Evidence map›Paper›PMID 36539781›Full record

Trial reportTrials2022

Patient-reported outcomes in terms of swallowing and quality of life after prophylactic versus reactive percutaneous endoscopic gastrostomy tube placement in advanced oropharyngeal cancer patients treated with definitive chemo-radiotherapy: Swall PEG study.

Tatiana Dragan, André Van Gossum, Frederic Duprez, Yassine Lalami, Yolene Lefebvre, Sofiana Mootassim-Billah, Sylvie Beauvois, Akos Gulyban, Christophe Vandekerkhove, Petra Boegner and 14 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04019548 (Patient Reported Outcomes in Term of Swallowing and Quality of Life After Prophylactic Versus Reactive Percutaneous Endoscopic Gastrostomy Tube Placement in Advanced Oropharyngeal Cancer Patients Treated With Definitive Chemo-radiotherapy), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 27% 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.

NCT04019548 phase3recruitingnot on this map

Patient Reported Outcomes in Term of Swallowing and Quality of Life After Prophylactic Versus Reactive Percutaneous Endoscopic Gastrostomy Tube Placement in Advanced Oropharyngeal Cancer Patients Treated With Definitive Chemo-radiotherapy

TypeinterventionalSponsorJules Bordet InstituteRan2019 to 2030Enrolled110ConditionsOropharyngeal CancerArmsPercutaneous Endoscopic Gastrotomy tube placement, Cisplatin injection, Radiotherapy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

24 authors at 3 institutions in 1 country.

Tatiana DraganDepartment of Radiation Oncology (Head and Neck Unit), Institut Jules Bordet, Université Libre de Bruxelles, 1 rue Héger Bordet, 1000, Brussels, Belgium. tatiana.dragan@bordet.be.ORCID http://orcid.org/0000-0002-3406-1683
André Van GossumConsultant at the Department of Gastroenterology and Clinical Nutrition, Hopital Erasme and Institut Jules Bordet, Brussels, Belgium.
Frederic DuprezDepartment of Radiotherapy-Oncology, Universitair Ziekenhuis Gent, Gent, Belgium.
Yassine LalamiMedical Oncology Clinic, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Yolene LefebvreDepartment of Radiology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Sofiana Mootassim-BillahDepartment of Radiation Oncology, Speech Therapy, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Sylvie BeauvoisDepartment of Radiation Oncology (Head and Neck Unit), Institut Jules Bordet, Université Libre de Bruxelles, 1 rue Héger Bordet, 1000, Brussels, Belgium.
Akos GulybanMedical Physics Department, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.
Christophe VandekerkhoveMedical Physics Department, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.
Petra BoegnerMedical Oncology Clinic, CHU de Bruxelles, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.
Marianne PaesmansData Centre, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Lieveke AmeyeData Centre, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Antoine DigonnetDepartment of Head and Neck Surgery, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Marie QuirinyDepartment of Head and Neck Surgery, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Didier DequanterDepartment of Otorhinolaryngology and Head and Neck Surgery, CHU de Bruxelles, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.
Samuel LipskiDepartment of Head and Neck Surgery, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Esther WillemseDepartment of Head and Neck Surgery, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Alejandra RodriguezDepartment of Otorhinolaryngology and Head and Neck Surgery, CHU de Bruxelles, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.
Sebastien CarlotDepartment of Otorhinolaryngology and Head and Neck Surgery, Erasmus Hospital, Université Libre de Bruxelles, Brussels, Belgium.
Yasemin KaracaStomatology, Oral and Maxillofacial Surgery Department, Erasmus Hospital, Université Libre de Bruxelles, Brussels, Belgium.
Marc LemortDepartment of Radiology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Patrick EmontsDepartment of Radiology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Clémence Al WardiDepartment of Radiation Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Dirk Van GestelDepartment of Radiation Oncology (Head and Neck Unit), Institut Jules Bordet, Université Libre de Bruxelles, 1 rue Héger Bordet, 1000, Brussels, Belgium.
Université Libre de Bruxelles · BEGhent University Hospital · BEInstitut Jules Bordet · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPercutaneous endoscopic gastrostomy (PEG) is often used to provide nutritional support in locally advanced head and neck cancer patients undergoing multimodality treatment. However, there is little published data on the impact of prophylactic versus reactive PEG. PEG placement may affect swallowing-related physiology, function, and quality of life. The Swall PEG study is a randomized controlled phase III trial testing the impact of prophylactic versus reactive PEG on patient-reported outcomes in terms of swallowing and quality of life in oropharyngeal cancer patients.

methodsPatients with locally advanced oropharyngeal cancer receiving chemo-radiotherapy will be randomized to either the prophylactic or reactive PEG tube group. Randomization will be stratified by human papillomavirus (HPV) status and unilateral versus bilateral positive neck lymph nodes. The primary objective of the study is the patient's reported outcome in terms of swallowing (MD Anderson Dysphagia Inventory (MDADI)) at 6 months. Secondary objectives include health-related quality of life, dosimetric parameters associated with patient-reported outcomes, chemo-radiation toxicities, PEG tube placement complications, the impact of nutritional status on survival and toxicity outcomes, loco-regional control, overall survival, the impact of HPV and tobacco smoking on survival outcomes and toxicities, and the cost-effectiveness of each treatment strategy. DISCUSSION: Findings from this study will enhance clinical evidence regarding nutritional management in oropharyngeal cancer patients treated by concurrent chemo-radiation.

trial registrationClinicalTrials.gov NCT04019548, study protocol version 2.0_08/08/2019. Registered on 15 July 2019.

Indexed as

Deglutition DisordersHead and Neck NeoplasmsOropharyngeal NeoplasmsPapillomavirus InfectionsChemoradiotherapyDeglutitionGastrostomyHumansPatient Reported Outcome MeasuresQuality of LifeTreatment OutcomeEndoscopic gastrostomyHead and neck cancerOropharyngeal squamous cell carcinomaPatient-reported outcomeRadiotherapy

Identifiers

PMID36539781
PMCPMC9768988
OpenAlexW4312114012

What OpenQuestion holds

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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.