Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy

A Retrospective Study of Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy in the Treatment of Ruptured Hepatocellular Carcinoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatocellular Carcinoma; Hyperthermic Intraperitoneal Chemotherapy; Ruptured Liver
• Intervention / Treatment: Procedure: intraperitoneal hyperthermic perfusion chemotherapy

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Mingxin Pan, Prof.; Phone Number: 189289 18928918216; Email: pmxwxy@sohu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy	Procedure: 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.; Other Names: simple surgical resection; Hepatic artery embolization
simple surgical resection; Control group: simple surgical resection	Procedure: 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.; Other Names: simple surgical resection; Hepatic artery embolization
other; imple interventional hemostasis group	Procedure: 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.; Other Names: simple surgical resection; Hepatic artery embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-abdominal recurrence-free survival (RFS)	Intra-abdominal recurrence-free survival (RFS):the time from surgical resection patients with HCC until the detection of intra-abdominal recurrence or metastasis or the end of the observation period, based on postoperative follow-up test criteria and imaging findings(2 years)	the time from surgical resection in patients with HCC until the detection of intra-abdominal recurrence or metastasis or the end of the observation period(2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall Survival (OS): time from partial hepatectomy for HCC until death from any cause or end of observation period(2 years)	time from partial hepatectomy for HCC until death from any cause or end of observation period(2 years)
survival rate	defined as 1-month,3-month,6-month, 1-year,2-year survival rate	time from partial hepatectomy for HCC until death from any cause or end of observation period

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Mingxin Pan, Prof., Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 25, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Hyperthermic intraperitoneal chemotherapy; recurrence-free survival; ruptured and bleeding of Hepatocellular carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Wounds and Injuries; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Body Temperature Changes; Heat Stress Disorders; Carcinoma; Carcinoma, Hepatocellular; Hyperthermia; Fever
• Other Study ID Numbers: 2023-KY-078-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No