Evidence map›Paper›PMID 37921599›Full record

Trial reportJournal of gynecologic oncology2024

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

Roberto Tozzi, Marco Noventa, Carlo Saccardi, Giulia Spagnol, Orazio De Tommasi, Davide Coldebella, Matteo Marchetti

Registry-linked trialOpen access · diamondAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of gynecologic oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05862740 (ULTRA-LAP Trial), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05862740 narecruitingnot on this map

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

TypeinterventionalSponsorAzienda Ospedaliera di PadovaRan2022 to 2027Enrolled62ConditionsOvarian CancerArmsLaparoscopic Debulking Surgery in advanced ovarian cancer, Standard laparotomic Debulking Surgery in advanced ovarian cancer
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 8 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 2 countries.

Roberto TozziDivision of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy. roberto.tozzi@unipd.it.ORCID 0000-0001-6123-1628
Marco NoventaDivision of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy.ORCID 0000-0002-7809-6001
Carlo SaccardiDivision of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy.ORCID 0000-0001-7476-997X
Giulia SpagnolDivision of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy.ORCID 0000-0003-3525-0571
Orazio De TommasiDivision of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy.ORCID 0000-0001-5890-9792
Davide ColdebellaDivision of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy.ORCID 0000-0002-8923-9135
Matteo MarchettiDivision of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy.ORCID 0000-0003-4427-0101
University of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveA 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.

methodsBetween 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.

resultsTwo 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.

conclusionIn 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 registrationClinicalTrials.gov Identifier: NCT05862740.

Indexed as

LaparoscopyOvarian NeoplasmsCarcinoma, Ovarian EpithelialCytoreduction Surgical ProceduresFeasibility StudiesFemaleHumansNeoplasm StagingPeritoneumPilot ProjectsProspective StudiesLaparoscopic DebulkingMinimally Invasive Debulking SurgeryOvarian CancerVisceral-Peritoneal Debulking

Identifiers

PMID37921599
PMCPMC10948990
OpenAlexW4387792020

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.