Massive AscitesAscitesLDLTNCT02867293
Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.
A study testing ultrasound guided ascitic fluid drainage, operative drainage of ascites through small skin incision after induction of anesthesia and ultrasound in people with Massive Ascites, run by Mansoura University at 2 sites in Egypt.
Trial summary
Massive ascites is usually controlled over several weeks pre-operatively in liver transplant recipients with the risk of encephalopathy and peritonitis. We hypothesized that intra-operative drainage of ascites will be safe and avoids the inherent risks of pre-operative drainage. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Massive Ascites
- What is being tested?
- ultrasound guided ascitic fluid drainage, operative drainage of ascites through small skin incision after induction of anesthesia and ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- Jan 2013to Jan 2016
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- liver transplant candidates with tense acsites
Who cannot join
- severe coagulpathy (INR more than 2 or platlet count less than 50) MELD more than 20
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mansoura university
Al Mansurah, Dakahlia Governorate, 62215
Mansoura university
Al Mansurah, Dkahleya
About this study
Massive ascites is usually controlled over several weeks pre-operatively in liver transplant recipients with the risk of encephalopathy and peritonitis. We hypothesized that intra-operative drainage of ascites will be safe and avoids the inherent risks of pre-operative drainage.
- Conditions
- Massive Ascites
- Being tested
- ultrasound guided ascitic fluid drainage, operative drainage of ascites through small skin incision after induction of anesthesia, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided ascitic fluid drainageProcedure or surgery
operative drainage of ascites through small skin incision after induction of anesthesiaProcedure or surgery
ultrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Preop-drainage | Active comparator | ascites drained over the pre-operative week through multiple ultrasound guided paracentesis Receives: Procedure: ultrasound guided ascitic fluid drainage; Device: ultrasound |
| Op-drainage | Active comparator | ascetic fluid drained through an abdominal incision after anesthesia Receives: Procedure: operative drainage of ascites through small skin incision after induction of anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft survival
Measured: one year
Secondary outcomes (1)
patient survival
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massive AscitesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867293
- Sponsor's protocol ID
- Ascites
- Acronym
- AscitesLDLT
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02867293
- Acronym / sponsor ID
- AscitesLDLT / Ascites
- Conditions
- Massive Ascites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 Aug 2016 (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.
Massive ascites is usually controlled over several weeks pre-operatively in liver transplant recipients with the risk of encephalopathy and peritonitis. We hypothesized that intra-operative drainage of ascites will be safe and avoids the inherent risks of pre-operative drainage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preop-drainage | Active comparator | Procedure: ultrasound guided ascitic fluid drainage, Device: ultrasoundascites drained over the pre-operative week through multiple ultrasound guided paracentesis |
| Op-drainage | Active comparator | Procedure: operative drainage of ascites through small skin incision after induction of anesthesiaascetic fluid drained through an abdominal incision after anesthesia |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- liver transplant candidates with tense acsites
Key exclusion criteria (1 listed)
- severe coagulpathy (INR more than 2 or platlet count less than 50) MELD more than 20
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 |
|---|---|---|
| ultrasound guided ascitic fluid drainage | Procedure or surgery | Preop-drainage |
| operative drainage of ascites through small skin incision after induction of anesthesia | Procedure or surgery | Op-drainage |
| ultrasound | Device | Preop-drainage |
Primary outcome
graft survival
Time frame: one year
1 secondary outcome
patient survival
Time frame: one year
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 15 Aug 2016.
- Individual participant dataSharing planned: Yes
Related trials for Massive Ascites
RecruitingPhase 1/2
Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer With Massive Ascites
Ovarian Neoplasms Malignant, Ascites
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided ascitic fluid drainage, operative drainage of ascites through small skin incision after induction of anesthesia and ultrasound in people with Massive Ascites, run by Mansoura University at 2 sites in Egypt.
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 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
graft survival (time frame: one year). 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 15 Aug 2016.