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CLASS-11: Indocyanine Green Tracer Using in Laparoscopic Radical Gastrectomy for Locally Advanced Gastric Cancer

Sponsor
Fujian Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04593615
Collaborator
(none)
1,070
Enrollment
2
Arms
58.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Patients with locally advanced gastric adenocarcinoma (CT2-4A N-/+ 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ICG near-infrared imaging
 Phase 3

Detailed Description

  1. Research purpose Patients with locally advanced gastric adenocarcinoma (CT2-4A N-/+ 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

  2. Research design prospective, multicenter, randomized controlled, open-control, Parallel assignment, superiority test 2.1 multicenter This study came from Fujian Medical university union hospital, Beijing University Cancer Hospital, Zhongshan Hospital, Fudan University, The First Hospital of Pu Tian City, Zhangzhou Affiliated Hospital of Fujian Medical University, Affiliated Cancer Hospital of Harbin Medical University, The first affiliated Hospital of Ji Lin University ,Nan fang Hospital, Southern Medical University, The first affiliated Hospital of Nan Jing University, Affiliated Hospital of Qinghai University, Qi Lu Hospital of Shang Dong University, Ren ji Hospital, Shanghai Jiao Tong University School of Medicine, Air Force Medical University（Fourth Military Medical University）Tang du Hospital, The first affiliated Hospital of USTC AnHui Provincial Hospital, Cancer Hospital Chinese academy of Medical Science, Sun Yat-Sen University Cancer Center, which jointly attended by 16 centers.

2.2 Case group Group A (Study Group): Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group) Group B (Control Group): Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group) 2.3 Estimate Sample Size 3 years disease-free survival (DFS) is the main effectiveness evaluation index in this study. The study is superiority test, assuming that the team's three years DFS is better than that of control group,23, according to previous research results of laparoscopic local advanced gastric cancer surgery ,three years DFS is 65.2%, the control group 3 years DFS is 65.2%, assuming that the experimental group 3 years DFS can be increased by 9%, that is 74.2%, inspection level 0.025 (unilateral), take 0.9 inspection efficiency, using PASS 11 Logrank tests (Lakatos)[Proportion surviving] Calculated: Sample size N=428, that is, each group needed 428 people to consider possible exclusion and loss of follow-up cases (20% drop rate). The final sample size for each group was 535 cases, and a total of 1070 cases were initially assigned to 66-67 cases in each center 2.4 randomization Stay into the group of cases after laparoscopic exploration, make sure comply with the standards, can be randomized groups in this study we adopt the central dynamic layered segment randomized method, considering the control factors are age, gender tumor site preoperative staging research center of the given seed number and segment length, application of SAS9.2 programming to produce serial number is 0001 ~ 1070 by corresponding treatment allocation, reserved in the data center and research center has the specialist is responsible for the cases of group information (age, gender tumor site preoperative staging research center) via email A telephone call or text message will be sent to the randomization implementation department of the data center, and the central randomization department will analyze the case information to determine the case enrollment and inform the research center where the case is located 2.5 Blinding Method: This research adopts an open design. 2.6 Research cycle: Estimated enrollment cycle: complete enrollment within 2 years. Follow-up period: the enrollment of the first case and the postoperative pathological report (generally 2 weeks after surgery) was the end point of follow-up for secondary study purposes other than 3-year overall survival rate and 3-year recurrence type Estimated time: 2020.10（to complete enrollment）-2022.09（to complete follow-up）

  1. Study Objects All patients who meet the inclusion criteria and do not conform to the exclusion criteria are qualified for this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1070 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Anticipated Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group)

Procedure: ICG near-infrared imaging
Indocyanine green tracer is used to guide laparoscopic D2 lymph node dissection for gastric cancer
Placebo Comparator: Group B

Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group)

Procedure: ICG near-infrared imaging
Indocyanine green tracer is used to guide laparoscopic D2 lymph node dissection for gastric cancer

Outcome Measures

Primary Outcome Measures

  1. 3-year disease free survival rate [3 years]

    Disease-free survival is calculated from the day of surgery to the day of recurrence or death

Secondary Outcome Measures

  1. Total number of retrieved lymph nodes [30 days]

    Total number of retrieved lymph nodes

  2. Lymph node noncompliance rate [30 days]

    Lymph node noncompliance rate

  3. Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A [30 days]

    Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A

  4. Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate) [30 days]

    Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)

  5. Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate) [30 days]

    Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)

  6. Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate) [30 days]

    Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age from 18 to 75 years

  2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy

  3. cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition

  4. No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs 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)

  4. History of previous gastric surgery (including ESD/EMR for gastric cancer)

  5. Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky No.10 lymph nodes

  6. Other malignant disease within the past 5 years

  7. History of previous neoadjuvant chemotherapy or radiotherapy

  8. History of unstable angina or myocardial infarction within past six months

  9. History of cerebrovascular accident within past six months

  10. History of continuous systematic administration of corticosteroids within one month

  11. Requirement for simultaneous surgery for other disease

  12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

  13. FEV1 (forced expiratory volume in one second)<50% of predicted values

  14. Linitis plastica, Widespread

  15. Preoperatively, tumors involving the dentate line or duodenum were confirmed

  16. A history of iodine allergy

  17. Refuse laparoscopic surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fujian Medical University

Investigators

  • Principal Investigator: Chang-Ming Huang, Pro., Fujian Medical University Union Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang-Ming Huang, Prof., Professor, Fujian Medical University Union Hospital
ClinicalTrials.gov Identifier:
NCT04593615
Other Study ID Numbers:
  • CLASS-11
First Posted:
Oct 20, 2020
Last Update Posted:
Oct 20, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chang-Ming Huang, Prof., Professor, Fujian Medical University Union Hospital
Indocyanine Green Tracer
Laparoscopic Gastrectomy
Gastric Cancer
Additional relevant MeSH terms:
Stomach Neoplasms

Study Results

No Results Posted as of Oct 20, 2020