An interventional study of Endoscopic retrograde cholangiopancreatography in Obstructive Jaundice, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-31.
Sponsored by Sohag University · Not applicable, Interventional, and Screening
The incidence of pancreato-biliary disorders ,including malignancy, is increasing in elderly patients. Endoscopic retrograde cholangiopancreatography (ERCP) is a well-known therapeutic tool for these pancreato-biliary disorders.
In general, old age is defined as being more than 65 years of age by the World Health Organization. The increase in the domestic aged population is related to the increasing demand for therapeutic ERCP in elderly patients with pancreato-biliary disorders. Common bile duct stones and cancer account for70 % of all jaundice cases in patients over the age of 65 years . This is related to increasing prevalences of cholelithiasis, choledocholithiasis, and malignancy with advancing age .
Endoscopic Retrograde Cholangiopancreatography(ERCP) represents the gold standard technique for the treatment of biliary or pancreatic tract pathology, and it could be often performed with therapeutic intent by realizing procedures such as insertion of bile duct stents and/or endoscopic sphincterotomy. However, evidence about its safety in the elderly is still controversial.
However, therapeutic ERCP is an invasive procedure and is associated with several complications, such as bleeding, pancreatitis, cholangitis, perforation, and mortality. A higher incidence of periprocedural complications might be expected in elderly patients because of the high prevalence of concomitant medical disorders, such as cardiopulmonary and cerebrovascular diseases, and the poor general condition of this population [8].
Despite many previous reports of the safety and efficacy of ERCP in elderly patients, in real clinical practice, there is concern regarding complications of ERCP performed in patients more than 65years old. Also comparative reports of the efficacy and safety of therapeutic ERCP, especially inpatients over 65 years of age, are limited. To investigate this issue, we will evaluate the clinical outcomes such as the technical success rate, procedure-related complications rate, and anesthesia-related adverse events rate of therapeutic ERCP in a older aged group (over than 65 years of age) and control group (less than 65 years of age) at a single tertiary center.
Aim of the work This study aims to evaluate the outcome and safety of ERCP in patients with obstructive jaundice over than 65 years of age.
62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.
This study's planned enrollment of 100 is above the median of 75 across 40 interventional studies indexed under Jaundice, Obstructive.
Browse Jaundice, Obstructive studies →Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
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Exclusion Criteria:
patients with obstructive jaundice equal or older than 65 years old
Procedure: Endoscopic retrograde cholangiopancreatography
patients with obstructive jaundice younger than 65 years old
Procedure: Endoscopic retrograde cholangiopancreatography
saftey and outcome in patients older than 65 years old
Pancreatitis
serum amylase and lipase using Mann Whitney test
Time frame: 12 months
Cholangitis
Temperature chart and serum bilirubin using Chi-square test
Time frame: 12 months
Technical success rate
procedure time and frequency of a second ERCP for complete success.
Time frame: 12 months
Start is estimated for Nov 2023; primary completion for Oct 2024, 11 months later.
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This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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