NCT05730595

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

19 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Sep 2023Jun 2027

First Submitted

Initial submission to the registry

February 7, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

3.3 years

First QC Date

February 7, 2023

Last Update Submit

August 26, 2023

Conditions

Colorectal NeoplasmsFluorescenceLymph Node Excision

Keywords

Colorectal cancerFluorescence laparoscopic navigationLymph node dissection

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

    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 (5)

  • The number of lymph node resection

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

  • Blood loss

    Until the end of the operation, an average of 8 hours.

  • Complications

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

  • Hospital stay after surgery

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

  • Function score

    Until one year after the patient's surgery

Study Arms (2)

D2 lymph node dissection

EXPERIMENTAL

The D2 lymph node region are dissected. And 1-3 lymph nodes of the D2 region will be selected for intraoperative frozen section. If no lymph node metastasis is found in freezing, the D3 region lymph nodes in the root of the submesenteric artery were preserved.

Procedure: lymph node dissection

D3 lymph node dissection

ACTIVE COMPARATOR

Thorough dissection of lymph nodes in the D3 region.

Procedure: lymph node dissection

Interventions

lymph node dissectionPROCEDURE

The extent of lymph node dissection varies between groups

Also known as: Fluorescence-guided laparoscopic surgery, Radical operation for rectal cancer and sigmoid Cancer
D2 lymph node dissectionD3 lymph node dissection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • Participants have no local complications before surgery.

You may not qualify if:

  • 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;
  • With contraindications to laparoscopic surgery;
  • Histoty of multiple abdominal and pelvic surgery or extensive abdominal adhesions;
  • Other malignancies were diagnosed within the past 5 years;
  • History of severe mental illness;
  • Pregnant or lactating women;
  • With uncontrolled infection before surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

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

Hefei, Anhui, 230001, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Chengdu, 610500, China

Location

Fujian Province Tumor Hospital

Fuzhou, Fujian, 350014, China

Location

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510320, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, 050000, China

Location

The Second Affiliated Hospital of Harbin Medical University

Haerbin, Heilongjiang, 150001, China

Location

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Jiangxi Provincial Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

Qinghai University Affiliated Hospital

Xining, Qinghai, 810001, China

Location

Binzhou Medical University

Binzhou, Shandong, 256603, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030013, China

Location

The Second People's Hospital of Yibin

Yibin, Sichuan, 644000, China

Location

The second People's Hospital of Yunnan Province

Kunming, Yunnan, 650021, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Jianqiang Tang, Dr.

CONTACT

+8613661090036doc_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

February 7, 2023

First Posted

February 16, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations

CN(19)