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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescence laparoscopic system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Left colic artery retention rate | Recording whether the left colic artery is preserved during surger. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianqiang Tang, Dr. | Contact | +8613661090036 | doc_tjq@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| From the beginning to the end of the surgery. |
| No.253 lymph node dissection time | Measured based on surgical videos. | From the beginning to the end of the surgery. |
| Operation time | Data obtained from anesthesia records. | From the beginning to the end of the surgery. |
| Intraoperative blood loss | Data obtained from anesthesia records. | From the beginning to the end of the surgery. |
| Protective ostomy rate | Data obtained from surgical records. | 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. | 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. | 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. | On the day the catheter was removed after surgery. |
| Arterial development time | Measured based on surgical videos. | From the beginning to the end of the surgery. |