Indocyanine GreenPhase 3NCT04219332

Randomized Controlled Trial on Effect of Lymph Node Mapping by Indocyanine Green Via Submucosal or Subserosal Injection

A Phase 3 study testing Subserosa injection of indocyanine green and submucosal injection of indocyanine green in people with Indocyanine Green and Gastric Cancer, run by Fujian Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The purpose of this study was to evaluate whether submucosal or subserous injection of indocyanine green during laparoscopic lymphadenectomy for patients with gastric cancer was different. The patients with gastric adenocarcinoma (cT1-4a, N0/+, M0) were studied. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Indocyanine Green, Gastric Cancer, Injection Site
What is being tested?: Subserosa injection of indocyanine green and submucosal injection of indocyanine green
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 266 participants
Where: 1 siteChina
Study dates: 31 Dec 2019to 28 Oct 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 T1-4a (cT1-4a), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound
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

Who cannot join

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
Rejection of laparoscopic resection
History of allergy to iodine agents

Show all 16Show fewer

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
Forced expiratory volume in 1 second (FEV1)<50% of predicted values
Linitis plastica, Widespread

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Gastric Surgery
Fuzhou, Fujian

Other trials in China

About this study

Official title: Comparison of Submucosal and Subserosal Approaches Toward Optimized Indocyanine Green Tracer-Guided Laparoscopic Lymphadenectomy for Patients With Gastric Cancer: The FUGES-019 Randomized Clinical Trial

Read the detailed description

In recent years, with the successful application of ICG (indocyanine green) fluorescence imaging technology in laparoscopic equipment, scholars have found that ICG near-infrared imaging has better tissue penetration and can better identify lymph nodes in hypertrophic adipose tissue than other dyes under visible light, which makes ICG fluorescence imaging guide laparoscopic radical resection of gastric cancer lymph node dissection has become a new exploration direction. ICG near-infrared imaging technology has important research value, good application prospects, and broad development space in laparoscopic radical resection of gastric cancer. However, at present, the application of ICG near-infrared imaging technology in laparoscopic radical resection of gastric cancer is still in the exploratory stage, and there is no unified standard. Therefore, in the world, there is still a lack of high-level evidence-based evidence of large-sample prospective randomized controlled trials to evaluate the effectiveness, safety, and feasibility of submucosal or subserous injection of ICG in guiding laparoscopic D2 resection of gastric cancer. The investigator first carried out this study in the world to evaluate the lymph node dissection and perioperative safety of gastric cancer patients who received a submucosal injection of ICG and subserous injection of ICG during laparoscopic radical gastrectomy in the same period, to promote the standardized development of ICG near-infrared imaging in laparoscopic radical gastrectomy.

Conditions: Indocyanine Green, Gastric Cancer, Injection Site
Being tested: Subserosa injection of indocyanine green, submucosal injection of indocyanine green
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Subserosa injection of indocyanine greenDrug
Also called No other intervention
After preoperative exploration, the indocyanine green powder (Dandong Yichuang Pharmaceutical Co) is dissolved in 0.5 mg/ml of sterile water and the prepared solution (1.5 ml for each point) is injected along the subserosal of the stomach at 6 specific points along the lesser and greater curvature of the stomach.
submucosal injection of indocyanine greenDrug
Also called No other intervention
One day before surgery, 1.25 mg/ml indocyanine green (Dandong Yichuang Pharmaceutical Co) was prepared in sterile water and 0.5 ml of the solution was injected into the submucosal layer at 4 quadrants around the primary tumor, amounting to 2.5 mg of indocyanine green.

Study groups in NCT04219332
Study group	Role	What they receive
Subserosal injection of indocyanine green tracer group	Experimental	Subserosal injection of indocyanine green, with a concentration of 0.5 mg /ml, 6 points along the lesser and greater curvature of the stomach, 1.5 ml for each point. Receives: Drug: Subserosa injection of indocyanine green
Submucosal injection of indocyanine green tracer group	Active comparator	Submucosal injection of indocyanine green, with a concentration of 1.25mg /ml, four points around the primary tumor, each point 0.5 ml. Receives: Drug: submucosal injection of indocyanine green

