Trial Title:
Evaluation of the Safety and Effectiveness of Pringle Method Combined With IVC Flow Limiting and Blocking Method in Laparoscopic Hepatectomy Based on Non-restrictive Fluid Therapy Strategy
NCT ID:
NCT06594289
Condition:
Liver Tumor
Conditions: Official terms:
Liver Neoplasms
Conditions: Keywords:
Liver cancer
Laparoscopic
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking description:
Complete random grouping method was used in this study. Patients meeting the inclusion
criteria were assigned to group A and Group B in a 1:1 ratio with 110 cases in each group
by random number table method. The results are hidden in an opaque sealed envelope, which
is then stored by the clinical study designer (i.e., a random code sheet). The researcher
opened the envelope on the morning of the operation to obtain the group of patients and
informed the operating physician and anesthesiologist to intervene accordingly according
to the study protocol.
Intervention:
Intervention type:
Procedure
Intervention name:
In laparoscopic hepatectomy, the subhepatic inferior vena cava was restricted and the patient was given non-restricted intraoperative fluid intake
Description:
The specific steps of IVC blocking were performed by the principal physician under
laparoscopic operation: slightly incision of the posterior peritoneum on both sides of
the inferior vena cava above the level of the renal vein. The "blood vessel blocking
band" is passed behind the inferior vena cava on the left or right side of the inferior
vena cava. According to the intraoperative situation, the blocking band (flow limiting
blocking/incomplete blocking of subhepatic inferior vena cava) was tightened to control
the bleeding from hepatic vein on the liver section. Patients in this group did not use
vasoactive drugs/underuse means to control CVP, so they need to strictly communicate with
the anesthesiologist, and take the fluid intake based on the physiological requirements
and fluid loss of individual patients (cancel the restriction of fluid intake).
Arm group label:
Observation group
Summary:
The relevant data of 220 patients undergoing laparoscopic hepatectomy in our hospital
were collected. Based on randomization, blindness and inclusion and exclusion criteria,
the patients were divided into group A (which included Pringle method + restricted fluid
management + vasoactive drug use by anesthesiologists) and group B (which included:
Pringle method +IVC flow limiting and blocking method, intraoperative fluid rehydration
according to physiological requirements and expected loss, no or less vasoactive drugs
used during the operation), and intraoperative and postoperative relevant indicators were
compared between the two groups, such as; CVP value, fluctuation range, length of
operation, time of liver amputation, total blood loss, amount of liver amputation, amount
of blood transfusion, and amount of fluid perfusion. Internal environmental indicators:
albumin, alanine aminotransferase, aspartate aminotransferase, γ-gt, total bilirubin,
renal function, lactic acid, blood gas analysis (three times during the operation).
Postoperative indexes: average length of stay and unplanned reoperation rate. While
taking into account the safety, effectiveness and interpretability of statistical
results, a new laparoscopic hepatectomy technique based on the optimized CLCVP process
was constructed to control intraoperative bleeding and GDFT standardized and streamlined
intervention strategy. This is not only an important innovation of the CLVCP concept, but
also an important link to accelerate the implementation of laparoscopic liver resection
technology in grassroots hospitals, and will significantly improve the quality of medical
services, which can bring more accurate and efficient treatment programs to patients.
Detailed description:
Overall design Research hypothesis: Based on the non-restrictive fluid management
strategy (intraoperative fluid rehydration according to physiological requirements and
expected loss, no or less use of vasoactive drugs during the operation) combined with
Pringle method and IVC flow restriction blocking method, the method of blocking hepatic
blood flow was applied to effectively control intraoperative bleeding. Reduce the degree
of intraoperative anesthesiologist dependence, improve the intraoperative compatibility
between surgeons and anesthesiologists, and optimize the traditional CLVCP process, so as
to achieve the goal of accurate maintenance of patients' organs in functional surgery and
more rapid and widespread promotion of laparoscopic liver resection technology.
Type of study: A prospective randomized controlled study will be used in this study 5.2
Research and design process 5.2.1 Study the specific implementation process A total of
220 patients undergoing elective laparoscopic partial hepatectomy were selected from our
hospital. All patients and their families knowingly and voluntarily signed informed
consent before enrollment. On the basis of randomization and inclusion and exclusion
criteria, the patients were divided into group A (110 cases) (Pringle method + restricted
fluid management + use of vasoactive drugs by anesthesiologists) and group B (110 cases)
(Pringle method +IVC flow restriction blocking + open fluid intake during the operation,
and no/less use of vasoactive drugs during the operation). Intraoperative and
postoperative related indexes were compared between the two groups, such as; CVP value,
duration, fluctuation range, length of operation, time of liver amputation, total blood
loss, amount of liver amputation, amount of blood transfusion, amount of liquid
perfusion, three blood gas analysis during the operation, blood glucose, and dosage of
vasoactive drugs. 3 days after operation: albumin, alanine aminotransferase, aspartate
aminotransferase, gamma-GT, total bilirubin, renal function, lactic acid and other
related indexes. Postoperative hospital stay (d), tracheal intubation and extubation time
(d), surgical cost (ten thousand yuan), abdominal effusion, pulmonary infection,
postoperative flatulence time (d), postoperative exhaust time (d), incision infection,
intestinal obstruction. To comprehensively evaluate the safety and efficacy of Pringle
method and IVC flow limiting blockade in the implementation of non-restrictive fluid
intake strategies.
