Prospektiv Randomisierte Studie Zum Vergleich Einer Ausgedehnten Mit Einer eingeschränkten Pelvinen Lymphadenektomie Bei Der Operativen Therapie Des Harnblasenkarzinoms
The extention of pelvic lymphadenectomy in the surgical treatment of muscle-invasive,
clinically locally bladder cancer is not yet standardized. There are no data from
prospective studies on the prognostic significance of regional lymphadenectomy.
Results of retrospective studies suggest, that the prognosis of patients with
muscle-invasive bladder cancer can be improved by extending the limits of pelvic
lymphadenectomy. Furthermore it could be demonstrated in a prospective study that the
pattern of metastasis of bladder cancer has a high variability. About two-thirds of lymph
node metastases are found outside the normally cleared areas of lymphadenectomy. In his
study patients will be randomized into arms with limited versus extended lymphadenectomy.
The limited lymphadenectomy includes the removal of the obturatorical and external iliac
lymph nodes, the extended one includes the removal of all lymph nodes between pelvic floor
and the departure of the inferior mesenteric artery. The primary objective of the study is
to record the progression-free survival. Secondary study objectives include the creation of
a standard for the surgical treatment and development of quality criteria and implementation
of those into international guidelines. The indication for adjuvant chemotherapy for locally
advanced tumors is not affected.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free Survival
Jürgen E. Gschwend, Prof. Dr.
AUO Arbeitsgemeinschaft Urologische Onkologie
Germany: Federal Institute for Drugs and Medical Devices