Gastric CancerNCT05369117
Application of Indocyanine Green Labeled Fluorescent Laparoscopy in Proximal Gastric Cancer
A study testing indocyanine green labeled fluorescent laparoscopy in people with Gastric Cancer, run by Guangyong Zhang.
Trial summary
Recently, laparoscopic gastrectomy has been gradually accepted by surgeons worldwide for gastric cancer treatment. Complete dissection of the lymph nodes and the establishment of the surgical margin are the most important considerations for curative gastric cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- indocyanine green labeled fluorescent laparoscopy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,016 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2022to 6 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years old < age < 75 years old
- The primary gastric lesion was pathologically diagnosed as proximal gastric adenocarcinoma by endoscopic biopsy (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR)
- Preoperative clinical staging was CT1-4A, N-/+, and M0, according to AJCC-8th TNM tumor staging
- No distant metastasis was found in preoperative examination, and the tumor did not directly invade pancreas, spleen or other adjacent organs
- ECOG physical status score 0/1 before surgery Preoperative ASA score I-III
- Informed consent of patients
Who cannot join
- Suffering from severe mental illness
- Severe complications cannot tolerate surgery
- Simultaneous surgical treatment of other diseases is required
- History of gastric surgery (including ESD/EMR for gastric cancer)
- Tumors involving esophagus or duodenum were confirmed preoperatively
- Neoadjuvant therapy has been implemented
- Leather stomach
- Refusing laparoscopic surgery
About this study
Official title: To Evaluate Whether the Clinical Efficacy of Laparoscopic Lymph Node Dissection With Indocyanine Green Tracer is Better Than Without Indocyanine Green Tracer
Recently, laparoscopic gastrectomy has been gradually accepted by surgeons worldwide for gastric cancer treatment. Complete dissection of the lymph nodes and the establishment of the surgical margin are the most important considerations for curative gastric cancer surgery. Previous studies have demonstrated that indocyanine green (ICG)-traced laparoscopic gastrectomy significantly improves the completeness of lymph node dissection. However, it remains difficult to identify the tumor location intraoperatively for gastric cancers that are staged ≤T3. Here, the investigatorsinvestigated the feasibility of ICG fluorescence for lymph node mapping and tumor localization during totally laparoscopic distal gastrectomy.Preoperative and perioperative data from consecutive patients with gastric cancer who underwent a laparoscopic proximal gastrectomy were collected and analyzed. The investigators want to know if near-infrared fluorescence imaging with ICG can be successfully used in laparoscopic proximal gastrectomy, and if it contributes to both the completeness of D2 lymph node dissection and confirmation of the gastric transection line. The application of ICG labeled near infrared imaging fluorescence laparoscopic technology is still in the stage of exploration and experience accumulation, and it needs to be comprehensively evaluated through a large number of prospective randomized controlled studies.
Read the detailed description
Recently, laparoscopic gastrectomy has been gradually accepted by surgeons worldwide for gastric cancer treatment. Complete dissection of the lymph nodes and the establishment of the surgical margin are the most important considerations for curative gastric cancer surgery. Previous studies have demonstrated that indocyanine green (ICG)-traced laparoscopic gastrectomy significantly improves the completeness of lymph node dissection. However, it remains difficult to identify the tumor location intraoperatively for gastric cancers that are staged ≤T3. Here, the investigatorsinvestigated the feasibility of ICG fluorescence for lymph node mapping and tumor localization during totally laparoscopic distal gastrectomy.Preoperative and perioperative data from consecutive patients with gastric cancer who underwent a laparoscopic proximal gastrectomy were collected and analyzed. The investigators want to know if near-infrared fluorescence imaging with ICG can be successfully used in laparoscopic proximal gastrectomy, and if it contributes to both the completeness of D2 lymph node dissection and confirmation of the gastric transection line. The application of ICG labeled near infrared imaging fluorescence laparoscopic technology is still in the stage of exploration and experience accumulation, and it needs to be comprehensively evaluated through a large number of prospective randomized controlled studies.By recruiting patients and signing informed consent, randomized control was used to divide patients into the experimental group (fluorescently labeled fluorescently laparoscopic proximal gastric cancer surgery) and the control group (fluorescently labeled fluorescently laparoscopic proximal gastric cancer surgery). In the experimental group, indocyanine green fluorescence labeling was performed under gastroscope before surgery and internal jugular vein puncture was performed routinely for better fluid replenishment after surgery. Lymph nodes and diseased stomach tissues were collected during operation. Postoperative assessment was made for ICU support, routine acid-suppressing therapy, prophylactic antibiotics, analgesia, and nausea suppression. The patients were followed up for 3 years. The primary outcome was 3-year disease-free survival, and the secondary outcome was lymph node positive rate, early complication rate and surgical mortality. The investigators plan to obtain more precise evidence-based medical evidence through this project.
