Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy

NCT06247293 | Unknown

• 1 other identifier: 2023-KY-078-02
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperthermic Intraperitoneal Chemotherapy; Hepatocellular Carcinoma; Ruptured Liver

Keywords

ruptured and bleeding of Hepatocellular carcinoma; Hyperthermic intraperitoneal chemotherapy; recurrence-free survival

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival (OS)

  time from partial hepatectomy for HCC until death from any cause or end of observation period(2 years)

• survival rate

  time from partial hepatectomy for HCC until death from any cause or end of observation period

Study Arms (3)

Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy

Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy

Procedure: intraperitoneal hyperthermic perfusion chemotherapy

simple surgical resection

Control group: simple surgical resection

Procedure: intraperitoneal hyperthermic perfusion chemotherapy

other

imple interventional hemostasis group

Procedure: intraperitoneal hyperthermic perfusion chemotherapy

Interventions

intraperitoneal hyperthermic perfusion chemotherapy 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.

Also known as: simple surgical resection, Hepatic artery embolization

Surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy; other; simple surgical resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• according to the clinical diagnostic criteria of primary liver cancer (2022 edition) or confirmed by pathology/cytology;
• preoperative diagnosis of rupture and hemorrhage of liver cancer by clinical manifestation, examination and imaging;
• Age 18-80 years;
• 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;
• ECOG-PS score of 0-1;
• without other neoplastic diseases;
• Sign and perfect the informed consent form before operation;
• without postoperative liver failure, without major complications such as massive hemorrhage, purulent infection and multiple organ failure, and without discharge from hospital.

You may not qualify if:

• having other active malignant tumor;
• the expected survival time is less than 3 months;
• Child-pugh class C, complicated with severe organic disease of important organs, complicated with severe cirrhosis.

Sponsors & Collaborators

• Zhujiang Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Rupture

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Wounds and Injuries

Study Officials

• Mingxin Pan, Prof.

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingxin Pan, Prof.

CONTACT

18928918216; pmxwxy@sohu.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: February 7, 2024
• Study Start: February 1, 2024
• Primary Completion: February 25, 2024
• Study Completion: March 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2023-06