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Completed

NCT Number: NCT05971069

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

" 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. "

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GangnamSeverance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

group1

Procedure

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

group2

Procedure

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

group3

Procedure

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

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

    Time frame: 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 outcomes

  1. Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2023
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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