Cholecystitis in Cirrhotic PatientsNCT06778928
Posterior Wall Sparing of Laparoscopic Cholecystectomy in Cirrhotic Patients
An observational study of Cholecystitis in Cirrhotic Patients, run by Assiut University.
Trial summary
To assess the outcome of posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients in Assuit university hospitals and El Rajhi hospital. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cholecystitis in Cirrhotic Patients
- What is being tested?
- laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to 1 Apr 2026
- How long will I take part?
- 1 Year
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 60 cirrhotic patients age from 18 to 60 years who were admitted for cholecystectomy
Who may be able to join
- Patient age 18 - 60 years old Child A and B cirrhotic patients with Cholelithiasis Patient fit for surgery
Who cannot join
- Patient with pervious abdominal surgery
Trial locations and contacts
No sites are listed yet.
About this study
To assess the outcome of posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients in Assuit university hospitals and El Rajhi hospital.
Read the detailed description
Cholelithiasis is found in about one third of patients with liver cirrhosis and about twice as much as in the overall population. Predisposing factors for that include functional gallbladder alterations (reduced motility and decreased emptying), reduction in bile acidity, increased unconjugated bilirubin secretion, increased levels of estrogen, and increased intravascular haemolysis due to hypersplenism. Symptomatic biliary stones in patients with liver cirrhosis are associated with higher morbidity and mortality rates than those in patients with a non-cirrhotic liver. laparoscopic cholecystectomy is the gold standard for the treatment of most of gallbladder problems because of its several advantages over open cholecystectomy including shorter convalescence period and hospital stay. Furthermore, considering its safety, it is the gold-standard procedure in selected patients with symptomatic cholelithiasis and hepatic cirrhosis, especially Child-Pugh score A and B patients. Separation of posterior wall of the gallbladder from the liver bed in cirrhotic individuals is difficult and risky during a laparoscopic cholecystectomy surgery because of high-risk gall bladder bed due to fibrosis and tortuous, dilated vessels there so the strategy is leaving the posterior wall intact with the liver and the remnant mucosa was removed either by mucosectomy in patients with acute cholecystitis or by electro fulguration in those with chronic cholecystitis.
- Conditions
- Cholecystitis in Cirrhotic Patients
- Being tested
- laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic cholecystectomyProcedure or surgery
Posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients
| Study group | Role | What they receive |
|---|---|---|
| Posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients | To assess the outcome of posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patient Receives: Procedure: laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra and Post-operative haemorrhage
Measured: Surgery then 2 days follow up
Postoperative bile leak
Measured: Surgery then 1 week follow up
Changes of liver function tests
AST, ALT, Billirubin
Measured: Surgery then 1 week follow up
Worsening of ascites
Measured: Surgery then 1 week follow up
Port site infection
Measured: Surgery then 1 week folow up
Secondary outcomes (2)
Operative time
Measured: From the end of induction of anasthesia to the closure of port site incisions
Postoperative hospital stay
Measured: surgery then up to 1 week hospital stay before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study startJan 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis in Cirrhotic PatientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778928
- Sponsor's protocol ID
- cholecystectomy cirrhotic
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shaikh AR, Muneer A. Laparoscopic cholecystectomy in cirrhotic patients. JSLS. 2009 Oct-Dec;13(4):592-6. doi: 10.4293/108680809X12589999537959.
PubMed 20202403Schiff J, Misra M, Rendon G, Rothschild J, Schwaitzberg S. Laparoscopic cholecystectomy in cirrhotic patients. Surg Endosc. 2005 Sep;19(9):1278-81. doi: 10.1007/s00464-004-8823-z. Epub 2005 Jul 21.
PubMed 16021366Palanivelu C, Rajan PS, Jani K, Shetty AR, Sendhilkumar K, Senthilnathan P, Parthasarthi R. Laparoscopic cholecystectomy in cirrhotic patients: the role of subtotal cholecystectomy and its variants. J Am Coll Surg. 2006 Aug;203(2):145-51. doi: 10.1016/j.jamcollsurg.2006.04.019. Epub 2006 Jun 22.
PubMed 16864026Cassinotti E, Baldari L, Boni L, Uranues S, Fingerhut A. Laparoscopic Cholecystectomy in the Cirrhotic: Review of Literature on Indications and Technique. Chirurgia (Bucur). 2020 Mar-Apr;115(2):208-212. doi: 10.21614/chirurgia.115.2.208.
