- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04499261
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
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
110
Phase
- 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
- Name: Shuguo Zheng, M.D.
- Phone Number: 0086-13508308676
- Email: shuguozh@yahoo.com.cn
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400038
- Recruiting
- Southwest Hospital
-
Contact:
- Shuguo Zheng, M.D.
- Phone Number: 0086-13508308676
- Email: shuguozh@yahoo.com.cn
-
-
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
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
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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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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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
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
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
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rate of blood transfusion.
Time Frame: during the operation
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intraoperative parameter
|
during the operation
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Other Outcome Measures
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
Investigators
- 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)
September 25, 2019
Primary Completion (Anticipated)
September 25, 2021
Study Completion (Anticipated)
September 25, 2022
Study Registration Dates
First Submitted
July 31, 2020
First Submitted That Met QC Criteria
August 4, 2020
First Posted (Actual)
August 5, 2020
Study Record Updates
Last Update Posted (Actual)
August 5, 2020
Last Update Submitted That Met QC Criteria
August 4, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID 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.
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