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

August 4, 2020 updated by: Shuguo Zheng, MD, Southwest Hospital, China

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Southwest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: laparoscopic surgery
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
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.
Active Comparator: Open surgery
Open surgery is the traditional surgical method for resection of paracaval-originating lesions.
Procedure: Open 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
survival rate
Time Frame: 3 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
operation time
Time Frame: during the operation
intraoperative parameter
during the operation
intraoperative blood loss
Time Frame: during the operation
intraoperative parameter
during the operation
rate of blood transfusion.
Time Frame: during the operation
intraoperative parameter
during the operation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: Duration hospitalization(an expected average of 7 days)
ascites, pleural effusion,cardiopulmonary insufficiency,mortality, postoperative liver function failure.
Duration hospitalization(an expected average of 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Southwest Hospital, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shuguo Zheng, M.D., Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery, Southwest Hospital, Army medical university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SWHZSG010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Paracaval Portion

Clinical Trials on laparoscopic surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings