Hepatobiliary DiseaseNCT05495178
Hepatobiliary Manifestations Following Two-Stages Elective Laparoscopic Restorative Proctocolectomy for Patients With Ulcerative Colitis. A Prospective Observational Study.
An observational study of Hepatobiliary Disease, run by Zagazig University.
Trial summary
Several studies using different methodological approach have revealed incomplete, old and conflicting data on the course of hepatobiliary manifestations after surgery. authors conducted a prospective observational study to evaluate the role of LRP on the course of hepatobiliary manifestations for a better knowledge of… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Hepatobiliary Disease
- What is being tested?
- laparoscopic restorative proctocolectomy
- Type of treatment
- Surgery or procedure
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 1 Jun 2022
- 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 69 years
- All sexes
- Adult, Older adult
Study population: A prospective observational study was planned in our university hospitals' Surgical, internal and hepatology units on 167 patients with hepatobiliary manifestations in patients underwent one stage elective LRP for ulcerative colitis from June 2013 to June 2018. Inclusion criteria were all patients between 18-69 years, both sex diagnosed as ulcerative colitis with at least one hepatobiliary manifestation underwent laparoscopic restorative proctocolectomy with ileal pouch anal anastomosis with or without gallstones.indication for surgery in patients with UC was indicated according to ECCO guidelines on therapeutics in ulcerative colitis
Who may be able to join
- patients between 18-69 years,
- both sex diagnosed as ulcerative colitis with at least one hepatobiliary manifestation
- underwent laparoscopic restorative proctocolectomy with ileal pouch anal anastomosis
- with or without gallstones.
Who cannot join
- age<18 years or > 69 years,
- alcohol abuse,
- pregnancy,
- severe heart failure or type II diabetes mellitus (defined as established diagnosis, HbA1c > 6.4%, non-fasting glucose level > 180 mg/dL, or on antidiabetic medication),
- development of complications or death related to the operation of LRP ,
- liver toxicity of IBD-related medications.,
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- chronic viral hepatitis,
- haemochromatosis,
- Wilson's disease,
About this study
Several studies using different methodological approach have revealed incomplete, old and conflicting data on the course of hepatobiliary manifestations after surgery. authors conducted a prospective observational study to evaluate the role of LRP on the course of hepatobiliary manifestations for a better knowledge of these manifestations that is necessary to improve their management.also, to evaluate the role of surgery on prevention of liver damage from progression of the disease.
Read the detailed description
Inflammatory bowel disease (IBD) prevalence is expected to reach 1% of the population in many regions over the next decade. despite the fact that the primary clinical manifestations of IBD are centred in the gastrointestinal tract, 25-40% of IBD patients develop at least one extraintestinal manifestation (EIM).
Hepatobiliary manifestations constitute one of the most common EIMs in IBD . Hepatobiliary manifestations are much more commonly associated with ulcerative colitis (UC) and include primary sclerosing cholangitis (PSC), autoimmune hepatitis (AIH), fatty liver, cholelithiasis, primary biliary cholangitis, portal vein thrombosis, and hepatic abscess.
Most UC patients can be managed medically, but a minority requires proctocolectomy. Two-stage laparoscopic proctocolectomy (LPC) with ileal pouch-anal anastomosis (IPAA) is a cure for colitis, but its effect on hepatobiliary diseases is controversial.
- Conditions
- Hepatobiliary Disease
- Being tested
- laparoscopic restorative proctocolectomy
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic restorative proctocolectomyProcedure or surgery
laparoscopic restorative proctocolectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of hepatobiliary manifestations after colectomy
severity of hepatobiliary manifestations are measured by abdominal ultrasonography,liver biopsy ,CT and MRCP
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Jun 2013
- Primary completion1 Jun 2018
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary DiseaseStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495178
- Sponsor's protocol ID
- hepatobiliary manifestations
- Status last verified
- Oct 2022
- First submitted
- 6 Aug 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatobiliary Manifestations Following Two-Stages Elective Laparoscopic Restorative Proctocolectomy for Patients With Ulcerative Colitis. A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05495178
- Acronym / sponsor ID
- hepatobiliary manifestations
- Conditions
- Hepatobiliary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 10 Aug 2022 (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.
Several studies using different methodological approach have revealed incomplete, old and conflicting data on the course of hepatobiliary manifestations after surgery. authors conducted a prospective observational study to evaluate the role of LRP on the course of hepatobiliary manifestations for a better knowledge of these manifestations that is necessary to improve their management.also, to evaluate the role of surgery on prevention of liver damage from progression of the disease.
Detailed description
Inflammatory bowel disease (IBD) prevalence is expected to reach 1% of the population in many regions over the next decade. despite the fact that the primary clinical manifestations of IBD are centred in the gastrointestinal tract, 25-40% of IBD patients develop at least one extraintestinal manifestation (EIM).
Hepatobiliary manifestations constitute one of the most common EIMs in IBD . Hepatobiliary manifestations are much more commonly associated with ulcerative colitis (UC) and include primary sclerosing cholangitis (PSC), autoimmune hepatitis (AIH), fatty liver, cholelithiasis, primary biliary cholangitis, portal vein thrombosis, and hepatic abscess.
Most UC patients can be managed medically, but a minority requires proctocolectomy. Two-stage laparoscopic proctocolectomy (LPC) with ileal pouch-anal anastomosis (IPAA) is a cure for colitis, but its effect on hepatobiliary diseases is controversial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A prospective observational study was planned in our university hospitals' Surgical, internal and hepatology units on 167 patients with hepatobiliary manifestations in patients underwent one stage elective LRP for ulcerative colitis from June 2013 to June 2018. Inclusion criteria were all patients between 18-69 years, both sex diagnosed as ulcerative colitis with at least one hepatobiliary manifestation underwent laparoscopic restorative proctocolectomy with ileal pouch anal anastomosis with or without gallstones.indication for surgery in patients with UC was indicated according to ECCO guidelines on therapeutics in ulcerative colitis
Key inclusion criteria (4 listed)
- patients between 18-69 years,
- both sex diagnosed as ulcerative colitis with at least one hepatobiliary manifestation
- underwent laparoscopic restorative proctocolectomy with ileal pouch anal anastomosis
- with or without gallstones.
Key exclusion criteria (9 listed)
- age<18 years or > 69 years,
- alcohol abuse,
- pregnancy,
- severe heart failure or type II diabetes mellitus (defined as established diagnosis, HbA1c > 6.4%, non-fasting glucose level > 180 mg/dL, or on antidiabetic medication),
- development of complications or death related to the operation of LRP ,
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 restorative proctocolectomylaparoscopic restorative proctocolectomy | Procedure or surgery | – |
Primary outcome
severity of hepatobiliary manifestations after colectomy
Time frame: 4 years
severity of hepatobiliary manifestations are measured by abdominal ultrasonography,liver biopsy ,CT and MRCP
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 13 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatobiliary Disease, run by Zagazig 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 9 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 13 Oct 2022. 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?
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?
severity of hepatobiliary manifestations after colectomy (time frame: 4 years). 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 13 Oct 2022.