Para Aortic Lymphadenectomy : Always ?

Cervical Cancer Clinical Trial

— PALA  

Official title:

Assesment of Paraaortic Lymphadenectomy in Locally Advanced Cervical Cancer, When no Pathologic Pelvic Lymph Node on PET/CT: Retrospective Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392895
• Other study ID #: RECHMPL20_0296
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 30, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients with :

• locally advanced cervical cancer,

• who undergone PAL

• with pre operative PET CT, between January 2015 and december 2019

Exclusion criteria:

• patients aged under 18

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Para Aortic Lymphadenectomy (PAL) by laparoscopy
Para Aortic Lymphadenectomy (PAL) by laparoscopy

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes.	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.	1 day
Secondary	morbidity of PAL	morbidity of PAL	1 day