Endometrial CancerNCT07306195
Comparison Between High and Low Level Para-aortic Lymphadenectomy in High and Intermediate Risk Endometrial Carcinoma
A study testing high level para-aortic lymphadenectomy and low level para-aortic lymphadenectomy in people with Endometrial Cancer, run by Ahmed Aouf at 1 site in Egypt.
Trial summary
Endometrial cancer (EC) is the most frequent gynecological malignancy in developed countries and ranks second in incidence worldwide after cervical cancer, accounting for nearly 10% of cancers in women . Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- high level para-aortic lymphadenectomy and low level para-aortic lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria consisted of women diagnosed with either intermediate- or high-risk EC, based on established pathological and radiological criteria. •Intermediate-risk patients included those with grade 1/2 endometrioid carcinoma with <50% myometrial invasion and tumor size >2 cm, grade 1/2 with 50-66% invasion, or grade 3 with <50% invasion.
- High-risk cases were defined as non-endometrioid histology (serous or clear cell), grade 1 or 2 endometrioid carcinoma with more than 66% invasion, grade 3 with more than 50% invasion, or the presence of adnexal metastasis.
Who cannot join
- Patients were excluded if they had general contraindications to surgery, morbid obesity that precluded safe operative access, or if they declined to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Endometrial cancer (EC) is the most frequent gynecological malignancy in developed countries and ranks second in incidence worldwide after cervical cancer, accounting for nearly 10% of cancers in women . With the adoption of comprehensive surgical staging, the identification of extra-uterine disease has become central to treatment and prognosis. Lymph node involvement, particularly para-aortic nodal metastasis, represents one of the most important independent prognostic factors .
The uterus has a complex lymphatic drainage, with pathways leading to the obturator, iliac, caval, aortic, parametrial, and presacral basins. Direct channels from the uterine fundus to the para-aortic nodes via the infundibulopelvic ligament explain metastatic spread to the para-aortic region, although isolated para-aortic involvement in the absence of pelvic nodal disease is uncommon. Recognition of these drainage patterns underscores the importance of evaluating both pelvic and para-aortic lymph nodes in high- and intermediate-risk patients .
Read more
Several studies suggest that systematic lymphadenectomy, including the para-aortic region, improves survival by enhancing staging accuracy and guiding adjuvant therapy. Combined pelvic and para-aortic lymphadenectomy (PALD) has been associated with increased 5-year overall survival, improved disease-free survival, reduced recurrence, and decreased need for adjuvant radiotherapy . However, the optimal extent of para-aortic dissection remains debated. Para-aortic nodes are subdivided relative to the inferior mesenteric artery (IMA) into inframesenteric (low-level) and supramesenteric (high-level). While high-level PALD may improve detection of occult metastases, it increases surgical complexity and morbidity .
Risk stratification of EC guides the extent of staging. High-risk disease includes non-endometrioid histologies, grade 3 endometrioid carcinoma with >50% myometrial invasion, and advanced local spread. Intermediate-risk disease encompasses grade 1-2 tumors with deep or larger-volume myometrial invasion. Patients in these categories have a significant risk of nodal involvement (up to 16%), warranting para-aortic evaluation .
The present study aims to compare high versus low PALD in intermediate- and high-risk EC with emphasis on nodal yield, histopathological characteristics, staging, and oncological outcomes.
- Conditions
- Endometrial Cancer
- Being tested
- high level para-aortic lymphadenectomy, low level para-aortic lymphadenectomy
- Keywords
- Endometrial Cancer, hystrectomy, para-aortic lymphadenectomy, high level para-aortic lymphadenectomy, low level para-aortic lymphadenectomy, survival outcome
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high level para-aortic lymphadenectomyProcedure or surgery
All women underwent total hysterectomy with bilateral salpingo-oophorectomy combined with systematic pelvic lymphadenectomy and high-level PALD was done .The small bowel and mesentery were carefully mobilized to expose the aorta and inferior vena cava (IVC) above the IMA, with dissection proceeding cranially to the left renal vein. The anatomical landmarks were consistently identified to ensure complete lymphatic clearance within the defined field. Excised lymph nodes were counted intraoperatively and verified by histopathology.
low level para-aortic lymphadenectomyProcedure or surgery
All women underwent total hysterectomy with bilateral salpingo-oophorectomy combined with systematic pelvic lymphadenectomy and high-level PALD was done .The small bowel and mesentery were carefully mobilized to expose the aorta and inferior vena cava (IVC) , the dissection was restricted to the infra-mesenteric region between the aortic bifurcation and the IMA. The anatomical landmarks were consistently identified to ensure complete lymphatic clearance within the defined field. Excised lymph nodes were counted intraoperatively and verified by histopathology.
| Study group | Role | What they receive |
|---|---|---|
| group A high | Active comparator | underwent high-level PALD, where lymphatic dissection was extended above the IMA up to the left renal vein. Receives: Procedure: high level para-aortic lymphadenectomy |
| group B low | Active comparator | underwent low-level PALD, in which lymph node dissection was confined to the infra-mesenteric region, extending from the aortic bifurcation to just below the IMA. Receives: Procedure: low level para-aortic lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
descriptive operative outcome
The primary surgical outcome is para-aortic nodal yield
how to measure paraaortic LN Yeild : surgical removal and pathological analysis, focusing on the number of nodes harvested (total yield) and the number of positive nodes (involved yield) relative to total nodes.
Measured: 1 week
Secondary outcomes (1)
survival outcome
Long-term oncological outcome, including (Overall survival) survival status at follow-up (alive, deceased, or lost to follow-up).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Oct 2022
- Primary completion30 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective, comparative clinical trial was conducted on 102 women diagnosed with high- or intermediate-risk EC , during the period from September 2022 to April 2025. The institutional review board (IRB) of Kafrelsheikh University approved the study. We complied with the ethical guidelines outlined in the Declaration of Helsinki throughout the study.The inclusion criteria consisted of women diagnosed with either intermediate- or high-risk EC, based on established pathological and radiological criteria.Eligible patients were stratified according to their risk category (intermediate or high risk) and subsequently randomized into two surgical groups based on the extent of PALD. Group A underwent high-level PALD, where lymphatic dissection was extended above the IMA up to the left renal vein. Group B underwent low-level PALD, in which lymph node dissection was confined to the inframesenteric region, extending from extending from the aortic bifurcation to just below the IMA.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Aouf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Aouf, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306195
- Sponsor's protocol ID
- KFSIRB200-762
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: there is a plan to make IPD available. It also means that a data dictionary (a description of the variables, or types of data, collected for each individual) will be provided so that the data can be fully interprete
Publications
Somashekhar, S. P. et al. Prospective Non-randomized Control Trial on Role of Systematic High Para-Aortic Lymphadenectomy in Endometrial Cancer: Indian Study. Indian J Gynecol Oncolog 19, 6 (2021). 2. Jung, U. S., Choi, J. S., Bae, J., Lee, W. M. & Eom, J. M. Systemic Laparoscopic Para-Aortic Lymphadenectomy to the Left Renal Vein. JSLS 23, e2018.00110 (2019). 3. El-Agwany, A. S. & Meleis, M. H. Value and best way for detection of Sentinel lymph node in early stage endometrial cancer: Selective lymphadenectomy algorithm. European Journal of Obstetrics & Gynecology and Reproductive Biology 225, 35-39 (2018). 4. Petousis, S. et al. Combined pelvic and para-aortic is superior to only pelvic lymphadenectomy in intermediate and high-risk endometrial cancer: a systematic review and meta-analysis. Arch Gynecol Obstet 302, 249-263 (2020). 5. AlHilli, M. M. & Mariani, A. The role of para-aortic lymphadenectomy in endometrial cancer. Int J Clin Oncol 18, 193-199 (2013). 6. Zammarrelli, W. A. et al. Risk Stratification of Stage I Grade 3 Endometrioid Endometrial Carcinoma in the Era of Molecular Classification. JCO Precis Oncol e2200194 (2022) doi:10.1200/PO.22.00194. 7. Yang, Y., Wu, S. F. & Bao, W. Molecular subtypes of endometrial cancer: Implications for adjuvant treatment strategies. International Journal of Gynecology & Obstetrics 164, 436-459 (2024). 8. Thammineedi, S. R., Iyer, R. R., Naren, B. & Patnaik, S. C. Lymphadenectomy in Endometrial Cancers-A Review. Indian J Gynecol Oncolog 19, 77 (2021). 9. AlHilli, M. M. et al. Preoperative biopsy and intraoperative tumor diameter predict lymph node dissemination in endometrial cancer. Gynecologic Oncology 128, 294-299 (2013). 10. Hashmi, A. A. et al. Morphological Spectrum and Pathological Parameters of Type 2 Endometrial Carcinoma: A Comparison With Type 1 Endometrial Cancers. Cureus 12, (2020). 11. Song, S.-H. et al. Clinicopathologic Characteristics and Prognostic Factors of Stage I and II Endometrial cancer of the uter
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between High and Low Level Para-aortic Lymphadenectomy in High and Intermediate Risk Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT07306195
- Acronym / sponsor ID
- KFSIRB200-762
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, hystrectomy, para-aortic lymphadenectomy, high level para-aortic lymphadenectomy, low level para-aortic lymphadenectomy, survival outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ahmed AoufUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 29 Dec 2025 (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.
