Clinical trial · Observational
Extraperitoneal Lymph Node Dissection in Patients With Cervical Cancer
A Pilot Study of Laparoscopic Extraperitoneal Lymph Node Dissection in Patients With Locally Advanced Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objectives: * To determine the feasibility of performing an extraperitoneal laparoscopic lymphadenectomy in patients with stage IB2-IVA cervical carcinoma who are dispositioned to undergo radiotherapy and concurrent chemotherapy. * To document intraoperative and postoperative complications in patients undergoing extraperitoneal laparoscopic lymphadenectomy. * To determine the rate of lymph node metastases in the para-aortic region in patients with stage IB2-IVA cervical cancer. * To correlate histopathological findings in the para-aortic lymph nodes with preoperative imaging studies (Positron emission tomography (PET) and magnetic resonance imaging (MRI) and computed tomography (CT)).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extraperitoneal Laparoscopic Lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Laparoscopy Procedure
- description
- Laparoscopy procedure in abdomen to remove para aortic lymph nodes of patients diagnosed with cervical cancer.
- interventionNames
- Procedure: Extraperitoneal Laparoscopic Lymphadenectomy
Primary outcomes (1)
- measure
- Complication Rates
- timeFrame
- 6 Years
- description
- Complication rates determined as number of participants with inherent complications to procedure calculated separately from overall complications divided by to total number of participants.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Patients with stage IB2-IVA cervical cancer who are candidates for treatment with radiotherapy and concurrent chemotherapy. * Patients with biopsy-proven cervical carcinoma, any histology. * Patients must have no evidence of para aortic lymphadenopathy (\< 2cm in diameter) on the preoperative computed tomography (CT) or magnetic resonance imaging (MRI) scan of the abdomen and pelvis. * Patients must sign an IRB approved informed consent. * Patients with adequate bone marrow, renal and hepatic function: White Blood Count (WBC) \>/= 3,000 cells/mcl, Platelets \>/= 100,000/mcl, Creatinine \</= 2.0 mg%, Bilirubin \</= 1.5 x the upper limit of normal and Serum glutamic pyruvic transaminase (SGPT) \</= 3 x the upper limit of normal. * Zubrod Performance Status of 0, 1, or 2. * Patients must be suitable candidates for surgery. * Patients who had a PET/CT scan prior to study entry are eligible if a) the study was done within 4 weeks of surgery, and b) they have no evidence of para aortic lymphadenopathy (\< 2cm in diameter) on either a preoperative CT or MRI scan of the abdomen and pelvis. Exclusion Criteria: * Patients who have had prior retroperitoneal surgery. * Patients who have received prior pelvic or abdominal radiotherapy. * Patients known to have upper abdominal intraperitoneal disease or evidence of ovarian metastases. * Patients who are pregnant. * Patients with evidence of distant metastases on chest x-ray, CT or MRI scan or by physical examination. * Patients with contraindications to laparoscopy.
References
Publications (0)
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