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Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer

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ClinicalTrials.gov Identifier: NCT05618821
Recruitment Status : Recruiting
First Posted : November 16, 2022
Last Update Posted : November 16, 2022
Sponsor:
Information provided by (Responsible Party):
Chang-Ming Huang, Prof., Fujian Medical University

Tracking Information
First Submitted Date  ICMJE June 3, 2022
First Posted Date  ICMJE November 16, 2022
Last Update Posted Date November 16, 2022
Actual Study Start Date  ICMJE June 3, 2022
Estimated Primary Completion Date April 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2022)		 Total Number of Retrieved Lymph Nodes [ Time Frame: 30 days ]
Total Number of Retrieved Lymph Nodes
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2022)
  • Lymph node noncompliance rate [ Time Frame: 30 days ]
    Lymph node noncompliance rate
  • 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
  • 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)
  • 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)
  • 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)
  • Number of Metastasis Lymph Nodes [ Time Frame: 30 days ]
    Number of Metastasis Lymph Nodes
  • Metastasis rate of lymph node [ Time Frame: 30 days ]
    Metastasis rate of lymph node
  • Postoperative morbidity rate [ Time Frame: 30 days ]
    Postoperative morbidity rate
  • Postoperative mortality rate [ Time Frame: 30 days ]
    Postoperative mortality rate
  • 3-year overall survival rate [ Time Frame: 3 years ]
    3-year overall survival rate
  • 3-year disease-free survival rate [ Time Frame: 3 years ]
    3-year disease-free survival rate
  • 3-year recurrence pattern [ Time Frame: 3 years ]
    3-year recurrence pattern
  • Postoperative recovery course [ Time Frame: 30 days ]
    Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay
  • Intraoperative situation [ Time Frame: 30 days ]
    Operation time, intraoperative blood loss, and intraoperative morbidity rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer
Official Title  ICMJE Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE Drug: Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer
Study Arms  ICMJE
  • Experimental: ICG
    Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group)
    Intervention: Drug: Indocyanine Green Tracer
  • Active Comparator: Non-ICG
    Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group)
    Intervention: Drug: Indocyanine Green Tracer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2022)		 68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2028
Estimated Primary Completion Date April 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hualong Zheng +8618359190587 291167038@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05618821
Other Study ID Numbers  ICMJE FUGES-027
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Chang-Ming Huang, Prof., Fujian Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fujian Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fujian Medical University
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP