Clinical trial · Interventional
Clinical Study of Indocyanine Green Displaying Pelvic Nerve in Radical Operation of Cervical Cancer
Single Center Clinical Study of Intravenous Indocyanine Green in Pelvic Nerve Visualization During Radical Hysterectomy for Cervical Cancer
NCT05087264CI-TRIAL-00057209unknownEarly Phase 1ClinicalTrials.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)
Indocyanine green was injected intravenously into patients with cervical cancer before operation. The nerve development was observed by infrared imaging system during operation, which was used as the basis for nerve preserving operation of type C cervical cancer. The recovery of bladder function was observed.
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 |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Indocyanine green injection
- description
- 43 cases received preoperative intravenous injection of indocyanine green and radical resection of q-mc1 cervical cancer under pelvic autonomic nerve fluorescence development
- interventionNames
- Drug: Indocyanine green
- type
- NO_INTERVENTION
- label
- Not Indocyanine green injection
- description
- 43 cases underwent routine surgery，not indocyanine green injection
Primary outcomes (1)
- measure
- Main indicators of bladder function recovery
- timeFrame
- 7 days after operation
- description
- Residual urine volume of bladder 7 days after operation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subjects have certain reading ability, can communicate effectively with the researchers, and voluntarily sign the informed consent form 2. they are 18-75 years old (including the boundary value) and the ECoG score is 0-1 3. Patients with newly diagnosed cervical squamous epithelial carcinoma and cervical adenocarcinoma confirmed by histology 4. according to NCCN guidelines, they are suitable for patients undergoing radical resection of q-m C1 cervical cancer, i.e. IB1 stage deep interstitial infiltrators / ib2-iia2 stage and early IIB stage 5. normal range of liver and kidney function: bilirubin ≤ 1.5 times ULN, ALT and AST ≤ 2.5 times ULN, creatinine ≤ 1.5 times ULN, Or creatinine clearance rate ≥ 50ml / min (using standard Cockroft Gault formula) 6. have good review and follow-up conditions, and be followed up for at least 1 year Exclusion Criteria: 1. The preoperative clinical stage was unclear and the surgical indications were controversial 2. Previous history of malignant tumor or radiotherapy or chemotherapy or antiangiogenic therapy 3. pathological types are neuroendocrine carcinoma, small cell tumor, clear cell carcinoma, sarcoma and other histological types 4. urinary disease obstruction and hydronephrosis 5. severe congestive heart failure of grade II or above of New York Heart Association, History of myocardial infarction or unstable angina pectoris within 6 months before operation; Stroke or transient ischemic attack within 6 months before operation 6. pregnancy or lactation 7. according to the judgment of the investigator, it may increase the risk related to the study, may interfere with the interpretation of the study results, or the investigator believes that the patients are not suitable for inclusion
References
Publications (0)
Data not yet available
No reference posted for this study.