Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Medical University
About this trial
This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from 18 to 75 years
Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
Clinical stage tumor T1 (cT1), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound
No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
Disqualifiers
Women during pregnancy or breast-feeding
Severe mental disorder
History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
Trial design
Design model
Single group
Treatments tested in this trial
Indocyanine Green
DrugLaparoscopic distal gastrectomy with lymph node dissection for early gastric cancer using Indocyanine Green Tracer
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: Experimental: Indocyanine Green TracerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
False negative rate
The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes
Time frame
One month after surgerySecondary outcomes
1
True positive rate
The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes
Time frame
One month after surgery2
False positive rate
The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes
Time frame
One month after surgery3
True negative rate
The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes
Time frame
One month after surgery4
Total number of retrieved lymph nodes
Total number of retrieved lymph nodes
Time frame
One month after surgerySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: