FluorescenceNCT06033794
Applications of Fluorescence Imaging Guided Lymph Node Dissection and Fluorescence Angiography of Inferior Mesenteric Artery Assisted Left Colic Artery Preservation
A study testing Fluorescence laparoscopic system in people with Fluorescence and Indocyanine Green, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To investigate the accuracy of fluorescence angiography technique IMA classification and the impact of lymph node mapping technique on the dissection of No. 253 lymph nodes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fluorescence, Indocyanine Green, Rectal Cancer Surgery
- What is being tested?
- Fluorescence laparoscopic system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 May 2024
- 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
- Patients aged between 18 and 75 years
- Colonoscopic biopsy confirmed colorectal adenocarcinoma
- The tumor was located in the rectum or upper rectum, and the surgical method was Dxion
- No local complications before operation (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, no local invasion)
- Preoperative imaging diagnosis was cT1-4aNxM0
- The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia
- Sign the informed consent form
Who cannot join
- Previous surgical history of malignant colorectal tumors
- The surgical methods were combined abdominoperineal resection, Hartman operation and ISR operation
- There are contraindication of laparoscopic surgery, such as severe cardiopulmonary insufficiency
- Patients who have undergone multiple abdominal and pelvic surgeries or extensive abdominal adhesion
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and other emergency operations
- ASA grade ≥IV and/or ECOG physical status score ≥2 points
Show all 9Show fewer
- Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases can not tolerate surgery
- Have a history of serious mental illness
- Patients with uncontrolled infection before operation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jianqiang Tang, Dr., +8613661090026, doc_tjq@hotmail.com
Jianqiang Tang, Dr.
About this study
Official title: Applications of Near-infrared Fluorescence Imaging Guided Lymph Node Dissection and Fluorescence Angiography of Inferior Mesenteric Artery Assisted Left Colic Artery Preservation: A Prospective Randomized Controlled Study
To investigate the accuracy of fluorescence angiography technique IMA classification and the impact of lymph node mapping technique on the dissection of No. 253 lymph nodes.
Read the detailed description
Multiple studies, including randomized controlled trials (RCTs), have demonstrated that lymph node imaging techniques can effectively increase the number of harvested lymph nodes in gastric and colorectal cancer surgeries . However, there remains a scarcity of research specifically focused on the surgical procedure of fluorescent-guided clearance of No. 253 lymph nodes. Most existing studies have been retrospective analyses, and the need for prospective studies is evident. Further clinical research is crucial to explore the successful application of fluorescence lymph node imaging combined with indocyanine green (ICG) fluorescence angiography and its multifunctional fusion. To address this gap, investigators plan to conduct a randomized controlled trial comparing the outcomes between the use of ICG Fluorescence lymph node Imaging combined with Fluorescence angiography (FIFA group) and conventional techniques (non-ICG group) in laparoscopic rectal cancer surgery. Specifically, investigators focus will be on the preservation of the left colic artery (LCA) and the clearance of No. 253 lymph nodes. The primary objectives of our study are to simplify surgical procedures, enhance surgical safety, and provide substantial evidence for the further promotion and adoption of this technique.
- Conditions
- Fluorescence, Indocyanine Green, Rectal Cancer Surgery
- Being tested
- Fluorescence laparoscopic system
- Keywords
- Left Colic Artery, Fluorescence, No. 253 lymph node, Inferior mesenteric artery, Indocyanine green
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence laparoscopic systemDevice
Intraoperative fluorescence imaging was performed using the DPM-ENDOCAM-03 and DPM-LIGHT-03 fluorescence imaging system (manufactured by Digital Precision Medicine Technology Co., Ltd., Zhuhai, China). This system provides original fluorescence mode, color mode, and fusion mode, allowing real-time quantitative analysis of the fluorescence signals.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic No. 253 lymph node dissection and preserving the LCA under fluorescence guidance. | Experimental | Preoperatively, indoycine green fluorescent dye was injected into the anus to trace the No. 253 lymph nodes, and intraoperatively, arterial branching of the mesentery was performed by intravenous injection of fluorescent dye to preserve the left colic artery. Receives: Device: Fluorescence laparoscopic system |
| Performing laparoscopic No. 253 lymph node dissection and preserving the LCA. | Active comparator | Conventional laparoscopic approach for dissection of the No. 253 lymph nodes and preservation of the left colic artery. Receives: Device: Fluorescence laparoscopic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of IMA fluorescence imaging
ICG solution was prepared at a concentration of 2.5 g/L. A dose of 0.05 mg-0.10 mg/kg body weight of ICG was administered intravenously through a peripheral or central vein. Before the injection of ICG, the fluorescence laparoscope was set to the original fluorescence mode to monitor the IMA region in real-time.Record the success or failure rate of IMA fluorescence imaging in the observation group. Classify the successful IMA fluorescence imaging results into four different types according to the Morro classification and calculate the proportion of each type in successful imaging.
