Surgery--ComplicationsNCT04705961
Bile Leakage Test in Emergency Hydatid Liver Cyst Surgery Case Report
An observational study of Surgery--Complications, run by Dr. Ersin Arslan Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Surgery--Complications
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 10 Jan 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: this study is a case report
Who may be able to join
- this study is a case report
Who cannot join
- this study is a case report
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Ersin Arslan Training and Resource Hospital
Gaziantep
About this study
In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Intraoperative bile leakage test has been shown to reduce postoperative biliary complications by revealing occult CBCs. However, bile leakage testing in emergency conditions such as hydatid cyst perforation has not been experienced so far.
Read the detailed description
In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Intraoperative bile leakage test has been shown to reduce postoperative biliary complications by revealing occult CBCs. However, bile leakage testing in emergency conditions such as hydatid cyst perforation has not been experienced so far.
Here, a bile leakage test performed in a 23-year-old male patient undergoing emergency surgery due to the perforation of the hydatid liver cyst was presented. Following the treatment of perforated hydatid liver cyst and biliary peritonitis, a bile leakage test was performed. The common bile duct was cannulated with a 22 Gauge catheter, normal saline and parenteral lipid solution were given to demonstrate the CBCs, and leakage areas were suture ligated. The patient was discharged postoperatively without any problem.
The investigators recommend detection and treatment of the CBCs even in emergency hydatid liver cyst surgery for prevention of postoperative biliary complications.
- Conditions
- Surgery--Complications
- Keywords
- Hydatidosis, complications, intra-biliary rupture, biliary duct, echinococcus, echinococcosis
- Medical subject headings
- Echinococcosis
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent hydatid cyst
presence of recurrent hydatid cyst
Measured: 2 or 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Dr. Ersin Arslan Education and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Uylas, Dr. Ersin Arslan Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705961
- Sponsor's protocol ID
- 10012021
- Status last verified
- Jan 2021
- First submitted
- 9 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bile Leakage Test in Emergency Hydatid Liver Cyst Surgery Case Report
- ClinicalTrials.gov ID
- NCT04705961
- Acronym / sponsor ID
- 10012021
- Conditions
- Surgery--Complications
- Keywords
- Hydatidosis, complications, intra-biliary rupture, biliary duct, echinococcus, echinococcosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dr. Ersin Arslan Education and Training HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 12 Jan 2021 (actual)
- 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.
In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Intraoperative bile leakage test has been shown to reduce postoperative biliary complications by revealing occult CBCs. However, bile leakage testing in emergency conditions such as hydatid cyst perforation has not been experienced so far.
Detailed description
In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Intraoperative bile leakage test has been shown to reduce postoperative biliary complications by revealing occult CBCs. However, bile leakage testing in emergency conditions such as hydatid cyst perforation has not been experienced so far.
Here, a bile leakage test performed in a 23-year-old male patient undergoing emergency surgery due to the perforation of the hydatid liver cyst was presented. Following the treatment of perforated hydatid liver cyst and biliary peritonitis, a bile leakage test was performed. The common bile duct was cannulated with a 22 Gauge catheter, normal saline and parenteral lipid solution were given to demonstrate the CBCs, and leakage areas were suture ligated. The patient was discharged postoperatively without any problem.
The investigators recommend detection and treatment of the CBCs even in emergency hydatid liver cyst surgery for prevention of postoperative biliary complications.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- this study is a case report
Key inclusion criteria (1 listed)
- this study is a case report
Key exclusion criteria (1 listed)
- this study is a case report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
recurrent hydatid cyst
Time frame: 2 or 3 month
presence of recurrent hydatid cyst
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 Jan 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications, run by Dr. Ersin Arslan Education and Training Hospital at 1 site in Turkey (Türkiye).
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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
recurrent hydatid cyst (time frame: 2 or 3 month). 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 Jan 2021.