Endoscopic Retrograde Cholangiopancreatography In Patients Older Than 65Years Old With Obstructive Jaundice: Efficacy And Outcome
NCT ID: NCT06093048
Last Updated: 2023-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2023-11-30
2024-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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group A
patients with obstructive jaundice equal or older than 65 years old
Endoscopic retrograde cholangiopancreatography
saftey and outcome in patients older than 65 years old
group B
patients with obstructive jaundice younger than 65 years old
Endoscopic retrograde cholangiopancreatography
saftey and outcome in patients older than 65 years old
Interventions
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Endoscopic retrograde cholangiopancreatography
saftey and outcome in patients older than 65 years old
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients under 18 years old
18 Years
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Mohamed Ezzat Mahmoud
specialist of internal medicine sohag university hospital
Principal Investigators
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Mohamed E Mahmoud, Specialist
Role: STUDY_DIRECTOR
Sohag University
Mohamed E Mahmoud
Role: STUDY_DIRECTOR
Sohag University
Locations
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Sohag university Hospital
Sohag, , Egypt
Countries
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Central Contacts
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Hassan A Hassanein, professor
Role: CONTACT
Facility Contacts
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Magdy M Amin, professor
Role: primary
References
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Zhang ZM, Liu Z, Liu LM, Zhang C, Yu HW, Wan BJ, Deng H, Zhu MW, Liu ZX, Wei WP, Song MM, Zhao Y. Therapeutic experience of 289 elderly patients with biliary diseases. World J Gastroenterol. 2017 Apr 7;23(13):2424-2434. doi: 10.3748/wjg.v23.i13.2424.
Ukkonen M, Siiki A, Antila A, Tyrvainen T, Sand J, Laukkarinen J. Safety and Efficacy of Acute Endoscopic Retrograde Cholangiopancreatography in the Elderly. Dig Dis Sci. 2016 Nov;61(11):3302-3308. doi: 10.1007/s10620-016-4283-2. Epub 2016 Aug 26.
Perisetti A, Goyal H, Sharma N. Clinical safety and outcomes of glucagon use during endoscopic retrograde cholangiopancreatography (ERCP). Endosc Int Open. 2022 Apr 14;10(4):E558-E561. doi: 10.1055/a-1747-3242. eCollection 2022 Apr.
Holt BA. Increased severity of post-endoscopic retrograde cholangiopancreatography complications in the elderly: an issue to be addressed. Dig Endosc. 2014 Jul;26(4):534-5. doi: 10.1111/den.12298. No abstract available.
Other Identifiers
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Soh-Med-23-10-07MD
Identifier Type: -
Identifier Source: org_study_id
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