- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06456476
Patients With Obstructive Jaundice In Sohag University Hospital (Jaundice)
Study Of Patients With Obstructive Jaundice In Sohag University Hospital
Study Overview
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alshaimaa I Hamdy, resident
- Phone Number: 01145927708 01068032698
- Email: alshaimaa_ibrahim_post@med.sohag.edu.eg
Study Contact Backup
- Name: Usama A Arafa, professor
- Phone Number: 01113100102 0106364007
Study Locations
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-
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Sohag, Egypt
- Recruiting
- Sohag University Hospital
-
Contact:
- Alshaimaa I Hamdy, resident
- Phone Number: 01145927708 01068032098
- Email: alshaimaa_ibrahim_post@med.sohag.edu.eg
-
Contact:
- Usama A Arafa, professor
- Phone Number: 01113100102 01063064007
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The patients, clinically diagnosed as suffering from obstructive jaundice and referred to the Department of Internal Medicine for further evaluation.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patints with obstructive jaundicep
The patients, clinically diagnosed as suffering from obstructive jaundice and referred to the Department of Internal Medicine for further evaluation.
|
ERCP used only if needed in some patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Qin 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.
- 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.
- Roche SP, Kobos R. Jaundice in the adult patient. Am Fam Physician. 2004 Jan 15;69(2):299-304.
- Moghimi 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-24-04-03MS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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