Obstructive JaundiceJaundiceNCT06456476
Patients With Obstructive Jaundice In Sohag University Hospital
An observational study of Obstructive Jaundice, run by Sohag University at 1 site in Egypt.
Trial summary
Study of patients with obstructive jaundice in Sohag university hospital study the clinical, laboratory and imaging charachteristics in patients with obstructive jaundice admitted to sohag university hospital, and to study the available therapeutic options which meight improve patient's quality of life and increase… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Jaundice
- What is being tested?
- ERCP
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2024to 20 Nov 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients, clinically diagnosed as suffering from obstructive jaundice and referred to the Department of Internal Medicine for further evaluation.
Who may be able to join
- The patients, clinically diagnosed as suffering from obstructive jaundice and referred to the Department of Internal Medicine for further evaluation.
Who cannot join
- Exclusion criteria were patients below 18 years of age; and patients with jaundice due to causes other than obstructive pathology like hemolytic or hepatocellular jaundice.
Trial locations and contacts
1 site in 1 country.
Alshaimaa I Hamdy, resident contact
Usama A Arafa, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Alshaimaa I Hamdy, resident, 01068032098 ext. 01145927708, alshaimaa_ibrahim_post@med.sohag.edu.eg
Usama A Arafa, professor, 01063064007 ext. 01113100102
About this study
Official title: Study Of Patients With Obstructive Jaundice In Sohag University Hospital
Study of patients with obstructive jaundice in Sohag university hospital study the clinical, laboratory and imaging charachteristics in patients with obstructive jaundice admitted to sohag university hospital, and to study the available therapeutic options which meight improve patient's quality of life and increase survival rates.
Read the detailed description
Jaundice is always a pathological sign on most occasions, so that it should never be ignored. It includes 3 types: haemolytic, hepatocellular and cholestatic (obstructive).
Cholestatic jaundice can be classified into two broad categories: intrahepatic and extrahepatic; Intrahepatic cholestatic jaundice is due to impaired hepatobiliary production and excretion of bile causing bile components to enter the circulation. The concentration of conjugated bilirubin in serum is elevated in cholestatic jaundice. Intrahepatic cholestasis may be due to primary biliary cirrhosis, hepatocellular disease such as acute viral hepatitis infection, drug-induced liver injury ,Dubin-Johnson syndrome, Rotor syndrome, or cholestatic disease of pregnancy. Wilson's disease may also lead to intrahepatic cholestasis due to copper deposition into liver parenchyma, with further hepatocellular dysfunction, and jaundice.1 Extrahepatic cholestasis may be the result of benign causes including choledocholithiasis (is the most frequent cause), primary sclerosing cholangitis, Mirrizi syndrome, postoperative billiary stricture, post inflammatory stricture, pancreatitis, choledochal cyst, pyogenic cholangitis, parasitic diseases, duodenal diverticulosis and AIDS cholangiopathy.2 While malignant causes include cancer head of pancreas, carcinoma of the gall bladder cholangiocarcinoma, carcinoma of the duodenum, ampullary tumors, hepatocellular carcinoma, lymphoma and metastatic tumors.3 Today's obstructive jaundice is more of a medical entity since gastroenterologists, rather than surgeons, handle the majority of obstructive jaundice cases with ERCP or stenting.4 Obstructive jaundice patients typically complain of jaundice, yellowish discoloration of skin and eyes, pruritus, clay colored stool, dark-colored urine and aneroxia.5 Jaundice in choledocholithiasis is intermittent and associated with pain.6-7 Malignant jaundice commonly presents with persistent and progressive painless jaundice, often accompanied by weight loss, anemia, and abdominal mass.6-8 Patients with obstructive jaundice are susceptible to developing deficiencies in nutrition, infectious complications , acute renal failure, and compromised cardiovascular function. Other adverse events , like endotoxemia, hypovolemia, and coagulopathy, can be subtle and dramatically raise mortality and morbidity.9 A combination of many approaches, such as the patient's history, physical examination, biochemical tests, and imaging are needed. Abdominal ultrasonography, the first-line imaging modality used for the diagnosis of obstructive jaundice because it is noninvasive, fast and widely accessible.10 However, it is necessary to combine ultrasonography with other imaging techniques such as; computed tomography (CT), endoscopic ultrasonography (EUS) or magnetic resonance cholangiography (MRCP) to establish local and distant complications and make a choice of the right therapeutic approach.11 also liver biopsy, as well as observation of patient's course, can lead to an accurate diagnosis.