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Number of Retrieved Lymph Nodes
Total Number of Retrieved Lymph Nodes
Measured: One month after surgery

Secondary outcomes (26)

Total number of fluorescent lymph nodes in groups A and B
Total number of fluorescent lymph nodes in groups A and B
Measured: One month after surgery
Relationship between fluorescent lymph nodes and positive lymph nodes in groups A and B (true positive rate)
Relationship between fluorescent lymph nodes and positive lymph nodes in groups A and B (true positive rate)
Measured: One month after surgery
Relationship between fluorescent lymph nodes and negative lymph nodes in groups A and B (false positive rate)
Relationship between fluorescent lymph nodes and negative lymph nodes in groups A and B (false positive rate)
Measured: One month after surgery
Relationship between non-fluorescent and negative lymph nodes in groups A and B (true negative rate)
Relationship between non-fluorescent and negative lymph nodes in groups A and B (true negative rate)
Measured: One month after surgery
Relationship between non-fluorescent lymph nodes and positive lymph nodes in groups A and B (false negative rate)
Relationship between non-fluorescent lymph nodes and positive lymph nodes in groups A and B (false negative rate)
Measured: One month after surgery
Number of Metastasis Lymph Nodes
Number of Metastasis Lymph Nodes
Measured: One month after surgery
Metastasis rate of lymph node
Metastasis rate of lymph node
Measured: One month after surgery
Mortality rates
This is for the early mortality, which defined as the event observed within 30 days after surgery.
Measured: 30 days
Morbidity rates
This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery.
Measured: 30 days
3-year disease free survival rate
Disease-free survival is calculated from the day of surgery to the day of recurrence or death (When the specific date of recurrence of the tumor is unknown, the endpoint is the date of death due to tumor causes). If neither death nor recurrence of the tumor is observed, the endpoint is the final date that a patient is confirmed as relapse-free. (The final date of DFS: The last date of the outpatient visit day or the date of acceptance of the examination).
Measured: 36 months
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.
Measured: 36 months
Time to first ambulation
Time to first ambulation in hours is used to assess the postoperative recovery course.
Measured: 30 days
Time to first flatus
Time to first flatus in days is used to assess the postoperative recovery course.
Measured: 30 days
Time to first liquid diet
Time to first liquid diet in days is used to assess the postoperative recovery course.
Measured: 30 days
Time to first soft diet
Time to first soft diet in days is used to assess the postoperative recovery course.
Measured: 30 days
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Measured: 30 days
The variation of weight
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Measured: 3, 6, 9 and 12 months
The variation of BMI in kg/m^2
The variation of BMI in kg/m^2 on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Measured: 3, 6, 9 and 12 months
Intraoperative morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Measured: 1 day
The variation of white blood cell count
The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of hemoglobin
The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein
The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
Lymph node noncompliance rate
Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.
Measured: 1 day
Modified EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT14)
Participants were asked to complete one modified European Organisation for Research and Treatment of Cancer (EORTC) IN-PATSAT14 questionnaire before their discharge from hospital.
Measured: 30 days
The Surgery Task Load Index (SURG-TLX)
Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.
Measured: 1 day
3-year overall survival rate
The overall survival is calculated from the day of surgery until death or until the final follow-up date, whichever occurs first. For survival cases, the endpoint is the last date that survival was confirmed. If the loss to follow-up occurred, the endpoint is the final date that survival could be confirmed.
Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 201928 Oct 2023