Endometrial cancer (EC) is the most frequent gynecological malignancy in developed countries and ranks second in incidence worldwide after cervical cancer, accounting for nearly 10% of cancers in women . With the adoption of comprehensive surgical staging, the identification of extra-uterine disease has become central to treatment and prognosis. Lymph node involvement, particularly para-aortic nodal metastasis, represents one of the most important independent prognostic factors .
The uterus has a complex lymphatic drainage, with pathways leading to the obturator, iliac, caval, aortic, parametrial, and presacral basins. Direct channels from the uterine fundus to the para-aortic nodes via the infundibulopelvic ligament explain metastatic spread to the para-aortic region, although isolated para-aortic involvement in the absence of pelvic nodal disease is uncommon. Recognition of these drainage patterns underscores the importance of evaluating both pelvic and para-aortic lymph nodes in high- and intermediate-risk patients .
Several studies suggest that systematic lymphadenectomy, including the para-aortic region, improves survival by enhancing staging accuracy and guiding adjuvant therapy. Combined pelvic and para-aortic lymphadenectomy (PALD) has been associated with increased 5-year overall survival, improved disease-free survival, reduced recurrence, and decreased need for adjuvant radiotherapy . However, the optimal extent of para-aortic dissection remains debated. Para-aortic nodes are subdivided relative to the inferior mesenteric artery (IMA) into inframesenteric (low-level) and supramesenteric (high-level). While high-level PALD may improve detection of occult metastases, it increases surgical complexity and morbidity .
Risk stratification of EC guides the extent of staging. High-risk disease includes non-endometrioid histologies, grade 3 endometrioid carcinoma with >50% myometrial invasion, and advanced local spread. Intermediate-risk disease encompasses grade 1-2 tumors with deep or larger-volume myometrial invasion. Patients in these categories have a significant risk of nodal involvement (up to 16%), warranting para-aortic evaluation .
The present study aims to compare high versus low PALD in intermediate- and high-risk EC with emphasis on nodal yield, histopathological characteristics, staging, and oncological outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This prospective, comparative clinical trial was conducted on 102 women diagnosed with high- or intermediate-risk EC , during the period from September 2022 to April 2025. The institutional review board (IRB) of Kafrelsheikh University approved the study. We complied with the ethical guidelines outlined in the Declaration of Helsinki throughout the study.The inclusion criteria consisted of women diagnosed with either intermediate- or high-risk EC, based on established pathological and radiological criteria.Eligible patients were stratified according to their risk category (intermediate or high risk) and subsequently randomized into two surgical groups based on the extent of PALD. Group A underwent high-level PALD, where lymphatic dissection was extended above the IMA up to the left renal vein. Group B underwent low-level PALD, in which lymph node dissection was confined to the inframesenteric region, extending from extending from the aortic bifurcation to just below the IMA.
| Arm | Type | Receives |
|---|---|---|
| group A high | Active comparator | Procedure: high level para-aortic lymphadenectomyunderwent high-level PALD, where lymphatic dissection was extended above the IMA up to the left renal vein. |
| group B low | Active comparator | Procedure: low level para-aortic lymphadenectomyunderwent low-level PALD, in which lymph node dissection was confined to the infra-mesenteric region, extending from the aortic bifurcation to just below the IMA. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The inclusion criteria consisted of women diagnosed with either intermediate- or high-risk EC, based on established pathological and radiological criteria. •Intermediate-risk patients included those with grade 1/2 endometrioid carcinoma with <50% myometrial invasion and tumor size >2 cm, grade 1/2 with 50-66% invasion, or grade 3 with <50% invasion.
Key exclusion criteria (1 listed)
- Patients were excluded if they had general contraindications to surgery, morbid obesity that precluded safe operative access, or if they declined to participate.
