Evidence map›Paper›PMID 39712295›Full record

ArticlePleura and peritoneum2024

Implementation and evaluation of Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) for the treatment of patients with malignant pleural effusion: study protocol for the Danish phase-I PITAC-OPC5 study.

Pernille Schjødt Hansen, Martin Graversen, Sönke Detlefsen, Alan Patrick Ainsworth, Claus Wilki Fristrup, Lise Eckhoff, Mia Jelin-Klaric, Michael Bau Mortensen

Abstract read
In one paragraph

Article in Pleura and peritoneum, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. [Research Progress on Local Treatment of Malignant Pleural Effusion].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2025
    Review
  2. Review
  3. Article
  4. Article
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

8 authors.

Pernille Schjødt HansenOdense PIPAC Center (OPC) and Odense Pancreas Center (OPAC), Odense University Hospital, Odense, Denmark.ORCID https://orcid.org/0009-0001-9615-8704
Martin GraversenOdense PIPAC Center (OPC) and Odense Pancreas Center (OPAC), Odense University Hospital, Odense, Denmark.ORCID https://orcid.org/0000-0001-5719-4916
Sönke DetlefsenOdense PIPAC Center (OPC) and Odense Pancreas Center (OPAC), Odense University Hospital, Odense, Denmark.ORCID https://orcid.org/0000-0002-9466-2333
Alan Patrick AinsworthOdense PIPAC Center (OPC) and Odense Pancreas Center (OPAC), Odense University Hospital, Odense, Denmark.ORCID https://orcid.org/0000-0001-8922-8877
Claus Wilki FristrupOdense PIPAC Center (OPC) and Odense Pancreas Center (OPAC), Odense University Hospital, Odense, Denmark.
Lise EckhoffDepartment of Oncology, Odense University Hospital, Odense, Denmark.
Mia Jelin-KlaricDepartment of Oncology, Odense University Hospital, Odense, Denmark.
Michael Bau MortensenOdense PIPAC Center (OPC) and Odense Pancreas Center (OPAC), Odense University Hospital, Odense, Denmark.ORCID https://orcid.org/0000-0002-7270-5005

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) is a minimally invasive cancer-directed therapy for patients with malignant pleural effusion (MPE) and/or pleural metastasis (PLM). PITAC is based on Pressurized IntraPeritoneal Aerosol Chemotherapy, which has proven to be safe and feasible. Since 2012, 47 PITACs have been published, and prospective data on feasibility, safety and potential local response are lacking. Methods: The prospective, controlled, phase-I study is designed to treat MPE with PITAC. There are no data to support the estimated number of patients needed, but previous experience estimates the non-access rate to 20 %. Twenty eligible patients with MPE will receive two or more PITACs at four-week intervals. During video-assisted thoracoscopy, MPE and/or pleural lavage fluid is evacuated, and the extent of visible PLM is assessed. Pleural biopsies are collected, if possible, for histological response as per Thoracic Regression Grading Score (TRGS). Patients are screened for treatment-related intra- and postoperative complications. The primary outcome is the number of patients with Clavien-Dindo ≥3b or Common Terminology Criteria for Adverse Events≥4 within 30 days. Secondary objectives include PLM-score, TRGS and cytology, length of hospitalization, personnel safety, quality of life, and change in MPE volume. Results: PITAC is expected to be safe and feasible for patients and personnel, and achieve positive results in the reduction of MPE volume. Conclusions: The results may significantly impact the next clinical, technical, and scientific steps in the implementation of PITAC. Given the suboptimal treatment options for MPE and the seemingly promising results of PITAC, we find the implementation of PITAC ethically reasonable and sound.

Indexed as

cancer-directed therapymalignant pleural effusionpalliative treatmentpressurized intrathoracic aerosol chemotherapythoracic regression grading score

Identifiers

PMID39712295
PMCPMC11661466

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Registered trials

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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.