First posted7 Jan 2020
Study start31 Dec 2019
Primary completion27 Nov 2020
Study completion28 Oct 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Indocyanine GreenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 266 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04219332
Sponsor's protocol ID: FUGES-019
Status last verified: Oct 2023
First submitted: 1 Jan 2020
Last updated: 10 Oct 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lee JH, Ryu KW, Kim CG, Kim SK, Choi IJ, Kim YW, Chang HJ, Bae JM, Hong EK. Comparative study of the subserosal versus submucosal dye injection method for sentinel node biopsy in gastric cancer. Eur J Surg Oncol. 2005 Nov;31(9):965-8. doi: 10.1016/j.ejso.2005.03.006.
PubMed 15908163
Kwon IG, Son T, Kim HI, Hyung WJ. Fluorescent Lymphography-Guided Lymphadenectomy During Robotic Radical Gastrectomy for Gastric Cancer. JAMA Surg. 2019 Feb 1;154(2):150-158. doi: 10.1001/jamasurg.2018.4267.
PubMed 30427990
Cianchi F, Indennitate G, Paoli B, Ortolani M, Lami G, Manetti N, Tarantino O, Messeri S, Foppa C, Badii B, Novelli L, Skalamera I, Nelli T, Coratti F, Perigli G, Staderini F. The Clinical Value of Fluorescent Lymphography with Indocyanine Green During Robotic Surgery for Gastric Cancer: a Matched Cohort Study. J Gastrointest Surg. 2020 Oct;24(10):2197-2203. doi: 10.1007/s11605-019-04382-y. Epub 2019 Sep 4.
PubMed 31485904
Herrera-Almario G, Patane M, Sarkaria I, Strong VE. Initial report of near-infrared fluorescence imaging as an intraoperative adjunct for lymph node harvesting during robot-assisted laparoscopic gastrectomy. J Surg Oncol. 2016 Jun;113(7):768-70. doi: 10.1002/jso.24226. Epub 2016 Mar 29.
PubMed 27021142
Chen QY, Zhong Q, Liu ZY, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Li P, Zheng CH, Huang CM. Does Noncompliance in Lymph Node Dissection Affect Oncological Efficacy in Gastric Cancer Patients Undergoing Radical Gastrectomy? Ann Surg Oncol. 2019 Jun;26(6):1759-1771. doi: 10.1245/s10434-019-07217-x. Epub 2019 Feb 12.
PubMed 30756329
Bredart A, Bottomley A, Blazeby JM, Conroy T, Coens C, D'Haese S, Chie WC, Hammerlid E, Arraras JI, Efficace F, Rodary C, Schraub S, Costantini M, Costantini A, Joly F, Sezer O, Razavi D, Mehlitz M, Bielska-Lasota M, Aaronson NK; European Organisation for Research and Treatment of Cancer Quality of Life Group and Quality of Life Unit. An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32). Eur J Cancer. 2005 Sep;41(14):2120-31. doi: 10.1016/j.ejca.2005.04.041.
PubMed 16182120
Wilson MR, Poolton JM, Malhotra N, Ngo K, Bright E, Masters RS. Development and validation of a surgical workload measure: the surgery task load index (SURG-TLX). World J Surg. 2011 Sep;35(9):1961-9. doi: 10.1007/s00268-011-1141-4.
PubMed 21597890
Tajima Y, Yamazaki K, Masuda Y, Kato M, Yasuda D, Aoki T, Kato T, Murakami M, Miwa M, Kusano M. Sentinel node mapping guided by indocyanine green fluorescence imaging in gastric cancer. Ann Surg. 2009 Jan;249(1):58-62. doi: 10.1097/SLA.0b013e3181927267.
PubMed 19106676
Chen QY, Xie JW, Zhong Q, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Li P, Zheng CH, Huang CM. Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):300-311. doi: 10.1001/jamasurg.2019.6033.
PubMed 32101269
Chen QY, Zhong Q, Li P, Xie JW, Liu ZY, Huang XB, Lin GT, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Zheng QL, Tu RH, Huang ZN, Zheng CH, Huang CM. Comparison of submucosal and subserosal approaches toward optimized indocyanine green tracer-guided laparoscopic lymphadenectomy for patients with gastric cancer (FUGES-019): a randomized controlled trial. BMC Med. 2021 Oct 27;19(1):276. doi: 10.1186/s12916-021-02125-y.
PubMed 34702260

