Clinical Study of Indocyanine Green Displaying Pelvic Nerve in Radical Operation of Cervical Cancer

Cervical Carcinoma Clinical Trial

Official title: Single Center Clinical Study of Intravenous Indocyanine Green in Pelvic Nerve Visualization During Radical Hysterectomy for Cervical Cancer

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cervical Carcinoma
• Uterine Cervical Neoplasms

• NCT number: NCT05087264
• Study type: Interventional
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: HL Nie
• Phone: 13539586288
• Email: 95862456@qq.com
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 10, 2022
• Completion date: October 16, 2025