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ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer

NCT05862740RecruitingNAINTERVENTIONAL

Summary

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.

Key Facts

Lead Sponsor

Azienda Ospedaliera di Padova

Enrollment

Start Date

2022-01-02

Completion Date

2026-12-31

Study Type

INTERVENTIONAL

Official Title

ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer: a Feasibility Prospective Study

Interventions

Laparoscopic Debulking Surgery in advanced ovarian cancerStandard laparotomic Debulking Surgery in advanced ovarian cancer

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Safety: rate of complications/morbidities

Safety will be measured as the rate of patients experiencing intra- and post-operative early and late morbidities (within and after the hospitalization up to 60 days from surgery) and it will be compared to the morbidity rate of patients having similar surgery by laparotomy. Complications are going to be graded according to Clavien-Dindo classification.

Time frame: 60 days

Efficacy: rate of complete resection (CR) in group 1

Efficacy will be measured as the rate of patients in which the surgical target set pre-operatively is achieved by laparoscopy.

Time frame: 60 days

Feasibility: rate of procedures completed by laparoscopy

Feasibility will be measured as the rate of patients who have their procedure completed by laparoscopy.

Time frame: 60 days

Secondary Outcomes

Progression Free Survival (PFS).

the time interval from the surgical treatment to the date of the documented first recurrence of disease, by CA 125 (Carbohydrate Antigen 125) and/or CT scan.

Time frame: 5 years

Overall Survival (OS).

time between surgery and death.

Time frame: 5 years

Locations

Azienda Ospedaliera Universitaria di Padova,, Padua, Italy

Linked Papers

2023-10-16

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

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. 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. 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. 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. ClinicalTrials.gov Identifier: NCT05862740.

2021-10-20

Laparoscopic management of advanced epithelial ovarian cancer after neoadjuvant chemotherapy: a phase II prospective multicenter non-randomized trial (the CILOVE study)

The aim of this study was to explore the feasibility and safety of the laparoscopic approach after neoadjuvant chemotherapy among selected chemosensitive patients with advanced ovarian cancer. The CILOVE study was a phase II prospective non-randomized multicenter study. It aimed to enroll 47 women with unresectable disease at the time of initial diagnosis (International Federation of Gynecology and Obstetrics (FIGO) stage IV and/or diffuse extensive carcinomatosis for advanced FIGO stage IIIC or patients unfit to withstand radical primary surgery), in response to chemotherapy and fit to undergo laparoscopy. Among the 48 patients enrolled in the trial, 44 (92%) patients underwent exploratory staging laparoscopy and, as a result, 41 patients were eligible for cytoreductive surgery. Among them, 32 were intended to be managed by laparoscopy and nine patients were managed by laparotomy. The conversion rate to laparotomy was 9.4% (3/32) and the reasons were multiple surgical adhesions (n=1), miliary carcinomatosis and adhesion to the intraperitoneal mesh (n=1), and poor laparoscopic evaluation of transverse colon involvement (n=1). All except one patient had optimal cytoreduction (97% complete cytoreduction, 3% incomplete cytoreduction (residual tumor <2.5 mm)). The median operative time was 267 min (range 146-415) and the median estimated blood loss was 150 mL (range 0-500). Two patients had intra-operative complications: one diaphragm rupture that was repaired during laparoscopy and one bradycardia. Six patients experienced early post-operative complications (<1 month), but there were no grade 3 and 4 complications (3 infections, 1 lymphoedema, 2 hemorrhage). After cytoreductive laparoscopy, the percentage of patients without progression at 12 months was 87.5%. Interval ovarian cytoreduction by a laparoscopic approach is safe and feasible for patients with a favorable response to chemotherapy. With the widespread use of neoadjuvant chemotherapy in the management of advanced ovarian cancer, a minimally invasive approach may be a potential option.