Applications of Fluorescence Imaging Guided Lymph Node Dissection and Fluorescence Angiography of Inferior Mesenteric Artery Assisted Left Colic Artery Preservation

NCT06033794 | Unknown

• 1 other identifier: NCC-4123
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluorescence; Indocyanine Green; Rectal Cancer Surgery

Keywords

Left Colic Artery; Fluorescence; No. 253 lymph node; Inferior mesenteric artery; Indocyanine green

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Left colic artery retention rate

  From the beginning to the end of the surgery.

• 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.

• Operation time

  From the beginning to the end of the surgery.

• Intraoperative blood loss

  From the beginning to the end of the surgery.

Study Arms (2)

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.

Device: Fluorescence laparoscopic system

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.

Device: Fluorescence laparoscopic system

Interventions

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.

Laparoscopic No. 253 lymph node dissection and preserving the LCA under fluorescence guidance.; Performing laparoscopic No. 253 lymph node dissection and preserving the LCA.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Central Study Contacts

Jianqiang Tang, Dr.

CONTACT

+8613661090036; doc_tjq@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 13, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)