CMRA for US-guided-MWA of Liver Tumors

NCT05990257 | Unknown

• 1 other identifier: CMRA123
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia; Pain Control; Microwave Ablation; Liver Tumors

Outcome Measures

Primary Outcomes (1)

• pain control

  NRS score was used to evaluate pain control

  at the time of the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure

Study Arms (3)

HHB+TAPB+and LA

EXPERIMENTAL

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

Procedure: HHB+TAPB+and LA

HHB+LA

EXPERIMENTAL

Group B: patients who received HHB and LA

Procedure: HHB+LA

TAPB+LA

EXPERIMENTAL

Group C: patients who received TAPB and LA

Procedure: TAPB+LA

Interventions

HHB+TAPB+and LA PROCEDURE

Hepatic Hilar Block (HHB), Transversus Abdominis Plane Block (TAPB), and Local Anesthesia (LA)

HHB+TAPB+and LA

HHB+LA PROCEDURE

Hepatic Hilar Block (HHB) and Local Anesthesia (LA)

HHB+LA

TAPB+LA PROCEDURE

Transversus Abdominis Plane Block (TAPB) and Local Anesthesia (LA)

TAPB+LA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The ASA grade is II or III.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lu Wang: lead

Study Sites (1)

Sichuan cancer hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Agnosia; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Man Lu, PHD

  Sichuan Cancer Hospital and Research Institute

  STUDY DIRECTOR

Central Study Contacts

Lu Wang

CONTACT

15828016725; 656121781@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 14, 2023
• Study Start: July 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

CN (1)