PubMed 32369724
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Wall Sparing of Laparoscopic Cholecystectomy in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT06778928
- Acronym / sponsor ID
- cholecystectomy cirrhotic
- Conditions
- Cholecystitis in Cirrhotic Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 16 Jan 2025 (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.
To assess the outcome of posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients in Assuit university hospitals and El Rajhi hospital.
Detailed description
Cholelithiasis is found in about one third of patients with liver cirrhosis and about twice as much as in the overall population. Predisposing factors for that include functional gallbladder alterations (reduced motility and decreased emptying), reduction in bile acidity, increased unconjugated bilirubin secretion, increased levels of estrogen, and increased intravascular haemolysis due to hypersplenism. Symptomatic biliary stones in patients with liver cirrhosis are associated with higher morbidity and mortality rates than those in patients with a non-cirrhotic liver. laparoscopic cholecystectomy is the gold standard for the treatment of most of gallbladder problems because of its several advantages over open cholecystectomy including shorter convalescence period and hospital stay. Furthermore, considering its safety, it is the gold-standard procedure in selected patients with symptomatic cholelithiasis and hepatic cirrhosis, especially Child-Pugh score A and B patients. Separation of posterior wall of the gallbladder from the liver bed in cirrhotic individuals is difficult and risky during a laparoscopic cholecystectomy surgery because of high-risk gall bladder bed due to fibrosis and tortuous, dilated vessels there so the strategy is leaving the posterior wall intact with the liver and the remnant mucosa was removed either by mucosectomy in patients with acute cholecystitis or by electro fulguration in those with chronic cholecystitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients | – | Procedure: laparoscopic cholecystectomyTo assess the outcome of posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patient |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 60 cirrhotic patients age from 18 to 60 years who were admitted for cholecystectomy
Key inclusion criteria (1 listed)
- Patient age 18 - 60 years old Child A and B cirrhotic patients with Cholelithiasis Patient fit for surgery
Key exclusion criteria (1 listed)
- Patient with pervious abdominal surgery
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 |
|---|---|---|
| laparoscopic cholecystectomyPosterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients | Procedure or surgery | Posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients |
Primary outcome
Intra and Post-operative haemorrhage
Time frame: Surgery then 2 days follow up
Postoperative bile leak
Time frame: Surgery then 1 week follow up
Changes of liver function tests
Time frame: Surgery then 1 week follow up
AST, ALT, Billirubin
Worsening of ascites
Time frame: Surgery then 1 week follow up
Port site infection
Time frame: Surgery then 1 week folow up
2 secondary outcomes
Operative time
Time frame: From the end of induction of anasthesia to the closure of port site incisions
Postoperative hospital stay
Time frame: surgery then up to 1 week hospital stay before discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Results publication: PubMed 20202403Shaikh AR, Muneer A. Laparoscopic cholecystectomy in cirrhotic patients. JSLS. 2009 Oct-Dec;13(4):592-6. doi: 10.4293/108680809X12589999537959.
- Results publication: PubMed 16021366Schiff J, Misra M, Rendon G, Rothschild J, Schwaitzberg S. Laparoscopic cholecystectomy in cirrhotic patients. Surg Endosc. 2005 Sep;19(9):1278-81. doi: 10.1007/s00464-004-8823-z. Epub 2005 Jul 21.
- Results publication: PubMed 16864026Palanivelu C, Rajan PS, Jani K, Shetty AR, Sendhilkumar K, Senthilnathan P, Parthasarthi R. Laparoscopic cholecystectomy in cirrhotic patients: the role of subtotal cholecystectomy and its variants. J Am Coll Surg. 2006 Aug;203(2):145-51. doi: 10.1016/j.jamcollsurg.2006.04.019. Epub 2006 Jun 22.
- Results publication: PubMed 32369724Cassinotti E, Baldari L, Boni L, Uranues S, Fingerhut A. Laparoscopic Cholecystectomy in the Cirrhotic: Review of Literature on Indications and Technique. Chirurgia (Bucur). 2020 Mar-Apr;115(2):208-212. doi: 10.21614/chirurgia.115.2.208.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Cholecystitis in Cirrhotic Patients, 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 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: status not confirmed, as of the sponsor's last update on 16 Jan 2025. 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 Adnan mohamed Mohamed Mohamed salem (01111846484, Adnan.16281240@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra and Post-operative haemorrhage (time frame: Surgery then 2 days follow up). The study lists 5 primary outcomes in all. 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 NCT06778928, which also lists 4 linked publications.
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 16 Jan 2025.