NCT05618821RecruitingPhase 2
Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer
Source: ClinicalTrials.gov · Last updated 16 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- First submitted
- 3 Jun 2022
- Start date
- 3 Jun 2022
- Primary completion date
- 1 Apr 2025
- Lead sponsor
- Fujian Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05618821
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 68
- From 3 Jun 2022 to the primary completion date, 1 Apr 2025
- 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 and gastrectomy)
- History of previous gastric surgery (including ESD/EMR for gastric cancer)
- Rejection of laparoscopic resection
- History of previous neoadjuvant chemotherapy or radiotherapy
Other illness
- Severe mental disorder
- History of allergy to iodine agents
- History of other malignant disease within past five years
- History of unstable angina or myocardial infarction within the past six months
- History of unstable angina or myocardial infarction within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for another disease
- Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
Other
- Women during pregnancy or breast-feeding
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- FEV1\<50% of the predicted values
- Linitis plastica, Widespread
Who the study is looking for
- Age from 18 to 75 years
- Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition)
- (4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations (5) Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale (6) ASA (American Society of Anesthesiology) class I to III (7) 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 | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.