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

NCT04499261 | Unknown DMC

• 1 other identifier: SWHZSG010
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Paracaval Portion

Keywords

Laparoscopy; hepatectomy; Caudate Lobe

Outcome Measures

Primary Outcomes (1)

• survival rate

  follow-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.

  3 years

Secondary Outcomes (3)

• operation time

  during the operation

• intraoperative blood loss

  during the operation

• rate of blood transfusion.

  during the operation

Other Outcomes (1)

• postoperative complications

  Duration hospitalization(an expected average of 7 days)

Study Arms (2)

laparoscopic surgery

EXPERIMENTAL

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.

Procedure: laparoscopic surgery

Open surgery

ACTIVE COMPARATOR

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

Procedure: Open surgery

Interventions

laparoscopic surgery PROCEDURE

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.

laparoscopic surgery

Open surgery PROCEDURE

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.

Open surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Interventions

Laparoscopy; Conversion to Open Surgery

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Shuguo Zheng, M.D.

  Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery, Southwest Hospital, Army medical university

  STUDY DIRECTOR

Central Study Contacts

Shuguo Zheng, M.D.

CONTACT

0086-13508308676; shuguozh@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: September 25, 2019
• Primary Completion: September 25, 2021
• Study Completion: September 25, 2022
• Last Updated: August 5, 2020

Record last verified: 2020-07

Locations

CN (1)