Clinical trial · Interventional
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
NCT06396806CI-TRIAL-00084861enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sigmoid Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indocyanine green fluorescence imaging lymphatic tracing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- radical sigmoidectomy
- description
- radical sigmoidectomy
- type
- EXPERIMENTAL
- label
- radical sigmoidectomy combined with indocyanine green fluorescence imaging
- description
- 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.
- interventionNames
- Procedure: indocyanine green fluorescence imaging lymphatic tracing
Primary outcomes (1)
- measure
- Disease-free survival rate
- timeFrame
- 3 years after the surgery
- description
- odisease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 and 75 years old 2. Confirmed sigmoid adenocarcinoma cancer pathologically 3. 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. 4. CT showed sigmoid colon cancer: T3-4a N+ M0 5. Patients with non-local recurrence or distant metastasis; 6. no multiple colorectal cancer; 7. no neoadjuvant therapy; 8. physical conditions such as heart, lung, liver and kidney function can tolerate surgery. 9. Willing and able to provide written informed consent for participation in this study Exclusion Criteria: 1. Complicated with other malignant tumors or previous history of malignant tumors; 2. patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc.; 3. patients with tumor invasion or involvement of adjacent organs requiring combined organ resection; 4. patients with poor anal function and incontinence before operation; 5. patients with inflammatory bowel disease or familial adenomatous polyposis 6. ASA grade ≥ IV and / or ECOG physical status score \> 2; 7. patients with severe hepatorenal function, cardiopulmonary function, blood coagulation dysfunction or severe underlying diseases unable to tolerate surgery; 8. history of severe mental illness; 9. pregnant or lactating women; 10. patients with uncontrolled infection before operation; 11. patients with other clinical and laboratory conditions considered by some researchers should not participate in this trial.
References
Publications (0)
Data not yet available
No reference posted for this study.