- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05618821
Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer
November 9, 2022 updated by: Chang-Ming Huang, Prof., Fujian Medical University
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
68
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hualong Zheng
- Phone Number: +8618359190587
- Email: 291167038@qq.com
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350000
- Recruiting
- Fujian Medical University Union Hospital
-
Contact:
- Hualong Zheng
- Phone Number: +8618359190587
- Email: 291167038@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- 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 allergy to iodine agents
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- 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
- FEV1<50% of the predicted values
- Linitis plastica, Widespread
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ICG
Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group)
|
Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer
|
Active Comparator: Non-ICG
Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group)
|
Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Number of Retrieved Lymph Nodes
Time Frame: 30 days
|
Total Number of Retrieved Lymph Nodes
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lymph node noncompliance rate
Time Frame: 30 days
|
Lymph node noncompliance rate
|
30 days
|
Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group
Time Frame: 30 days
|
Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group
|
30 days
|
Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)
Time Frame: 30 days
|
Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)
|
30 days
|
Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)
Time Frame: 30 days
|
Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)
|
30 days
|
Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)
Time Frame: 30 days
|
Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)
|
30 days
|
Number of Metastasis Lymph Nodes
Time Frame: 30 days
|
Number of Metastasis Lymph Nodes
|
30 days
|
Metastasis rate of lymph node
Time Frame: 30 days
|
Metastasis rate of lymph node
|
30 days
|
Postoperative morbidity rate
Time Frame: 30 days
|
Postoperative morbidity rate
|
30 days
|
Postoperative mortality rate
Time Frame: 30 days
|
Postoperative mortality rate
|
30 days
|
3-year overall survival rate
Time Frame: 3 years
|
3-year overall survival rate
|
3 years
|
3-year disease-free survival rate
Time Frame: 3 years
|
3-year disease-free survival rate
|
3 years
|
3-year recurrence pattern
Time Frame: 3 years
|
3-year recurrence pattern
|
3 years
|
Postoperative recovery course
Time Frame: 30 days
|
Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay
|
30 days
|
Intraoperative situation
Time Frame: 30 days
|
Operation time, intraoperative blood loss, and intraoperative morbidity rate
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2022
Primary Completion (Anticipated)
April 1, 2025
Study Completion (Anticipated)
April 1, 2028
Study Registration Dates
First Submitted
June 3, 2022
First Submitted That Met QC Criteria
November 9, 2022
First Posted (Actual)
November 16, 2022
Study Record Updates
Last Update Posted (Actual)
November 16, 2022
Last Update Submitted That Met QC Criteria
November 9, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUGES-027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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