Measured: From the beginning to the end of the surgery.
Secondary outcomes (10)
Left colic artery retention rate
Recording whether the left colic artery is preserved during surger.
Measured: From the beginning to the end of the surgery.
Incidence of IMA bleeding events
Document incidents of mesenteric artery or vein bleeding caused by vascular injury during surgery.
Measured: From the beginning to the end of the surgery.
No.253 lymph node dissection time
Measured based on surgical videos.
Measured: From the beginning to the end of the surgery.
Operation time
Data obtained from anesthesia records.
Measured: From the beginning to the end of the surgery.
Intraoperative blood loss
Data obtained from anesthesia records.
Measured: From the beginning to the end of the surgery.
Protective ostomy rate
Data obtained from surgical records.
Measured: From the beginning to the end of the surgery.
Complication rate within 30 days after operation
According to the Clavien-Dindo classification system, complications were categorized into five grades. The postoperative status of each patient was recorded within 30 days, and the proportion of complications in each grade was calculated as a percentage of the total number of observations.
Measured: within 30 days after operation.
Assessment of postoperative anal function urinary function within 30 days
Evaluation of Low Anterior Resection Syndrome (LARS) scale, assessed using the following scales at preoperative, postoperative day 7, and day 30. Scores range from 0 to 42, with lower scores indicating better outcomes.
Measured: Assessment conducted once before surgery, on postoperative day 7, and on postoperative day 30.
Measurement of residual urine volume in the bladder.
Bladder residual urine volume was measured on the same day as catheter removal. A bladder residual urine volume of less than 50 ml was considered indicative of good bladder function, while a volume greater than or equal to 50 ml was considered indicative of urinary retention.
Measured: On the day the catheter was removed after surgery.
Arterial development time
Measured based on surgical videos.
Measured: From the beginning to the end of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 May 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FluorescenceStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianqiang Tang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033794
- Sponsor's protocol ID
- NCC-4123
- Status last verified
- Sep 2023
- First submitted
- 23 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applications of Near-infrared Fluorescence Imaging Guided Lymph Node Dissection and Fluorescence Angiography of Inferior Mesenteric Artery Assisted Left Colic Artery Preservation: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06033794
- Acronym / sponsor ID
- NCC-4123
- Conditions
- Fluorescence, Indocyanine Green, Rectal Cancer Surgery
- Keywords
- Left Colic Artery, Fluorescence, No. 253 lymph node, Inferior mesenteric artery, Indocyanine green
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 13 Sep 2023 (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.
To investigate the accuracy of fluorescence angiography technique IMA classification and the impact of lymph node mapping technique on the dissection of No. 253 lymph nodes.
