Ireland
--:--IST
Recruiting Not applicable

Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy

NCT07895212 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-06-26
Last updated
2026-10-26

Condition(s) studied

Ovary CancerCervical CancerEndometrial Cancer

Investigational drug(s) / intervention(s)

One-Finger Technique

One-Finger Technique: A specific anatomical dissection technique using a single finger to bluntly dissect the retroperitoneal space and identify the upper left ureter during open para-aortic lymphadenectomy.

Study summary

Para-aortic lymphadenectomy plays an important role in the surgical treatment of major gynecological malignancies (ovarian, endometrial, and cervical cancer). Identifying bilateral ureters is a crucial step, and dissecting the upper left ureter is particularly challenging with no standardized method. This study introduces an anatomical technique called the "One-Finger Technique" for this purpose. This prospective, single-arm exploratory study aims to evaluate the feasibility and safety of the "One-Finger Technique" during open para-aortic lymphadenectomy.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Females aged 18-75 years; * Diagnosed with gynecological malignancies (e.g., cervical cancer, endometrial cancer, ovarian cancer) confirmed by histopathology or cytology; * Planned to receive open surgical treatment and have surgical indications for para-aortic lymphadenectomy according to guidelines; * ECOG performance status score: 0\~1; * Fully understand the purpose, nature, methods, and potential risks and benefits of this study, voluntarily participate in this study, and sign a written informed consent form. Exclusion Criteria: * Concurrently have malignant tumors in other systems; * Previous history of left kidney or ureter surgery, or known severe anatomical variations of the urinary system (such as duplex kidney, duplex ureter, pelvic ectopic kidney, etc.); * Severe intestinal adhesions caused by previous abdominal surgery for other reasons; * Previous history of pelvic/abdominal radiotherapy, or severe adhesions and unclear anatomical structures in the retroperitoneal space due to previous abdominal surgery or severe pelvic/abdominal infection; * Preoperative imaging (CT/MRI) indicates massive confluent lymph nodes in the retroperitoneum, or lymph nodes that have encased major blood vessels such as the left ureter, abdominal aorta, and inferior vena cava, where routine space dissection is expected to be impossible; * Presence of absolute contraindications for open surgery, such as severe cardiac, hepatic, or renal insufficiency, or coagulopathy; * Other conditions deemed unsuitable for enrollment by the investigator.

Primary outcome measure(s)

  • Success rate of separating and identifying the upper left ureter within 5 minutes — Intraoperative (Evaluated within 5 minutes during the specific surgical step)
    The proportion of patients in whom the upper left ureter (up to the level of the left renal vein or the intersection of ovarian vessels) is successfully and clearly exposed without surrounding tissue obstruction, meeting the visual requirements for subsequent safe lymph node resection. The procedure is timed via video recording. The start time is when the surgeon's finger enters the space after the lower left ureter is identified; the end time is when the upper left ureter is completely exposed and visually confirmed by the surgeon.

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07895212 on ClinicalTrials.gov ↗ ← All trials in China