Back to resultsApplications of Fluorescence Imaging Guided Lymph Node Dissection and Fluorescence Angiography of Inferior Mesenteric Artery Assisted Left Colic Artery Preservation
Primary Purpose
Fluorescence, Indocyanine Green, Rectal Cancer Surgery
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fluorescence laparoscopic system
Sponsored by
About this trial
This is an interventional treatment trial for Fluorescence focused on measuring Left Colic Artery, Fluorescence, No. 253 lymph node, Inferior mesenteric artery, Indocyanine green
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Sites / Locations
- Cancer Hospital Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laparoscopic No. 253 lymph node dissection and preserving the LCA under fluorescence guidance.
Performing laparoscopic No. 253 lymph node dissection and preserving the LCA.
Arm Description
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.
Conventional laparoscopic approach for dissection of the No. 253 lymph nodes and preservation of the left colic artery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Left colic artery retention rate
Recording whether the left colic artery is preserved during surger.
Incidence of IMA bleeding events
Document incidents of mesenteric artery or vein bleeding caused by vascular injury during surgery.
No.253 lymph node dissection time
Measured based on surgical videos.
Operation time
Data obtained from anesthesia records.
Intraoperative blood loss
Data obtained from anesthesia records.
Protective ostomy rate
Data obtained from surgical records.
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.
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.
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.
Arterial development time
Measured based on surgical videos.
Full Information
NCT ID
NCT06033794
First Posted
August 23, 2023
Last Updated
September 10, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT06033794
Brief Title
Applications of Fluorescence Imaging Guided Lymph Node Dissection and Fluorescence Angiography of Inferior Mesenteric Artery Assisted Left Colic Artery Preservation
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluorescence, Indocyanine Green, Rectal Cancer Surgery
Keywords
Left Colic Artery, Fluorescence, No. 253 lymph node, Inferior mesenteric artery, Indocyanine green
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic No. 253 lymph node dissection and preserving the LCA under fluorescence guidance.
Arm Type
Experimental
Arm Description
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.
Arm Title
Performing laparoscopic No. 253 lymph node dissection and preserving the LCA.
Arm Type
Active Comparator
Arm Description
Conventional laparoscopic approach for dissection of the No. 253 lymph nodes and preservation of the left colic artery.
Intervention Type
Device
Intervention Name(s)
Fluorescence laparoscopic system
Intervention Description
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.
Primary Outcome Measure Information:
Title
success rate of IMA fluorescence imaging
Description
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.
Time Frame
From the beginning to the end of the surgery.
Secondary Outcome Measure Information:
Title
Left colic artery retention rate
Description
Recording whether the left colic artery is preserved during surger.
Time Frame
From the beginning to the end of the surgery.
Title
Incidence of IMA bleeding events
Description
Document incidents of mesenteric artery or vein bleeding caused by vascular injury during surgery.
Time Frame
From the beginning to the end of the surgery.
Title
No.253 lymph node dissection time
Description
Measured based on surgical videos.
Time Frame
From the beginning to the end of the surgery.
Title
Operation time
Description
Data obtained from anesthesia records.
Time Frame
From the beginning to the end of the surgery.
Title
Intraoperative blood loss
Description
Data obtained from anesthesia records.
Time Frame
From the beginning to the end of the surgery.
Title
Protective ostomy rate
Description
Data obtained from surgical records.
Time Frame
From the beginning to the end of the surgery.
Title
Complication rate within 30 days after operation
Description
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.
Time Frame
within 30 days after operation.
Title
Assessment of postoperative anal function urinary function within 30 days
Description
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.
Time Frame
Assessment conducted once before surgery, on postoperative day 7, and on postoperative day 30.
Title
Measurement of residual urine volume in the bladder.
Description
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.
Time Frame
On the day the catheter was removed after surgery.
Title
Arterial development time
Description
Measured based on surgical videos.
Time Frame
From the beginning to the end of the surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianqiang Tang, Dr.
Phone
+8613661090036
Email
doc_tjq@hotmail.com
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianqiang Tang, Dr.
Phone
+8613661090026
Email
doc_tjq@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jianqiang Tang, Dr.
12. IPD Sharing Statement
Learn more about this trial
Applications of Fluorescence Imaging Guided Lymph Node Dissection and Fluorescence Angiography of Inferior Mesenteric Artery Assisted Left Colic Artery Preservation
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