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Head and Neck Squamous Cell Carcinoma
RecruitingPhase 4
Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)
Head and Neck Cancer (H&N), Free Tissue Flaps
Recruiting
Image-Guided Platform-Assisted Sentinel Lymph Node Retrieval in Early Gastric Cancer
Early Gastric Cancer, Gastric Adenocarcinoma
Not yet recruiting
Examination of Rectal Blood Supply During Rectal Cancer Surgery Using Laser Speckle Contrast Imaging
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Recruiting
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All Indocyanine Green trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Submucosal and Subserosal Approaches Toward Optimized Indocyanine Green Tracer-Guided Laparoscopic Lymphadenectomy for Patients With Gastric Cancer: The FUGES-019 Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04219332
Acronym / sponsor ID: FUGES-019
Conditions: Indocyanine Green, Gastric Cancer, Injection Site
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 266 participants (estimated)
Lead sponsor: Fujian Medical UniversityUniversity, hospital or other
Study start: 31 Dec 2019 (actual)
Primary completion: 27 Nov 2020 (actual)
Study completion: 28 Oct 2023 (estimated)
First posted: 7 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Subserosal injection of indocyanine green tracer group	Experimental	Drug: Subserosa injection of indocyanine greenSubserosal injection of indocyanine green, with a concentration of 0.5 mg /ml, 6 points along the lesser and greater curvature of the stomach, 1.5 ml for each point.
Submucosal injection of indocyanine green tracer group	Active comparator	Drug: submucosal injection of indocyanine greenSubmucosal injection of indocyanine green, with a concentration of 1.25mg /ml, four points around the primary tumor, each point 0.5 ml.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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 T1-4a (cT1-4a), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound
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)

Key exclusion criteria (16 listed)

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
Rejection of laparoscopic resection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Subserosa injection of indocyanine greenAlso: No other interventionAfter preoperative exploration, the indocyanine green powder (Dandong Yichuang Pharmaceutical Co) is dissolved in 0.5 mg/ml of sterile water and the prepared solution (1.5 ml for each point) is injected along the subserosal of the stomach at 6 specific points along the lesser and greater curvature of the stomach.	Drug	Subserosal injection of indocyanine green tracer group
submucosal injection of indocyanine greenAlso: No other interventionOne day before surgery, 1.25 mg/ml indocyanine green (Dandong Yichuang Pharmaceutical Co) was prepared in sterile water and 0.5 ml of the solution was injected into the submucosal layer at 4 quadrants around the primary tumor, amounting to 2.5 mg of indocyanine green.	Drug	Submucosal injection of indocyanine green tracer group

Primary outcome

Total Number of Retrieved Lymph Nodes
Time frame: One month after surgery
Total Number of Retrieved Lymph Nodes

