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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date September 2023
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Jianqiang Tang, Dr.
Phone +8613661090036
Email doc_tjq@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fluorescence laparoscopic system
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.

Locations

Country Name City State
China Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

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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