Ways to reduce bias
1. Complete random grouping: This study adopts the complete random grouping method;
Patients meeting the inclusion criteria were assigned to group A and Group B in a
1:1 ratio with 110 cases in each group by random number table method. The results
are hidden in an opaque sealed envelope, which is then stored by the clinical study
designer (i.e., a random code sheet). The researcher opened the envelope on the
morning of the operation to obtain the group of patients and informed the operating
physician and anesthesiologist to intervene accordingly according to the study
protocol.
2. Baseline control of patients Group A (Pringle method + restricted fluid management +
use of vasoactive drugs by anesthesiologists) : The means of use and anesthetic
drugs in this group were all conventional technical means without special
intervention, so it was the control group.
Group B (Pringle method +IVC flow limiting and blocking method + open fluid intake during
operation; Observation group: Patients in this group did not use anesthesia related drugs
to control CVP, so they should strictly communicate with the anesthesiologist, and
achieve homogeneity in the use of vasoactive drugs and narcotic drugs.
In order to reduce the deviation: 1. During the implementation of the subject, the group
concealization was strictly implemented, and the designer informed the operating
physician and anesthesiologist of the patient intervention plan one day before the
operation.
2. Fluid intake 12 hours before surgery for all enrolled patients was strictly
regulated according to preoperative ERAS.
3. All enrolled patients were strictly defined for the use of vasoactive drugs during
the operation to reduce the deviation of statistical results caused by the use of
different vascular drugs 4. All enrolled patients were performed by the same surgeon
and anesthesiologist 5.4 Definition of the end of the study (e.g., the last study
subject completes the last follow-up) The end of the study was defined when all
enrolled patients completed surgery and the last patient completed follow-up 5.5
Statistical Analysis 5.5.1 Sample size and calculation basis Clinical data of
patients undergoing laparoscopic hepatectomy in the Department of Hepatobiliary
Surgery of Sun Yat-sen Memorial Hospital meeting the above inclusion criteria were
collected. Intraoperative blood loss and intraoperative CVP control were used as the
main observation indexes.
In this study, intraoperative blood loss and intraoperative CVP were respectively used to
calculate the minimum sample size. According to previous observations, the mean
difference of intraoperative blood loss between the two groups was about 28ml, the common
standard deviation was conservatively estimated to be 55ml, the mean difference of
intraoperative CVP between the two groups was about 2cmH2O, and the common standard
deviation was conservatively estimated to be 1.5cmH2O. The Class I error α and class II
error β of hypothesis test were set as 0.05, and the number of subjects in the two groups
was 1:1. The PASS15.0 software was used for calculation, and the sample size of
intraoperative blood loss was obtained as n=83 persons in each group, and the sample size
of intraoperative CVP was obtained as n=13 persons in each group, and the larger value
was adopted, that is, the sample size was 83 persons in each group. Assuming a 20% loss
rate, the final sample size is 104 people per group, for a total of 208 people.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Preoperative Child-Pugh classification of liver function Grade A and grade B;
2. No contraindications for laparoscopic hepatectomy;
3. Liver diseases include: primary liver cancer, hepatic hemangioma, intrahepatic bile
duct calculus, intrahepatic bile duct cell carcinoma, etc.
4. Patients voluntarily participate and sign informed consent;
5. According to the Ban difficulty scoring system of laparoscopic hepatectomy, patients
with difficulty score of 5 or more were included; Neoplasms near the hepatic portal;
Extensive hepatectomy (3 hepatic segments). Patients aged 18-70 years (including
18-70 years)
Exclusion Criteria:
1. Poor liver reserve function, ICG retention rate > 15%;
2. severe heart and lung diseases, unable to tolerate general anesthesia surgery;
3. Previous history of liver surgery;
4. More than medium amount of chest and abdominal fluid with clinical symptoms:
5. hepatic encephalopathy;
6. having a history of psychotropic drug abuse, unable to quit or having a history of
mental disorders;
7. Patients who have received solid organ transplantation or bone marrow
transplantation, or within 2 years before surgery
8. An active autoimmune disease requiring systemic treatment has occurred;
9. There is an immune deficiency disease or HIV infection;
10. Those who were not considered suitable for inclusion by the researchers.
11. Progression of the disease or toxic side effects or serious adverse events that the
subjects could not tolerate before surgery after treatment;
12. Poor patient compliance, non-cooperation, concealment, false reporting and other
phenomena: others
13. Cases where the principal investigator determines that the research protocol is
seriously violated.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yajin Chen
Phone:
13719006202
Email:
cyj0509@126.com
Contact backup:
Last name:
Changzhen Shang
Phone:
13711279678
Email:
shangchangzhen@139.com
Start date:
September 15, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06594289
