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New surgical technique aims to reduce cancer spread in cervical cancer patients

NCT ID NCT07256977

Disease control Sponsor: Seoul National University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two surgical methods for early-stage cervical cancer (IB2-IIA1). One is traditional open surgery, and the other is a minimally invasive approach using a stapler to prevent cancer cells from spreading. About 494 participants will be followed for 4.5 years to see which method works better and has fewer complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 494 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

I. Inclusion Criteria: 1. 2018 FIGO stage IB2 or IIA1 cervical cancer (tumor maximum diameter ≥2 cm and \<4 cm) 2. Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma 3. Planned for Type B or C radical hysterectomy 4. With adequate bone marrow, renal, and hepatic function * WBC \>3.0 × 10⁹ cells/L * Platelets \>100 × 10⁹ cells/L * Creatinine \<180 μmol/L * Bilirubin \<1.5 × normal range * AST, ALT \< 3 × normal range 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 6. Previous history of other invasive malignancies with no evidence of recurrence for at least 5 years 7. Signed and approved consent form II. Exclusion Criteria: 1. Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma 2. Tumor size less than 2 cm classified as 2018 FIGO stage IA1, IA2, or IB1 disease 3. The following are observed on preoperative CT or MRI * Tumor size ≥4 cm * Lymph node metastasis (short axis ≥15 mm) * Paracervical invasion * Bladder or rectal invasion * Distant metastasis 4. Prior pelvic or abdominal radiotherapy 5. Prior neoadjuvant chemotherapy before surgery 6. Unsuitable for surgery due to severe systemic disease at the investigator's discretion 7. Difficult to consider intraoperative lymphatic mapping due to * Allergy to triphenylmethane compounds * History of prior retroperitoneal surgery * History of prior pelvic radiotherapy * Cases where cold knife or loop electrosurgical excision procedure (LEEP) was performed within 4 weeks prior to study participation * Allergy to triphenylmethane compounds

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma Pain, Postoperative Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer stage IB2 Cervical cancer stage IIA

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Seoul National University College of Medicine

    Seoul, 03080, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.