Paracentèse à domicile pour les femmes atteintes d'ascite maligne liée au cancer (Paracentèse) (Paracentesis)
Une étude pilote de la paracentèse à domicile pour les femmes atteintes d'ascite maligne liée au cancer : un essai d'intervention décentralisé (Paracentèse)
The goal of this study is to evaluate the change in symptoms for cancer-related malignant ascites who complete an at-home paracentesis procedure.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Susan Sharry
- Numéro de téléphone: 801-585-3453
- E-mail: susan.sharry@hci.utah.edu
Lieux d'étude
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Utah
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Salt Lake City, Utah, États-Unis, 84112
- Recrutement
- Huntsman Cancer Institute at the University of Utah
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Contact:
- Susan Sharry
- Numéro de téléphone: 801-585-3453
- E-mail: Susan.sharry@hci.utah.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Participants aged ≥ 18 years
- Able to speak and understand English.
- Has completed an initial clinic-based paracentesis procedure.
- Confirmed diagnosis of cancer.
- Symptoms related to ascites requiring procedure in the opinion of the investigator.
- Eligible to receive an ultrasound-guided paracentesis procedure at home in the opinion of the investigator.
- If applicable, participant is able to safely hold anticoagulant therapy per institutional standards prior to the procedure in the opinion of the investigator.
- For participants of child-bearing potential, participant is following standard of care guidelines for contraception.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria:
- Rapidly deteriorating condition or suspected bowel obstruction.
- Large ventral hernias or prior complications from paracentesis.
- Need for concurrent procedures requiring hospital resources.
- Known lack of safe environment or inability to obtain sterile conditions at home.
- Any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the procedure or clinical study due to safety concerns or compliance with clinical study procedures. For example,
- Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: At-home Paracentesis
Participants receive an at-home-based paracentesis procedure, which may occur anytime following confirmation of eligibility. |
Paracentesis is a bedside procedure to obtain ascitic fluid from the peritoneum through needle aspiration, performed for both diagnostic and therapeutic purposes. The procedure involves needle insertion into the peritoneal cavity to remove fluid for analysis or to relieve symptoms from tense ascites. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis.
Délai: 3 months
|
To evaluate the change in symptoms in patients who complete at-home paracentesis. The AIM survey consists of 3 questions from 0 (No Symptoms) to 5 (Very Severe). A lower score is better. At the end of the study, all the results will be added together for the TSS. A lower score is preferred to show a positive outcome. |
3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
Délai: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).
Délai: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
Délai: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
Délai: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to the study intervention.
Délai: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The rate of procedure-related complications, including pain, bleeding, infection, and volume depletion.
Délai: 3 months
|
To assess the rate of procedure-related complications after at-home paracentesis. |
3 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Anna Beck, MD, Huntsman Cancer Institute
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HCI198711
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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