NCT06396806

Brief Summary

he purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic radical sigmoidectomy for sigmoid adenocarcinoma (cT2-T4a N0 M0，T1-T4a N+ M0).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,072

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress30%
May 2024Dec 2030

First Submitted

Initial submission to the registry

April 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

3.7 years

First QC Date

April 30, 2024

Last Update Submit

January 15, 2025

Conditions

Sigmoid Cancer

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival rate

    odisease-free survival was defined as the time from surgery to the time of recurrence or death from any cause

    3 years after the surgery

Secondary Outcomes (18)

  • Total number of retrieved lymph nodes

    14 days after the surgery

  • Number of Metastasis Lymph Nodes

    14 days after the surgery

  • The number of lymph nodes at each station

    14 days after the surgery

  • The rate of fluorescence

    14 days after the surgery

  • Positive rate

    14 days after the surgery

  • +13 more secondary outcomes

Study Arms (2)

radical sigmoidectomy

NO INTERVENTION

radical sigmoidectomy

radical sigmoidectomy combined with indocyanine green fluorescence imaging

EXPERIMENTAL

At the end of routine operation, indocyanine green was used for lymph node tracing, and further lymph node dissection was performed according to the tracer results.

Procedure: indocyanine green fluorescence imaging lymphatic tracing

Interventions

indocyanine green fluorescence imaging lymphatic tracingPROCEDURE

At the end of routine operation, indocyanine green was used for lymph node tracing, and further lymph node dissection was performed according to the tracer results.

radical sigmoidectomy combined with indocyanine green fluorescence imaging

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 75 years old
  • Confirmed sigmoid adenocarcinoma cancer pathologically
  • Location of tumor: the sigmoid colon (descending colon from vertical to horizontal point) is the starting point of sigmoid colon, and the end point of sigmoid colon is at 15cm of anal margin.
  • CT showed sigmoid colon cancer: T3-4a N+ M0
  • Patients with non-local recurrence or distant metastasis;
  • no multiple colorectal cancer;
  • no neoadjuvant therapy;
  • physical conditions such as heart, lung, liver and kidney function can tolerate surgery.
  • Willing and able to provide written informed consent for participation in this study

You may not qualify if:

  • Complicated with other malignant tumors or previous history of malignant tumors;
  • patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
  • patients with tumor invasion or involvement of adjacent organs requiring combined organ resection;
  • patients with poor anal function and incontinence before operation;
  • patients with inflammatory bowel disease or familial adenomatous polyposis
  • ASA grade ≥ IV and / or ECOG physical status score \> 2;
  • patients with severe hepatorenal function, cardiopulmonary function, blood coagulation dysfunction or severe underlying diseases unable to tolerate surgery;
  • history of severe mental illness;
  • pregnant or lactating women;
  • patients with uncontrolled infection before operation;
  • patients with other clinical and laboratory conditions considered by some researchers should not participate in this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun yat-sen University, Sixth Affiliated Hospital

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Sigmoid Neoplasms

Condition Hierarchy (Ancestors)

Colonic NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesSigmoid Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician，Assistant to the dean

Study Record Dates

First Submitted

April 30, 2024

First Posted

May 2, 2024

Study Start

May 6, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2030

Last Updated

January 17, 2025

Record last verified: 2025-01

Locations

CN(1)