Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-28 @ 12:47 PM
Study NCT ID:
NCT02119169
Status:
UNKNOWN
Last Update Posted:
2017-12-27
First Post:
2014-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010996', 'term': 'Pleural Effusion'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-22', 'studyFirstSubmitDate': '2014-04-14', 'studyFirstSubmitQcDate': '2014-04-18', 'lastUpdatePostDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in chest radiography', 'timeFrame': 'baseline, daily after treatment within admission'}], 'secondaryOutcomes': [{'measure': 'Chest X-ray and any complications recorded', 'timeFrame': 'weekly in first month and monthly for 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pleural Effusion']}, 'referencesModule': {'references': [{'pmid': '27340399', 'type': 'DERIVED', 'citation': 'Sharaf-Eldin M, Bediwy AS, Kobtan A, Abd-Elsalam S, El-Kalla F, Mansour L, Elkhalawany W, Elhendawy M, Soliman S. Pigtail Catheter: A Less Invasive Option for Pleural Drainage in Egyptian Patients with Recurrent Hepatic Hydrothorax. Gastroenterol Res Pract. 2016;2016:4013052. doi: 10.1155/2016/4013052. Epub 2016 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'The effectiveness of pigtail catheter as a less invasive option for pleural drainage in patients with resistant hepatic hydrothorax.', 'detailedDescription': 'Hepatic hydrothorax (HH) is defined as a transudative pleural effusion in patients with liver cirrhosis in the absence of cardiopulmonary disease. The estimated prevalence among patients with liver cirrhosis is approximately 5-6% (Baikati et al., 2014).\n\nHH is an infrequent but a well-known complication of portal hypertension. Trans-diaphragmatic passage of ascitic fluid from peritoneal to the pleural cavity through numerous diaphragmatic defects has been shown to be the predominant mechanism in the formation of HH (Kumar\\&Kumar, 2014).\n\nPatients with hepatic hydrothoraces often have few options (Goto et al., 2011). Diuretic-resistant HH could be managed with liver transplantation, transjugular intrahepatic portosystemic shunt (TIPS) or indwelling pleural catheters. However, tube thoracotomy and pleurodesis failed in most patients (Singh et al., 2013).\n\nCase reports and small case series have reported a high rate of complications associated with chest tube placement for hepatic hydrothorax. The most common reported complications were acute kidney injury, pneumothorax, and empyema. Death has been recorded in some cases. Chest tube insertion for hepatic hydrothorax carries significant morbidity and mortality, with questionable benefit (Orman\\&Lok, 2009).\n\nPigtail catheter insertion is an effective and safe method of draining pleural fluid. Its use is safe and recommended for all cases of pleural effusion requiring chest drain except for empyema and other loculated effusions that yielded low success rate (Bediwy and Amer, 2012).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with cirrhotic liver and recurrent pleural effusion.\n* Pleural fluid should be transudate according to Light's criteria:\n\n * Pleural fluid-to-serum protein ratio less than 0.5\n * Pleural fluid lactic dehydrogenase (LDH) less than 200 IU\n * Pleural fluid-to-serum LDH ratio and pleural fluid-to-high normal serum LDH ratio less than 0.6\n\nExclusion Criteria:\n\n* Diagnosis of hepatocellular carcinoma or other neoplasm able to shorten life expectancy.\n* Congestive heart failure.\n* Recent (i.e. within the previous 2 weeks) episode of digestive hemorrhage.\n* Exudative pleural effusion.\n* Ascitic fluid or pleural fluid infection\n* Platelet count below 50,000\n* Prothrombin activity below 50%"}, 'identificationModule': {'nctId': 'NCT02119169', 'acronym': 'HH', 'briefTitle': 'Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax', 'orgStudyIdInfo': {'id': 'Mohamed Sharaf-Eldin'}, 'secondaryIdInfos': [{'id': 'Tanta university hospital', 'type': 'OTHER_GRANT', 'domain': 'tanta university hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pigtail catheter', 'description': 'Pigtail catheter for pleural drainage of recurrent hepatic hydrothorax', 'interventionNames': ['Device: Pigtail catheter']}], 'interventions': [{'name': 'Pigtail catheter', 'type': 'DEVICE', 'description': 'pigtail catheter for pleural drainage', 'armGroupLabels': ['pigtail catheter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abd-Elsalam', 'role': 'CONTACT', 'phone': '00201000040794'}], 'facility': 'Tanta university hospital', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Sherief M Abd-Elsalam, doctor', 'role': 'CONTACT', 'email': 'Sherif_tropical@yahoo.com', 'phone': '00201000040794'}], 'overallOfficials': [{'name': 'Mohamed A. Sharaf-Eldin, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TUH'}, {'name': 'Adel S Bediwy, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TUH'}, {'name': 'Sherief M Abd-Elsalam, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'TUH'}, {'name': 'Abdelrahman a kobtan, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'TUH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherief Abd-Elsalam', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}