Clinical trial · Interventional
ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer
ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer: a Feasibility Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ULTRA-LAP is a prospective study is to investigate the safety, efficacy and feasibility of laparoscopic debulking surgery (LDS) for the treatment of patients with advanced ovarian cancer. The outcomes to measure are: * Safety: the rate of patients experiencing intra- and post-operative early and late morbidities (within the hospitalization and up to 60 days from surgery) * Efficacy: the rate of patients in which the surgical target set pre-operatively (complete resection) is achieved by laparoscopy. * Feasibility: the rate of patients who have their procedure completed by laparoscopy Patients will undergo laparoscopic debulking surgery (LDS) if the surgical target can be met. If it cannot be achieved by laparoscopy the surgeon will convert to laparotomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Debulking Surgery in advanced ovarian cancer | Procedure | — | UNRESOLVED |
| Standard laparotomic Debulking Surgery in advanced ovarian cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic debulking surgery - LDS
- description
- Primary debulking surgery or Interval debulking surgery performed by laparoscopy (P-LDS and I-LDS)
- interventionNames
- Procedure: Laparoscopic Debulking Surgery in advanced ovarian cancer
- type
- ACTIVE_COMPARATOR
- label
- Debulking surgery - DS
- description
- Primary debulking surgery or Interval debulking surgery performed by/converted to laparotomy (PDS and IDS)
- interventionNames
- Procedure: Standard laparotomic Debulking Surgery in advanced ovarian cancer
Primary outcomes (3)
- measure
- Safety: rate of complications/morbidities
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced epithelial ovarian cancer (II-IV Stage FIGO) candidates to PDS (primary debulking surgery) or IDS (interval debulking surgery: neoadjuvant chemotherapy followed by IDS). * Participant is willing and able to give informed consent for participation in the study. * Female aged 18 years or above. * Primary diagnosis of advanced epithelial ovarian cancer (tubal and peritoneal cancer included). Exclusion Criteria: * Comorbidities non-allowing for radical surgery * Poor Performance Status (Karnofsky Index \< 70) * Concomitant or past history of malignancy, regardless of treatment status * Recent or past story of pancreatitis or hepatitis * Recent or past story of pleural effusion or lung injuries or respiratory failure * Cardiac major pathologies
References
Publications (6)
- RESULTElattar A, Bryant A, Winter-Roach BA, Hatem M, Naik R. Optimal primary surgical treatment for advanced epithelial ovarian cancer. Cochrane Database Syst Rev. 2011 Aug 10;2011(8):CD007565. doi: 10.1002/14651858.CD007565.pub2. PMID 21833960
- RESULTShih KK, Chi DS. Maximal cytoreductive effort in epithelial ovarian cancer surgery. J Gynecol Oncol. 2010 Jun;21(2):75-80. doi: 10.3802/jgo.2010.21.2.75. Epub 2010 Jun 30. PMID 20613895
- RESULTElstrand MB, Sandstad B, Oksefjell H, Davidson B, Trope CG. Prognostic significance of residual tumor in patients with epithelial ovarian carcinoma stage IV in a 20 year perspective. Acta Obstet Gynecol Scand. 2012 Mar;91(3):308-17. doi: 10.1111/j.1600-0412.2011.01316.x. Epub 2012 Jan 9. PMID 22050605
- RESULTPomel C, Akladios C, Lambaudie E, Rouzier R, Ferron G, Lecuru F, Classe JM, Fourchotte V, Paillocher N, Wattiez A, Montoriol PF, Thivat E, Beguinot M, Canis M. Laparoscopic management of advanced epithelial ovarian cancer after neoadjuvant chemotherapy: a phase II prospective multicenter non-randomized trial (the CILOVE study). Int J Gynecol Cancer. 2021 Dec;31(12):1572-1578. doi: 10.1136/ijgc-2021-002888. Epub 2021 Oct 20. PMID 34670829
- RESULTFagotti A, Gueli Alletti S, Corrado G, Cola E, Vizza E, Vieira M, Andrade CE, Tsunoda A, Favero G, Zapardiel I, Pasciuto T, Scambia G. The INTERNATIONAL MISSION study: minimally invasive surgery in ovarian neoplasms after neoadjuvant chemotherapy. Int J Gynecol Cancer. 2019 Jan;29(1):5-9. doi: 10.1136/ijgc-2018-000012. PMID 30640676
- DERIVEDTozzi R, Noventa M, Saccardi C, Spagnol G, De Tommasi O, Coldebella D, Marchetti M. Feasibility of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III-IV ovarian cancer: the ULTRA-LAP trial pilot study. J Gynecol Oncol. 2024 Mar;35(2):e14. doi: 10.3802/jgo.2024.35.e14. Epub 2023 Oct 16. PMID 37921599