Clinical Study of Indocyanine Green Displaying Pelvic Nerve in Radical Operation of Cervical Cancer
Primary Purpose
Cervical Carcinoma
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Indocyanine green
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Carcinoma focused on measuring Cervical Carcinoma, Indocyanine green, Neural phenomenon, Infrared imaging
Eligibility Criteria
Inclusion Criteria:
- The subjects have certain reading ability, can communicate effectively with the researchers, and voluntarily sign the informed consent form
- they are 18-75 years old (including the boundary value) and the ECoG score is 0-1
- Patients with newly diagnosed cervical squamous epithelial carcinoma and cervical adenocarcinoma confirmed by histology
- 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
- 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)
- have good review and follow-up conditions, and be followed up for at least 1 year
Exclusion Criteria:
- The preoperative clinical stage was unclear and the surgical indications were controversial
- Previous history of malignant tumor or radiotherapy or chemotherapy or antiangiogenic therapy
- pathological types are neuroendocrine carcinoma, small cell tumor, clear cell carcinoma, sarcoma and other histological types
- urinary disease obstruction and hydronephrosis
- 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
- pregnancy or lactation
- 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
Sites / Locations
- FifthSunYetSenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Indocyanine green injection
Not Indocyanine green injection
Arm Description
43 cases received preoperative intravenous injection of indocyanine green and radical resection of q-mc1 cervical cancer under pelvic autonomic nerve fluorescence development
43 cases underwent routine surgery,not indocyanine green injection
Outcomes
Primary Outcome Measures
Main indicators of bladder function recovery
Residual urine volume of bladder 7 days after operation
Secondary Outcome Measures
Other indicators of bladder function recovery
① Micturition time, micturition times, tension urinary incontinence, prolonged micturition time, abdominal pressure micturition, incomplete micturition and dysuria; ② Urodynamic examination, monitoring the maximum urinary flow rate (MFR), average urinary flow rate (AFR), residual urine volume (RU), initial urinary bladder volume (FVS), maximum urinary bladder volume (MVS), detrusor contraction and maximum detrusor contraction force (MDP); ③ Pelvic floor function evaluation: pelvic floor function examination was performed 24 weeks after operation.
Full Information
NCT ID
NCT05087264
First Posted
September 25, 2021
Last Updated
March 17, 2022
Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT05087264
Brief Title
Clinical Study of Indocyanine Green Displaying Pelvic Nerve in Radical Operation of Cervical Cancer
Official Title
Single Center Clinical Study of Intravenous Indocyanine Green in Pelvic Nerve Visualization During Radical Hysterectomy for Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Anticipated)
Primary Completion Date
October 16, 2025 (Anticipated)
Study Completion Date
October 16, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
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.
Detailed Description
This study is an open, randomized and prospective clinical study. 86 patients are planned to be randomly assigned according to 1:1. 43 patients underwent preoperative intravenous injection of indocyanine green, radical resection of q-mc1 cervical cancer under pelvic autonomic nerve fluorescence, and 43 patients underwent routine surgery to observe the medium and long-term urinary system function and pelvic floor function of the subjects.
Before operation, confirm the pathological type, pelvic and abdominal enhancement CT or MRI examination, urography (if necessary), two researchers with senior professional title of gynecology respectively carry out gynecological double diagnosis and triple diagnosis examination, and carry out clinical staging according to figo2018 staging standard; According to NCCN guidelines, subjects who are suitable for radical resection of q-m type C1 cervical cancer (IB1 stage deep interstitial Infiltrator / ib2-iia2 stage) are enrolled for routine preoperative examination, and surgical contraindications are excluded. The operation method is open radical resection of q-m C1 cervical cancer. The same group of researchers with rich experience in gynecological tumor operation act as the chief surgeon. Gradually open the retroperitoneum, walk along the ureter to complete anatomical exposure, observe and record the fluorescence staining degree of pelvic autonomic nerve at different time nodes, and compare with the surrounding blood vessels / lymphatic vessels / adipose tissue, Observe the bladder branch of pelvic visceral nerve, dissociate the pelvic visceral nerve plexus from the rectum uterus / rectocervical ligament, preserve the nerve tissue behind the ureter and bladder, and perform extensive resection.
The shape map of pelvic autonomic nerve (including near-infrared region I and region II) was developed. The researchers recorded the identification of nerve after operation and recorded the best observation time point.
The researchers recorded the operation time, the amount of bleeding, the length of the resected uterosacral ligament, main ligament and bladder cervical ligament, and the distal margin was reserved for nerve staining and quantitative analysis.
Safety observation: allergic reaction, influence on liver and kidney function, influence on hemagglutination state.
Observation of recent indicators of bladder dysfunction after operation: the catheter was removed 1 week after operation, and the residual urine volume was measured by ultrasonography. The catheter was placed again if it was > 100ml, and then rechecked once a week until the residual urine volume was less than 30ml.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Carcinoma
Keywords
Cervical Carcinoma, Indocyanine green, Neural phenomenon, Infrared imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Experimental group, control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Indocyanine green injection
Arm Type
Experimental
Arm Description
43 cases received preoperative intravenous injection of indocyanine green and radical resection of q-mc1 cervical cancer under pelvic autonomic nerve fluorescence development
Arm Title
Not Indocyanine green injection
Arm Type
No Intervention
Arm Description
43 cases underwent routine surgery,not indocyanine green injection
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Intervention Description
ICG retention test and clearance test: intravenous injection, 0.5mg/l. Liver blood flow measurement: intravenous drip, dissolve 25mg ICG in 100ml injection water, and drip at a constant speed for about 50min to make the ICG concentration reach equilibrium.
Primary Outcome Measure Information:
Title
Main indicators of bladder function recovery
Description
Residual urine volume of bladder 7 days after operation
Time Frame
7 days after operation
Secondary Outcome Measure Information:
Title
Other indicators of bladder function recovery
Description
① Micturition time, micturition times, tension urinary incontinence, prolonged micturition time, abdominal pressure micturition, incomplete micturition and dysuria; ② Urodynamic examination, monitoring the maximum urinary flow rate (MFR), average urinary flow rate (AFR), residual urine volume (RU), initial urinary bladder volume (FVS), maximum urinary bladder volume (MVS), detrusor contraction and maximum detrusor contraction force (MDP); ③ Pelvic floor function evaluation: pelvic floor function examination was performed 24 weeks after operation.
Time Frame
12, 24 and 48 weeks after operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subjects have certain reading ability, can communicate effectively with the researchers, and voluntarily sign the informed consent form
they are 18-75 years old (including the boundary value) and the ECoG score is 0-1
Patients with newly diagnosed cervical squamous epithelial carcinoma and cervical adenocarcinoma confirmed by histology
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
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)
have good review and follow-up conditions, and be followed up for at least 1 year
Exclusion Criteria:
The preoperative clinical stage was unclear and the surgical indications were controversial
Previous history of malignant tumor or radiotherapy or chemotherapy or antiangiogenic therapy
pathological types are neuroendocrine carcinoma, small cell tumor, clear cell carcinoma, sarcoma and other histological types
urinary disease obstruction and hydronephrosis
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
pregnancy or lactation
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HL Nie
Phone
13539586288
Email
95862456@qq.com
Facility Information:
Facility Name
FifthSunYetSen
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huilong Nie, Doc.
Phone
13727081129
Email
95862456@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical Study of Indocyanine Green Displaying Pelvic Nerve in Radical Operation of Cervical Cancer
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