A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients
NCT ID: NCT04591028
Last Updated: 2023-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2022-01-31
2022-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Intervention
Injection of Indocyamine Green.
Indocyanine green
A one time injection of IDC prior to the day of scheduled surgery.
Interventions
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Indocyanine green
A one time injection of IDC prior to the day of scheduled surgery.
Eligibility Criteria
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Inclusion Criteria
* Primary gastric adenocarcinoma of any histological subtype confirmed pathologically by endoscopic biopsy.
* Clinical stage tumor T1-4a (cT1-4a), N -/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
* No distant metastasis, no direct invasion of adjacent organs such as pancreas and spleen in preoperative exams.
* American Society of Anesthesiology score (ASA) class I, II, or III.
* Written informed consent.
Exclusion Criteria
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy).
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection.
* History of allergy to iodine agents.
* History of other malignant disease within past five years.
* Emergency surgery due to complication caused by gastric cancer, such as bleeding obstruction or perforation.
* Patients intraoperatively/postoperatively confirmed as T4b.
* Patients intraoperatively confirmed as unable to complete D2 lymph node dissection or R0 dissection.
18 Years
75 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Enrique F. Elli
Principal Investigator
Principal Investigators
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Enrique F Elli, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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20-002747
Identifier Type: -
Identifier Source: org_study_id
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