Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging

Not Applicable

Completed

• Conditions: Stomach Neoplasm
• Interventions: Procedure: Group1; Procedure: Group2; Procedure: Group3

• Registration Number: NCT05971069
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

" Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation should consider the oncologic safety and liver-related complication. Theoretically, the ALHA preservation is the most ideal in the aspect of liver function protection. However, it is technically difficult which consumes much time. Not only that, oncologic safety could be threatened as some soft tissues, including lymph nodes, could be remained while in preserving the ALHA.

There has been no standardized method to evaluate the ALHA, and to decide whether preserve or ligate it.

This prospective study has been designed to develop the decision algorithm to define the ALHA preservation/ligation, using near-infrared fluorescence imaging during surgery. "

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-17
• Primary Completion: 2023-06-12
• Study Completion: 2023-06-12
• Status Verified: 2023-07
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-24
• Last Update Submitted: 2023-07-24
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients diagnosed with gastric adenocarcinoma pathologically before surgery
2. Patients aged between 20 to 80
3. Patients with an ECOG 0 or 1
4. Patients who were confirmed the presence of aberrant left hepatic artery before or during surgery

Exclusion Criteria

1. Patients with abnormal liver function test befor surgery
2. Patients who diagnosed liver cirrhosis or infectious liver disease
3. Patients who underwent liver resection, or chemotherapy for gastric cancer
4. Patients planned for combined liver resection or cholecystectomy during gastrectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group1	Group1	Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery
Group2	Group2	Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
Group3	Group3	No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery

Primary Outcome Measures

Name	Time	Method
The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging	Real time near-infrared fluorescence image will be obtained during the surgery.	Investigator discretionally designed the decision algorithm for aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging.; The order of the algorithm is as follows: First, when surgeons identify the aberrant left hepatic artery during surgery, clamping the artery and injectioning indocyanine green (5mg/mL) intravenously would be performed.; After that, in a few seconds, liver perfusion could be detected through real time near-infrared fluorescence imaging.; The ligation or preservation of the aberrant left hepatic artery would be decided according to the proportion of the near-infrared fluorescence imaging defect. Investigator's like to confirm the safety and efficacity of this decision algorithm.

Secondary Outcome Measures

Name	Time	Method
Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT)	Serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) will be estimated in postoperative 1st, 2nd, 3rd and 5th day.	The elevated proprtion of the serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) compared to preoperative value will be calculated and compared by groups.

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of