Indocyanine Green Clinical Trial
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
NCT number | NCT06033794 |
Other study ID # | NCC-4123 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | May 1, 2024 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 1, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From the beginning to the end of the surgery. | |
Secondary | Left colic artery retention rate | Recording whether the left colic artery is preserved during surger. | From the beginning to the end of the surgery. | |
Secondary | Incidence of IMA bleeding events | Document incidents of mesenteric artery or vein bleeding caused by vascular injury during surgery. | From the beginning to the end of the surgery. | |
Secondary | No.253 lymph node dissection time | Measured based on surgical videos. | From the beginning to the end of the surgery. | |
Secondary | Operation time | Data obtained from anesthesia records. | From the beginning to the end of the surgery. | |
Secondary | Intraoperative blood loss | Data obtained from anesthesia records. | From the beginning to the end of the surgery. | |
Secondary | Protective ostomy rate | Data obtained from surgical records. | From the beginning to the end of the surgery. | |
Secondary | 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. | within 30 days after operation. | |
Secondary | 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. | Assessment conducted once before surgery, on postoperative day 7, and on postoperative day 30. | |
Secondary | 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. | On the day the catheter was removed after surgery. | |
Secondary | Arterial development time | Measured based on surgical videos. | From the beginning to the end of the surgery. |
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