Clinical trial NCT04499261: Laparoscopic Versus Open Surgery for Lesions Originating in the Paracaval Portion of the Caudate Lobe
Official title: A Prospective Cohort Study: Laparoscopic Versus Open Surgery for Lesions Originating in the Paracaval Portion of the Caudate Lobe
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paracaval Portion
Keywords: Laparoscopy
hepatectomy
Caudate Lobe
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

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Primary outcomes:
measure: survival rate
timeFrame: 3 years
Secondary outcomes:
measure: operation time
timeFrame: during the operation
measure: intraoperative blood loss
timeFrame: during the operation
measure: rate of blood transfusion.
timeFrame: during the operation
Other outcomes:
measure: postoperative complications
timeFrame: Duration hospitalization(an expected average of 7 days)
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
affiliation: Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery, Southwest Hospital, Army medical university
name: Shuguo Zheng, M.D.
role: STUDY_DIRECTOR
References: