search
Back to results

Effect of CNSI vs. ICG in Lymph Node Tracing During Gastrectomy (FUTURE-01)

Primary Purpose

Gastric Cancer

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
carbon nanoparticles
Indocyanine green
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. clinical stage tumor 1-4a (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 Eastern Cooperative Oncology Group scale (ECOG)
  6. American Society of Anesthesiology score (ASA) class I, II, or 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 laparoscopic cholecystectomy)
  4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  5. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  6. History of other malignant disease within past five 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 of simultaneous surgery for other disease
  12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  13. FEV1<50% of predicted values
  14. Diffuse; widespread; plastica

Sites / Locations

  • Fourth Affiliated Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carbon nanoparticle suspension injection (CNSI) group

Indocyanine green (ICG) group

Arm Description

CNSI (50 mg/dose) was produced by Chongqing Lesmei Pharmaceutical Co., Ltd.: Carbon nanoparticles were marked in the endoscopy division 1 day before surgery, and CNSI was injected submucosally at 4 points (proximal side, distal side, and left and right sides) 0.5-1 cm from the tumor edge under endoscopy. The test dose for each point was approximately 0.25 ml.

ICG (25 mg/dose) was produced by Dandong Yichuang Pharmaceutical. ICG was marked in the endoscopy division 1 day before surgery and injected submucosally at 4 points (proximal side, distal side, and left and right sides) 0.5-1 cm from the tumor edge under endoscopy. The test dose for each point was approximately 0.5 ml. Both procedures were performed by a designated medical practitioner.

Outcomes

Primary Outcome Measures

Total Number of Retrieved Lymph Nodes
Compare total number of retrieved lymph nodes in both group.

Secondary Outcome Measures

The rate of black-stained/fluorescence
The number of black-stained/fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group
Positive rate
The number of positive lymph nodes in black-stained/fluorescent lymph nodes is divided by the number of total black-stained/fluorescent lymph nodes in experimental group
False positive rate
The number of negative lymph nodes in black-stained/fluorescent lymph nodes is divided by the number of total black-stained/fluorescent lymph nodes in experimental group
Negative rate
The number of negative lymph nodes in not black-stained/fluorescent lymph nodes is divided by the number of total not black-stained/fluorescent lymph nodes in experimental group
False negative rate
The number of positive lymph nodes in not black-stained/fluorescent lymph nodes is divided by the number of total not black-stained/fluorescent lymph nodes in experimental group
Number of Metastasis Lymph Nodes
Compare number of positive lymph nodes in both group.
Morbidity and mortality rates
This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.
3-year disease free survival rate
Disease-free survival is calculated from the day of surgery to the day of recurrence (When the specific date of recurrence of the tumor is unknown, the ending point is the date of death due to tumor causes). In the event that neither death nor recurrence of the tumor are observed, the end point is the final date that a patient is confirmed as relapse-free.
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Intraoperative blood loss
Intraoperative blood loss
Postoperative lymph node anatomy duration
Postoperative lymph node anatomy duration

Full Information

First Posted
January 15, 2022
Last Updated
October 17, 2023
Sponsor
Hebei Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05229874
Brief Title
Effect of CNSI vs. ICG in Lymph Node Tracing During Gastrectomy
Acronym
FUTURE-01
Official Title
A Prospective Randomized Controlled Study of the Efficacy of Carbon Nanoparticles Versus Indocyanine Green in Robotic or Laparoscopic Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
January 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy and safety of carbon nanoparticle suspension injection and indocyanine green tracer-guided lymph node dissection during gastrectomy in patients with gastric cancer
Detailed Description
Da Vinci robot surgery XI system has fluorescence imaging function, which can realize indocyanine green lymph node tracking navigation technology in the operation. At the same time, the lymph node tracking effect of nano carbon suspension injection is not affected by equipment. The flexible mechanical arm of Da Vinci robot combined with the application of lymph node tracing technology makes the lymph node dissection of gastric cancer surgery more thorough, and also reduces the difficulty of surgery. Indocyanine green navigational lymphadenectomy can also be performed by fluorescence laparoscopy. By comparing the two tracer techniques, the lymph node tracer technique which is more suitable for robot or laparoscopic surgery system is selected to provide help and choice for clinical surgeons.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbon nanoparticle suspension injection (CNSI) group
Arm Type
Experimental
Arm Description
CNSI (50 mg/dose) was produced by Chongqing Lesmei Pharmaceutical Co., Ltd.: Carbon nanoparticles were marked in the endoscopy division 1 day before surgery, and CNSI was injected submucosally at 4 points (proximal side, distal side, and left and right sides) 0.5-1 cm from the tumor edge under endoscopy. The test dose for each point was approximately 0.25 ml.
Arm Title
Indocyanine green (ICG) group
Arm Type
Active Comparator
Arm Description
ICG (25 mg/dose) was produced by Dandong Yichuang Pharmaceutical. ICG was marked in the endoscopy division 1 day before surgery and injected submucosally at 4 points (proximal side, distal side, and left and right sides) 0.5-1 cm from the tumor edge under endoscopy. The test dose for each point was approximately 0.5 ml. Both procedures were performed by a designated medical practitioner.
Intervention Type
Drug
Intervention Name(s)
carbon nanoparticles
Other Intervention Name(s)
carbon nanoparticle suspension injection
Intervention Description
Endoscopic injection
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Other Intervention Name(s)
ICG
Intervention Description
Endoscopic injection
Primary Outcome Measure Information:
Title
Total Number of Retrieved Lymph Nodes
Description
Compare total number of retrieved lymph nodes in both group.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
The rate of black-stained/fluorescence
Description
The number of black-stained/fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group
Time Frame
10 days
Title
Positive rate
Description
The number of positive lymph nodes in black-stained/fluorescent lymph nodes is divided by the number of total black-stained/fluorescent lymph nodes in experimental group
Time Frame
10 days
Title
False positive rate
Description
The number of negative lymph nodes in black-stained/fluorescent lymph nodes is divided by the number of total black-stained/fluorescent lymph nodes in experimental group
Time Frame
10 days
Title
Negative rate
Description
The number of negative lymph nodes in not black-stained/fluorescent lymph nodes is divided by the number of total not black-stained/fluorescent lymph nodes in experimental group
Time Frame
10 days
Title
False negative rate
Description
The number of positive lymph nodes in not black-stained/fluorescent lymph nodes is divided by the number of total not black-stained/fluorescent lymph nodes in experimental group
Time Frame
10 days
Title
Number of Metastasis Lymph Nodes
Description
Compare number of positive lymph nodes in both group.
Time Frame
10 days
Title
Morbidity and mortality rates
Description
This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.
Time Frame
30 days
Title
3-year disease free survival rate
Description
Disease-free survival is calculated from the day of surgery to the day of recurrence (When the specific date of recurrence of the tumor is unknown, the ending point is the date of death due to tumor causes). In the event that neither death nor recurrence of the tumor are observed, the end point is the final date that a patient is confirmed as relapse-free.
Time Frame
36 months
Title
3-year recurrence pattern
Description
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time Frame
36 months
Title
Intraoperative blood loss
Description
Intraoperative blood loss
Time Frame
1 day
Title
Postoperative lymph node anatomy duration
Description
Postoperative lymph node anatomy duration
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy clinical stage tumor 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) American Society of Anesthesiology score (ASA) class I, II, or III Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy) History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection 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 past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of predicted values Diffuse; widespread; plastica
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qun Zhao
Organizational Affiliation
Departments of Third Surgery, Fourth Hospital of Hebei Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Fourth Affiliated Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China

12. IPD Sharing Statement

Learn more about this trial

Effect of CNSI vs. ICG in Lymph Node Tracing During Gastrectomy

We'll reach out to this number within 24 hrs