Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06161207

3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer

Led by Fujian Medical University · Updated on 2024-06-24

702

Participants Needed

1

Research Sites

312 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.

CONDITIONS

Official Title

3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from 18 to 75 years
  • Primary gastric adenocarcinoma confirmed by endoscopic biopsy (including papillary, tubular, mucinous, signet ring cell, or poorly differentiated types)
  • Clinical stage cT2-4a, N-/+, M0 based on AJCC Cancer Staging Manual, 8th Edition
  • No distant metastasis or direct invasion of pancreas, spleen, or other adjacent organs
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • American Society of Anesthesiology class I to III
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Women who are pregnant or breastfeeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastric surgery including ESD/EMR for gastric cancer
  • Enlarged or bulky regional lymph node over 3 cm in diameter
  • Other malignant diseases within the past 5 years
  • Previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • Continuous systemic corticosteroid use within one month
  • Need for simultaneous surgery for other diseases
  • Emergency surgery due to complications from gastric cancer such as bleeding, obstruction, or perforation
  • Forced expiratory volume in one second (FEV1) less than 50% of predicted
  • Diffuse invasive gastric cancer
  • History of iodine allergy
  • Patients who declined laparoscopic surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

Actively Recruiting

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Research Team

M

Mi Lin

CONTACT

H

Hua-Long Zheng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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