Prospective, Randomized and Multicentre Study for Investigation of Valence of Sentinel Lymph Nodes Concept in Patients With Cervical Cancer ≤ 2 cm
After randomization and assignment to experimental or control group lymphadenectomy is
Four different techniques can be used: 1) laparoscopic transperitoneal 2) laparoscopic
retroperitoneal 3) open extraperitoneal 4) open transperitoneal. Radioactive labeling of
sentinel-lymph nodes with 99technetium-marked colloid and/or patent blue is carried out. On
the day prior to the operation 50mBq 99technetium or on the day of operation 10 mBq
99technetium is injected subepithelially in the cervix at 12, 3, 6 and 9 o'clock.
Preoperatively 4 cc patent blue are injected in the same manner subepithelially. At the
beginning of surgery parametrial tumor involvement, intrabdominal tumor dissemination,
invasion of vesica-cervical and recto-vaginal septum are excluded. A lavage of cul-de-sac
for cytological analysis is performed. The retroperitoneum is opened lateral of iliac
vessels and blue colored lymph or radioactive nodes are removed. Sentinel- lymph node's
radioactive signal is documented in counts per second (cps).
If no sentinel-lymph node is detected, complete pelvic lymph node dissection is carried out.
If tumor involved pelvic lymph nodes are shown, paraaortic lymph node dissection is carried
out. If sentinel- or pelvic lymph nodes are quoted as tumor free at frozen sections, radical
hysterectomy or radical trachelectomy is performed. Radical hysterectomy follows in an
extension a type-2 variation. In patients with positive lymph nodes in frozen section or in
definitive histo-pathology primary chemoradiation is performed.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary study end point is that overall survival of patients with sentinel-concept, has not to differentiate from that one of patients with systematic lymph node dissection.
Germany: Ethics Commission