Detailed description
Multiple studies, including randomized controlled trials (RCTs), have demonstrated that lymph node imaging techniques can effectively increase the number of harvested lymph nodes in gastric and colorectal cancer surgeries . However, there remains a scarcity of research specifically focused on the surgical procedure of fluorescent-guided clearance of No. 253 lymph nodes. Most existing studies have been retrospective analyses, and the need for prospective studies is evident. Further clinical research is crucial to explore the successful application of fluorescence lymph node imaging combined with indocyanine green (ICG) fluorescence angiography and its multifunctional fusion. To address this gap, investigators plan to conduct a randomized controlled trial comparing the outcomes between the use of ICG Fluorescence lymph node Imaging combined with Fluorescence angiography (FIFA group) and conventional techniques (non-ICG group) in laparoscopic rectal cancer surgery. Specifically, investigators focus will be on the preservation of the left colic artery (LCA) and the clearance of No. 253 lymph nodes. The primary objectives of our study are to simplify surgical procedures, enhance surgical safety, and provide substantial evidence for the further promotion and adoption of this technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic No. 253 lymph node dissection and preserving the LCA under fluorescence guidance. | Experimental | Device: Fluorescence laparoscopic systemPreoperatively, indoycine green fluorescent dye was injected into the anus to trace the No. 253 lymph nodes, and intraoperatively, arterial branching of the mesentery was performed by intravenous injection of fluorescent dye to preserve the left colic artery. |
| Performing laparoscopic No. 253 lymph node dissection and preserving the LCA. | Active comparator | Device: Fluorescence laparoscopic systemConventional laparoscopic approach for dissection of the No. 253 lymph nodes and preservation of the left colic artery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged between 18 and 75 years
- Colonoscopic biopsy confirmed colorectal adenocarcinoma
- The tumor was located in the rectum or upper rectum, and the surgical method was Dxion
- No local complications before operation (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, no local invasion)
- Preoperative imaging diagnosis was cT1-4aNxM0
Key exclusion criteria (9 listed)
- Previous surgical history of malignant colorectal tumors
- The surgical methods were combined abdominoperineal resection, Hartman operation and ISR operation
- There are contraindication of laparoscopic surgery, such as severe cardiopulmonary insufficiency
- Patients who have undergone multiple abdominal and pelvic surgeries or extensive abdominal adhesion
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and other emergency operations
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 |
|---|---|---|
| Fluorescence laparoscopic systemIntraoperative fluorescence imaging was performed using the DPM-ENDOCAM-03 and DPM-LIGHT-03 fluorescence imaging system (manufactured by Digital Precision Medicine Technology Co., Ltd., Zhuhai, China). This system provides original fluorescence mode, color mode, and fusion mode, allowing real-time quantitative analysis of the fluorescence signals. | Device | Laparoscopic No. 253 lymph node dissection and preserving the LCA under fluorescence guidance., Performing laparoscopic No. 253 lymph node dissection and preserving the LCA. |
Primary outcome
success rate of IMA fluorescence imaging
Time frame: From the beginning to the end of the surgery.
ICG solution was prepared at a concentration of 2.5 g/L. A dose of 0.05 mg-0.10 mg/kg body weight of ICG was administered intravenously through a peripheral or central vein. Before the injection of ICG, the fluorescence laparoscope was set to the original fluorescence mode to monitor the IMA region in real-time.Record the success or failure rate of IMA fluorescence imaging in the observation group. Classify the successful IMA fluorescence imaging results into four different types according to the Morro classification and calculate the proportion of each type in successful imaging.
10 secondary outcomes
Left colic artery retention rate
Time frame: From the beginning to the end of the surgery.
Incidence of IMA bleeding events
Time frame: From the beginning to the end of the surgery.
No.253 lymph node dissection time
Time frame: From the beginning to the end of the surgery.
Operation time
Time frame: From the beginning to the end of the surgery.
Intraoperative blood loss
Time frame: From the beginning to the end of the surgery.
Protective ostomy rate
Time frame: From the beginning to the end of the surgery.
Complication rate within 30 days after operation
Time frame: within 30 days after operation.
Assessment of postoperative anal function urinary function within 30 days
Time frame: Assessment conducted once before surgery, on postoperative day 7, and on postoperative day 30.
Measurement of residual urine volume in the bladder.
Time frame: On the day the catheter was removed after surgery.
Arterial development time
Time frame: From the beginning to the end of the surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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 Fluorescence laparoscopic system in people with Fluorescence and Indocyanine Green, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 7 inclusion and 9 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 13 Sep 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.
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 Jianqiang Tang, Dr. (+8613661090036, doc_tjq@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of IMA fluorescence imaging (time frame: From the beginning to the end of the surgery.). 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 13 Sep 2023.