

simple surgical resection

Control group: simple surgical resection

intraperitoneal hyperthermic perfusion chemotherapy

Intervention Type: PROCEDURE

（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.

other

imple interventional hemostasis group

intraperitoneal hyperthermic perfusion chemotherapy

Intervention Type: PROCEDURE

（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.

Interventions

intraperitoneal hyperthermic perfusion chemotherapy

（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.

Intervention Type: PROCEDURE

Other Intervention Names

simple surgical resection; Hepatic artery embolization

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mingxin Pan, Prof.

Role: PRINCIPAL_INVESTIGATOR

Southern Medical University, China

Central Contacts

Mingxin Pan, Prof.

Role: CONTACT

pmxwxy@sohu.com

18928918216 ext. 189289

Other Identifiers

2023-KY-078-02

Identifier Type: -

Identifier Source: org_study_id