Article Text

Download PDFPDF
160 ULTRA-LAP trial (Phase II): laparoscopic debulking surgery (LDS) in advanced ovarian cancer
  1. Roberto Tozzi1,
  2. Marco Noventa2,
  3. Carlo Saccardi2,
  4. Giulia Spagnol2,
  5. Orazio De Tommasi2,
  6. Davide Coldebella2 and
  7. Matteo Marchetti2
  1. 1Department of Medicine and Surgery, University of Padova, Padova, Italy
  2. 2University of Padua, Padova, Italy


Introduction/Background The contribution of surgery to ovarian cancer (OC) is witnessed by the undisputed prognostic significance of the complete resection (CR), regardless of the initial treatment modality. It is therefore justified that gynecologic oncologists strive to increase CR rate to the highest possible. Alongside this, the effort has been to reduce the surgical morbidity by introducing the use of laparoscopy to complete the whole surgical debulking.

A non-randomized prospective phase I-II clinical trial (ULTRA-LAP) ( NCT05862740) to test safety, side effects and efficacy of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III-IV OC was performed. The pilot study was designed to identify which OC patients are suitable to undergo L-VPD.

Methodology From March 2016 all consecutive patients with OC underwent exploratory laparoscopy (EXL). Patients whose disease was deemed amenable for a complete resection (CR) based on imaging and EXL underwent VPD. In all patients, a consistent attempt was made at completing L-VPD.

Results In the study period, 208 OC patients underwent EXL: 121 underwent interval VPD and 87 up-front VPD. Overall, 158 patients had VPD by laparotomy (75.9%) and 50 (24.1%) had L-VPD, of which 34 patients as interval (iL-VPD) and 16 as up-front (uL-VPD). Intra- and post-operative morbidity were very low in the L-VPD group. CR rate was 98% in L-VPD group and 94% in VPD. The most common reason for conversion was diaphragmatic disease extending dorsally.

Conclusion In the pilot study, L-VPD was completed in 24,1% of OC. Initial analysis supports the feasibility of L-VPD in 2 groups of OC: those with no gross disease at interval surgery and those with gross visible disease at upfront or interval surgery, but limited to: pelvis (including recto-sigmoid), gastro colic omentum, peritoneum and diaphragm, the latter not requiring dorsal liver mobilization. Both groups had 100% feasibility and have been thus forth recruited to ULTRA-LAP.

Disclosures None

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.