Endoscopic Retrograde Cholangiopancreatography In Patients Older Than 65Years Old With Obstructive Jaundice: Efficacy And Outcome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Endoscopic Retrograde Cholangiopancreatography In Patients Older Than 65Years Old With Obstructive Jaundice: Efficacy And Outcome

Conditions
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Obstructive Jaundice

Intervention / Treatment
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* Procedure: Endoscopic retrograde cholangiopancreatography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with obstructive jaundice older than 18 years old Exclusion Criteria: patients who refuse consent patients under 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>patients with obstructive jaundice equal or older than 65 years old | Procedure: Endoscopic retrograde cholangiopancreatography<br>* saftey and outcome in patients older than 65 years old<br>|
| Active Comparator: group B<br>patients with obstructive jaundice younger than 65 years old | Procedure: Endoscopic retrograde cholangiopancreatography<br>* saftey and outcome in patients older than 65 years old<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatitis | serum amylase and lipase using Mann Whitney test | 12 months | 
| Cholangitis | Temperature chart and serum bilirubin using Chi-square test | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | procedure time and frequency of a second ERCP for complete success. | 12 months |