Skip to content

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

A Prospective Cohort Study: Laparoscopic Versus Open Surgery for Lesions Originating in the Paracaval Portion of the Caudate Lobe

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04499261
Enrollment
110
Registered
2020-08-05
Start date
2019-09-25
Completion date
2022-09-25
Last updated
2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paracaval Portion

Keywords

Laparoscopy, hepatectomy, Caudate Lobe

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.

Interventions

PROCEDURElaparoscopic surgery

Patients were supine in a reverse Trendelenburg position and received intravenous inhalation combined with anesthesia. The patients' legs were spread apart. A carbon dioxide pneumoperitoneum was established. The intermittent Pringle's maneuver was carried out when necessary. Five trocars were placed in a fan shape around the lesion. Cholecystectomy was performed routinely. First, the liver was mobilized. Then, the liver parenchyma was transected and the branches of the hepatic veins and pedicles encountered were clipped and divided. The lesion was meticulously separated from the vascular structures and liver parenchyma and completely resected. The raw surface was treated with bipolar coagulation to achieve hemostasis and repeatedly washed until no bleeding or bile leakage was confirmed. Finally, the specimens were packed in a specimen bag and removed. The raw surface was packed with biological hemostatic materials, and drainage tubes were routinely placed.

PROCEDUREOpen surgery

Patients were placed in the supine position and received intravenous inhalation combined with anesthesia. The intermittent Pringle's maneuver was carried out when necessary. Routinely, a reversed L-shape incision was performed. Cholecystectomy was performed routinely. First, the liver was mobilized. Then, the liver parenchyma was transected and the branches of the hepatic veins and pedicles encountered were clipped and divided. The lesion was meticulously separated from the vascular structures and liver parenchyma and completely resected. The raw surface was treated with bipolar coagulation to achieve hemostasis and repeatedly washed until no bleeding or bile leakage was confirmed. Finally, the specimens were packed in a specimen bag and removed. The raw surface was packed with biological hemostatic materials, and drainage tubes were routinely placed.

Sponsors

Southwest Hospital, China
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
survival rate3 yearsfollow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates,disease-free survival rates , recurrence and metastasis rate.

Secondary

MeasureTime frameDescription
operation timeduring the operationintraoperative parameter
intraoperative blood lossduring the operationintraoperative parameter
rate of blood transfusion.during the operationintraoperative parameter

Other

MeasureTime frameDescription
postoperative complicationsDuration hospitalization(an expected average of 7 days)ascites, pleural effusion,cardiopulmonary insufficiency,mortality, postoperative liver function failure.

Countries

China

Contacts

Primary ContactShuguo Zheng, M.D.
shuguozh@yahoo.com.cn0086-13508308676

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026