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

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05971069
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 3
• Actual Duration (Months): 17.8
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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. "

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasm	Procedure: Group1; Procedure: Group2; Procedure: Group3	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: Enrolled patients will be divided into three groups according to the real time near-infrared fluorescence imaging during surgery.
• Primary Purpose: Diagnostic
• Official Title: Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging: Prospective Study to Develop Decision Algorithm to Define the Preservation/Ligation of an Aberrant Left Hepatic Artery
• Actual Study Start Date: Dec 17, 2021
• Actual Primary Completion Date: Jun 12, 2023
• Actual Study Completion Date: Jun 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group1 Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery	Procedure: Group1; Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery
Experimental: Group2 Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery	Procedure: Group2; Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
Experimental: Group3 No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery	Procedure: Group3; No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GangnamSeverance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: In Gyu Kwon, Associate Professor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT05971069
• Other Study ID Numbers: 3-2021-0376
• First Posted: Aug 2, 2023
• Last Update Posted: Aug 2, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stomach Neoplasms

Study Results

No Results Posted as of Aug 2, 2023