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

NCT05971069 | Completed

• 1 other identifier: 3-2021-0376
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. "

Conditions

Stomach Neoplasm

Outcome Measures

Primary Outcomes (1)

• The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging

  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.

  Real time near-infrared fluorescence image will be obtained during the surgery.

Secondary Outcomes (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.

Study Arms (3)

Group1

EXPERIMENTAL

Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery

Procedure: Group1

Group2

EXPERIMENTAL

Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery

Procedure: Group2

Group3

EXPERIMENTAL

No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery

Procedure: Group3

Interventions

Group1 PROCEDURE

Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery

Group1

Group2 PROCEDURE

Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery

Group2

Group3 PROCEDURE

No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery

Group3

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Enrolled patients will be divided into three groups according to the real time near-infrared fluorescence imaging during surgery.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: August 2, 2023
• Study Start: December 17, 2021
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-07

Locations

KR (1)