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Clinical Trial
. 2024 Mar;35(2):e14.
doi: 10.3802/jgo.2024.35.e14. Epub 2023 Oct 16.

Feasibility of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III-IV ovarian cancer: the ULTRA-LAP trial pilot study

Roberto Tozzi  1 , Marco Noventa  2 , Carlo Saccardi  2 , Giulia Spagnol  2 , Orazio De Tommasi  2 , Davide Coldebella  2 , Matteo Marchetti  2
Affiliations
Clinical Trial

Feasibility of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III-IV ovarian cancer: the ULTRA-LAP trial pilot study

Roberto Tozzi et al. J Gynecol Oncol. 2024 Mar.

Abstract

Objective: A non-randomized prospective clinical trial (ULTRA-LAP) was registered to test safety, side effects and efficacy of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III-IV ovarian cancer (OC). A pilot study was designed to identify which OC patients are suitable to undergo L-VPD.

Methods: Between March 2016 and October 2021, all consecutive patients with OC underwent exploratory laparoscopy (EXL). All patients whose disease was deemed amenable for a complete resection (CR) at imaging review and EXL, underwent VPD. In all patients a consistent attempt was made at completing L-VPD.

Results: Two hundred and eight OC had EXL in the study period: 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 was very low in the L-VPD group. CR rate was 98% in L-VPD group and 94% in VPD. Most common reason for conversion was diaphragmatic disease extending dorsally.

Conclusion: In the pilot study of ULTRA-LAP, 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.

Trial registration: ClinicalTrials.gov Identifier: NCT05862740.

Keywords: Laparoscopic Debulking; Minimally Invasive Debulking Surgery; Ovarian Cancer; Visceral-Peritoneal Debulking.

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Conflict of interest statement

No potential conflict of interest relevant to this article was reported.

Figures

Fig. 1
Fig. 1. Patient’s flow-chart of the ULTRA-LAP trial pilot study.
CT, computed tomography; EXL, exploratory laparoscopy; iL-VPD, interval laparoscopic visceral-peritoneal debulking; i-VPD, interval visceral-peritoneal debulking; MDT, multidisciplinary team; uL-VPD, up-front laparoscopic visceral-peritoneal debulking; u-VPD, up-front visceral-peritoneal debulking; VPD, visceral-peritoneal debulking.
See this image and copyright information in PMC

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