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CMRA for US-guided-MWA of Liver Tumors

Primary Purpose

Regional Anesthesia, Pain Control, Microwave Ablation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HHB+TAPB+and LA
HHB+LA
TAPB+LA
Sponsored by
Lu Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Regional Anesthesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Primary hepatic carcinoma was considered if characterized by a solitary tumor (≤5cm in maximum diameter) or by the presence of multiple tumors (2-3 in number, each ≤3cm in maximum diameter). Importantly, these tumors were required to be devoid of vascular invasion, biliary intrusion, contiguous organ invasion, or any evidence of distant metastasis. Another group included in the study were patients with hepatic metastases, limited to no more than 5 tumors each measuring ≤3cm in maximum diameter. Furthermore, patients with hepatic hemangioma were also considered for inclusion. Specific criteria applied in these cases included tumors larger than 5cm in maximum diameter that showed considerable growth (imaging findings suggest that the diameter of the tumor has increased by more than 1cm) in the preceding two years and were associated with persistent hemangioma-related abdominal pain or discomfort. Alternatively, tumors measuring up to 5cm in maximum diameter, exhibiting a pronounced growth propensity and located at the first, second, or third hilar region in close proximity to the hilar bile duct, portal vein, hepatic artery, hepatic vein, or inferior vena cava were also considered. And all these patients cannot tolerate surgery due to other organ damage or do not want to undergo surgical treatment. The ASA grade is II or III. Exclusion Criteria: Patients with severe underlying medical conditions that could potentially prevent them from tolerating the US-guided MWA procedure were ruled out. Those with tumors invading blood vessels, bile ducts, adjacent organs, or presenting with extrahepatic metastasis were also excluded. Further, any cases presenting with uncorrectable coagulation disorders, thrombocytopenia, or currently under administration of anticoagulant agents were deemed unfit for the study. Finally, patients were excluded if a safe trajectory for executing US-guided MWA was not feasible.

Sites / Locations

  • Sichuan cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

HHB+TAPB+and LA

HHB+LA

TAPB+LA

Arm Description

Group A: patients who received a HHB, TAPB, and LA

Group B: patients who received HHB and LA

Group C: patients who received TAPB and LA

Outcomes

Primary Outcome Measures

pain control
NRS score was used to evaluate pain control

Secondary Outcome Measures

Full Information

First Posted
August 6, 2023
Last Updated
August 12, 2023
Sponsor
Lu Wang
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1. Study Identification

Unique Protocol Identification Number
NCT05990257
Brief Title
CMRA for US-guided-MWA of Liver Tumors
Official Title
Combined Multiple Regional Anesthesia for Microwave Ablation of Liver Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lu Wang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These patients were allocated into three groups based on tumor size and number: A, B, and C. Prior to the ablation procedure, Group A patients received a combination of hepatic hilar block (HHB), Transversus abdominis plane block (TAPB), and local anesthesia (LA). Patients in Group B were administered HHB in conjunction with LA, while those in Group C received TAPB and LA. Evaluative parameters included the Numerical Rating Scale (NRS) scores, consumption of morphine, incidence of complications, and factors influencing perioperative pain.
Detailed Description
Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These patients were allocated into three groups based on tumor size and number: A, B, and C. Prior to the ablation procedure, Group A patients received a combination of hepatic hilar block (HHB), Transversus abdominis plane block (TAPB), and local anesthesia (LA). Patients in Group B were administered HHB in conjunction with LA, while those in Group C received TAPB and LA.Pain levels were routinely assessed through the Numerical Rating Scale (NRS), with scores being recorded by the attending nurse every 15 minutes. The frequency of these assessments would be increased if the patient reported discomfort or if there were changes observed in vital signs. If a patient reported a pain level of ≥4 on the NRS scale, an intravenous dose of 10mg morphine was administered, provided that cardiopulmonary safety could be assured. The determination of cardiopulmonary safety was made by the interventional radiologist (M. L. with 20 years of experience). Following the ablation procedure, all patients were monitored for a period of 36 hours. During this period, several parameters were recorded at the time of the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure. These parameters included the NRS score, vital signs, any need for morphine, and the occurrence of any adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia, Pain Control, Microwave Ablation, Liver Tumors

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HHB+TAPB+and LA
Arm Type
Experimental
Arm Description
Group A: patients who received a HHB, TAPB, and LA
Arm Title
HHB+LA
Arm Type
Experimental
Arm Description
Group B: patients who received HHB and LA
Arm Title
TAPB+LA
Arm Type
Experimental
Arm Description
Group C: patients who received TAPB and LA
Intervention Type
Procedure
Intervention Name(s)
HHB+TAPB+and LA
Intervention Description
Hepatic Hilar Block (HHB), Transversus Abdominis Plane Block (TAPB), and Local Anesthesia (LA)
Intervention Type
Procedure
Intervention Name(s)
HHB+LA
Intervention Description
Hepatic Hilar Block (HHB) and Local Anesthesia (LA)
Intervention Type
Procedure
Intervention Name(s)
TAPB+LA
Intervention Description
Transversus Abdominis Plane Block (TAPB) and Local Anesthesia (LA)
Primary Outcome Measure Information:
Title
pain control
Description
NRS score was used to evaluate pain control
Time Frame
at the time of the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary hepatic carcinoma was considered if characterized by a solitary tumor (≤5cm in maximum diameter) or by the presence of multiple tumors (2-3 in number, each ≤3cm in maximum diameter). Importantly, these tumors were required to be devoid of vascular invasion, biliary intrusion, contiguous organ invasion, or any evidence of distant metastasis. Another group included in the study were patients with hepatic metastases, limited to no more than 5 tumors each measuring ≤3cm in maximum diameter. Furthermore, patients with hepatic hemangioma were also considered for inclusion. Specific criteria applied in these cases included tumors larger than 5cm in maximum diameter that showed considerable growth (imaging findings suggest that the diameter of the tumor has increased by more than 1cm) in the preceding two years and were associated with persistent hemangioma-related abdominal pain or discomfort. Alternatively, tumors measuring up to 5cm in maximum diameter, exhibiting a pronounced growth propensity and located at the first, second, or third hilar region in close proximity to the hilar bile duct, portal vein, hepatic artery, hepatic vein, or inferior vena cava were also considered. And all these patients cannot tolerate surgery due to other organ damage or do not want to undergo surgical treatment. The ASA grade is II or III. Exclusion Criteria: Patients with severe underlying medical conditions that could potentially prevent them from tolerating the US-guided MWA procedure were ruled out. Those with tumors invading blood vessels, bile ducts, adjacent organs, or presenting with extrahepatic metastasis were also excluded. Further, any cases presenting with uncorrectable coagulation disorders, thrombocytopenia, or currently under administration of anticoagulant agents were deemed unfit for the study. Finally, patients were excluded if a safe trajectory for executing US-guided MWA was not feasible.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Wang
Phone
15828016725
Email
656121781@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Man Lu, PHD
Organizational Affiliation
Sichuan Cancer Hospital and Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Sichuan cancer hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Wang
Phone
15828016725
Email
656121781@qq.com

12. IPD Sharing Statement

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CMRA for US-guided-MWA of Liver Tumors

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