Ovary CancerNCT07895212
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
A study testing One-Finger Technique in people with Ovary Cancer and Cervical Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovary Cancer, Cervical Cancer, Endometrial Cancer
- What is being tested?
- One-Finger Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Dongyan Wang, MD, +86 15017554658, wangdy35@mail.sysu.edu.cn
About this study
Official title: Feasibility Evaluation of the "One-Finger Technique" for Dissecting and Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy: A Prospective, Single-Center, Single-Arm Clinical Study
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.
- Conditions
- Ovary Cancer, Cervical Cancer, Endometrial Cancer
- Being tested
- One-Finger Technique
- Keywords
- One-Finger Technique
- Medical subject headings
- Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-Finger TechniqueProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| "One-Finger Technique" Group | Experimental | The patients in this arm will receive the "One-Finger Technique" for dissecting and identifying the upper left ureter during para-aortic lymphadenectomy. Receives: Procedure: One-Finger Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of separating and identifying the upper left ureter within 5 minutes
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.
Measured: Intraoperative (Evaluated within 5 minutes during the specific surgical step)
Secondary outcomes (4)
Incidence of left ureter complications
The proportion of patients experiencing left ureter injuries. This includes intraoperative macroscopically visible ureteral contusion or rupture, and postoperative complications occurring within 30 days due to ischemia or injury, such as ureterovaginal fistula or ureteral stricture.
Measured: Intraoperative and up to 30 days postoperatively
Incidence of adjacent vessel or organ injury
The rate of collateral damage occurring during the "One-Finger Technique" dissection that requires additional suturing or repair, such as adjacent vessel tearing/bleeding or bowel serosal tearing.
Measured: Intraoperative
Blood loss during the target step
The estimated local blood volume lost specifically during the single process of dissecting and identifying the upper left ureter. Because this step is brief and bleeding is usually minimal, it is recorded using visual estimation.
Measured: Intraoperative (Assessed immediately after the completion of the specific surgical step)
Conversion rate to traditional methods
The proportion of cases where the "One-Finger Technique" is abandoned in favor of traditional direct sharp dissection due to severe local adhesions, unclear anatomy, or high pushing resistance. This reflects the clinical applicability of the technique.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start26 Jun 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Jing Li, MD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895212
- Sponsor's protocol ID
- SYSKY-2026-308-02
- Status last verified
- May 2026
- First submitted
- 20 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Evaluation of the "One-Finger Technique" for Dissecting and Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy: A Prospective, Single-Center, Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07895212
- Acronym / sponsor ID
- SYSKY-2026-308-02
- Conditions
- Ovary Cancer, Cervical Cancer, Endometrial Cancer
- Keywords
- One-Finger Technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "One-Finger Technique" Group | Experimental | Procedure: One-Finger TechniqueThe patients in this arm will receive the "One-Finger Technique" for dissecting and identifying the upper left ureter during para-aortic lymphadenectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-Finger TechniqueA 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. | Procedure or surgery | "One-Finger Technique" Group |
Primary outcome
Success rate of separating and identifying the upper left ureter within 5 minutes
Time frame: 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.
4 secondary outcomes
Incidence of left ureter complications
Time frame: Intraoperative and up to 30 days postoperatively
Incidence of adjacent vessel or organ injury
Time frame: Intraoperative
Blood loss during the target step
Time frame: Intraoperative (Assessed immediately after the completion of the specific surgical step)
Conversion rate to traditional methods
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Li, MD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-Finger Technique in people with Ovary Cancer and Cervical Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongyan Wang, MD (+86 15017554658, wangdy35@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of separating and identifying the upper left ureter within 5 minutes (time frame: Intraoperative (Evaluated within 5 minutes during the specific surgical step)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.