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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fluorescence
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- success rate of IMA fluorescence imaging
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Jianqiang Tang
Associate professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Left colic artery retention rate(From the beginning to the end of the surgery.)
- Operation time(From the beginning to the end of the surgery.)
- Protective ostomy rate(From the beginning to the end of the surgery.)
- Complication rate within 30 days after operation(within 30 days after operation.)
- Incidence of IMA bleeding events(From the beginning to the end of the surgery.)
- No.253 lymph node dissection time(From the beginning to the end of the surgery.)
- Intraoperative blood loss(From the beginning to the end of the surgery.)
- Assessment of postoperative anal function urinary function within 30 days(Assessment conducted once before surgery, on postoperative day 7, and on postoperative day 30.)
- Measurement of residual urine volume in the bladder.(On the day the catheter was removed after surgery.)
- Arterial development time(From the beginning to the end of the surgery.)