Liver CirrhosisNCT02508688
Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax
A study testing thoracoscopic diaphragmatic repair in people with Liver Cirrhosis, run by National Taiwan University Hospital.
Trial summary
The management of refractory hepatic hydrothorax is challenging and usually unsuccessful. The study will discuss the perioperative treatment, effectiveness, and morphology of diaphragmatic defects of hepatic hydrothorax in thoracoscopic mesh repair. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- thoracoscopic diaphragmatic repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with refractory hepatic hydrothorax (> 3 times thoracentesis and failure to maximal doses of diuretics)
Who cannot join
- Patients with systemic bacteremia, positive culture of bacteria of pleural effusion or ascites were excluded from the study because of potential mesh contamination.
About this study
Official title: Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax: 10 Years' Experience From a Single Large-volume Center
The management of refractory hepatic hydrothorax is challenging and usually unsuccessful. The study will discuss the perioperative treatment, effectiveness, and morphology of diaphragmatic defects of hepatic hydrothorax in thoracoscopic mesh repair. Risk factors associated with increased three-month mortality in these critically ill patients will be studied.
Read the detailed description
Objective The objective was to analyze the outcomes of thoracoscopic mesh repair for hepatic hydrothorax (HH) at the institution of the investigators during the past 10 years.
Methods A total of 63 patients with refractory HH, who underwent thoracoscopic mesh onlay reinforcement to repair diaphragmatic defects from January 2005 to December 2014, were included in the study. Mesh covering alone was used in 47 patients and mesh with suturing was used in 16 patients. Patient demographics, Child-Pugh class, and model for end-stage liver disease (MELD) score were evaluated to predict morbidity and mortality.
- Conditions
- Liver Cirrhosis
- Being tested
- thoracoscopic diaphragmatic repair
- Keywords
- hepatic hydrothorax, thoracoscopic surgery, diaphragmatic defect
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracoscopic diaphragmatic repairProcedure or surgery
patients with refractory hepatic hydrothorax (> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair
| Study group | Role | What they receive |
|---|---|---|
| thoracoscopic mesh repair group | Experimental | 63 patients with refractory HH (> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair were included in this study. Receives: Procedure: thoracoscopic diaphragmatic repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
one-month mortality
one-month mortality after thoracoscopic mesh repair
Measured: one month
three-month mortality
three-month mortality after thoracoscopic mesh repair
Measured: three month
Secondary outcomes (1)
recurrence of hepatic hydrothorax
recurrence of hepatic hydrothorax after thoracoscopic mesh repair
Measured: 20.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startJan 2005
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Ming Huang, MD, PhD, Principal investigator, Department of Surgery, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508688
- Sponsor's protocol ID
- 201506012RIND
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax: 10 Years' Experience From a Single Large-volume Center
- ClinicalTrials.gov ID
- NCT02508688
- Acronym / sponsor ID
- 201506012RIND
- Conditions
- Liver Cirrhosis
- Keywords
- hepatic hydrothorax, thoracoscopic surgery, diaphragmatic defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The management of refractory hepatic hydrothorax is challenging and usually unsuccessful. The study will discuss the perioperative treatment, effectiveness, and morphology of diaphragmatic defects of hepatic hydrothorax in thoracoscopic mesh repair. Risk factors associated with increased three-month mortality in these critically ill patients will be studied.
Detailed description
Objective The objective was to analyze the outcomes of thoracoscopic mesh repair for hepatic hydrothorax (HH) at the institution of the investigators during the past 10 years.
Methods A total of 63 patients with refractory HH, who underwent thoracoscopic mesh onlay reinforcement to repair diaphragmatic defects from January 2005 to December 2014, were included in the study. Mesh covering alone was used in 47 patients and mesh with suturing was used in 16 patients. Patient demographics, Child-Pugh class, and model for end-stage liver disease (MELD) score were evaluated to predict morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thoracoscopic mesh repair group | Experimental | Procedure: thoracoscopic diaphragmatic repair63 patients with refractory HH (> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair were included in this study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with refractory hepatic hydrothorax (> 3 times thoracentesis and failure to maximal doses of diuretics)
Key exclusion criteria (1 listed)
- Patients with systemic bacteremia, positive culture of bacteria of pleural effusion or ascites were excluded from the study because of potential mesh contamination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracoscopic diaphragmatic repairpatients with refractory hepatic hydrothorax (> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair | Procedure or surgery | thoracoscopic mesh repair group |
Primary outcome
one-month mortality
Time frame: one month
one-month mortality after thoracoscopic mesh repair
three-month mortality
Time frame: three month
three-month mortality after thoracoscopic mesh repair
1 secondary outcome
recurrence of hepatic hydrothorax
Time frame: 20.5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Symptom recovery after thoracic surgery: Measuring patient-reported outcomes with the MD Anderson Symptom InventoryLink provided by the sponsor.
- Effect of the amount of intraoperative fluid administration on postoperative pulmonary complications following anatomic lung resectionsLink provided by the sponsor.
- Hepatorenal DisordersLink provided by the sponsor.
- Management of refractory hepatic hydrothoraxLink provided by the sponsor.
- Hepatic hydrothoraxLink provided by the sponsor.
- Percutaneous transhepatic biliary drainage complicated with hepatic hydrothoraxLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Ming Huang, MD, PhD principal investigator
Department of Surgery, National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing thoracoscopic diaphragmatic repair in people with Liver Cirrhosis, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one-month mortality (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.