Gall Bladder DiseaseNCT05927870
Ultrasound Guided Percutaneous Cholecystostomy.
A study testing pigtail in people with Gall Bladder Disease, run by Assiut University.
Trial summary
Surgical cholecystostomy has proven value in the management of both inflammatory and obstructive biliary tract disease Read more about this study
- Who is it for?
- Ages 4 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Gall Bladder Disease
- What is being tested?
- pigtail
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Sep 2024
- 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 4 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pyocele of the gallbladder
- Mucocele of the gallbladder
- Perforated gallbladder
- Malignant causes of gallbladder obstruction
Who cannot join
- Uncontrolled bleeding disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Guided Percutaneous Cholecystostomy as Preoperative Step for Obstructive Gallbladder Diseases.
Surgical cholecystostomy has proven value in the management of both inflammatory and obstructive biliary tract disease
Read the detailed description
The etiology of biliary obstruction can be benign or malignant. Benign disease, such as calculi, strictures, or pancreatitis, can be common causes in adult patients [5], whereas benign strictures including posttransplant anastomotic strictures and strictures secondary to hepatic artery insufficiency, stone disease, infection, and iatrogenic causes can be seen in children [6]. Obstruction can also be seen in the setting of biliary tract abnormalities, such as biliary atresia in neonates and symptomatic choledochal cysts, autoimmune pancreatitis, and sclerosing cholangitis in older children [7]. Biliary obstruction secondary to neoplasm commonly occurs with pancreatic cancer, cholangiocarcinoma, or metastases in adult patients and biliary rhabdomyosarcoma or neuroblastoma in younger patients [8].
The question remains as to whether all patients undergoing PCT drainage require a definitive cholecystectomy. Previous publications have suggested that there is a reluctance to use PCT in older and comorbid patients due to concerns of potentially committing such patients to an interval surgical procedure for which they may not be suitable.
- Conditions
- Gall Bladder Disease
- Being tested
- pigtail
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pigtailProcedure or surgery
placing a small amount of local anaesthetic subcutaneously at the site of the gallbladder, a skin incision was made through which the catheter was introduced. A 7-Fr pigtail catheter was used in all cases . If possible, the catheter was introduced into the gallbladder after passing through the liver. The catheter was thereafter fixed, either by an internal locking device or by means of a suture to the skin. The catheter was rinsed with saline solution daily in order to prevent clogging.
| Study group | Role | What they receive |
|---|---|---|
| pyocele | Experimental | obstructed gallbladder with infection on top Receives: Procedure: pigtail |
What is being measured
The primary outcome is the main question the study is designed to answer.
value of cholecystostomy as preoperative step in critically ill patients
The aim of this study was to assess the clinical outcomes of PCT use, with particular emphasis on a subgroup of patients who did not proceed to cholecystectomy.
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gall Bladder DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Fawzy Abd Elhameed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927870
- Sponsor's protocol ID
- percutaneous cholecystostomy
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akhan O, Akinci D, Ozmen MN. Percutaneous cholecystostomy. Eur J Radiol. 2002 Sep;43(3):229-36. doi: 10.1016/s0720-048x(02)00158-4.
PubMed 12204405
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Percutaneous Cholecystostomy as Preoperative Step for Obstructive Gallbladder Diseases.
- ClinicalTrials.gov ID
- NCT05927870
- Acronym / sponsor ID
- percutaneous cholecystostomy
- Conditions
- Gall Bladder Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 3 Jul 2023 (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.
Surgical cholecystostomy has proven value in the management of both inflammatory and obstructive biliary tract disease
Detailed description
The etiology of biliary obstruction can be benign or malignant. Benign disease, such as calculi, strictures, or pancreatitis, can be common causes in adult patients [5], whereas benign strictures including posttransplant anastomotic strictures and strictures secondary to hepatic artery insufficiency, stone disease, infection, and iatrogenic causes can be seen in children [6]. Obstruction can also be seen in the setting of biliary tract abnormalities, such as biliary atresia in neonates and symptomatic choledochal cysts, autoimmune pancreatitis, and sclerosing cholangitis in older children [7]. Biliary obstruction secondary to neoplasm commonly occurs with pancreatic cancer, cholangiocarcinoma, or metastases in adult patients and biliary rhabdomyosarcoma or neuroblastoma in younger patients [8].
The question remains as to whether all patients undergoing PCT drainage require a definitive cholecystectomy. Previous publications have suggested that there is a reluctance to use PCT in older and comorbid patients due to concerns of potentially committing such patients to an interval surgical procedure for which they may not be suitable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pyocele | Experimental | Procedure: pigtailobstructed gallbladder with infection on top |
Who may qualify
- Ages
- 4 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pyocele of the gallbladder
- Mucocele of the gallbladder
- Perforated gallbladder
- Malignant causes of gallbladder obstruction
Key exclusion criteria (1 listed)
- Uncontrolled bleeding disorders
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 |
|---|---|---|
| pigtailplacing a small amount of local anaesthetic subcutaneously at the site of the gallbladder, a skin incision was made through which the catheter was introduced. A 7-Fr pigtail catheter was used in all cases . If possible, the catheter was introduced into the gallbladder after passing through the liver. The catheter was thereafter fixed, either by an internal locking device or by means of a suture to the skin. The catheter was rinsed with saline solution daily in order to prevent clogging. | Procedure or surgery | pyocele |
Primary outcome
value of cholecystostomy as preoperative step in critically ill patients
Time frame: basline
The aim of this study was to assess the clinical outcomes of PCT use, with particular emphasis on a subgroup of patients who did not proceed to cholecystectomy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Background: PubMed 12204405Akhan O, Akinci D, Ozmen MN. Percutaneous cholecystostomy. Eur J Radiol. 2002 Sep;43(3):229-36. doi: 10.1016/s0720-048x(02)00158-4.
- Related InfoLink 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.
Questions about this trial
What is this clinical trial studying?
A study testing pigtail in people with Gall Bladder Disease, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basma Fawzy Abd Elhameed, Resident doctor (01062649652, basmafawzy80@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
value of cholecystostomy as preoperative step in critically ill patients (time frame: basline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05927870, which also lists 1 linked publication.
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 14 Jul 2023.