Early and precise detection of etiology of obstructive jaundice can help to manage such patients and thus will enhance the patient's quality of life and increase the survival rate of patients with malignant pathology.12
- Conditions
- Obstructive Jaundice
- Being tested
- ERCP
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPDiagnostic test
ERCP used only if needed in some patients
| Study group | Role | What they receive |
|---|---|---|
| patints with obstructive jaundicep | The patients, clinically diagnosed as suffering from obstructive jaundice and referred to the Department of Internal Medicine for further evaluation. Receives: Diagnostic Test: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Of Patients With Obstructive Jaundice In Sohag University Hospital
rate of patients with obstructive jaundice admitted in sohag university hospital
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start20 May 2024
- Primary completion20 Nov 2024 (estimated)
- Study completion20 Nov 2024 (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 Obstructive JaundiceStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaimaa Ibrahim Hamdy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456476
- Sponsor's protocol ID
- Soh-Med-24-04-03MS
- Acronym
- Jaundice
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
deLemos AS, Ghabril M, Rockey DC, Gu J, Barnhart HX, Fontana RJ, Kleiner DE, Bonkovsky HL; Drug-Induced Liver Injury Network (DILIN). Amoxicillin-Clavulanate-Induced Liver Injury. Dig Dis Sci. 2016 Aug;61(8):2406-2416. doi: 10.1007/s10620-016-4121-6. Epub 2016 Mar 22.
PubMed 27003146Roche SP, Kobos R. Jaundice in the adult patient. Am Fam Physician. 2004 Jan 15;69(2):299-304.
PubMed 14765767Moghimi M, Marashi SA, Salehian MT, Sheikhvatan M. Obstructive jaundice in Iran: factors affecting early outcome. Hepatobiliary Pancreat Dis Int. 2008 Oct;7(5):515-9.
PubMed 18842499Qin LX, Tang ZY. Hepatocellular carcinoma with obstructive jaundice: diagnosis, treatment and prognosis. World J Gastroenterol. 2003 Mar;9(3):385-91. doi: 10.3748/wjg.v9.i3.385.
PubMed 12632482
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of Patients With Obstructive Jaundice In Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06456476
- Acronym / sponsor ID
- Jaundice / Soh-Med-24-04-03MS
- Conditions
- Obstructive Jaundice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 13 Jun 2024 (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.
Study of patients with obstructive jaundice in Sohag university hospital study the clinical, laboratory and imaging charachteristics in patients with obstructive jaundice admitted to sohag university hospital, and to study the available therapeutic options which meight improve patient's quality of life and increase survival rates.
Detailed description
Jaundice is always a pathological sign on most occasions, so that it should never be ignored. It includes 3 types: haemolytic, hepatocellular and cholestatic (obstructive).
