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Trial Title:
Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer
NCT ID:
NCT05618821
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Indocyanine Green Tracer
Laparoscopic Gastrectomy
Remnant Gastric Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Indocyanine Green Tracer
Description:
Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using
Indocyanine Green Tracer
Arm group label:
ICG
Arm group label:
Non-ICG
Summary:
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.
Detailed description:
Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application
in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer is at
the stage of cases accumulation, method studying and clinical research. There is no
prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using
in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer. On the
basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for
remnant gastric cancer, we want to apply the Indocyanine Green Tracer, a cheap, easy to
operate and no radiation pollution way, to predict the positive lymph nodes in remnant
gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant
gastric cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age from 18 to 75 years
2. 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
Exclusion Criteria:
1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy
and gastrectomy)
4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
5. Rejection of laparoscopic resection
6. History of allergy to iodine agents
7. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
8. History of other malignant disease within past five years
9. History of previous neoadjuvant chemotherapy or radiotherapy
10. History of unstable angina or myocardial infarction within the past six months
11. History of unstable angina or myocardial infarction within past six months
12. History of continuous systematic administration of corticosteroids within one month
13. Requirement of simultaneous surgery for another disease
14. Emergency surgery due to complications (bleeding, obstruction or perforation) caused
by gastric cancer
15. FEV1<50% of the predicted values
16. Linitis plastica, Widespread
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hualong Zheng
Phone:
+8618359190587
Email:
291167038@qq.com
Start date:
June 3, 2022
Completion date:
April 1, 2028
Lead sponsor:
Agency:
Fujian Medical University
Agency class:
Other
Source:
Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05618821
