Laparoscopic Versus Open Surgery for Lesions Originating in the Paracaval Portion of the Caudate Lobe

Army Medical University

Status: Unknown

Conditions: Paracaval Portion

Treatments: Procedure: laparoscopic surgery; Procedure: Open surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04499261

SWHZSG010

Details and patient eligibility

About

This study aimed to evaluate the safety, feasibility and efficacy of laparoscopic for resecting paracaval-originating lesions by contrast of open procedures.

Full description

The paracaval portion of the caudate lobe is located in the core of the liver. Lesions originating in the paracaval portion often cling to or even invade major hepatic vascular structures. Open surgery is the traditional surgical method for resection of paracaval-originating lesions. With the development of laparoscopic surgery, paracaval-originating lesions are no longer an absolute contraindication for laparoscopic procedures. The high-definition magnified view and ability to change perspectives with the laparoscope are conducive to subtle manipulation, and compression of the carbon dioxide pneumoperitoneum can reduce venous bleeding. Nevertheless, laparoscopic anterior hepatic transection for paracaval-originating lesion resection is still a challenging procedure, and only a few cases have been reported. This study aimed to evaluate the safety, feasibility and efficacy of laparoscopic for resecting paracaval-originating lesions by contrast of open procedures.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: Between 18 to 70 years, both male and female
2. The general condition of the patient can tolerate anesthesia and surgery
3. Paracaval-originating lesion diagnosis is clear preoperative
4. No rupture of the tumor, no bloody ascites, no invasion of the surrounding tissues and distant metastasis
5. Liver function ≥ Child-pugh level B, indocyanine green retention rate at 15 min ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%.
6. Upper abdominal surgery, radiofrequency ablation, Transhepatic Arterial Chemotherapy And Embolization treatment, radiotherapy and chemotherapy have not been implemented
7. Volunteer to participate in the study and sign informed consent

Exclusion criteria

1. Age:Younger than 18 or more than 70 years old 2. Pregnant and lactating women 3. Severe cirrhosis, portal hypertension, or active hepatitis are present 4. Severe upper abdominal adhesions 5. The lesion originated in other parts of the liver other than the paracaval portion 6. Patients with poor general condition and could not tolerate surgery or anesthesia

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

laparoscopic surgery

Experimental group

Description:

The laparoscopic view is caudal to cephalic, which is consistent with the direction of hepatic transection. In addition, the high-definition magnified view and ability to change perspectives with the laparoscope are conducive to subtle manipulation, and compression of the carbon dioxide pneumoperitoneum can reduce venous bleeding. Therefore, laparoscopic surgery may have certain advantages in the treatment of paracaval-originating lesions.

Treatment:

Procedure: laparoscopic surgery

Open surgery

Active Comparator group

Description:

Open surgery is the traditional surgical method for resection of paracaval-originating lesions.

Treatment:

Procedure: Open surgery