Cholestatic jaundice can be classified into two broad categories: intrahepatic and extrahepatic; Intrahepatic cholestatic jaundice is due to impaired hepatobiliary production and excretion of bile causing bile components to enter the circulation. The concentration of conjugated bilirubin in serum is elevated in cholestatic jaundice. Intrahepatic cholestasis may be due to primary biliary cirrhosis, hepatocellular disease such as acute viral hepatitis infection, drug-induced liver injury ,Dubin-Johnson syndrome, Rotor syndrome, or cholestatic disease of pregnancy. Wilson's disease may also lead to intrahepatic cholestasis due to copper deposition into liver parenchyma, with further hepatocellular dysfunction, and jaundice.1 Extrahepatic cholestasis may be the result of benign causes including choledocholithiasis (is the most frequent cause), primary sclerosing cholangitis, Mirrizi syndrome, postoperative billiary stricture, post inflammatory stricture, pancreatitis, choledochal cyst, pyogenic cholangitis, parasitic diseases, duodenal diverticulosis and AIDS cholangiopathy.2 While malignant causes include cancer head of pancreas, carcinoma of the gall bladder cholangiocarcinoma, carcinoma of the duodenum, ampullary tumors, hepatocellular carcinoma, lymphoma and metastatic tumors.3 Today's obstructive jaundice is more of a medical entity since gastroenterologists, rather than surgeons, handle the majority of obstructive jaundice cases with ERCP or stenting.4 Obstructive jaundice patients typically complain of jaundice, yellowish discoloration of skin and eyes, pruritus, clay colored stool, dark-colored urine and aneroxia.5 Jaundice in choledocholithiasis is intermittent and associated with pain.6-7 Malignant jaundice commonly presents with persistent and progressive painless jaundice, often accompanied by weight loss, anemia, and abdominal mass.6-8 Patients with obstructive jaundice are susceptible to developing deficiencies in nutrition, infectious complications , acute renal failure, and compromised cardiovascular function. Other adverse events , like endotoxemia, hypovolemia, and coagulopathy, can be subtle and dramatically raise mortality and morbidity.9 A combination of many approaches, such as the patient's history, physical examination, biochemical tests, and imaging are needed. Abdominal ultrasonography, the first-line imaging modality used for the diagnosis of obstructive jaundice because it is noninvasive, fast and widely accessible.10 However, it is necessary to combine ultrasonography with other imaging techniques such as; computed tomography (CT), endoscopic ultrasonography (EUS) or magnetic resonance cholangiography (MRCP) to establish local and distant complications and make a choice of the right therapeutic approach.11 also liver biopsy, as well as observation of patient's course, can lead to an accurate diagnosis.
Early and precise detection of etiology of obstructive jaundice can help to manage such patients and thus will enhance the patient's quality of life and increase the survival rate of patients with malignant pathology.12
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patints with obstructive jaundicep | – | Diagnostic Test: ERCPThe patients, clinically diagnosed as suffering from obstructive jaundice and referred to the Department of Internal Medicine for further evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients, clinically diagnosed as suffering from obstructive jaundice and referred to the Department of Internal Medicine for further evaluation.
Key inclusion criteria (1 listed)
- The patients, clinically diagnosed as suffering from obstructive jaundice and referred to the Department of Internal Medicine for further evaluation.
Key exclusion criteria (1 listed)
- Exclusion criteria were patients below 18 years of age; and patients with jaundice due to causes other than obstructive pathology like hemolytic or hepatocellular jaundice.
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 |
|---|---|---|
| ERCPERCP used only if needed in some patients | Diagnostic test | patints with obstructive jaundicep |
Primary outcome
Study Of Patients With Obstructive Jaundice In Sohag University Hospital
Time frame: 6 months
rate of patients with obstructive jaundice admitted in sohag university hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 27003146deLemos AS, Ghabril M, Rockey DC, Gu J, Barnhart HX, Fontana RJ, Kleiner DE, Bonkovsky HL; Drug-Induced Liver Injury Network (DILIN). Amoxicillin-Clavulanate-Induced Liver Injury. Dig Dis Sci. 2016 Aug;61(8):2406-2416. doi: 10.1007/s10620-016-4121-6. Epub 2016 Mar 22.
- Background: PubMed 14765767Roche SP, Kobos R. Jaundice in the adult patient. Am Fam Physician. 2004 Jan 15;69(2):299-304.
- Background: PubMed 18842499Moghimi M, Marashi SA, Salehian MT, Sheikhvatan M. Obstructive jaundice in Iran: factors affecting early outcome. Hepatobiliary Pancreat Dis Int. 2008 Oct;7(5):515-9.
- Background: PubMed 12632482Qin LX, Tang ZY. Hepatocellular carcinoma with obstructive jaundice: diagnosis, treatment and prognosis. World J Gastroenterol. 2003 Mar;9(3):385-91. doi: 10.3748/wjg.v9.i3.385.
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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.
Alshaimaa I Hamdy, resident contact
Usama A Arafa, professor contact
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 Obstructive Jaundice, run by Sohag University 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 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 13 Jun 2024. 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.
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 Alshaimaa I Hamdy, resident (01068032698 ext. 01145927708, alshaimaa_ibrahim_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Of Patients With Obstructive Jaundice In Sohag University Hospital (time frame: 6 months). 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 NCT06456476, 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 13 Jun 2024.