Clinical trial NCT06033794: 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
Overall status: RECRUITING
Phase: NA
Conditions: Fluorescence
Indocyanine Green
Rectal Cancer Surgery
Keywords: Left Colic Artery
Fluorescence
No. 253 lymph node
Inferior mesenteric artery
Indocyanine green
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: success rate of IMA fluorescence imaging
timeFrame: From the beginning to the end of the surgery.
Secondary outcomes:
measure: Left colic artery retention rate
timeFrame: From the beginning to the end of the surgery.
measure: Incidence of IMA bleeding events
timeFrame: From the beginning to the end of the surgery.
measure: No.253 lymph node dissection time
timeFrame: From the beginning to the end of the surgery.
measure: Operation time
timeFrame: From the beginning to the end of the surgery.
measure: Intraoperative blood loss
timeFrame: From the beginning to the end of the surgery.
measure: Protective ostomy rate
timeFrame: From the beginning to the end of the surgery.
measure: Complication rate within 30 days after operation
timeFrame: within 30 days after operation.
measure: Assessment of postoperative anal function urinary function within 30 days
timeFrame: Assessment conducted once before surgery, on postoperative day 7, and on postoperative day 30.
measure: Measurement of residual urine volume in the bladder.
timeFrame: On the day the catheter was removed after surgery.
measure: Arterial development time
timeFrame: From the beginning to the end of the surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: