Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

To explore the short-term and long-term outcomes of fluorescence laparoscopic navigation D2 lymph node dissection for colorectal cancer surgery by comparing it with D3 lymph node dissection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants are aged 18-75;

Colonoscopy biopsy confirms colorectal adenocarcinoma;

Colonoscopy shows that the lower edge of the tumor is located more than 10 cm from the margin or the tumor is located in the upper rectum and sigmoid colon by imaging diagnosis;

The tumor is staged cT1-4aNxM0 by preoperative imaging;

Disqualifiers

Previous history of malignant colorectal tumor;

Multiple primary colorectal tumors;

Preoperative imaging reveals suspicious positive lymph nodes in the submesenteric artery root region (area 253);

Patients undergoing neoadjuvant therapy before surgery;

Trial design

Design model

Parallel

Treatments tested in this trial

  • lymph node dissection

    Procedure/Surgery

    The extent of lymph node dissection varies between groups

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: D2 lymph node dissectionExperimental treatment 1 intervention
Group B: D3 lymph node dissectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease-free survival

Disease-free survival is defined as the time from the surgery to disease recurrence or last follow-up, which was measured in months.

Time frame
The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 36 months.
2

Overall survival

Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.

Time frame
The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 36 months.

Secondary outcomes

1

The number of lymph node resection

The number of lymph nodes removed during surgery, which is obtained by postoperative pathological results

Time frame
Until the pathological result is available , an average of 14 days.
2

Blood loss

Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).

Time frame
Until the end of the operation, an average of 8 hours.
3

Complications

Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.

Time frame
Until the patient recovered and was discharged from the hospital, an average of 10 days.
4

Hospital stay after surgery

Hospital stay after surgery is defined as the length of time from the end of surgery

Time frame
Until the patient recovered and was discharged from the hospital, an average of 10 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Fudan University

Collaborator

Fujian Province Tumor Hospital

Collaborator

Guangdong Provincial People's Hospital

Collaborator

Shengjing Hospital

Collaborator

Affiliated Hospital of Qinghai University

Collaborator

Hebei Medical University Fourth Hospital

Collaborator

The Second Affiliated Hospital of Harbin Medical University

Collaborator

Jiangxi Provincial Cancer Hospital

Collaborator

The First Hospital of Jilin University

Collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

Collaborator

Shanxi Province Cancer Hospital

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator

Second People's Hospital of Yunnan Province

Collaborator

Binzhou Medical University

Collaborator

The First Affiliated Hospital of University of Science and Technology of China

Collaborator

First Affiliated Hospital of Chengdu Medical College

Collaborator

The Second People's Hospital of Yibin

Collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborator

This trial is not recruiting at the moment. You can still explore other options: