Para Aortic Lymphadenectomy : Always ?

Completed

• Conditions: Cervical Cancer
• Interventions: Procedure: Para Aortic Lymphadenectomy (PAL) by laparoscopy

• Registration Number: NCT04392895
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Cervical cancer affects more than 3000 new cases per year in France. The treatment of stage IB3 to IVA cervical cancer is based on concomitant radio-chemotherapy. The irradiation volumes are based, according to current recommendations, on imaging examinations and / or on the results of a laparoscopic Para-aortic lymphadenectomy (PAL). There is some risk of false negatif with the PET/CT. For this reason, most of the time, PAL is offered when there is no pathological paraaortic lymph node on PET/CT. The investigators suppose that this staging surgery could be avoid when no pathological pelvic nodes are identified on PET/CT. The investigators use a retrospective study, to analyse histological report of systematic PAL, comparing to results of pre-operative PET/CT.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-19
• Primary Completion: 2020-05-29
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with locally advanced cervical cancer	Para Aortic Lymphadenectomy (PAL) by laparoscopy	Patients with locally advanced cervical cancer, who had undergone a PAL

Primary Outcome Measures

Name	Time	Method
negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes.	1 day	negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes.; The intraoperative 3D optical scan gives the tumor localization obtained by radioguided occult lesion localization thanks to pen marking left by the surgeon. The comparison is done by superimposing both acquisitions.

Secondary Outcome Measures

Name	Time	Method
morbidity of PAL	1 day	morbidity of PAL

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France