Fluorescence imaging for lymph node dissection in rectal cancer surgery
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
This study is testing if using special fluorescent imaging during rectal cancer surgery can help doctors remove more lymph nodes and protect important blood vessels better than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06033794 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of fluorescence imaging techniques combined with indocyanine green (ICG) fluorescence angiography in enhancing lymph node dissection during laparoscopic surgery for rectal cancer. It aims to compare outcomes between a group using these advanced imaging techniques and a control group using conventional methods. The focus is on improving the preservation of the left colic artery and increasing the number of harvested lymph nodes, specifically the No. 253 lymph nodes. By conducting a randomized controlled trial, the study seeks to provide robust evidence for the adoption of these innovative surgical techniques.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with confirmed colorectal adenocarcinoma located in the rectum or upper rectum, who meet specific preoperative health criteria.
Not a fit: Patients with a history of malignant colorectal tumors or those who have contraindications for laparoscopic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective surgical procedures for patients with rectal cancer.
How similar studies have performed: While there have been successful studies using fluorescence imaging in other cancer surgeries, this specific application in rectal cancer surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Jianqiang Tang, Dr.
- Email: doc_tjq@hotmail.com
- Phone: +8613661090036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.