- Conditions
- Gastric Cancer
- Being tested
- indocyanine green labeled fluorescent laparoscopy
- Keywords
- 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.
indocyanine green labeled fluorescent laparoscopyBehavioural
indocyanine green fluorescence labeling was performed under gastroscope before surgery and internal jugular vein puncture was performed routinely for better fluid replenishment after surgery
| Study group | Role | What they receive |
|---|---|---|
| indocyanine green labeled fluorescent laparoscopy | Experimental | The experimental group was marked with indocyanine green, while the control group was not marked with indocyanine green Receives: Behavioral: indocyanine green labeled fluorescent laparoscopy |
| The pathological staging | Experimental | They were grouped by different pathological stages Receives: Behavioral: indocyanine green labeled fluorescent laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-year disease-free survival rate
To evaluate the difference of 3-year disease-free survival rate between the experimental group and the control group
Measured: Through study completion，an average of 3 years
Secondary outcomes (3)
lymph node positive rate
To evaluate the difference oflymph node positive rate between the experimental group and the control group
Measured: up to 1 week
Incidence of early complications
The incidence of lymphatic leakage, shock and gastric stump leakage were used as secondary outcome measures
Measured: up to 1 week
operative mortality
To investigate whether the mortality of laparoscopic proximal gastric cancer surgery marked with indocyanine green was lower than that of the control group
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start31 May 2022 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion6 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,016 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangyong Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guangyong Zhang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369117
- Sponsor's protocol ID
- YXLL-KY-2022(021)
- Status last verified
- May 2022
- First submitted
- 25 Apr 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate Whether the Clinical Efficacy of Laparoscopic Lymph Node Dissection With Indocyanine Green Tracer is Better Than Without Indocyanine Green Tracer
- ClinicalTrials.gov ID
- NCT05369117
- Acronym / sponsor ID
- YXLL-KY-2022(021)
- Conditions
- Gastric Cancer
- Keywords
- Indocyanine green
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,016 participants (estimated)
- Lead sponsor
- Guangyong ZhangUniversity, hospital or other
- Study start
- 31 May 2022 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 6 May 2027 (estimated)
- First posted
- 11 May 2022 (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.
Recently, laparoscopic gastrectomy has been gradually accepted by surgeons worldwide for gastric cancer treatment. Complete dissection of the lymph nodes and the establishment of the surgical margin are the most important considerations for curative gastric cancer surgery. Previous studies have demonstrated that indocyanine green (ICG)-traced laparoscopic gastrectomy significantly improves the completeness of lymph node dissection. However, it remains difficult to identify the tumor location intraoperatively for gastric cancers that are staged ≤T3. Here, the investigatorsinvestigated the feasibility of ICG fluorescence for lymph node mapping and tumor localization during totally laparoscopic distal gastrectomy.Preoperative and perioperative data from consecutive patients with gastric cancer who underwent a laparoscopic proximal gastrectomy were collected and analyzed. The investigators want to know if near-infrared fluorescence imaging with ICG can be successfully used in laparoscopic proximal gastrectomy, and if it contributes to both the completeness of D2 lymph node dissection and confirmation of the gastric transection line. The application of ICG labeled near infrared imaging fluorescence laparoscopic technology is still in the stage of exploration and experience accumulation, and it needs to be comprehensively evaluated through a large number of prospective randomized controlled studies.
