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3D fluorescent laparoscopy in laparoscopic radical gastrectomy for gastric cancer: a prospective randomized controlled clinical study

3D fluorescent laparoscopy in laparoscopic radical gastrectomy for gastric cancer: a prospective randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062914
Enrollment
Unknown
Registered
2022-08-23
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

experimental group:lymph node dissection guided by 3D fluorescent laparoscopy and ICG NIR imaging
control group:D2 lymph node dissection with Common visible light source 3D laparoscopy

Sponsors

Peking University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Aged between 18 and 80 Primary gastric adenocarcinoma confirmed histologically (papillary, tubular, mucinous, signed-ring cell, poorly differentiated) Clinical stages were cT1-4a, Nany, M0 according to the 8th edition of AJCC staging With or without neoadjuvant chemotherapy ECOG score 0 or 1 A KPS score of 70 or higher Sign written informed consent

Exclusion criteria

Exclusion criteria: Pregnant or breastfeeding women Severe mental illness /serious underlying illness or condition: Such as clinically severe (activities) heart disease, serious, uncontrolled medical disease and infection, serious uncontrolled digestive system disorders, severe electrolyte disorder, active disseminated intravascular coagulation; major organ failure, such as decompensated heart, lung, liver, kidney failure, peripheral neuropathy symptoms etc., in which situation that D2 radical gastrectomy was not tolerated. History of upper abdominal surgery (except for laparoscopic cholecystectomy) Previous gastric surgery (excluding ESD and EMR) Preoperative imaging showed tumors larger than 5cm in length, leather stomach or presence of Bulky N lymph nodes (more than 3cm) Other malignancies within 5 years Unstable angina attack or myocardial infarction within 6 months Emergency surgery (due to bleeding, obstruction, perforation, etc.)

Design outcomes

Secondary

MeasureTime frame
Noncompliance rate of lymph nodes;Lymph node metastasis rate;Postoperative complications and perioperative death;Postoperative recovery;operation time;intraoperative blood loss;blood amylase after operation;Postoperative changes in hemoglobin;Postoperative leucocyte changes;Postoperative CRP changes;subjective evaluation of laparoscopic equipment;

Primary

MeasureTime frame
total retrieved Lymph Nodes in D2 region;

Countries

China

Contacts

Public ContactLi Ziyu

Peking University Cancer Hospital

xjy356@pku.edu.cn01088121122

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026