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

Primary Purpose

Stomach Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Group1
Group2
Group3
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stomach Neoplasm

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GangnamSeverance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group1

Group2

Group3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 4, 2023
Last Updated
July 24, 2023
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05971069
Brief Title
Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
June 12, 2023 (Actual)
Study Completion Date
June 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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. "

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study 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.
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group1
Arm Type
Experimental
Arm Description
Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery
Arm Title
Group2
Arm Type
Experimental
Arm Description
Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
Arm Title
Group3
Arm Type
Experimental
Arm Description
No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
Intervention Type
Procedure
Intervention Name(s)
Group1
Intervention Description
Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery
Intervention Type
Procedure
Intervention Name(s)
Group2
Intervention Description
Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
Intervention Type
Procedure
Intervention Name(s)
Group3
Intervention Description
No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
Primary Outcome Measure Information:
Title
The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging
Description
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.
Time Frame
Real time near-infrared fluorescence image will be obtained during the surgery.
Secondary Outcome Measure Information:
Title
Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT)
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
GangnamSeverance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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