Fact CheckerSign in

NCT06396806Enrolling by invitation

A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical Sigmoidectomy for Sigmoid Cancer Versus Radical Sigmoidectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracing Dissection in the Treatment of Sigmoid Cancer

Source: ClinicalTrials.gov · Last updated 17 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
1072 (estimated)
First submitted
30 Apr 2024
Start date
May 2024
Primary completion date
Dec 2027
Lead sponsor
Sun Yat-sen University
NCT number
NCT06396806

What you commit to

  • Study type: Interventional
  • Planned participants: 1072
  • From May 2024 to the primary completion date, Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • patients with tumor invasion or involvement of adjacent organs requiring combined organ resection;

Other illness

  • Complicated with other malignant tumors or previous history of malignant tumors;
  • patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
  • patients with inflammatory bowel disease or familial adenomatous polyposis
  • patients with severe hepatorenal function, cardiopulmonary function, blood coagulation dysfunction or severe underlying diseases unable to tolerate surgery;
  • history of severe mental illness;
  • patients with uncontrolled infection before operation;

Lab values

  • patients with other clinical and laboratory conditions considered by some researchers should not participate in this trial.

Other

  • patients with poor anal function and incontinence before operation;
  • ASA grade ≥ IV and / or ECOG physical status score \> 2;
  • pregnant or lactating women;

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun yat-sen University, Sixth Affiliated Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.