Fluorescence LaparoscopyNCT03647540
The Application of Fluorescence Laparoscopy in the Treatment of Adenocarcinoma of the Esophagogastric Junction
A study testing fluorescent laparoscopic radical gastrectomy and traditional laparoscopic radical gastrectomy in people with Fluorescence Laparoscopy and Adenocarcinoma of the Esophagogastric Junction, run by Dong Yang at 1 site in China.
Trial summary
The fluorescent laparoscopic technique would be applied to the radical resection of gastric cancer at the junction of esophagus and stomach, and compared with the traditional laparoscopic radical resection of gastric cancer to find a better surgical method for patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fluorescence Laparoscopy, Adenocarcinoma of the Esophagogastric Junction
- What is being tested?
- fluorescent laparoscopic radical gastrectomy and traditional laparoscopic radical gastrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2018to 30 Aug 2022
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. All cases should be diagnosed as adenocarcinoma of the esophagogastric junctionncer by histology. The tumor is within 1 cm above or 2 cm below the anatomic cardia. The clinical stage is T1-3, Nx, M0 for gastric cancer which can undergo the laparoscopic surgery.
- 2. Eastern Cooperative Oncology Group (ECOG) scale 0-2 3. Heart, lung, liver, and kidney function can tolerate operation 4. Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent.
Who cannot join
- 1. history of stomach malignant disease 2. recent diagnosis of other malignant tumors (except for papillary carcinoma of the thyroid gland and basal cell carcinoma of the skin) 3. patients with obstruction, perforation, bleeding requiring emergency surgery 4. a history of abdominal surgery (which makes it difficult to perform laparoscopic procedures), severe systemic disease such as diabetes, severe chronic lung disease, cirrhosis, other malignant diseases 5. combined stomach multiple carcinomas 6. with a history of serious mental illness 7. pregnant or lactating women 8. The researchers believe that the patients are unsuitable to participate in the researchers with other cases.
- -
Trial locations and contacts
1 site in 1 country.
Dong Yang, Master contact
China1 site, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Ch’ang-ch’un, Jilin, 130021
Quan Wang, Professor, 18844097668@163.com
About this study
The fluorescent laparoscopic technique would be applied to the radical resection of gastric cancer at the junction of esophagus and stomach, and compared with the traditional laparoscopic radical resection of gastric cancer to find a better surgical method for patients
- Being tested
- fluorescent laparoscopic radical gastrectomy, traditional laparoscopic radical gastrectomy
- Keywords
- fluorescence laparoscopy, adenocarcinoma of the esophagogastric junction (AEG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescent laparoscopic radical gastrectomyProcedure or surgery
The gastrectomy for group F would be underwent by the fluorescence laparoscopy. All surgical procedures will be performed by the surgery team ,which is leaded by professor Wang Quan.
traditional laparoscopic radical gastrectomyProcedure or surgery
The gastrectomy for group L would be underwent by the laparoscopy.All surgical procedures will be performed by the surgery team ,which is leaded by professor Wang Quan.
| Study group | Role | What they receive |
|---|---|---|
| Group F | Experimental | Group F received endoscopic submucosal injection of indocyanine green (ICG) 2 hours before operation, followed by fluorescent laparoscopic radical gastrectomy. All specimens were grouped for lymph node collection, and the postoperative management was unified according to enhanced recovery after surgery (ERAS). All basic clinical and pathological data were statistically analyzed Receives: Procedure: fluorescent laparoscopic radical gastrectomy |
| Group L | Active comparator | Group L received traditional laparoscopic radical gastrectomy. All specimens were grouped for lymph node collection, and the postoperative management was unified according to enhanced recovery after surgery (ERAS). All basic clinical and pathological data were statistically analyzed Receives: Procedure: traditional laparoscopic radical gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of the dissected lymph nodes
It includes the total number of the dissected lymph nodes and every group of lymph nodes
Measured: in the perioperative period
Secondary outcomes (7)
3-year disease-free survival
Measured: three years after operation]
the incidence of complications
Measured: one month after surgery
the operation time
The descriptive name of unit would be minute (min).
Measured: in the perioperative period
the blood loss during the operation
The descriptive name of unit would be millilitre (ml).
Measured: in the perioperative period
Postoperative recovery of intestinal peristalsis
The descriptive name of unit would be hour (h).
Measured: in the perioperative period
cases converted to open surgery
Measured: in the perioperative period
The mean postoperative hospital stay
The descriptive name of unit would be day (d).
