Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy

Not yet recruiting

• Conditions: Ruptured Liver; Hepatocellular Carcinoma; Hyperthermic Intraperitoneal Chemotherapy
• Interventions: Procedure: intraperitoneal hyperthermic perfusion chemotherapy

• Registration Number: NCT06247293
• Lead Sponsor: Zhujiang Hospital

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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-08-11
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study Start: 2024-02-01
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-02-25
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
simple surgical resection	intraperitoneal hyperthermic perfusion chemotherapy	Control group: simple surgical resection
other	intraperitoneal hyperthermic perfusion chemotherapy	imple interventional hemostasis group
Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy	intraperitoneal hyperthermic perfusion chemotherapy	Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy

Primary Outcome Measures

Name	Time	Method
Intra-abdominal recurrence-free survival (RFS)	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)	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)

Secondary Outcome Measures

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