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 |
|---|---|---|
| high level para-aortic lymphadenectomyAll women underwent total hysterectomy with bilateral salpingo-oophorectomy combined with systematic pelvic lymphadenectomy and high-level PALD was done .The small bowel and mesentery were carefully mobilized to expose the aorta and inferior vena cava (IVC) above the IMA, with dissection proceeding cranially to the left renal vein. The anatomical landmarks were consistently identified to ensure complete lymphatic clearance within the defined field. Excised lymph nodes were counted intraoperatively and verified by histopathology. | Procedure or surgery | group A high |
| low level para-aortic lymphadenectomyAll women underwent total hysterectomy with bilateral salpingo-oophorectomy combined with systematic pelvic lymphadenectomy and high-level PALD was done .The small bowel and mesentery were carefully mobilized to expose the aorta and inferior vena cava (IVC) , the dissection was restricted to the infra-mesenteric region between the aortic bifurcation and the IMA. The anatomical landmarks were consistently identified to ensure complete lymphatic clearance within the defined field. Excised lymph nodes were counted intraoperatively and verified by histopathology. | Procedure or surgery | group B low |
Primary outcome
descriptive operative outcome
Time frame: 1 week
The primary surgical outcome is para-aortic nodal yield how to measure paraaortic LN Yeild : surgical removal and pathological analysis, focusing on the number of nodes harvested (total yield) and the number of positive nodes (involved yield) relative to total nodes.
1 secondary outcome
survival outcome
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Results publicationSomashekhar, S. P. et al. Prospective Non-randomized Control Trial on Role of Systematic High Para-Aortic Lymphadenectomy in Endometrial Cancer: Indian Study. Indian J Gynecol Oncolog 19, 6 (2021). 2. Jung, U. S., Choi, J. S., Bae, J., Lee, W. M. & Eom, J. M. Systemic Laparoscopic Para-Aortic Lymphadenectomy to the Left Renal Vein. JSLS 23, e2018.00110 (2019). 3. El-Agwany, A. S. & Meleis, M. H. Value and best way for detection of Sentinel lymph node in early stage endometrial cancer: Selective lymphadenectomy algorithm. European Journal of Obstetrics & Gynecology and Reproductive Biology 225, 35-39 (2018). 4. Petousis, S. et al. Combined pelvic and para-aortic is superior to only pelvic lymphadenectomy in intermediate and high-risk endometrial cancer: a systematic review and meta-analysis. Arch Gynecol Obstet 302, 249-263 (2020). 5. AlHilli, M. M. & Mariani, A. The role of para-aortic lymphadenectomy in endometrial cancer. Int J Clin Oncol 18, 193-199 (2013). 6. Zammarrelli, W. A. et al. Risk Stratification of Stage I Grade 3 Endometrioid Endometrial Carcinoma in the Era of Molecular Classification. JCO Precis Oncol e2200194 (2022) doi:10.1200/PO.22.00194. 7. Yang, Y., Wu, S. F. & Bao, W. Molecular subtypes of endometrial cancer: Implications for adjuvant treatment strategies. International Journal of Gynecology & Obstetrics 164, 436-459 (2024). 8. Thammineedi, S. R., Iyer, R. R., Naren, B. & Patnaik, S. C. Lymphadenectomy in Endometrial Cancers-A Review. Indian J Gynecol Oncolog 19, 77 (2021). 9. AlHilli, M. M. et al. Preoperative biopsy and intraoperative tumor diameter predict lymph node dissemination in endometrial cancer. Gynecologic Oncology 128, 294-299 (2013). 10. Hashmi, A. A. et al. Morphological Spectrum and Pathological Parameters of Type 2 Endometrial Carcinoma: A Comparison With Type 1 Endometrial Cancers. Cureus 12, (2020). 11. Song, S.-H. et al. Clinicopathologic Characteristics and Prognostic Factors of Stage I and II Endometrial cancer of the uter
- Individual participant dataSharing planned: Yes. there is a plan to make IPD available. It also means that a data dictionary (a description of the variables, or types of data, collected for each individual) will be provided so that the data can be fully interprete
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high level para-aortic lymphadenectomy and low level para-aortic lymphadenectomy in people with Endometrial Cancer, run by Ahmed Aouf at 1 site in Egypt.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 Dec 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
descriptive operative outcome (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07306195, which also lists 1 linked publication.
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 29 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.