NCT04593615Active, not recruiting
Indocyanine Green Tracer Using in Laparoscopic Radical Gastrectomy for Locally Advanced Gastric Cancer
Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy with Lymph Node Dissection for Locally Advanced Gastric Cancer (CLASS-11)
Source: ClinicalTrials.gov · Last updated 30 Dec 2024
Brief summary (registry, in English)
Patients with locally advanced gastric adenocarcinoma (CT2-4a N0/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic D2 lymph node dissection for gastric cancer by comparing injection ICG group and non-injection ICG group.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1070 (actual)
- First submitted
- 16 Oct 2020
- Start date
- 10 Nov 2020
- Primary completion date
- 17 Aug 2026
- Lead sponsor
- Fujian Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04593615
What you commit to
- Study type: Interventional
- Participants enrolled: 1070
- From 10 Nov 2020 to the primary completion date, 17 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR for gastric cancer)
- History of previous neoadjuvant chemotherapy or radiotherapy
- Patients who declined laparoscopic surgery
Other illness
- Severe mental disorder
- Other malignant disease within the past 5 years
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement for simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- Diffuse invasive gastric cancer
- History of an iodine allergy
Other
- Women during pregnancy or breast-feeding
- Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky No.10 lymph nodes
- FEV1 (forced expiratory volume in one second)\<50% of predicted values
- Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum
Who the study is looking for
- Age from 18 to 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition
- No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations
- Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.