Rectal CancerNCT03854890
Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy
A study testing Indocyanine Green in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to compare the number of lymph nodes retrieved with or without the use of intraoperative fluorescence lymphography in laparoscopic radical resection of rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 1 May 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of rectal carcinoma.
- Without multiple primary cancer.
- Without receiving neoadjuvant chemoradiotherapy.
- Sufficient organ function.
- Able to provide written informed consent.
Who cannot join
- Younger than 18 years or older than 75 years
- Synchronous or metachronous malignancy within 5 years.
- Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
- Patients with a history of pelvic irradiation.
- ASA (American Society of Anesthesiologists) grade IV or V.
- Women who are pregnant (confirmed by serum β-Human Chorionic Gonadotropin in women of reproductive age) or breast feeding.
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- Severe mental illness.
- Patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery.
- Patients who received steroid therapy within one month.
- Patients or family members misunderstand the conditions and goals of this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Fluorescent Lymphography-Guided Lymphadenectomy Using Indocyanine Green During Laparoscopic Radical Resection Of Rectal Cancer
The purpose of this study is to compare the number of lymph nodes retrieved with or without the use of intraoperative fluorescence lymphography in laparoscopic radical resection of rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Indocyanine Green
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Indocyanine Green will be injected to the submucosal layer around the lesion one day before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lymphadenectomy without indocyanine green injection | No intervention | Laparoscopic lymphadenectomy will be performed in a standard way. |
| Lymphadenectomy with indocyanine green injection | Experimental | Injection of indocyanine green to the submucosal layer around rectal cancer 1 day before surgery. Laparoscopic proctectomy with lymph nodes dissection will be performed under near-infrared imaging. Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total number of lymph nodes retrieved
Measured: During the surgery
The positive number of lymph nodes retrieved
Measured: During the surgery
Secondary outcomes (2)
The duration of the operation to remove the lymph nodes
Measured: During the surgery
Detection rate of indocyanine green-positive para-aortic lymph node
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Jul 2019 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI XIN-XIANG, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854890
- Sponsor's protocol ID
- Fudan FLGI
- Status last verified
- Feb 2019
- First submitted
- 19 Feb 2019
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescent Lymphography-Guided Lymphadenectomy Using Indocyanine Green During Laparoscopic Radical Resection Of Rectal Cancer
- ClinicalTrials.gov ID
- NCT03854890
- Acronym / sponsor ID
- Fudan FLGI
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 26 Feb 2019 (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 purpose of this study is to compare the number of lymph nodes retrieved with or without the use of intraoperative fluorescence lymphography in laparoscopic radical resection of rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphadenectomy without indocyanine green injection | No intervention | –Laparoscopic lymphadenectomy will be performed in a standard way. |
| Lymphadenectomy with indocyanine green injection | Experimental | Drug: Indocyanine GreenInjection of indocyanine green to the submucosal layer around rectal cancer 1 day before surgery. Laparoscopic proctectomy with lymph nodes dissection will be performed under near-infrared imaging. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed diagnosis of rectal carcinoma.
- Without multiple primary cancer.
- Without receiving neoadjuvant chemoradiotherapy.
- Sufficient organ function.
- Able to provide written informed consent.
Key exclusion criteria (10 listed)
- Younger than 18 years or older than 75 years
- Synchronous or metachronous malignancy within 5 years.
- Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
- Patients with a history of pelvic irradiation.
- ASA (American Society of Anesthesiologists) grade IV or V.
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 GreenIndocyanine Green will be injected to the submucosal layer around the lesion one day before surgery. | Drug | Lymphadenectomy with indocyanine green injection |
Primary outcome
The total number of lymph nodes retrieved
Time frame: During the surgery
The positive number of lymph nodes retrieved
Time frame: During the surgery
2 secondary outcomes
The duration of the operation to remove the lymph nodes
Time frame: During the surgery
Detection rate of indocyanine green-positive para-aortic lymph node
Time frame: During the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green in people with Rectal Cancer, run by Fudan University 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 5 inclusion and 10 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 14 May 2019. 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 Xinxiang Li, MD,PhD (+8613761291659, lxx1149@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total number of lymph nodes retrieved (time frame: During the surgery). The study lists 2 primary outcomes in all. 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 14 May 2019; AzTrials last refreshed its copy on 4 Nov 2026.