26 secondary outcomes

Total number of fluorescent lymph nodes in groups A and B
Time frame: One month after surgery
Relationship between fluorescent lymph nodes and positive lymph nodes in groups A and B (true positive rate)
Time frame: One month after surgery
Relationship between fluorescent lymph nodes and negative lymph nodes in groups A and B (false positive rate)
Time frame: One month after surgery
Relationship between non-fluorescent and negative lymph nodes in groups A and B (true negative rate)
Time frame: One month after surgery
Relationship between non-fluorescent lymph nodes and positive lymph nodes in groups A and B (false negative rate)
Time frame: One month after surgery
Number of Metastasis Lymph Nodes
Time frame: One month after surgery
Metastasis rate of lymph node
Time frame: One month after surgery
Mortality rates
Time frame: 30 days
Morbidity rates
Time frame: 30 days
3-year disease free survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
Time to first ambulation
Time frame: 30 days
Time to first flatus
Time frame: 30 days
Time to first liquid diet
Time frame: 30 days
Time to first soft diet
Time frame: 30 days
Duration of postoperative hospital stay
Time frame: 30 days
The variation of weight
Time frame: 3, 6, 9 and 12 months
The variation of BMI in kg/m^2
Time frame: 3, 6, 9 and 12 months
Intraoperative morbidity rates
Time frame: 1 day
The variation of white blood cell count
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of hemoglobin
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
Lymph node noncompliance rate
Time frame: 1 day
Modified EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT14)
Time frame: 30 days
The Surgery Task Load Index (SURG-TLX)
Time frame: 1 day
3-year overall survival rate
Time frame: 36 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Background: PubMed 15908163Lee JH, Ryu KW, Kim CG, Kim SK, Choi IJ, Kim YW, Chang HJ, Bae JM, Hong EK. Comparative study of the subserosal versus submucosal dye injection method for sentinel node biopsy in gastric cancer. Eur J Surg Oncol. 2005 Nov;31(9):965-8. doi: 10.1016/j.ejso.2005.03.006.
Background: PubMed 30427990Kwon IG, Son T, Kim HI, Hyung WJ. Fluorescent Lymphography-Guided Lymphadenectomy During Robotic Radical Gastrectomy for Gastric Cancer. JAMA Surg. 2019 Feb 1;154(2):150-158. doi: 10.1001/jamasurg.2018.4267.
Background: PubMed 31485904Cianchi F, Indennitate G, Paoli B, Ortolani M, Lami G, Manetti N, Tarantino O, Messeri S, Foppa C, Badii B, Novelli L, Skalamera I, Nelli T, Coratti F, Perigli G, Staderini F. The Clinical Value of Fluorescent Lymphography with Indocyanine Green During Robotic Surgery for Gastric Cancer: a Matched Cohort Study. J Gastrointest Surg. 2020 Oct;24(10):2197-2203. doi: 10.1007/s11605-019-04382-y. Epub 2019 Sep 4.
Background: PubMed 27021142Herrera-Almario G, Patane M, Sarkaria I, Strong VE. Initial report of near-infrared fluorescence imaging as an intraoperative adjunct for lymph node harvesting during robot-assisted laparoscopic gastrectomy. J Surg Oncol. 2016 Jun;113(7):768-70. doi: 10.1002/jso.24226. Epub 2016 Mar 29.
Background: PubMed 30756329Chen QY, Zhong Q, Liu ZY, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Li P, Zheng CH, Huang CM. Does Noncompliance in Lymph Node Dissection Affect Oncological Efficacy in Gastric Cancer Patients Undergoing Radical Gastrectomy? Ann Surg Oncol. 2019 Jun;26(6):1759-1771. doi: 10.1245/s10434-019-07217-x. Epub 2019 Feb 12.
Background: PubMed 16182120Bredart A, Bottomley A, Blazeby JM, Conroy T, Coens C, D'Haese S, Chie WC, Hammerlid E, Arraras JI, Efficace F, Rodary C, Schraub S, Costantini M, Costantini A, Joly F, Sezer O, Razavi D, Mehlitz M, Bielska-Lasota M, Aaronson NK; European Organisation for Research and Treatment of Cancer Quality of Life Group and Quality of Life Unit. An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32). Eur J Cancer. 2005 Sep;41(14):2120-31. doi: 10.1016/j.ejca.2005.04.041.
Background: PubMed 21597890Wilson MR, Poolton JM, Malhotra N, Ngo K, Bright E, Masters RS. Development and validation of a surgical workload measure: the surgery task load index (SURG-TLX). World J Surg. 2011 Sep;35(9):1961-9. doi: 10.1007/s00268-011-1141-4.
Background: PubMed 19106676Tajima Y, Yamazaki K, Masuda Y, Kato M, Yasuda D, Aoki T, Kato T, Murakami M, Miwa M, Kusano M. Sentinel node mapping guided by indocyanine green fluorescence imaging in gastric cancer. Ann Surg. 2009 Jan;249(1):58-62. doi: 10.1097/SLA.0b013e3181927267.
Background: PubMed 32101269Chen QY, Xie JW, Zhong Q, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Li P, Zheng CH, Huang CM. Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):300-311. doi: 10.1001/jamasurg.2019.6033.
Derived from this study: PubMed 34702260Chen QY, Zhong Q, Li P, Xie JW, Liu ZY, Huang XB, Lin GT, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Zheng QL, Tu RH, Huang ZN, Zheng CH, Huang CM. Comparison of submucosal and subserosal approaches toward optimized indocyanine green tracer-guided laparoscopic lymphadenectomy for patients with gastric cancer (FUGES-019): a randomized controlled trial. BMC Med. 2021 Oct 27;19(1):276. doi: 10.1186/s12916-021-02125-y.

Related trials for Indocyanine Green

RecruitingObservational study
Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma
RecruitingPhase 4
Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)
Head and Neck Cancer (H&N), Free Tissue Flaps
Recruiting
Image-Guided Platform-Assisted Sentinel Lymph Node Retrieval in Early Gastric Cancer
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Not yet recruiting
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Recruiting
Robotic Adrenalectomy With Versus Without Indocyanine Green Fluorescence Imaging
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chang-Ming Huang, MD study chair

Fujian Medical University Union Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Retrieved Lymph Nodes (time frame: One month after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04219332, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.