Clinical trial · Interventional
Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer
A Randomized Controlled Trial of Fluorescence Laparoscopic Navigation of the Extent of Lymph Node Dissection for High Rectal Cancer and Sigmoid Colon Cancer
NCT05730595CI-TRIAL-00069153FLORA-01not yet recruitingN/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)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Fluorescence | — | UNRESOLVED | — |
| Lymph Node Excision | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lymph node dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- D2 lymph node dissection
- description
- 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.
- interventionNames
- Procedure: lymph node dissection
- type
- ACTIVE_COMPARATOR
- label
- D3 lymph node dissection
- description
- Thorough dissection of lymph nodes in the D3 region.
- interventionNames
- Procedure: lymph node dissection
Primary outcomes (2)
- measure
- Disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.