UnknownPhase 2

Effect of CNSI vs. ICG in Lymph Node Tracing During Gastrectomy

China96 participantsStarted 2022-01-20

Plain-language summary

The purpose of this study is to assess the efficacy and safety of carbon nanoparticle suspension injection and indocyanine green tracer-guided lymph node dissection during gastrectomy in patients with gastric cancer

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 1-4a (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 pancreas, spleen or other organs nearby in the preoperative examinations
✓. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
✓. American Society of Anesthesiology score (ASA) class I, II, or III
✓. Written informed consent

Exclusion criteria

✕. 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
✕. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
✕. History of other malignant disease within past five years
✕. History of previous neoadjuvant chemotherapy or radiotherapy
✕. History of unstable angina or myocardial infarction within past six months

What they're measuring

Total Number of Retrieved Lymph Nodes

Timeframe: 10 days

Trial details

NCT IDNCT05229874

SponsorHebei Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-09

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