Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue

Dokuz Eylül University (DEU)

Status: Enrolling

Conditions: Sentinel Lymph Node; Endometrial Cancer Stage I; Metastasis; Endometrial Neoplasms

Treatments: Procedure: Sentinel Lymph Node Detection/Cervical Methylene Blue Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07040657

693-SBKAEK

Details and patient eligibility

About

This clinical trial evaluates lymph node mapping in newly diagnosed endometrial cancer patients undergoing surgery. The standard technique uses a 2-point methylene blue cervical injection. The study aims to determine if increasing injection points improves mapping success.

Full description

In recent years, Sentinel Lymph Node (SLN) mapping has become a key focus in improving surgical outcomes for endometrial cancer. While methylene blue is a cost-effective option for SLN mapping, its detection rates remain suboptimal. This study aims to evaluate whether increasing the injection points from the standard 2-point to a 4-point methylene blue injection improves SLN mapping success.

This randomized controlled trial will include patients with preoperative stage I endometrial carcinoma. Participants will be randomized into two groups: one group will receive a 2-point methylene blue cervical injection, and the other group will receive a 4-point injection.

The primary endpoint is the difference in SLN detection rates between the two techniques. Findings from this study will provide detailed insights into whether the 4-point injection offers a significant advantage over the standard 2-point method.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals diagnosed with stage I endometrial cancer based on CT and PET-CT imaging.
• Individuals with a pathologically confirmed diagnosis of stage I endometrial cancer.

Exclusion criteria

Medical Conditions

• Individuals diagnosed with dementia.
• Individuals with allergies to methylene blue or iodine.
• Individuals who have received active treatment for another malignancy within the past five years.
• Inability to successfully perform PLD (pelvic lymphadenectomy) or history of prior PLD.
• Women with multiple and confluent lymph nodes identified as positive on FDG-PET/CT (such cases are not considered stage I).

Cancer-Related Conditions

• Individuals with clinically or radiologically identified positive lymph nodes or metastatic disease.
• Individuals with a history of pelvic dissection and/or radiation therapy.
• Individuals with advanced cervical or uterine cancer.
• Individuals with T3/T4 lesions.
• Individuals with cervical tumors larger than 2 cm.

Organ Dysfunction

• Individuals with hepatic dysfunction and a MELD score ≥ 10 and creatinine ≥ 2·0 mg/dl patients.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

2- Point Methylene Blue Injection

Experimental group

Description:

In the 2-point injection arm, participants will receive the standard sentinel lymph node (SLN) mapping technique using methylene blue. The procedure involves injecting methylene blue dye into two specific locations on the cervix: At the 3 o'clock position At the 9 o'clock position

Treatment:

Procedure: Sentinel Lymph Node Detection/Cervical Methylene Blue Injection

4- Point Methylene Blue Injection

Active Comparator group

Description:

In the 4-point injection arm, participants will receive the standard sentinel lymph node (SLN) mapping technique using methylene blue. The procedure involves injecting methylene blue dye into two specific locations on the cervix: At the 2 o'clock position At the 4 o'clock position At the 8 o'clock position At the 10 o'clock position

Treatment:

Procedure: Sentinel Lymph Node Detection/Cervical Methylene Blue Injection