Laparoscopic CholecystectomyPhase 4NCT01103570
Cholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy
A Phase 4 study testing cholecystocholangiography and cystic duct cholangiography in people with Laparoscopic Cholecystectomy and Gall Stone Disease, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Standard cystic duct cholangiography (CDC) during laparoscopic cholecystectomy can be difficult, time consuming and bile duct injury may be caused by attempts to cannulate the cystic duct. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Gall Stone Disease, Biliary Tract Anatomy
- What is being tested?
- cholecystocholangiography and cystic duct cholangiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2009to Mar 2010
- Phase
- Phase 4
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with symptomatic gall bladder stones.
Who cannot join
- unfit Patients and/or had previous surgery
- history of obstructive jaundice and acute attacks or previous ERCP were excluded
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of General Surgery * Theodore Bilharz Research Institute
Cairo, 112124
About this study
Official title: Cholecystocholangiography Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy: A Prospective Controlled Randomized Trial
Standard cystic duct cholangiography (CDC) during laparoscopic cholecystectomy can be difficult, time consuming and bile duct injury may be caused by attempts to cannulate the cystic duct. Operative cholangiography performed by direct puncture of the gall bladder fundus or Cholecystocholangiography (CCC) is a valid and easier alternative.
Read the detailed description
This study was conducted on 60 patients with symptomatic gall bladder stones undergoing laparoscopic cholecystectomy. Patients were randomized into two groups: Group (1) was evaluated by cholecyst-cholangiography by puncture through the gall bladder fundus. Group (2) was evaluated for the standard cystic duct cholangiography.Cholangiography was considered successful if it could be performed with complete delineation of the biliary tree with flow of the dye through the duodenum occurred. It is to be noted that inability to cannulate the cystic duct for example, is considered a failure.
- Conditions
- Laparoscopic Cholecystectomy, Gall Stone Disease, Biliary Tract Anatomy, Common Bile Duct Stones.
- Being tested
- cholecystocholangiography, cystic duct cholangiography
- Keywords
- Laparoscopic cholecystectomy, Intra-operative cholangiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecystocholangiographyProcedure or surgery
Also called cholangiography via gallbladder
a central venous pressure catheter was introduced through the anterior abdominal wall subcostally in a direction parallel to the gallbladder bed under direct vision so that it emerges close to the gall bladder. Then the catheter was advanced into the fundus of the gall bladder . The dye was prepared by diluting 20ml of 76% urografin with 20ml normal saline in a 50ml syringe
cystic duct cholangiographyProcedure or surgery
Also called cholangiography via cystic dict
Then a 14G cannula was introduced through the anterior abdominal wall subcostally, (size 4F), was introduced through this cannula. The catheter was inserted into the cystic duct no more than 1 cm, by a grasper Then a 50ml syringe with the diluted urografin dye, as above, was attached to the catheter and cholangiography was performed by slowly injecting the dye under control of C-arm image intensifier.
| Study group | Role | What they receive |
|---|---|---|
| group 1 cholecystocholangiography | Experimental | cholangiography via gall bladder Receives: Procedure: cholecystocholangiography |
| group2 cystic duct cholangiography | Experimental | cystic duct cholangiography Receives: Procedure: cystic duct cholangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
Measured: 6 months
Secondary outcomes (1)
procedure-related complications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startMar 2009
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103570
- Sponsor's protocol ID
- cholangiography
- Status last verified
- Apr 2010
- First submitted
- 9 Apr 2010
- Last updated
- 14 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholecystocholangiography Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy: A Prospective Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT01103570
- Acronym / sponsor ID
- cholangiography
- Conditions
- Laparoscopic Cholecystectomy, Gall Stone Disease, Biliary Tract Anatomy, Common Bile Duct Stones.
- Keywords
- Laparoscopic cholecystectomy, Intra-operative cholangiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 14 Apr 2010 (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.
Standard cystic duct cholangiography (CDC) during laparoscopic cholecystectomy can be difficult, time consuming and bile duct injury may be caused by attempts to cannulate the cystic duct. Operative cholangiography performed by direct puncture of the gall bladder fundus or Cholecystocholangiography (CCC) is a valid and easier alternative.
Detailed description
This study was conducted on 60 patients with symptomatic gall bladder stones undergoing laparoscopic cholecystectomy. Patients were randomized into two groups: Group (1) was evaluated by cholecyst-cholangiography by puncture through the gall bladder fundus. Group (2) was evaluated for the standard cystic duct cholangiography.Cholangiography was considered successful if it could be performed with complete delineation of the biliary tree with flow of the dye through the duodenum occurred. It is to be noted that inability to cannulate the cystic duct for example, is considered a failure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 cholecystocholangiography | Experimental | Procedure: cholecystocholangiographycholangiography via gall bladder |
| group2 cystic duct cholangiography | Experimental | Procedure: cystic duct cholangiographycystic duct cholangiography |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with symptomatic gall bladder stones.
Key exclusion criteria (2 listed)
- unfit Patients and/or had previous surgery
- history of obstructive jaundice and acute attacks or previous ERCP were excluded
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 |
|---|---|---|
| cholecystocholangiographyAlso: cholangiography via gallbladdera central venous pressure catheter was introduced through the anterior abdominal wall subcostally in a direction parallel to the gallbladder bed under direct vision so that it emerges close to the gall bladder. Then the catheter was advanced into the fundus of the gall bladder . The dye was prepared by diluting 20ml of 76% urografin with 20ml normal saline in a 50ml syringe | Procedure or surgery | group 1 cholecystocholangiography |
| cystic duct cholangiographyAlso: cholangiography via cystic dictThen a 14G cannula was introduced through the anterior abdominal wall subcostally, (size 4F), was introduced through this cannula. The catheter was inserted into the cystic duct no more than 1 cm, by a grasper Then a 50ml syringe with the diluted urografin dye, as above, was attached to the catheter and cholangiography was performed by slowly injecting the dye under control of C-arm image intensifier. | Procedure or surgery | group2 cystic duct cholangiography |
Primary outcome
success rate
Time frame: 6 months
1 secondary outcome
procedure-related complications
Time frame: 3 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 14 Apr 2010.
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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?
A Phase 4 study testing cholecystocholangiography and cystic duct cholangiography in people with Laparoscopic Cholecystectomy and Gall Stone Disease, run by Theodor Bilharz Research Institute at 1 site 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 2 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 14 Apr 2010. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
success rate (time frame: 6 months). 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 14 Apr 2010.