Detailed description
Recently, laparoscopic gastrectomy has been gradually accepted by surgeons worldwide for gastric cancer treatment. Complete dissection of the lymph nodes and the establishment of the surgical margin are the most important considerations for curative gastric cancer surgery. Previous studies have demonstrated that indocyanine green (ICG)-traced laparoscopic gastrectomy significantly improves the completeness of lymph node dissection. However, it remains difficult to identify the tumor location intraoperatively for gastric cancers that are staged ≤T3. Here, the investigatorsinvestigated the feasibility of ICG fluorescence for lymph node mapping and tumor localization during totally laparoscopic distal gastrectomy.Preoperative and perioperative data from consecutive patients with gastric cancer who underwent a laparoscopic proximal gastrectomy were collected and analyzed. The investigators want to know if near-infrared fluorescence imaging with ICG can be successfully used in laparoscopic proximal gastrectomy, and if it contributes to both the completeness of D2 lymph node dissection and confirmation of the gastric transection line. The application of ICG labeled near infrared imaging fluorescence laparoscopic technology is still in the stage of exploration and experience accumulation, and it needs to be comprehensively evaluated through a large number of prospective randomized controlled studies.By recruiting patients and signing informed consent, randomized control was used to divide patients into the experimental group (fluorescently labeled fluorescently laparoscopic proximal gastric cancer surgery) and the control group (fluorescently labeled fluorescently laparoscopic proximal gastric cancer surgery). In the experimental group, indocyanine green fluorescence labeling was performed under gastroscope before surgery and internal jugular vein puncture was performed routinely for better fluid replenishment after surgery. Lymph nodes and diseased stomach tissues were collected during operation. Postoperative assessment was made for ICU support, routine acid-suppressing therapy, prophylactic antibiotics, analgesia, and nausea suppression. The patients were followed up for 3 years. The primary outcome was 3-year disease-free survival, and the secondary outcome was lymph node positive rate, early complication rate and surgical mortality. The investigators plan to obtain more precise evidence-based medical evidence through this project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| indocyanine green labeled fluorescent laparoscopy | Experimental | Behavioral: indocyanine green labeled fluorescent laparoscopyThe experimental group was marked with indocyanine green, while the control group was not marked with indocyanine green |
| The pathological staging | Experimental | Behavioral: indocyanine green labeled fluorescent laparoscopyThey were grouped by different pathological stages |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old < age < 75 years old
- The primary gastric lesion was pathologically diagnosed as proximal gastric adenocarcinoma by endoscopic biopsy (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR)
- Preoperative clinical staging was CT1-4A, N-/+, and M0, according to AJCC-8th TNM tumor staging
- No distant metastasis was found in preoperative examination, and the tumor did not directly invade pancreas, spleen or other adjacent organs
- ECOG physical status score 0/1 before surgery Preoperative ASA score I-III
Key exclusion criteria (8 listed)
- Suffering from severe mental illness
- Severe complications cannot tolerate surgery
- Simultaneous surgical treatment of other diseases is required
- History of gastric surgery (including ESD/EMR for gastric cancer)
- Tumors involving esophagus or duodenum were confirmed preoperatively
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 |
|---|---|---|
| indocyanine green labeled fluorescent laparoscopyindocyanine green fluorescence labeling was performed under gastroscope before surgery and internal jugular vein puncture was performed routinely for better fluid replenishment after surgery | Behavioural | The pathological staging, indocyanine green labeled fluorescent laparoscopy |
Primary outcome
Three-year disease-free survival rate
Time frame: Through study completion，an average of 3 years
To evaluate the difference of 3-year disease-free survival rate between the experimental group and the control group
3 secondary outcomes
lymph node positive rate
Time frame: up to 1 week
Incidence of early complications
Time frame: up to 1 week
operative mortality
Time frame: up to 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing indocyanine green labeled fluorescent laparoscopy in people with Gastric Cancer, run by Guangyong Zhang.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Three-year disease-free survival rate (time frame: Through study completion，an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2022.