Measured: in the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start30 Aug 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluorescence LaparoscopyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Yang, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647540
- Sponsor's protocol ID
- 130020
- Status last verified
- Apr 2020
- First submitted
- 23 Aug 2018
- Last updated
- 17 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Fluorescence Laparoscopy in the Treatment of Adenocarcinoma of the Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT03647540
- Acronym / sponsor ID
- 130020
- Keywords
- fluorescence laparoscopy, adenocarcinoma of the esophagogastric junction (AEG)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Dong YangUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 27 Aug 2018 (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.
The fluorescent laparoscopic technique would be applied to the radical resection of gastric cancer at the junction of esophagus and stomach, and compared with the traditional laparoscopic radical resection of gastric cancer to find a better surgical method for patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group F | Experimental | Procedure: fluorescent laparoscopic radical gastrectomyGroup F received endoscopic submucosal injection of indocyanine green (ICG) 2 hours before operation, followed by fluorescent laparoscopic radical gastrectomy. All specimens were grouped for lymph node collection, and the postoperative management was unified according to enhanced recovery after surgery (ERAS). All basic clinical and pathological data were statistically analyzed |
| Group L | Active comparator | Procedure: traditional laparoscopic radical gastrectomyGroup L received traditional laparoscopic radical gastrectomy. All specimens were grouped for lymph node collection, and the postoperative management was unified according to enhanced recovery after surgery (ERAS). All basic clinical and pathological data were statistically analyzed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. All cases should be diagnosed as adenocarcinoma of the esophagogastric junctionncer by histology. The tumor is within 1 cm above or 2 cm below the anatomic cardia. The clinical stage is T1-3, Nx, M0 for gastric cancer which can undergo the laparoscopic surgery.
- 2. Eastern Cooperative Oncology Group (ECOG) scale 0-2 3. Heart, lung, liver, and kidney function can tolerate operation 4. Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent.
Key exclusion criteria (2 listed)
- 1. history of stomach malignant disease 2. recent diagnosis of other malignant tumors (except for papillary carcinoma of the thyroid gland and basal cell carcinoma of the skin) 3. patients with obstruction, perforation, bleeding requiring emergency surgery 4. a history of abdominal surgery (which makes it difficult to perform laparoscopic procedures), severe systemic disease such as diabetes, severe chronic lung disease, cirrhosis, other malignant diseases 5. combined stomach multiple carcinomas 6. with a history of serious mental illness 7. pregnant or lactating women 8. The researchers believe that the patients are unsuitable to participate in the researchers with other cases.
- -
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 |
|---|---|---|
| fluorescent laparoscopic radical gastrectomyThe gastrectomy for group F would be underwent by the fluorescence laparoscopy. All surgical procedures will be performed by the surgery team ,which is leaded by professor Wang Quan. | Procedure or surgery | Group F |
| traditional laparoscopic radical gastrectomyThe gastrectomy for group L would be underwent by the laparoscopy.All surgical procedures will be performed by the surgery team ,which is leaded by professor Wang Quan. | Procedure or surgery | Group L |
Primary outcome
the number of the dissected lymph nodes
Time frame: in the perioperative period
It includes the total number of the dissected lymph nodes and every group of lymph nodes
7 secondary outcomes
3-year disease-free survival
Time frame: three years after operation]
the incidence of complications
Time frame: one month after surgery
the operation time
Time frame: in the perioperative period
the blood loss during the operation
Time frame: in the perioperative period
Postoperative recovery of intestinal peristalsis
Time frame: in the perioperative period
cases converted to open surgery
Time frame: in the perioperative period
The mean postoperative hospital stay
Time frame: in the perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer（IDEAL Stage 2b）
Early Gastric Cancer
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Indocyanine Green-Guided Versus Standard Laparoscopic Distal Pancreatectomy for Pancreatic Body and Tail Lesions
Pancreatic Neoplasms, Pancreatic Cancer
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ICG in Colon Cancer
Colon Cancer, ICG (Indocyanine Green)
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Acute Cholecystitis Biliary Complications - ICG
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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.
Dong Yang, Master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluorescent laparoscopic radical gastrectomy and traditional laparoscopic radical gastrectomy in people with Fluorescence Laparoscopy and Adenocarcinoma of the Esophagogastric Junction, run by Dong Yang at 1 site in China.
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 2 inclusion and 2 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 17 Apr 2020. 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.
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?
Contact Dong Yang, Master (714488468@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of the dissected lymph nodes (time frame: in the perioperative period). 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 17 Apr 2020.