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RecruitingNCT06456476JaundiceUpdated Jun 13, 2024

Patients With Obstructive Jaundice In Sohag University Hospital

An observational study in Obstructive Jaundice, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
130
Ages
18 Years and older
Sex
All
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Study 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 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

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Conditions studied

  • Obstructive Jaundice

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03

In context

Jaundice, Obstructive

62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.

This study's planned enrollment of 130 is close to the median of 125 across 20 observational studies indexed under Jaundice, Obstructive.

Browse Jaundice, Obstructive studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The patients, clinically diagnosed as suffering from obstructive jaundice and referred to the Department of Internal Medicine for further evaluation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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:

  • 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.
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
130 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • patints with obstructive jaundicep

    The patients, clinically diagnosed as suffering from obstructive jaundice and referred to the Department of Internal Medicine for further evaluation.

    Diagnostic Test: ERCP

Interventions

  • Diagnostic testERCP

    ERCP used only if needed in some patients

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What researchers measure

Primary outcomes

  1. Study Of Patients With Obstructive Jaundice In Sohag University Hospital

    rate of patients with obstructive jaundice admitted in sohag university hospital

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
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References and documents

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 27003146 ↗
  • Roche SP, Kobos R. Jaundice in the adult patient. Am Fam Physician. 2004 Jan 15;69(2):299-304. PubMed 14765767 ↗
  • 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. PubMed 18842499 ↗
  • 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. PubMed 12632482 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2024 (actual). Primary completion is estimated for Nov 2024, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2024
First posted
Jun 13, 2024
StartActual
May 20, 2024
Primary completionEst.
Nov 20, 2024
CompletionEst.
Nov 20, 2024
Last update
Jun 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06456476
Lead sponsor
Sohag University
Responsible party
Al Shaimaa Ibrahim Hamdy (principal investigator, Sohag University) — Principal investigator
First posted
Jun 13, 2024
Start date
May 20, 2024
Primary completion
Nov 20, 2024 (estimated)
Completion
Nov 20, 2024 (estimated)
Last update
Jun 13, 2024

Study contacts

Alshaimaa I Hamdy, resident
Contact
alshaimaa_ibrahim_post@med.sohag.edu.eg
01068032698 ext. 01145927708
Usama A Arafa, professor
Contact
0106364007 ext. 01113100102

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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